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Directive 98/8/EC concerning the placing biocidal products on the market

Inclusion of active substances in Annex I to Directive 98/8/EC

Draft Assessment Report

Didecyldimethylammonium chloride Product-type PT 8

(Wood preservative)

Draft July 2007

Annex I – Italy

Company Name The Activa / Pelgar BQ-25 and Difenacoum Task Force

Name of A.S. BQ-25 Month/Year: June 2005

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Lonza GmbH; Stepan Europe; McKenna Long & Aldridge

Rapporteur Member State: Italy

Didecyldimethylammonium Chloride July 2007

Didecyldimethylammonium Chloride

Assessment report

Finalised in the Standing Committee on Biocidal Products at its meeting on Error:Reference source not found in view of its inclusion in Annex I to Directive 98/8/EC

CONTENTS

1. STATEMENT OF SUBJECT MATTER AND PURPOSE..................................5

1.1. Procedure followed.......................................................................................5

1.2. Purpose of the assessment report.................................................................6

1.3. Overall conclusion in the context of Directive 98/8/EC...............................7

2. OVERALL SUMMARY AND CONCLUSIONS..................................................8

2.1. Identity, Physico-Chemical Properties, Intended Uses, Effectiveness and Classification and Labelling of the Active Substance...............................10

2.1.1. Identity, Physico-Chemical Properties & Analysis........................10

2.1.2. Intended Uses.................................................................................13

2.1.3. Effectiveness...................................................................................13

2.1.4. Classification and Labelling...........................................................14

2.2. Summary of the Risk Assessment..............................................................15

2.2.1. Impact on Animal and Human Health...........................................15

2.2.1.1 Hazard identification.......................................................................15

2.2.1.2 Effects assessment...........................................................................15

2.2.1.3 Exposure assessment.......................................................................16

2.2.1.4 Risk characterization.......................................................................18

2.2.2. Biocidal Product.............................................................................19

2.2.3. Summary and conclusion...............................................................19

2.2.4. Impact on the Environment............................................................20

3. PROPOSAL FOR THE DECISION....................................................................30

3.1. Background to the Proposed Decision.......................................................30

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3.2. Proposed Decision regarding Inclusion in Annex I...................................30

3.3. Factors to be taken into account by Member States when authorising products....................................................................................................... 30

3.4. Requirement for further information........................................................30

3.5. Recommended Measures............................................................................30

3.6. Updating this Assessment Report...............................................................30

Appendix I: Listing of end points........................................................................31

Chapter 1: Identity, Physical and Chemical Properties, Details of Uses, Further Information, and Proposed Classification and Labelling........................................................................................31

Chapter 2: Methods of Analysis.......................................................33

Chapter 3: Impact on Human Health..............................................35

Absorption, distribution, metabolism and excretion in mammals (Annex IIA, point 6.2).................................................................................35

Chapter 4: Fate and Behaviour in the Environment......................40

Chapter 5: Effects on Non-target Species........................................42

Chapter 6: Other End Points...........................................................43

Appendix II: List of Uses Supported by Available Data.........................................44

Appendix III: List of Studies..................................................................................45

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1. STATEMENT OF SUBJECT MATTER AND PURPOSE

1.1. Procedure followed

This assessment report has been established as a result of the evaluation of Didecyldimethylammonium Chloride as product-type 8 (wood preservative), carried out in the context of the work programme for the review of existing active substances provided for in Article 16(2) of Directive 98/8/EC concerning the placing of biocidal products on the market 1, with a view to the possible inclusion of this substance into Annex I or IA to the Directive.

Didecyldimethylammonium Chloride (CAS no. 7173-51-5) was notified as an existing active substance, by Lonza GmbH, Stepan Europe, McKenna, Long & Aldridge LLC, hereafter referred to as the applicant, in product-type 8.

Commission Regulation (EC) No 2032/2003 of 4 November 20032 lays down the detailed rules for the evaluation of dossiers and for the decision-making process in order to include or not an existing active substance into Annex I or IA to the Directive.

In accordance with the provisions of Article 5(2) of that Regulation, Italy was designated as Rapporteur Member State to carry out the assessment on the basis of the dossier submitted by the applicant. The deadline for submission of a complete dossier for Didecyldimethylammonium Chloride as an active substance in Product Type 8 was 28th March 2004, in accordance with Annex V of Regulation (EC) No 2032/2003.

On 28th March 2004, the Italian Competent Authority received a dossier from the applicant. The Rapporteur Member State accepted the dossier as complete for the purpose of the evaluation on 28th September 2004.

On 27th June 2005 the time period was suspended and the evaluation taken up again on 27 th

March 2006 after the applicant has submitted the necessary data. After that, the evaluation phase was suspended again on the 17th July 2006 and taken up on 18th July 2007.

On [date], the Rapporteur Member State submitted, in accordance with the provisions of Article 10(5) and (7) of Regulation (EC) No 2032/2003, to the Commission and the applicant a copy of the evaluation report, hereafter referred to as the competent authority report. The Commission made the report available to all Member States by electronic means on [date]. The competent

1 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing biocidal products on the market. OJ L 123, 24.4.98, p.1

2 Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market and amending Regulation (EC) No 1896/2000. OJ L 307, 24.11.2003, p. 1

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authority report included a recommendation for the inclusion of Didecyldimethylammonium Chloride in Annex I to the Directive for PT 8.

In accordance with Article 12 of Regulation (EC) No 2032/2003, the Commission made the competent authority report publicly available by electronic means on [date]. This report did not include such information that was to be treated as confidential in accordance with Article 19 of Directive 98/8/EC.

In order to review the competent authority report and the comments received on it, consultations of technical experts from all Member States (peer review) were organised by the Commission. Revisions agreed upon were presented at technical and competent authority meetings and the competent authority report was amended accordingly.

On the basis of the final competent authority report, the Commission proposed the inclusion of Didecyldimethylammonium Chloride in Annex I to Directive 98/8/EC and consulted the Standing Committee on Biocidal Product on date.

In accordance with Article 11(4) of Regulation (EC) No 2032/2003, the present assessment report contains the conclusions of the Standing Committee on Biocidal Products, as finalised during its meeting held on date.

1.2. Purpose of the assessment report

This assessment report has been developed and finalised in support of the decision to include Didecyldimethylammonium Chloride in AnnexI to Directive 98/8/EC for product-type 8. The aim of the assessment report is to facilitate the authorisation in Member States of individual biocidal products in product-type 8 that contain Didecyldimethylammonium Chloride. In their evaluation, Member States shall apply the provisions of Directive 98/8/EC, in particular the provisions of Article 5 as well as the common principles laid down in Annex VI.

For the implementation of the common principles of Annex VI, the content and conclusions of this assessment report, which is available at the Commission website3, shall be taken into account.

However, where conclusions of this assessment report are based on data protected under the provisions of Directive 98/8/EC, such conclusions may not be used to the benefit of another applicant, unless access to these data has been granted.

3 http://ec.europa.eu/comm/environment/biocides/index.htm

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http://ec.europa.eu/comm/environment/biocides/index.htm




1.3. Overall conclusion in the context of Directive 98/8/EC

The overall conclusion from the evaluation is that it may be expected that there are products containing Didecyldimethylammonium Chloride for the product-type 8, which will fulfil the requirements laid down in Article 10(1) and (2) of Directive 98/8/EC. This conclusion is however subject to:

i. compliance with the particular requirements in the following sections of this assessment report,

ii. the implementation of the provisions of Article 5(1) of Directive 98/8/EC, and

iii. the common principles laid down in Annex VI to Directive 98/8/EC.

Furthermore, these conclusions were reached within the framework of the uses that were proposed and supported by the applicant (see Appendix II). Extension of the use pattern beyond those described will require an evaluation at product authorisation level in order to establish whether the proposed extensions of use will satisfy the requirements of Article 5(1) and of the common principles laid down in Annex VI to Directive 98/8/EC.

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July 2007

2. OVERALL SUMMARY AND CONCLUSIONS

Participant and manufacters of the active substance and the product

Applicant:

1) Lonza GmbH

Morianstrasse 32

DE-042041 Wuppertal

Germany

Tel: 00 49 202 245 38 0

Fax: 00 49 202 245 38 30

Email: [email protected]

2) Stepan Europe

Chemin Jongkind BP 127

38340 Voreppei

France

Tel: 0033 4 76505100

Fax: 0033 4 76505110


3) McKenna, Long & Aldridge LLC

56, Rue des Colonies, Box 14

B-1000 Brussels

Belgium

Tel: (32-2) 278-1211

Fax: (32-2) 278-1200


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mailto:[email protected]






July 2007

Manufacturer of the active substance:

Clariant GmbH (toll manufacturer for Lonza GmbH)

Werk Gendorf

DE-084504 Burgkirchen

Germany

Phone: 0049 867970

Fax: 0049 86794545

Cromogenia-Units S.A. (toll manufacturer for Lonza GmbH)

Faarell, 9

08014 Barcelona

Spain

Phone: +93 431 7700

Fax: +93 422 6014

Stepan Company

Chemin Jongkind BP 127

38340 Voreppe

France

Phone: 00334 76505100

Fax: 00334 76505110

Mason Chemical Company

721 W. Algonquin Road

IL 60005 Arlington Heights

USA

Phone: 001847 2901621

Fax: 001847 2901625

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July 2007

2.1. Identity, Physico-Chemical Properties, Intended Uses, Effectiveness and Classification and Labelling of the Active Substance

2.1.1. Identity, Physico-Chemical Properties & Analysis

Identification of the active substance

CAS No. 7173-51-5

EINECS No. 230-525-2Other substance No.: None assignedIUPAC Name N,N-Didecyl-N, N-dimethylammonium ChlorideCommon name, synonyms DDAC,Didecyldimethylammonium ChlorideChemical name (CA) 1-Decanaminium, N-decyl-N,N-dimethyl-, chlorideMolecular formula C22H48NClStructural formula

N+

R Cl-

R

R = C10H21Molecular weight (g/mol) 362.1

Purity 87.0-99.5% w/wImpurities See Confidential DataDidecyldimethylammonium Chloride does not contain additives or impurities that would be of toxicological or environmental concern.

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July 2007

Identification of the representative product

Trade name BC-25Manufacturers development code number Not assignedActive substance Didecyldimethylammonium ChlorideContent of the active substance 25%Function Fungicide, insecticidePhysical state of preparation LiquidNature of preparation SolutionThe product is a solution of active substance (25%) in water (75%) and does not contain substance of concern.

Physico-chemical properties

The active substance Didecyldimethylammonium Chloride is a light-coloured solid with melting point between 188 and 205°C. The substance is thermally stable and decompose before boiling. Decomposition was observed at approximately 280°C. Its relative density was determined to be 0.902 at 20 °C.

Its vapour pressure was calculated to be 5.9E-06 Pa at 20°C, 1.1E-05 at 25°C and 2.3E-04 at 50°C with a Henry’s Law constant of 4.27E-09 Pa m3 mol –1at 20°C.

The Didecyldimethylammonium Chloride is very highly soluble in water (water solubility at 20°C is 500000 mg/L at pH 2.2 and at pH 9.2). Furthermore, it is readily soluble in Acetone (>600000 mg/l at 20°C), Methanol (>600000 mg/l at 20°C) and Octanol (>250000 mg/l at 20°C).

The partition coefficient n-octanol/water is not determinable since DDAC is a surfactant in the octanol/water system, thus preventing the use of the shake-flask method. Estimation by the HPLC Method is not valid either, due to the absence of suitable calibration compounds and since ionic compounds interact with the HPLC column by forces other than partitioning.

Didecyldimethylammonium Chloride does not exhibit hazardous physical-chemical properties. The substance is thermally stable and does not show explosive or oxidising properties. DDAC is not classified as flammable, but has a self-ignition temperature of 195°C. It has a low vapour pressure and it is highly soluble in water. There is no risk to be expected due to the physical-chemical properties of the product, either.

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July 2007

Analytical methods

As for the analysis of active substance as manufacture, both studies summarised in Doc. IIIA Section 4.1 (1) and (2) were not compliant with Technical Notes for Guidance requirements and, thus, were not considered acceptable. Hence, fully validated analytical methods for the active substance as well as for relevant and/or significant impurities are required. The notifier has been requested to perform the analytical method before the completion of the present CAR.

A new analytical method (“Kurz M. and Ranft V. (2007) “Determination of quaternary ammonium compounds and related quaternary impurities by HPLC-ELSD”, Section 4.1(3) Doc.IIIA) was submitted at the mid-july 2007. The method has not been deemed acceptable, due to the deficiencies/mistakes affecting the validation work and the original study report. Hence, the developed method must be fully-validated for DDAC (including impurities > 0.1% w/w) in compliance with SANCO/3030/99 rev.4 11/07/00.

As regards the analysis of DDAC residues, LC-MS methods have been used in soil and water with a LOQ of 0.01 mg/kg and 0.1 g/l, respectively. These methods are sufficiently specific, linear and precise and, therefore, have been considered acceptable.

Justifications for non-submission of analytical methods for DDAC residues in air, foodstuffs and human body fluids/tissue were considered acceptable.

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July 2007

2.1.2. Intended Uses

Didecyldimethylammonium Chloride (DDAC) is a wood preservative used for preventive protection of wood and constructional timbers in Hazard Classes 1 to 4A against wood destroying organisms and wood discolouring moulds and fungi.

2.1.3. Effectiveness

It has properties similar to the benzyl QUATS but with Organic Soil and Hard Water Tolerance.

DDAC is a cationic surfactant type active substance. Due to its interaction with phospholipid-bilayer structures, it severely alters the cell wall permeability, disturbs membrane-bound ion-translocation mechanisms, and may facilitate the uptake of other biocides.

The use concentration depends on the type of application technique, use class required and on additional formulation components. Against fungi, there exists a selective activity spectrum.

The biocidal product (BC-25 ) contains 25% DDAC in water. It is a wood preservative with preventive efficacy against wood-destroying fungi (basidiomycetes) and insects and against soft rot fungi. It is used in drenching/dipping and vacuum pressure process applications. In practice it is always used in formulations in combination with other active substances.

The degree of dilution will vary depending on the wood species, type of wood product and anticipated use. The requirements for the final concentration of Didecyldimethylammonium Chloride vary between 0.3% and 1.8%. The application rate of DDAC in wood is 1.8 kg/m3.

Number and timing of applications depends on application technique, wood species, moisture and hazard class. An uptake of approximately 1.8 kg/m3 should be achieved by these application methods in order to ensure the protection level for the different use classes required.

Since after approx. 40 years of use worldwide no reports of selective acquisition of DDAC-resistance in the field of wood protection exists the risk of development of resistance to is considered negligible. This thesis of the applicant , although reasonable ( also because the use of the product not as a stand alone product but in combination with other inhibiting/fungicide products) is however not supported by any scientific publication or laboratory ad hoc demonstration. Some more information , also in other similar fields where QUATS are used , would be needed.

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July 2007

2.1.4. Classification and Labelling

The proposed ClassificationClassification as in Directive 67/548/EECClass of danger Xn triggered by R22

C triggered by R34N triggered by R50

R phrases R22 Harmful if swallowedR34 Causes burnsR50 Very toxic to aquatic organisms

S phrases S1/2 Keep locked up and out of reach of children.S26 In case of contact with eyes, rinse immediately with plenty of water and seek medical adviceS28 After contact with skin, wash immediately with plenty of…S36/37/39 Wear suitable protective clothing, gloves and eye/face protectionS45 In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible)S60 This material and its container must be disposed of as hazardous waste.S61 Avoid release into the environment. Refer to special instructions/safety data sheets.

Specific concentration limits for the environmental classification

Cn ≥ 2.5 %: N; R50

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July 2007

2.2. Summary of the Risk Assessment

2.2.1. Impact on Animal and Human Health

2.2.1.1 Hazard identification

DDAC is highly ionic and, therefore, it is expected not to be readily absorbed from the gastrointestinal tract or skin. The majority (>90% ) of orally administered DDAC is excreted very likely unabsorbed via the faeces. Based on data on urine ecretion (<3%) and tissue residues (<1%), and on the highly ionic nature of the a.s., it is expected that its oral absorption is limited (<10%). The majority of DDAC metabolism is expected to be carried out by intestinal flora giving rise to hydroxylation products in the alkyl chain.

About 0.1% of a DDAC dose delivered as aqueous solution fully penetrated human skin in vitro in 24 h; mean total DDAC absorbed was 9.41%, including the radioactivity present in the epidermis at the dose site.

The lowest determined oral LD50 for DDAC is 238 mg/kg. No clinical signs or mortality were observed until a dosage or a concentration is attained that causes irritation of the gut mucosa or affects the gastrointestinal flora. The rabbit acute dermal LD50 of DDAC is 3342 mg/kg. Inhalation of DDAC is not considered a potential route of exposure based on use patterns and vapour pressure 2.3E-04 Pa at 50ºC. DDAC is corrosive to the skin and eye, but not a skin sensitiser.

2.2.1.3 Medical data

No medical reports on the manufacturing personnel have been submitted.

2.2.1.2 Effects assessment

As with acute exposure, DDAC repeated intake results in death in rodents at a concentration that affects the gastrointestinal mucosa or microflora. The subchronic oral NOELs were 107-134 mg/kg/day in mice and 61-74 mg/kg/day in rats. In a 1-year feeding study in dogs with DDAC, the two highest doses (10 and 20 mg/kg/day) resulted in g.i.-related complications including emesis and abnormal faeces, resulting in death of 2 out of 4 animal at 20 mg/kg/day. The NOEL was determined to be 3 mg/kg/day based on severe clinical signs observed at the higher dose. The NOELs for non neoplastic effects after chronic administration were 32-41 mg/kg/day for rats and 76 – 93 mg/kg/day for mice. In a 90-day subchronic dermal study, no effects were seen at the highest dose that could be applied without excessive skin irritation.

Didecyldimethylammonium Chloride (DDAC) displayed no genotoxic activity in the three mutagenicity tests required for the authorisation of Biocidal Products: in-vitro gene mutation assay in S. typhimurium (Ames test), in vitro chromosomal aberrations assay in CHO cells and CHO/HGPRT forward mutation assay. Moreover, no clastogenic activity was observed in chromosomal aberration test in rat bone marrow in vivo. Therefore DDAC can be considered not genotoxic.

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July 2007

Didecyldimethylammonium Chloride is carcinogenic and does not affect reproduction or development at doses that are not toxic to the mother. No evidence of neurotoxicity was observed in any of the acute, subchronic or chronic studies.

2.2.1.4 Exposure assessment

The biocidal product containing the active substance is used in two wood preservative treatment applications: dipping and vacuum pressure processes. For both processes, the preservative is delivered to the processing plant by tanker in the form of a concentrate. The concentrate contains 25% of the active substance Didecyldimethylammonium Chloride. It is diluted down to a suitable working strength with water. The degree of dilution varies depending on the wood species, type of wood product and anticipated use. Didecyldimethylammonium Chloride concentrations in both processes vary between 0.3% and 1.8%.

Furthermore, the use classes 1 to 4A are envisaged for the Didecyldimethylammonium Chloride containing wood preservative product.

Professional exposure

There are four main strata of workers that may potentially be exposed to the wood preservative in the process plant: workers that handle wet treated lumber, workers that handle treated wood after drying, maintenance workers of equipment, forklift operators.

Professional exposure from the use processes has been estimated using EASE model (within the EUSES model) subdividing the wood treatment process into 8 different patterns of use to reflect a broad range of exposure possibilities. The model predicts potential exposure assuming that no PPE is employed. In reality, PPE will be worn, hence the exposure estimates obtained are overestimates.

As a worst case scenario, all calculations are based on the wood treatment solution employed containing 1.8% a.s. The neat concentrate of the substance (containing 25% a.s.) is only handled under closed conditions and so is modelled under Use Pattern 1.

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July 2007

In the following table EASE Model Predictions for Hands-Only Exposure to Didecyldimethylammonium Chloride in Wood Preservation are reported

Use Scenario

Dermal Exposure Inhalation Exposure Estimated total uptake(mg/kg/d)(worst case)

dermal weight of a.s. on the skin of workersmg/cm2/d

potential dermal uptake for workers*mg/kg/d

vapour concentration in air for workersppm

vapour concentration in air for workers*mg/m3

potential inhalatory uptake for workers**mg/kg/d

1 0 0 0-0.1 0-0.378 0-0.054 0.0542 0 0 0-0.1 0-0.0272 0-0.00389 0.003893 0 0 0-0.1 0-0.0272 0-0.00389 0.003894 0 0 0-0.1 0-0.0272 0-0.00389 0.003895 0-0.1 0-2.16E-03 0-0.1 0-0.0272 0-0.00389 0.006056 0.1-1 2.16E-03 –

2.16E-020-0.1 0-0.0272 0-0.00389 0.02549

7 1-5 2.16E-02 – 0.108

0-0.1 0-0.0272 0-0.00389 0.11189

8 1-5 2.16E-02 – 0.108

0-0.1 0-0.0272 0-0.00389 0.11189

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July 2007

Non-professional exposure (Consumers)

Consumers are not involved in the application (wood treatment) stage. Consumer exposure is restricted to handling of treated lumber in operations such as erecting fences. Consumers are not involved in the application stage. The level of exposure is considered to be comparable to (or less than) occupation exposure to workers that handle treated wood after it is dry.

Indirect exposure as a result of use of the active substance in biocidal product

Indirect exposure through the environment has been calculated using EUSES model for Use Patterns 1 to 4

The following local total daily uptake for humans are calculated:

Use pattern 1 Dipping application: 1.57E-04 mg/kg/d

Use pattern 2 Storage of dipping/immersed wood: 9.76E-05 mg/kg/d

Use pattern 3 Vacuum pressure application: 3.76E-03 mg/kg/d

Use pattern 4 Storage of Vacuum pressure treated wood: 1.40E-03 mg/kg/d

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July 2007

2.2.1.5 Risk characterization

AOEL (Acceptable operator exposure level)

The lowest NOAEL in a repeated does study is the one of 3 mg/kg b.w/day derived from the 52 weeks study on dogs. This value is then used in deriving the AOEL. An assessment factor of 3.5 is used for interspecies variability and an assessment factor of 5 for taking into account intraspecies variability. The AOEL value corresponds to 0.17 mg/kg/day

Exposure and risk from use of the productNo risks for workers are predicted. This is evident comparing the AOEL with workers exposure values as shown in the table below. Negligible exposure is predicted for consumers and man via the environment.

Use scenarioEstimated total uptake(mg/kg/d)(worst case)

MOE for workers, total uptake (dermal+inhalation)AOEL/body dose (AOEL = 0.17 mg/kg/d)

% of the AOEL

(AOEL = 0.17 mg/kg/d)

1 0.054 3,0 31,82 0.00389 44 2,293 0.00389 44 2,294 0.00389 44 2,295 0.00605 28 3,566 0.02549 6,7 15,07 0.11189 1,5 65,88 0.11189 1,5 65,8

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July 2007

Indirect exposure as a result of useMOS value are calculated by the ratio of the NOAEL of 3 mg/kg/d derived from the 52 weeks oral study in dogs (see section 1.2.2.1) and the total daily uptake for humans (see section 3.2.4 – Doc. II B).

Use Pattern (as designated in the EUSES model) MOS local, total exposure via all media

1 Dipping application 1.91E+042 Storage of dipping/immersed wood 3.07E+043 Vacuum pressure application 7.98E+024 Storage of Vacuum pressure treated wood 2.14E+03All use patterns have MOS values > 100.

A MOS reference values of 100 for the general population indirectly exposed (AF= 10 x 10) has been derived.

Combined exposure

Combined exposure to Didecyldimethylammonium Chloride used in a wood preservative product is not expected to occur, since only industrial use is envisaged. Theoretically, a combined exposure scenario is possible when an operator, after the working day, inhales the volatile residues indoors at home. However, due to the low vapour pressure of the active substance, this latter exposure can be considered as negligible. For this reason combined exposure has not been quantitatively evaluated in this dossier.

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July 2007

2.2.2. Biocidal Product

An in vitro dermal absorption study showed that less than 0.1% DDAC fully penetrate human skin in 24 h; considering also epidermis and dermis material at the dose site, receptor fluid and rinse receptor fluid, 9.41% of total absorption can be assumed.

An acute oral toxicity study has been performed on 5% aqueous dilutions of DDAC resulting in an LD50 = 238 mg/kg and leading to the classification Xn, R22 being applied . According to the provisions of directive 1999/45/EC, this product is also classified as Xn, R22 (trigger concentration is 25%).

An acute dermal toxicity study has been performed on an 80% solution of DDAC resulting in an LD50 = 3342 mg/kg. According to the provisions of directive 1999/45/EC this product is also not classified for dermal toxicity.

This product contains 25% DDAC in water and no other components. DDAC is not volatile as the vapour pressure is 2.3E-04 Pa at 50°C. Therefore there is no concern for inhalation exposure.

Skin and eye irritation studies have been performed on an 80% dilution of DDAC, which lead to the classification as corrosive, R34 being applied. According to the provisions of directive 1999/45/EC, this product is also classified as C, R34 (trigger concentration is 10%)

An aqueous dilution of DDAC, at a higher concentration than BC-25, did not show any senisitizing potential.

2.2.3. Summary and conclusion

Based on the toxicological and ecotoxicological properties, the active substance Didecyldimethylammonium Chloride is classified as harmful if swallowed, causes burns and very toxic to aquatic organisms. Furthermore, the active substance is thermally stable, not classified as flammable and does not show explosive or oxidising properties.Therefore, no risk is to be expected due to the physical-chemical properties both of the active substance and product.Furthermore, no risk is expected due to exposure to Didecyldimethylammonium Chloride during its use both for professional and non-professional users. In conclusion, risk for consumers and man indirectly exposed via the environment is not expected, as well.

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July 2007

2.2.4. Impact on the Environment

2.2.4.1. Fate and Distribution in the Environment

2.2.4.1.1. Biodegradation

Didecyldimethylammonium Chloride can be considered readily biodegradable

A study to measure biodegradation in seawater was not conducted as Didecyldimethylammonium Chloride used as a wood preservative will not be released to the marine environment in considerable amounts.

Didecyldimethylammonium Chloride biodegraded in aerobic conditions. At test termination (28 days), 93.3% of the radioactivity was evolved as 14CO2 , 1.32% was recovered in the extracts and 3.28% remained in the solid. In the abiotic sample 92.22% of the radioactivity was recovered in the extracts and 1.5% remained in the solid.

For consideration of anaerobic degradation, Didecyldimethylammonium Chloride is readily biodegradable, will be used in wood preservative products, and is being supported as a biocidal active substance under Product Type 8. It is considered that under this Product Type, exposure to anaerobic conditions is unlikely. Thus, it is considered that a water/sediment degradation study is not required.: However. a biodegradation study in two water/sediment systems has been performed and shoed that the substance easily migrates from the aqueous phase to the sediment phase and is also easily adsorbed to sediments (high Koc). The degradation in the sediment phase did not increase very much after the first month and the DT50 of the total system was not reached within the 120 days test duration

Due to the fact that Didecyldimethylammonium Chloride was readily biodegradable, field studies on accumulation in the sediment, aerobic degradation studies in soil, field soil dissipation and accumulation studies were not needed. However a biodegradation study in two water/sediment systems has been performed and shoed that the substance easily migrates from the aqueous phase to the sediment phase and is also easily adsorbed to sediments (high Koc). The degradation in the sediment phase did not increase very much after the first month and the DT50 of the total system was not reached within the 120 days test duration.

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July 2007

2.2.4.1.2. Abiotic Degradation

Didecyldimethylammonium Chloride was hydrolytically stable during the 30-day hydrolysis study at pH 5, 7 or 9 at 25°C.

Didecyldimethylammonium Chloride was found to be photolytically stable in the absence of a photosensitiser. An accurate estimate of the photolysis rate constants and the half-life for solutions containing no photosensitiser and all dark controls (both sensitised and nonsensitised) could not be determined since no significant degradation of the test substance was detected during the 30-day evaluation period The half life of the test compound was determined to be 227 days with 7% degradation after 30 days.

The test substance was stable and not subject to photodegradation on soil. Extractable residues decreased from 90.5% to 80.8% (exposed) and 81.1% (non-exposed). Soil bound residues increased from 9.48% to 25.2% (exposed) and 20.9% (non-exposed). 73.8 to 74% of activity was recovered in the extractable bound residues. Half-lives were calculated as t1/2 = 132 days (exposed) and t1/2 = 169 days (non-exposed). Rate constants were calculated as 5.26 E-03/days (exposed) and 4.11E-03/days (non-exposed).

2.2.4.1.3. Distribution

Didecyldimethylammonium Chloride can be classified as immobile in four soil/sediment types with the adsorption (Kd) and mobility (Koc) coefficients of Kd=1,095 and Koc=437,805 for sand, Kd=8,179 and Koc=908,757 for sandy loam, Kd=32,791 and Koc=1,599,564 for silty clay loam, and Kd=30,851 and Koc=1,469,081 for silt loam.

2.2.4.1.4. Mobility

The results of this study indicated that Didecyldimethylammonium Chloride had little or no potential for mobility in soil and should not pose an environmental risk for contamination of ground water. Therefore, mobility-lysimeter studies were not justified.

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July 2007

2.2.4.1.5. Bioaccumulation

Based on a measured BCFfish (81) it is considered that DDAC has a low potential for bioaccumulation.

No data are available on the BCFearthworm; calculation according to TGD (eq. 82d) is not applicable. Nevertheless, bioaccumulation in the terrestrial food chain would pose birds and mammals at risk of secondary poisoning in case of BCFsearthworm in excess of 2598 and 7241, respectively (see IIA, 4.1.3; IIB, 3.3.5; IIIA, 7.5.5.1). In conclusion, terrestrial bioaccumulation cannot be estimated with the data available; however the risk of secondary poisoning via the terrestrial food chain is unlikely.

2.2.4.2. Effects Assessment

2.2.4.2.1. Aquatic Compartment

The results of acute toxicity studies indicate that DDAC is very toxic to fish, daphnia and algae. The most sensitive group is algae (Selenastrum capricornutum 96 hours EbC50: 0.026 mg/l) whilst the less sensitive group is fish (fathead minnow 96 hours LC50: 0.195 mg/l under flow through conditions). DDAC is harmful to microbial activity in STP, being this inhibited at a concentration higher than any other aquatic group (3h respiration inhibition test EC50 of 11.0 mg/l).

The results of long term toxicity studies with DDAC indicates the substance is very toxic to fish and to the highest extent to daphnia.

In a test performed under flow-through conditions, the 34d LC0 was 0.032 mg/L for Zebra fish with no effect on hatching.

Daphnia magna was more sensitive than fish, with a 21d NOEC (survival) of 0.010 mg/L recorded under flow-through conditions.

2.2.4.2.2. Sediment

The hazard of DDAC to sediment dwelling organisms is based on 28 days test with Chironomus tentans in which the NOEC (survival) was 2085 mg/kg.

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July 2007

2.2.4.2.3. Terrestrial Compartment

The effect of DDAC on earthworms was assessed in an acute toxicity test with E. foetida. The 14-day LC50 was in excess of 1000 mg/kg dry soil, the NOEC was 1000 mg/kg dry soil.

No effect of DDAC on nitrite, nitrate, ammonium and carbon dioxide formation is observed at a concentration of 1000 mg/kg dry soil.

The EC50 for terrestrial plants is observed at 283 mg/kg dw (20 days growth test with mustard, mung bean and wheat).

The acute LD50 for birds is 229 mg/kg bw (northern bobwhite quail). The short term dietary LC50 for birds is > 5620 mg/kg (northern bobwhite quail and mallard).

DDAC is toxic to mammals with a NOEC value of 100 mg/kg in mice in a 18 months body weight gain test.

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July 2007

2.2.4.3. Environmental Exposure Assessment

2.2.4.3.1. Aquatic Compartment Exposure assessment

Local PEC

Worst-case

(OECD ESD)

Use pattern 1: Dipping application

PEClocalwater STP 0.0097 mg/l

PEClocalsed STP 337.4 mg/kgwwt

PECmicroorganism STP (homogeneous mixing) 0.329 mg/l

Use pattern 2: Storage of dipping/immersed wood

PEClocalwater run-off 7.4 10-5 mg/l

PEClocalsed run-off 2.6 mg/kgwwt

PECmicroorganism STP (homogeneous mixing) 0 mg/l

Use pattern 3: Vacuum pressure application

PEClocalwater STP 2.9 10-3 mg/l

PEClocalsed STP 100.9 mg/kgwwt

PECmicroorganism STP (homogeneous mixing) 0.099 mg/l

Use pattern 4: Storage of Vacuum pressure treted wood

PEClocalwater run-off 5.6 10-5 mg/l

PEClocalsed run-off 1.94 mg/kgwwt

PECmicroorganism STP (homogeneous mixing) 0 mg/l

Use pattern 5: Treated wood in service Noise barrier

PECmicroorganism STP (homogeneous mixing) 6.3 10-4 mg/l

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July 2007

For the Dipping application Scenario (OECD Emission Scenario Document, OECD ESD), the Applicant suggested to lower the value of volume of treated wood from 100 (OECD-ESD) to 10 m3/day. In their opinion, the OECD default value is based on information derived from a sapstain treatment facility in Canada, and therefore might be unrealistically high for Europe.

According to the Technical Bulletin from the WEI Wood Producers, in western Europe 6.5 million m3 of wood are treated annually. Sleepers, poles, roundwood, and garden timbers are not treated by dipping; dipping is primarily used for construction timber. Therefore, 44% of the 6.5 million m3 is construction wood or 2.8 million m3 per year. It is estimated that 65% of this construction wood is treated by dipping; or 1.8 million m3 per year.

It is estimated that there are approximately 4000 treatment plants in Europe; for example, Germany on its own has about 2000 dipping chests (mainly directly at the saw mills). Therefore, taking the total dipping volume across 4000 plants provides the following: 1.8 million m3 of wood per year treated with dipping process with all possible products (Cu-Azoles, ACQ (the only quat formulation used), Cu-HDO, etc.) gives 1.8 million m3 / 4000 plants = 450 m3 per plant per year.

In order to develop a “Worst Case Scenario”, it has been assumed that the largest plant treats 1350 m3/year (3X the average) and 33% of market is ACQ (this is very high for the overall market). Therefore, the largest plant treats a maximum of 445 m3/year with ACQ. Moreover, it has been assumed that treatment occurs 220 days/year. Thus, a maximum of 2.0 m3/day is treated with ACQ at any plant. The risk assessment used 5X this quantity (i.e. 10 m3/day) which is far in excess of the maximum treated.

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July 2007

In the following table has been reported the PECs calculated using the refinement values of 10 m3/day of wood treated volume.

Local PEC

Realistic Worst-case

(Wood trated volume = 10 m3/day))


PEClocalwater STP 9.7E-04 mg/lPEClocalsed STP 33.74 mg/kgPECmicroorganism STP (homogeneous mixing)

0.0369 mg/l

2.2.4.3.2. Terrestrial Compartment Exposure assessment

Local PEC

Use pattern2: Storage of dipping/immersed wood

PEClocalsoil agricultural 10.37 mg/kgPEClocalsoil, porew agricultural 3.5 10-4 mg/lUse pattern 4: Storage of Vacuum pressure treted wood

PEClocalsoil agricultural 10.37 mg/kgPEClocalsoil, porew agricultural 3.5 10-4 mg/lUse pattern 5: Treated wood in service Noise barrier

PEClocalsoil agricultural 0.32 mg/kgPEClocalsoil, porew agriculturalUse pattern 7: Treated wood in service House

PEClocalsoil agricultural 0.84 mg/kgUse pattern 8: Treated wood in service Transmission pole

PEClocalsoil agricultural 0.21 mg/kgUse pattern 9: Treated wood in service fence post

PEClocalsoil agricultural 0.06 mg/kg

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2.2.4.3.3. Atmospheric Compartment Exposure assessment

Local PEC


Annual average local PEC in air 3.98 10-5 mg/m3

Use pattern3: Vacuum pressure application:

Annual average local PEC in air 1.2 10 -5mg/m3

2.2.4.4. Risk Characterisation for the Environment

2.2.4.4.1. Aquatic Compartment

Use pattern PEC/PNEC values

Worst-case

PEC/PNEC values

Realistic Worst-case

Water compartmen

t

Sediment compartmen

t

Sewage treatmen

t plant

Water compartmen

t

Sediment compartmen

t

Sewage treatmen

t plant

Use Pattern 1 - Dipping

application

9.7 63.7 2.99 0.97 6.37 0.299

Use Pattern 2- Storage of

dipping/immersed wood

7.4E-02 4.91E-01 0

Use Pattern 3- Vacuum pressure

application

2.9 1.9E+01 0.9

Use Pattern 4- Storage of

Vacuum pressure treted wood

5.6E-02 3.66E-01 0

Use Pattern 5- Treated wood in

service Noise barrier

- - 5.73E-3

Surface waterFor surface water, there is no unacceptable risks from the storage phases investigated (i.e. Use pattern 2: Storage of dipping/immersed wood and Use pattern 4: Storage of Vacuum pressure treated wood) and for the use patterns 1 (Dipping application). For use pattern 3 (Vacuum pressure application) the PEC/PNEC values is > 1 indicating possible unacceptable risks.

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July 2007

Sediment For the sediment compartment possible risk is predicted for use patterns 1 (Dipping application) and 3 (Vacuum pressure application). No risk is expected under Use patterns 2, 4 and 5.

Sewage Treatment PlantFor the STP, no risk is predicted.

ConclusionsHowever, despite of the risk characterisation findings indicating unacceptable risk for several use patterns for the different compartment, the Rapporteur believes that the OECD ESD Guidance is representing an extreme worst case due to the fact that degradation processes are not taken into account. Indeed, Didecyldimethylammonium Chloride is readily biodegradable indicating that the possible release to the STP during its use has to be considered as negligible. These considerations suggest that the risks for the aquatic compartment related to product, if any, are only localized.

However, in the aquatic compartment (Surface water, sediment and STP), the risk arose from the Dipping application (Use pattern 1) has been considerably reduced taking into account the realistic worst-case. Calculated on the basis of 10m3/day of wood treated, this refinement well represents the western Europe situation

2.2.4.4.2. Terrestrial Compartment including Groundwater

Use pattern PEC/PNEC values

Terrestrial compartment

Use pattern2: Storage of dipping/immersed wood 36,64

Use pattern 4: Storage of Vacuum pressure treted wood 36.64

Use pattern 5: Treated wood in service Noise barrier 1.13

Use pattern 7: Treated wood in service House 2.97

Use pattern 8: Treated wood in service Transmission pole 0.74

Use pattern 9: Treated wood in service fence post 0.21

For the use patterns 2, 4, 5 and 7 the PEC/PNEC values are > 1 indicating unacceptable risk. No risk is predicted for Use patterns 8 and 9. The Storage scenarios (2 and 4) assume that all freshly treated wood is stored on site for several days without considering degradation phenomena. Indeed Didecyldimethylammonium Chloride is readily biodegradable and it has little mobility in soil indicating that the effects of that contamination are restricted to the

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immediate environment and would not pose any risk to the wider environment. As regards the use patterns 5 and 7 we can consider the risks posed by these as acceptable due to the relatively low values calculated without considering the ready biodegradability of the substance. Moreover the substance has little or no potential for mobility in soil and should not pose an environmental risk for contamination of ground water and the possible effect on soil are only localised.However for the storage phases (use patterns 2 and 4) we propose to restrict the storage of the treated wood to areas with impermeable ground in order to avoid any possible loss of the product. Furthermore an appropriate recycling or disposal system should be developed.

2.2.4.4.3. Environmental risk in the atmosphere

For the atmosphere compartment no PNEC values are available. However, for all use patterns, the PEC in air is considered to be negligible (≤ 1E-05) suggesting that there is no concern for this compartment.

2.2.4.4.4. Primary and secondary poisoning (non compartment specific effects relevant to the food chain)

Use pattern PEC/PNEC valuesFish-eating mammals Fish-eating birds

Use pattern 1: Dipping application 0.2359 0.4202Use pattern 2: Storage of dipping/immersed wood 0.0018 0.0032Use pattern 3: Vacuum pressure application 0.0705 0.1256Use pattern 4: Storage of Vacuum pressure treated wood 0.0014 0.0024

All PEC/PNEC values are < 1 for all use patterns, there is no concern with regard to non compartment specific effects relevant to the food chain (secondary poisoning via aquatic food chain).

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3. PROPOSAL FOR THE DECISION

3.1. Background to the Proposed Decision

On the basis of the proposed and supported uses and the evaluation conducted as summarised in chapter 2 of this document, it can be concluded that under the conditions listed in chapter 3.2 Didecyldimethylammonium Chloride fulfils the requirements laid down in Article 5(1) (b), (c), and (d) of Directive 98/8/EC, apart from requirement in TNsG Chapter 2 Section 4.1. Didecyldimethylammonium Chloride is proposed to be included in Annex I of the Directive pending on the submission of a fully-validated analytical method for DDAC and its impurities > 0.1% w/w.

The Annex I – entry should, however , only include the intended uses with the conditions and restrictions proposed in this report.

3.2. Proposed Decision regarding Inclusion in Annex I

The Italian CA recommends that Didecyldimethylammonium Chloride is included in Annex I to Directive 98/8/EC as an active substance for use in wood preservative products (Product-type 8), subject to the following specific provisions:

Common name: Didecyldimethylammonium Chloride

IUPAC name: Not applicable

CAS No.: 7173-51-5

EC No.: 230-525-2

Minimum degree of purity of the active substance:

The active substance as manufactured shall have a minimum purity of 95% (w/w).

Identity and maximum content of impurities:

The identity and maximum content of impurities must not differ in such a way as to invalidate the assessment for the inclusion of the active substance on to Annex I.

Product types:

Wood preservative (product-type 8)

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July 2007

Specific provisions:

Member States shall ensure that authorisations are subject to the following condition:

Even if no risk is identified from the professional operator scenarios, it is suggested that Personal Protective Equipment (PPE) should be worn to minimize the exposure.

Wood products treated with Didecyldimethylammonium Chloride must not come in contact with food or feedstuffs. Since neither analytical methods nor toxicological risk assessment for Didecyldimethylammonium Chloride contamination in food and feedstuffs has been carried out, the use of Didecyldimethylammonium Chloride-based wood preservative must exclude applications that may lead to contact with food and feedstuffs and contaminants thereof.

All timber treated by dipping and vacuum pressure applications must be stored on impermeable hard standing to prevent direct losses to soil and allow losses to be collected for re-use or disposal.

Labels and/or safety data sheets of products authorised for industrial use must indicate that freshly timber treated by dipping and vacuum pressure applications must be stored after treatment on impermeable hard standing to prevent direct losses to soil and that any losses must be collected for re-use or disposal.

3.3. Factors to be taken into account by Member States when authorising products

Products containing Didecyldimethylammonium Chloride, may be used in the treatment of wood by Dipping/immersion process and vacuum pressure application by professional users.

Human Health and Environmental Risk Assessment has been performed on the knowledge that the wood treatment solution employed contains 1.8% a.s. The neat concentrate of the substance (containing 25% a.s.) is only handled under closed conditions and so is modelled under Use Pattern 1 (see below for more details). Therefore any deviation from the value of 1.8% increasing the concentration of the substance in the product, must undergo through a specific risk assessment.

When authorising the product use Member States Authorities should ensure that the Risk Reduction Measure described in Sections 3.2 and 3.5 are applied.

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July 2007

3.4. Requirement for further information

The need for the following studies should in particular be considered:

A suitable method for the determination of the pure active substance in the active substance as manufactured and, where appropriate, for relevant degradation products, isomers and impurities of active substances and their additives should be submitted since the requirements stated in TNsG Chapter 2 Section 4.1 were not accomplished.

Second and third study on effects on sediment dwelling organisms (III-A, Section 7.4.3.5.1) is needed to refine the risk arising for sediment organisms.

Aquatic plant toxicity (IIIA, Section 7.4.3.5.2) is required. Risk is observed for the aquatic compartment with the invertebrates showing the highest sensitivity. Nevertheless, the long term sensitivity of invertebrates, fish and algae is of the same order of magnitude (NOECs, mg/l: 0.01,0.03, 0.04, respectively) and therefore, the relevance of aquatic plants cannot be excluded due to the fact that DDAC similarly affects the three aquatic trophic levels and, like other quaternary ammonium salt, has an aspecific mode of action.

Long-term test with terrestrial plants (III-A, Section 7.5.2.2) is required since risk is observed for the soil compartment. Among the soil organisms tested, plants are the most sensitive and should be further tested upon long term exposure for the risk refinement.

3.5. Recommended Measures

Due to the fact that for the representative wood preservative, different intended uses (dipping and vacuum pressure treatment) should be conducted with formulations which are containing the active substance in a concentration no higher than 1.8% w/w, measures for a good application should be prescribed. As regards occupational safety measures it suggested that PPE should be worn for minimizing exposure. For the environment as risk scenarios have been identified for on-site storage, timber treated with Didecyldimethylammonium Chloride wood preservative formulations must be stored on impermeable grounds.

Moreover an appropriate recycling or disposal system should be developed in order to reduce in the storage phases any possible loss in the terrestrial compartment and also the contamination of the aquatic compartment.

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July 2007

3.6. Updating this Assessment Report

This assessment report may need to be updated periodically in order to take account of scientific developments and results from the examination of any of the information referred to in Articles 7, 10.4 and 14 of Directive 98/8/EC. Such adaptations will be examined and finalised in connection with any amendment of the conditions for the inclusion of Didecyldimethylammonium Chloride in Annex I to the Directive.

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Appendix I: Listing of end points

Chapter 1: Identity, Physical and Chemical Properties, Details of Uses, Further Information, and Proposed Classification and Labelling

Active substance (ISO Common Name) Didecyldimethylammonium Chloride (DDAC)

Function (e.g. fungicide) Fungicide and insecticide

Rapporteur Member State Italy

Identity (Annex IIA, point II.)

Chemical name (IUPAC) N,N-Didecyl-N,N-dimethylammonium Chloride

Chemical name (CA) 1-Decanaminium, N-decyl-N,N-dimethyl-, chloride

CAS No 7173-51-5

EC No 230-525-2

Other substance No. None

Minimum purity of the active substance as manufactured (g/kg or g/l)

87.0-99.5 % w/w

Identity of relevant impurities and additives (substances of concern) in the active substance as manufactured (g/kg)

See Confidential Data

Molecular formula C22 H48 N Cl

Molecular mass 362.1 g/mol

Structural formula

N+

R Cl-

R

R = C10H21

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July 2007

Physical and chemical properties (Annex IIA, point III., unless otherwise indicated)

Melting point (state purity) The melting range is between 188 and 205 °C (98.2 %).

Boiling point (state purity) The substance decomposed before boiling. Decomposition was observed at approximately 280C

Temperature of decomposition No decomposition or chemical transformation was observed below 150°C. Therefore, the test substance is considered to be thermally stable.

Appearance (state purity) Light-coloured solid (98.2 %)

Relative density (state purity) 0.902 at 20 °C (98.2 %)

Surface tension 27.0 mN/m at 20°C and a concentration of 1 g/l.

Vapour pressure (in Pa, state temperature) 5.9E-06 Pa @ 20C (calculated)

1.1E-05 Pa @ 25C (calculated)

2.3E-04 Pa @ 50ºC (calculated)

Henry’s law constant (Pa m3 mol -1) 4.27E-09 Pa•m3/mol @ 20C

Solubility in water (g/l or mg/l, state temperature) pH__2.2__: 500 g/l at 20 °C

pH__9.2____: 500 g/l at 20 °C

pH______:

Solubility in organic solvents (in g/l or mg/l, state temperature) (Annex IIIA, point III.1)

Acetone: > 600000 mg/l

Methanol: > 600000 mg/l

Octanol: > 250000 mg/l @ 20ºC

Stability in organic solvents used in biocidal products including relevant breakdown products (IIIA, point III.2)

Ethanol: Stable < 5% loss for 14 days at 55°C

Isopropanol: Stable < 5% loss for 14 days at 55°C

Partition coefficient (log POW) (state temperature) Not determinable

Dissociation constant (not stated in Annex IIA or IIIA; additional data requirement from TNsG)

Study not conducted as the substance is irreversibly ionized.

UV/VIS absorption (max.) (if absorption > 290 nm state at wavelength)

The ultraviolet/visible absorption spectra were consistent with the assigned structure of DDAC. No maxima determined due to lack of chromophores in the molecular structure.

Flammability Non flammable

Explosive properties Not explosive

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July 2007

Classification and proposed labelling (Annex IIA, point IX.)

with regard to physical/chemical data No classificationwith regard to toxicological data C- Corrosive

R22; R34; S1/2; S26, S28; S36/37/39; S45with regard to fate and behaviour data No classificationwith regard to ecotoxicological data N- Dangerous for the environment

R50; S60; S61Specific concentration limits for the environmental classification

Cn ≥ 2.5 %: N; R50

Chapter 2: Methods of Analysis

Analytical methods for the active substance

Technical active substance (principle of method) (Annex IIA, point 4.1)

Quaternary ammonium chloride content: Biphasic titration between water and chloroform with bromophenol blue indicator.Alkyl chain length distribution: Gas chromatograph-flame ionization detector (GC-FID).The method is not acceptable

Screening by ion chromatography.The method is not acceptable

Analytical method for the determination of a variety of biocidal quaternary ammonium compound using HPLC with evaporative light scattering detection (ELSD). Confirmation and impurities identification by LC-MS.The method is not acceptable

Impurities in technical active substance (principle of method) (Annex IIA, point 4.1)

Free amine: Titration against hydrochloric acid/bromophenol blue.Amine hydrochloride: Titration against standardized potassium hydroxide/phenolphthalein. Ash content: Mass difference before and after combustion.The method is not acceptable

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July 2007

Analytical methods for residues

Soil (principle of method and LOQ) (Annex IIA, point 4.2)

Extraction with methanol:water (90:10 v:v) containing 0.01 m ammonium formate and 0.1% formic acid. Analysis by liquid chromatography with mass spectrometric detection (LC-MS). LOQ = 0.01 mg/kg

Air (principle of method and LOQ) (Annex IIA, point 4.2)

Justification for non-submission of data

Water (principle of method and LOQ) (Annex IIA, point 4.2)

Partition with 0.1 m heptanesulfonic acid and dichloromethane. Concentration by rotary evaporation and redissolution in 0.1% formic acid in methanol. Analysis by liquid chromatography with mass spectrometric detection (LC-MS). LOQ = 0.1 µg/l

Body fluids and tissues (principle of method and LOQ) (Annex IIA, point 4.2)


Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes) (Annex IIIA, point IV.1)


Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes) (Annex IIIA, point IV.1)


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July 2007

Chapter 3: Impact on Human Health

Absorption, distribution, metabolism and excretion in mammals (Annex IIA, point 6.2)

Rate and extent of oral absorption: The majority (>90% )of orally administered a.s is excreted very likely unabsorbed via the faeces. Based on data on urine ecretion (<3%) and tissue residues (<1%), and on the highly ionic nature of the a.s., it is expected that its oral absorption is limited (<10%).

Rate and extent of dermal absorption: Less than 0.1% of the applied 14C-DDAC dose dissolved in water fully penetrated human skin in 24 h. The total dermal absorption is evaluated equal to 9.41% .

Distribution: Following oral administration, tissue residues were less than 1%.

Potential for accumulation: None

Metabolism Four major metabolites of DDAC were identified, as the product of alkyl chain hydroxylation. It can be hypothesized that DDAC metabolism is carried out by gut microflora.

Rate and extent of excretion: Following oral administration in rats: 89 – 99% excreted in faeces, 2.5% excreted in urine

Toxicologically significant metabolite None

Acute toxicity (Annex IIA, point 6.1)

Rat LD50 oral 238 mg/kg bw

Rat LD50 dermal 3342 mg/kg bw (rabbit)

Rat LC50 inhalation Study not conducted- not relevant

Skin irritation Corrosive

Eye irritation Corrosive

Skin sensitisation (test method used and result) Epicutaneous maximization test – Not sensitising

Buehler Method – Not sensitising

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July 2007

Repeated dose toxicity (Annex IIA, point 6.3)

Species/ target / critical effect Rat/Dog / GI tract/ severe irritation of g.i. mucosa- emesis

Lowest relevant oral NOAEL / LOAEL NOEL 3 mg/kg bw/day (Dog – 1 year)

Lowest relevant dermal NOAEL / LOAEL NOEL = 12 mg/kg bw/day (Rat 90 days)

Lowest relevant inhalation NOAEL / LOAEL Not conducted – not relevant

Genotoxicity (Annex IIA, point 6.6)

In-vitro: Ames test – negative (with and without metabolic activation)

Chromosomal aberration test – negative (with and without metabolic activation)

Mammalian cell gene mutation assay – negative (with and without metabolic activation)

In-vivo: Chromosomal aberration test in rat bone marrow - negative

Carcinogenicity (Annex IIA, point 6.4)

Species/type of tumour Rat/none, Mouse/none

lowest dose with tumours Negative

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July 2007

Reproductive toxicity (Annex IIA, point 6.8)

Species/ Reproduction target / critical effect Rat /NOEL/reduced body weight and food consumption in parental and F1-F2 animals

Lowest relevant reproductive NOAEL / LOAEL LOEL/NOEL parental = 1500/750 mg/kg food (> 64 mg/kg bw/day / > 31 mg/kg bw/day)

LOEL/NOEL F1 offspring = 1500/750 mg/kg food (> 64 mg/kg bw/day / > 31 mg/kg bw/day)

LOEL/NOEL F2 offspring = 1500/750 mg/kg food (> 64 mg/kg bw/day / > 31 mg/kg bw/day)

Species/Developmental target / critical effect Rat / NOEL / maternal toxicity

Lowest relevant developmental NOAEL / LOAEL LOEL/NOEL maternal = 8.1 mg/kg bw/day / 0.8 mg/kg bw/day

NOEL developmental ≥ 16.2 mg/kg bw/day

Species/Developmental target / critical effect Rabbit / NOAEL /maternal toxicity

Lowest relevant developmental NOAEL / LOAEL LOEL/NOEL maternal = 2.4 mg/kg bw/day / 0.8 mg/kg bw/day

NOEL developmental ≥ 8.1 mg/kg bw/day

Neurotoxicity / Delayed neurotoxicity (Annex IIIA, point VI.1)

Species/ target/critical effect Study not conducted- not relevant

Lowest relevant developmental NOAEL / LOAEL

Other toxicological studies (Annex IIIA, VI/XI)

........................................................................... None required

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July 2007

Medical data (Annex IIA, point 6.9)

........................................................................

.......No substance-specific effects have been noted. No specific observations or sensitivity/allergenicity have been reported

Summary

Value Study Safety factor

Non-Professional users

ADI (if residues in food or feed)

Not applicable

Professional users

AOEL (Operator/Worker Exposure)

0.17 mg/kg/day 52 week oral study in dogs 17.5

Reference value for dermal absorption

10 % In vitro on human skin

Drinking water limit 0.1 g/L As set by EU drinking water Directive 98/83/EC

ARfD (acute reference dose)

Not applicable

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July 2007

Acceptable exposure scenarios (including method of calculation)

Professional users MOE = AOEL/total body dose

MOE = 3-44 (for indirect handling scenarios

MOE = 1.5 – 28 for direct handling scenarios

Production of active substance: Not applicable

Formulation of biocidal product Not applicable

Secondary exposure Not applicable

Non-professional users Not applicable

Indirect exposure as a result of use MOS = 798 – 3.07E+04 (EUSES)

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July 2007

Chapter 4: Fate and Behaviour in the Environment

Route and rate of degradation in water (Annex IIA, point 7.6, IIIA, point XII.2.1, 2.2)

Hydrolysis of active substance and relevant metabolites (DT50) (state pH and temperature)

pH___5___: >30 days at 25°C

pH___7___: >30 days at 25°C

pH___9___: >30 days at 25°C

Photolytic / photo-oxidative degradation of active substance and resulting relevant metabolites

ca. 0% after 30 days (direct)

ca. 7% after 30 days (indirect)

Readily biodegradable (yes/no) Yes

Biodegradation in seawater Not used in seawater

Non-extractable residues Not applicable

Distribution in water / sediment systems (active substance)

A biodegradation study in two water/sediment systems has been performed and shoed that the substance easily migrates from the aqueous phase to the sediment phase and is also easily adsorbed to sediments (high Koc). The degradation in the sediment phase did not increase very much after the first month and the DT50 of the total system was not reached within the 120 days test duration

Distribution in water / sediment systems (metabolites)

Not applicable

Route and rate of degradation in soil (Annex IIIA, point VII.4, XII.1.1, XII.1.4; Annex VI, para. 85)Mineralization (aerobic) No data available

Laboratory studies (range or median, with number of measurements, with regression coefficient)

No data available

Field studies (state location, range or median with number of measurements)

Not applicable

Anaerobic degradation Active substance is readily biodegradable;

Soil photolysis Stable, not subject to photogradation in soil

Non-extractable residues No data available

Relevant metabolites - name and/or code, % of applied a.i. (range and maximum)

Not measured

Soil accumulation and plateau concentration No data available

Adsorption/desorption (Annex IIA, point XII.7.7; Annex IIIA, point XII.1.2)

Ka , Kd Ka (Kaoc) values for four soil types:

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Kaoc , Kdoc

pH dependence (yes / no) (if yes type of dependence)

Sand: 1’095 (437’805)Sandy loam: 8’179 (908’757)Silty clay loam: 32’791 (1’599’564)Silt loam: 30’851 (1’469’081)

Kd (Kdoc) values for four soil types:Sand: 591 (236’473)Sandy loam: 2074 (230’498)Silty Clay loam: 8309 (405’328)Silt loam: 7714 (367’334)

No pH dependence

Fate and behaviour in air (Annex IIIA, point VII.3, VII.5)

Direct photolysis in air Atmospheric t½ = 2.8 hr (AOPWIN)

Quantum yield of direct photolysis Not specified

Photo-oxidative degradation in air Latitude: ............. Season: ................. DT50 ..............

Volatilization Not volatile [vapour pressure 2.3 E-06 hPa (2.3E-04 Pa) @ 50°C]

Monitoring data, if available (Annex VI, para. 44)

Soil (indicate location and type of study) No data available

Surface water (indicate location and type of study)

No data available

Ground water (indicate location and type of study)

No data available

Air (indicate location and type of study) No data available

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Chapter 5: Effects on Non-target Species

Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2, Annex IIIA, point 10.2)Species Time-scale Endpoint Toxicity

FishZebra fish (Brachydanio rerio)

34 d Growth NOEC 0.0322 mg/l

InvertebratesDaphnia magna 21 d Reproduction NOEC 0.010 mg/lAlgaeSelenastrum capricornutum

96 hours Biomass production and growth rate

NOErC 0.014 mg/l

MicroorganismsActivated sewage sludge 3 hr Respiration

inhibitionEC50 11.0 mg/l

Effects on earthworms or other soil non-target organisms

Acute toxicity to Eisenia foetida(Annex IIIA, point XIII.3.2)

LC50 > 1000 mg/kg, in artificial soilNOEC 1000 mg/kg, in artificial soil

Reproductive toxicity to …………………………(Annex IIIA, point XIII.3.2)

No data available.

Effects on soil micro-organisms (Annex IIA, point 7.4)

Nitrogen mineralization EC50 > 1000 mg/kgCarbon mineralization EC50 > 1000 mg/kg

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Effects on terrestrial vertebrates

Dose-related reduction in body weight gain - mammals(Annex Point IIA6.8.2)

NOEC 100 mg/kg

Acute toxicity to birds(Annex IIIA, point XIII.1.1)

Northern bobwhite quailLD50 = 229 mg a.s./kg bw

Dietary toxicity to birds(Annex IIIA, point XIII.1.2)

Northern bobwhite quail and mallardLC50 = >5620 mg/kg a.s. food

Reproductive toxicity to birds(Annex IIIA, point XIII.1.3)

Not available

Effects on honeybees (Annex IIIA, point XIII.3.1)

Acute oral toxicity Not appropriateAcute contact toxicity Not appropriate

Effects on other beneficial arthropods (Annex IIIA, point XIII.3.1)

Acute oral toxicity Not appropriateAcute contact toxicity Not appropriateAcute toxicity to…………………………………..

Not appropriate

Bioconcentration (Annex IIA, point 7.5)Bioconcentration factor (BCF) Measured BCFfish = 81

BCFearthworm not availableDepuration time (DT50)

(DT90)14d

Level of metabolites (%) in organisms accounting for > 10 % of residues

No data available

Chapter 6: Other End Points

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Appendix II: List of Uses Supported by Available Data

Summary of intended uses The biocidal product containing the active substance is used in two wood preservative treatment applications: dipping and vacuum pressure processes.For both processes the preservative is delivered to the processing plant by tanker in the form of a concentrate. The concentrate contains 25% of the active substance Didecyldimethylammonium Chloride. It is diluted to a suitable working strength with water. The degree of dilution varies depending on the wood species, type of wood product and anticipated use. The requirements for Didecyldimethylammonium Chloride concentration in both processes vary between 0.3% and 1.8%.

Dipping/ immersion process Application rate: 1.8 kg a.s./m3 (worst case site-specific information)Total amount of a.s. processed per site per day: 3.6 kgTotal tonnage of a.s. processed per site per year: Confidential (Reference B) (worst case)Total tonnage of a.s. used in region: Confidential (Reference C) (widespread use, 10% of tonnage used in default region)

Vacuum pressure process Application rate: 1.8 kg a.s./m3 (worst-case site-specific information)Total amount of a.s. processed per day: Confidential (Reference E)Total tonnage of a.s. processed per site per year: Confidential (Reference F) (worst case)Total tonnage of a.s. used in region: Confidential (Reference C) (widespread use, 10% of tonnage used in default region)

Organisms to be controlled Wood destroying basidiomycetes (Coniophora puteana / Coniophora spec., Coriolus versicolor, Gloephyllum trabeum, Poria vaillantii / Poria spec., Fomes spec., Trametes spec., etc.)Wood staining molds (Aureobasidium pullulans, Sclerophoma pityopila, Ophistostoma piliferum, Aspergillus niger, Aspergillus terreus, Chaetomium globosum, Paecilomyces variotii, Penicillium funicolosum, Trichoderma viridae, etc.)Wood boring insects (Hylotrupes bajulus, Anobium punctatum, Lyctus brunneus, termites, etc.)

Products to be protected Wood, use classes 1 to 4A according to ISO draft standard (see Document IIIA Section 2 Table 2.10.2.2.2-1)

Use concentration The use concentration depends on the type of application technique, use class required and on additional formulation components. For details see exposure-scenarios in the Risk Assessments.

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Appendix III: List of Studies

Document III A

Endpoint ReferenceNo.

ReferenceNon-Key Studies are italicized.

3.1.1 – Melting point D47(LON 3256)

Schneider, S. (2000) Determination of the melting temperature of Dodigen 1881 AS (pure active substance of Bardac 22) in accordance with OECD-Guideline 102 and according to EECGuideline A.1. Clariant GmbH - Werk Cassella-Offenbach, Analytische und Physikalische Abteilung, Frankfurt, Germany.Report No. B 077/2000 (unpublished).

3.1.3 – Density D48(LON 3257)

Schneider, S. (2000) Determination of the density of Dodigen 1881 AS (pure active substance of Bardac22) inaccordance with OECD-Guideline 109 and according toEEC-Guideline A.3. Clariant GmbH - Werk Cassella-Offenbach, Analytische und Physikalische Abteilung, Frankfurt, Germany.Report No. B079/2000 (unpublished).

3.2 – Vapor pressure D49(LON 3275)

Smeykal, H. (2000) Dodigen 1881 AS - DD 00/004: Vapour pressure. Siemens Axiva GmbH & Co. KG, Frankfurt, Germany.Report No. SI092-00 (unpublished).

3.4.1 – UV/VIS3.4.2 – IR3.4.3 – NMR3.4.4 – MS

D93(LON 3278)

Petrovic P. (2000) Characterization of the structure of Dodigen1881 AS. Clariant GmbH - Werk Cassella-Offenbach, Analytischeund Physikalische Abteilung, Frankfurt, Germany. Report No. B 085/2000 (unpublished).

3.5 – Solubility in water D51(LON 3280)

Schneider, S. (2000) Determination of the water solubility ofDodigen 1881 AS (pure active substance of Bardac 22) inaccordance with EEC-Guideline A.6. Clariant GmbH - WerkCassella-Offenbach, Analytische und Physikalische Abteilung, Frankfurt, Germany. Report No. B 080/2000(unpublished).

3.7(1) – Solubility in organicsolvents

D101(LON 3279)

Schneider, S. (2001) Determination of the solubility of Dodigen 1881 AS [pure active substance of Bardac22] in organic solvents. AllessaChemie GmbH - Werk Cassella-Offenbach, Analytik,Frankfurt, Germany. Report No. B 084/2000 (unpublished).

3.7(2) – Solubility in organicsolvents

D92(LON 3802)

Young S. (2004) N,N-Didecyl-N,N-dimethylammonium chloride(DDAC): Solubility in octanol. Huntingdon Life Sciences,Huntingdon, Cambridgeshire, England. Report No. DKG/011033992 (unpublished).

3.8 – Stability in organicsolvents

D94(LON 3803)

Young, S. (2004) N,N-Didecyl-N,N-dimethylammonium chloride(DDAC): Stability in ethanol and isopropanol. Huntingdon LifeSciences, Huntingdon, Cambridgeshire, England. Report No.DKG/012 042290 (unpublished).

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3.9 – Partition coefficient D137 Nixon, W.B. (1998) DDAC octanol/water partition coefficienttest. Unpublished letter report dated August 14, 1998; fromWildlife International, Ltd., Easton, MD, USA. (unpublished).

3.9 – Partition coefficient D92(LON 3802)

Young, S. (2004) N,N-Didecyl-N,N-dimethylammonium chloride(DDAC): Solubility in octanol. Huntingdon Life Sciences,Huntingdon, Cambridgeshire, England. Report No. DKG/011033992 (unpublished).[REPORT FILED UNDER ENDPOINT 3.7]

3.10 – Thermal stability D95(LON 3449)

Keipert, W. (2001) Determination of the thermal stability andstability in air of Dodigen 1881 AS (Bardac 22 AS) in accordancewith OECD-Guideline 113. AllessaChemie GmbH - WerkCassella-Offenbach, Analytik, Frankfurt, Germany. Report No. B012/2001 (unpublished).

3.11(1) – Flammability(solids) & Autoflammability

D96(LON 3446)

Keipert, W. (2001) Determination of the relative self ignitiontemperature of Dodigen 1881 AS (Bardac 22 AS) in accordancewith EEC-Guideline A.16. AllessaChemie GmbH - WerkCassella-Offenbach, Analytik, Frankfurt, Germany. Report No. B022/2001 (unpublished).

3.11(2) – Flammability(solids) & Autoflammability

D97(LON 3447)

Keipert, W. (2001) Determination of the flammability of Dodigen1881 AS (Bardac 22 AS) in accordance with EEC-Guideline A.10.AllessaChemie GmbH - Werk Cassella-Offenbach, Analytik,Frankfurt, Germany. Report No. B 021/2001 (unpublished).

3.13 – Surface tension D98(LON 3448)

Schneider, S. (2001) Determination of the surface tension of anaqueous solution of Dodigen 1881 AS (Bardac 22 AS) inaccordance with OECD-Guideline 115. AllessaChemie GmbH,Analytik, Frankfurt, Germany. Report No. B 023/2001(unpublished).

3.14 – Viscosity D135(LON 3660)

Keipert, W. (2003) Determination of the viscosity of Bardac22/Dodigen 1881 in accordance with OECD-Guideline 114.AllessaChemie GmbH, Analytik, Frankfurt, Germany. Report No.B 019/2003 (unpublished).

3.15(1) – Explosiveproperties

D99(LON 3445)

Dodigen 1881 AS (Bardac 22 AS) in accordance with EECGuideline A.14. AllessaChemie GmbH - Werk Cassella-Offenbach, Analytik, Frankfurt, Germany. Report No. B 024/2001(unpublished).

3.15(2) – Explosiveproperties

D100(LON 3612)

Tremain, S.P. (2002) Didecyl dimethylammonium chloride(DDAC): Determination of explosive and oxidising properties,expert statement. Safepharm Laboratories Ltd., Shardlow,Derbyshire, England. SPL Project No. 102/438 (unpublished).

3.16 – Oxidising properties D100(LON 3612)

Tremain, S.P. (2002) Didecyl dimethylammonium chloride(DDAC): Determination of explosive and oxidising properties,

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expert statement. Safepharm Laboratories Ltd., Shardlow,Derbyshire, England. SPL Project No. 102/438 (unpublished).[REPORT FILED UNDER ENDPOINT 3.15]

4.1(1) – Analytical methodsfor purity/impurity

D136(LON 3843)

Sloan, R. (1994) Bardac 2280 - Characterization of the testsubstance. Huntingdon Life Sciences, Huntingdon,Cambridgeshire, England. Report No. 94-013 (unpublished).

4.1(2) – Analytical methodsfor purity/impurity

D91(LON 3804)

Young, S. (2003) Didecyldimethylammonium chloride (DDAC;CAS RN 7173-51-5): Screening by ion chromatography.Huntingdon Life Sciences Ltd., Huntingdon, Cambridgeshire,England. Study No. DKG/010 (unpublished).

4.1(3) – Analytical methodsfor purity/impurity (new submission)

Lonza Report No. 4134

Kurz M. and Ranft V. (2007) Determination of quaternary ammonium compounds and related quaternary impurities by HPLC-ELSD. Study No.CSPE-44/BS-07-70. Lonza AG. (Unpublished).

4.2 (a) – Analytical methodsfor determination of residuesin soil

D46(LON 3701)

Brewin, S. (2003) Didecyldimethylammonium chloride (DDAC;CAS RN 7173-51-5): Validation of methodology for thedetermination of residues in soil. Huntingdon Life Sciences Ltd.,Huntingdon, Cambridgeshire, England. Report No. ADB/014033180 (unpublished).

4.2 (c) – Analytical methodsfor determination of residuesin water

D90(LON 3702)

Brewin, S. (2003) Didecyldimethylammonium chloride (DDAC;CAS RN 7173-51-5): Validation of methodology for thedetermination of residues in drinking, ground and surface water.Huntingdon Life Sciences Ltd., Huntingdon, Cambridgeshire,England. Report No. ADB/015 033168 (unpublished).

5.3.1 – Effects on TargetOrganisms

D139 Archer, K., Nicholas, D.D. and T.P. Schultz (1995) Screening ofwood preservatives: Comparison of the soil block, agar block andagar plate tests. Forest Prod. J. 45(1): 86-89.

D142 Linfield, W.M. (1969) Chapter 2: Straight-chain alkylammoniumcompounds. In E. Jungermann (Ed.), CationicSurfactants. Marcel Dekker: New York, NY, USA, pp 9-70.

D151 Wazny, J. and L.J. Cookson (1993) A comparison of Coniophoraolivacea and Coniophora puteana test strains. InternationalResearch Group on Wood Preservation Document No.IRG/WP/20004.

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D152 Wazny, J. and L.J. Cookson (1994) Comparison of the agar blockand soil block methods used for evaluation of fungitoxic value ofQAC and CCA wood preservatives. International Research Groupon Wood Preservation Document No. IRG/WP/20039.

6.1.1 – Acute oral toxicity D9(LON 3746)

Morris, T.D. (1992) Acute oral toxicity in rats – Median lethaldosage determination with didecyldimethylammonium chloride(DDAC). Hill Top Biolabs, Inc., Miamiville, Ohio, USA. StudyNo. 91-8114-21(A) (unpublished).

6.1.1 – Acute oral toxicity D102(LON 1239)

Ullman, L. and R. Sacher (1983) Acute oral toxicity study (LD50)with P 0151 in rats. Research & Consulting Company AG, Itingen,Switzerland. Project No. 021532 (unpublished).

6.1.2 – Acute dermal toxicity D85(LON 3805)

Siglin, J.C. (1987) Acute dermal toxicity study in rabbits LD50test (EPA) with DMD10AC. Springborn Institute for Bioresearch,Inc., Spencerville, OH, USA. Study No. 3165.1.2C (unpublished).

6.1.2 – Acute dermal toxicity D71(LON 1237)

Nitka S. (1980) An acute dermal LD50 study in albino rabbitsConsumer Product Testing, Fairfield, NJ, USA. Report No 8044-10 (unpublished).

6.1.4(1) – Skin irritation D103(LON 1241)

Jones, J.R. and T.A. Collier (1986) P0151: OECD 404 Acutedermal irritation/corrosion test in the rabbit. SafepharmLaboratories Ltd., Derbyshire, England. Project No. 102/1(unpublished).

6.1.4 – Skin irritation D104(LON 2424)

Allan, D.J. (1995) P4289: Acute dermal irritation test in rabbitsSafepharm Laboratories Ltd., Derbyshire, England. Project No.102/1908 (unpublished).

6.1.4 – Skin irritation D11(LON 3807)

Morris, T.D. (1991) Primary skin irritation study in rabbits withdidecyldimethylammoniumchloride (DDAC). Hilltop Biolabs, Inc.,Miamiville, OH, USA. Study No. 91-8114-2 (B) (unpublished).

6.1.4(2) – Eye irritation D10(LON 3806)

Morris, T.D. (1991) Primary eye irritation study in rabbits withdidecyldimethylammonium chloride (DDAC). Hill Top Biolabs,Inc., Cincinnati, OH, USA. Study No. 91-8114-21 (unpublished).

6.1.5(1) – Skin sensitisation D105(LON 1243)

Clement, C. (1992) BARDAC-22: Test to evaluate the sensitizingpotential by topical applications in the guinea pig. Hazleton-

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Institute Français de Toxicologie, L’Arbresle, France. Report No.704323 RE (unpublished).


Kukulinski, M. (2003) Skin sensitization study of Maquat 4480-E,Batch #30717J5, OPPTS 870.2600. Tox Monitor Laboratories,Inc., Oak Park, IL, USA. Project No. 03-092-5 (unpublished).


Merkel, D.J. (2004) Bardac 2280: Dermal sensitization test inguinea pigs (Buehler method). Product Safety Laboratories,Dayton, NJ, USA. Study No. 15512 (unpublished).

6.1.5 – Skin sensitisation D12(LON 3808)

Morris T.D. (1991) Photoallergy study in guinea pigs withdidecyldimethylammoniumchloride (DDAC). Hill Top Biolabs,Cincinnati, OH , USA. Study No. 91-8114-21(D) (unpublished).

6.2(1) – Metabolism inmammals (toxicokinetics;dermal absorption)

D45(LON 3329)

Roper, C.S. (2001) The in vitro percutaneous absorption of [14C]-Didecyldimethylammonium chloride (DDAC) through human skin.Inveresk Research, Tranent, Scotland. Report No. 19128(unpublished).

6.2(2) – Metabolism inmammals (toxicokinetics;dermal absorption)

D34, D35(LON 1779)

Selim, S. (1989) Absorption, distribution, metabolism andexcretion studies of didecyldimethylammoniumchloride (DDAC)in the rat. Biological Test Center, Irvine, CA, USA. Study No.P01421 (unpublished).

6.4.1(1) – Subchronic oraltoxicity (rat)

D27(LON 1257)

Van Miller, J.P. (1988) Ninety-day dietary subchronic oraltoxicity study with didecyldimethylammoniumchloride in rats.Union Carbide, Bushy Run Research Center, Export, PA, USA.Report No. 51-506 (unpublished).

6.4.1(2) – Subchronic oraltoxicity (dog)

D16(LON 1256)

Osheroff, M.R. (1990) Subchronic oral toxicity study ofdidecyldimethylammonium chloride in dogs. HazeltonLaboratories America, Inc., Vienna, VA, USA. Study No. 2545-100 (unpublished).

6.4.1(3) – Subchronic oraltoxicity (mouse)

D19(LON 1775)

Van Miller, J.P. (1988) Subchronic dietary dose range findingstudy with didecyldimethylammonium chloride in mice. UnionCarbide, Bushy Run Research Center, Export, PA, USA. ReportNo. 51-507 (unpublished).

6.4.1 – Subchronic oraltoxicity

D108(LON 1256A)

Cox, G.E. and Bailey, D. (1975) 90-Day feeding study in dogswith a quaternary ammonium sanitizer BARDAC-22. Food andDrug Research Laboratories, Inc., Waverly, NY, USA.(unpublished).

6.4.2 – Subchronic dermaltoxicity test (rat)

D14(LON 1255)

Gill, M.W. and J.P. Van Miller (1988) Ninety-day subchronicdermal toxicity study with didecyldimethylammonium chloride inrats. Union Carbide, Bushy Run Research Center, Export, PA,USA. Project No. 51-554 (unpublished).

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6.5(1) – Chronic toxicity(dog)

D18(LON 1778)

Schulze, G.E. (1991) Chronic oral toxicity study of didecyldimethylammoniumchloridein dogs. Hazelton Washington, Inc.,Vienna, VA, USA. Study No. 2545-102 (unpublished).

6.5(2) – Chronic toxicity (rat) D30(LON 1755)

Gill, M.W., Chun, J.S. and C.L. Wagner (1991) Chronic dietarytoxicity/oncogenicity study with didecyldimethylammoniumchloridein rats. Union Carbide, Bushy Run Research Center,Export, PA, USA. Report No. 53-566 (unpublished).

6.6.1 – In vitro gene mutationstudy in bacteria

D87(LON 3341)

Thompson, P.W. (2001) LZ1043 (Didecyldimethylammoniumchloride): Reverse mutation assay "Ames Test" using Salmonellatyphimurium. Safepharm Laboratories Ltd., Derby, England.Project No. 102/368 (unpublished).

6.6.2 – In vitro cytogenicitystudy in mammalian cells

D31(LON 1253)

Holmstrom, M., Leftwich, D.J. and I.A. Leddy (1986) PO151:Chromosomal aberrations assay with Chinese hamster ovary cellsin vitro. Inveresk Research International, Musselburgh, Scotland.Report No. 4236 (unpublished).

6.6.3 – In vitro gene mutationassay in mammalian cells

D32(LON 1254)

Young, R.R. (1988) Mutagenicity test on didecyldimethylammoniumchloride(DDAC) in the CHO/HGPRT forwardmutation assay. Hazleton Laboratories America, Inc., Kensington,MD, USA. Report No. 10141-0-435 (unpublished).

6.6.4 – In vivo Mutagenicity(conditional)

D84(LON 1252)

Allen, J.A., Proudlock R.J. and P.C. Brooker (1987) Analysis ofmetaphase chromosomes obtained from bone marrow of ratstreated with P0151 (Bardac 22). Report No. LZA 24/8761.Huntingdon Research Centre, Ltd., Huntingdon, England.(unpublished).

6.6.5 – In vivo Mutagenicity(conditional)

D33(LON 1499)

Cifone, M.A. (1988) Mutagenicity test on didecyldimethyl –ammoniumchloride (DDAC) in the rat primary hepatocyteunscheduled DNA synthesis assay. Hazleton Laboratories America,Inc., Kensington, MD, USA. Study No. 10141-0-447 (unpublished).

6.7(1) – Carcinogenicity(mouse)

D21(LON 1776)

Gill, M.W., Hermansky, S.J. and C.L. Wagner (1991) Chronicdietary oncogenicity study with didecyldimethylammoniumchloride in mice. Union Carbide, Bushy Run Research Center,Export, PA, USA. Report No. 53-528 (unpublished).

6.7(2) – Carcinogenicity (rat) D30(LON 1755)

Gill, M.W., Chun, J.S. and C.L. Wagner (1991) Chronic dietarytoxicity/oncogenicity study with didecyldimethylammoniumchloride in rats. Union Carbide, Bushy Run Research Center,Export, PA, USA. Report No. 53-566 (unpublished).[REPORT FILED UNDER 6.5]

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6.8.1(1) – Teratogenicity, rat D23(LON 1781)

Neeper-Bradley, T.L. (1991) Developmental toxicity evaluationof didecyldimethylammoniumchloride administered by gavage toCD® (Sprague-Dawley) rats. Union Carbide, Bushy Run ResearchCenter, Export, PA, USA. Project No: 53-534 (unpublished).

6.8.1(2) – Teratogenicity,rabbit

D26(LON 1770)

Tyl, R.W. (1989) Developmental toxicity study ofdidecyldimethylammoniumchloride administered by gavage toNew Zealand white rabbits. Union Carbide, Bushy Run ResearchCenter, Export, PA, USA. Project No. 51-590 (unpublished).

6.8.2 – Two generationreproduction study

D29(LON 1777)

Neeper-Bradley, T. L. (1991) Two-generation reproduction studyin Sprague-Dawley (CD) rats with didecyldimethylammoniumchloride administered in the diet. Union Carbide, Bushy RunResearch Center, Export, PA, USA. Report No. 52-648(unpublished).

6.11 – Studies on otherroutes of administration(parenteral routes) – AcuteIV study in rats

D106(LON 1248)

Duprey, L.P. and J.O. Hoppe (1967) TS 19: Toxicity andirritation studies on quarternary ammonium compounds. SterlingWinthrop Research Institute, Renssalaer, NY, USA. (unpublished).

7.1.1.1.1 – Hydrolysis D36(LON 1791)

Dykes, J. and M. Fennessey (1989) Hydrolysis ofdidecyldimethylammoniumchloride (DDAC) as a function of pH at25°C. ABC Laboratories Inc., Columbia, MO, USA. Report No.37004 (unpublished).

7.1.1.1.2 –Phototransformationin water

D37(LON 1793)

Dykes, J. and M. Fennessey (1989) Determination of thephotolysis rate of didecyldimethylammoniumchloride (DDAC) inpH 7 buffered solution at 25°C. ABC Laboratories Inc., Columbia,MO, USA. Report No. 37005 (unpublished).

7.1.1.2.1(1) – Readybiodegradability

D52(LON 2305)

Downing, J.L. (1993) Aerobic aquatic biodegradation ofdidecyldimethylammonium chloride using a shake flask testsystem. ABC Laboratories, Inc., Environmental Fate andAssessment Division, Columbia, MO, USA. Report No. 40687(unpublished).


D61a(LON 2923)

Schaefer E.C. (1996) Aerobic aquatic biodegradation test withdidecyldimethylammoniumchloride (DDAC) and a bentoniteclay:DDAC complex conducted with natural sediment and sitewater. Wildlife International Ltd., Easton, MD, USA. Project No.434E-101 (unpublished).


D110(LON 2970)

Hirschen, D.M., Ziemer, M. and D. Seifert (1998) Bardac 22:DOC die-away test OECD 301 A with pre-adapted inoculum.Clariant GmbH, Frankfurt, Germany. Report No. D0094-1

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(unpublished).7.1.1.2.1(4) – Readybiodegradability

D134(LON 3796)

Bazzon, M and F. Deschamps (2002) Biotic degradationbiodegradability evaluation on aqueous medium ultimate aerobia ofthe referenced compounds, CATIGENE T 50. INERIS, Vert-lepetit,France. Study No. 506223 (unpublished).

7.1.1.2.2 – Inherentbiodegradability

D110(LON 2970)

Hirschen, D.M., Ziemer, M. and D. Seifert (1998) Bardac 22:DOC die-away test OECD 301 A with pre-adapted inoculum.Clariant GmbH, Frankfurt, Germany. Report No. D0094-1(unpublished).[REPORT FILED UNDER ENDPOINT 7.1.1.2.1]

7.1.2.1.1 – Aerobicbiodegradation

D60(LON 3438)

Schaefer, E.C. (2001) Didecyldimethylammonium chloride(DDAC): Dieaway in activated sludge. Wildlife International,Inc., Easton, MA, USA. Project No. 289E-112 (unpublished).

Other Non-KeyBiodegradability Report(s)Included in This Submission

D111(LON 1266)

Bücking H. -W. (1989) Prüfung des biologischen Abbaus vonBARDAC 22 im OECD-Confirmatory-Test. Hoechst, Frankfurt,Germany. Report No. 95/89(B) (unpublished).

D40(LON 1798)

Cranor, W. (1991) Anaerobic aquatic metabolism of 14CDidecyldimethylammoniumchloride(14C-DDAC) ABCLaboratories, Inc., Columbia, MO, USA. Report No. 37007(unpublished).

D41(LON 1794)

Cranor, W. (1991) Aerobic aquatic metabolism of 14CDidecyldimethylammoniumchloride(14C-DDAC) ABCLaboratories, Inc., Columbia, MO, USA. Report No. 37008(unpublished).

D65(LON 3255)

de Vette, H.Q.M., van Asten, J.G. and A.O. Hanstveit (2000) Awater/sediment study of didecyldimethylammonium chloride(DDAC) using [14C]-DDAC. TNO Nutrition and Food Research,Delft, The Netherlands. Study No. IMW-99-9048-01 (unpublished).

D39(LON 1796)

Cranor, W. (1991) Aerobic soil metabolism of 14C -Didecyldimethylammonium chloride (14C-DDAC). ABCLaboratories, Columbia, MO, USA. Report No. 37006(unpublished).

D120(LON 1957)

Todt K. (1991) Abbau von Didecydimethylammoniumchlorid imBoden unter Praxisbedingungen. Natec, Hamburg, Deutschland.Abschlußbericht NA 91 9601 (unpublished).

7.2.2.4 – Other soildegradation studies

D38(LON 3069)

Schmidt, J. (1992) Determination of the photolysis rate ofdidecyldimethylammonium chloride on the surface of soil. ABCLaboratories, Columbia, MO, USA. Report No. 39505(unpublished).

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7.2.3.1 – Adsorption anddesorption

D42(LON 1792)

Daly, D. (1989) Soil/sediment adsorption-desorption of 14C - Didecyldimethylammoniumchloride(DDAC). Analytical Bio-Chemistry Laboratories, Inc., Columbia, MO, USA. Report No.37009 (unpublished).

7.4.1.1(1) – Acute toxicity tofish (Oncorhynchus kisutch)

D5(LON 1788)

LeLievre, M.K. (1990) Evaluation of didecyldimethylammoniumchloride (DDAC) in a static acute toxicity test with Coho salmon,Oncorhynchus kisutch. Springborn Laboratories, Inc., Wareham,MA, USA. SLI Report No. 90-4-3290 (unpublished).

7.4.1.1(2) – Acute toxicity tofish (Lepomis macrochirus)

D4(LON 1786)

LeLievre, M.K. (1990) Evaluation of Didecyldimethylammoniumchloride (DDAC) in a static acute toxicity test with bluegillsunfish, Lepomis macrochirus. Springborn Laboratories, Inc.,Wareham, MA, USA. SLI Report No. 89-10-3111 (unpublished).

7.4.1.1(3) – Acute toxicity tofish (Pimephales promelas)

D56(LON 2937)

Putt, A.E. (1994) Didecyldimethylammoniumchloride (DDAC):Static acute toxicity to fathead minnow (Pimephales promelas)with and without the presence of humic acid. SpringbornLaboratories, Inc., Wareham, MA, USA. Report No. 94-1-5122(unpublished).

7.4.1.1(4) – Acute toxicity tofish (Pimephales promelas)

D68(LON 3087)

Swigert, J.P., Graves, W.C. and M.A. Mank (1995) An evaluationof didecyldimethylammoniumchloride (DDAC) in a 96-hour flowthroughacute toxicity study with the fathead minnow (Pimephalespromelas). Wildlife International Ltd., Easton, MD, USA. ProjectNo. 289A-124 (unpublished).

7.4.1.1(5) – Acute toxicity tofish (Oncorhynchus mykiss)

D69(LON 3809)

Swigert, J.P., W.C. Graves and M.A. Mank (1995) An evaluationof didecyldimethylammonium chloride (DDAC) in a 96-hour flowthroughacute toxicity study with the rainbow trout (Oncorhynchusmykiss). Wildlife International Ltd., Easton, MD, USA. ProjectNo. 289A-125 (unpublished).

7.4.1.1 – Acute toxicity to fish(Cyprinodon variegatus)

D54(LON 3166)

Collins, M.K. (1994) Didecyldimethylammonium-chloride(DDAC): Evaluation in a static acute toxicity test with sheepsheadminnow (Cyprinodon variegatus). Springborn Laboratories, Inc.,Wareham, MA, USA. SLI Report No. 93-6-4833 (unpublished).

7.4.1.1 – Acute toxicity to fish(Acipenser transmontanus)

D55(LON 2948)

Miller, J.L. (1997) Evaluation of Bardac 2280 in a static-renewalacute toxicity test with juvenile white sturgeon, Acipensertransmontanus. Aqua-Science Environmental Toxicology

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Specialists, Davis, CA, USA. (unpublished).7.4.1.1 – Acute toxicity to fish(Oncorhynchus mykiss)

D112(LON 1270)

Luy, T. and S. Frances (1971) Report on fish (rainbow trout)toxicity testing using BARDAC 22. Wells Laboratories, Inc.,Jersey City, NJ, USA. (unpublished).

7.4.1.1 – Acute toxicity to fish(Poecilia reticulata)

D113(ON 1268)

Adema, D.M.M. (1978) The acute toxicity of Barquat MB 50,Barquat 4250 and Bardac 22 to young guppies. CentraalLaboratorium TNO, Delft, The Netherlands. Report No. CL 78/34(unpublished).

7.4.1.1 – Acute toxicity to fish(Acipenser transmontanus) inthe presence of Fraser Riversediment

D64(LON 2950)

Miller, J.L. (1997) Evaluation of Bardac 2280 in a static-renewalacute toxicity test with juvenile white sturgeon Acipensertransmontanus, in the presence of Fraser River sediment. Aqua-Science, Davis, CA, USA. (unpublished).

7.4.1.1 – Acute toxicity to fish(Oncorhynchus mykiss)

D70(LON 2938)

Swigert, J.P., Graves, W.C. and M.A. Mank (1995) Evaluation ofa Bentonite clay:didecyldimethylammoniumchloride (DDAC)complex in a 96-hour static acute toxicity study with the rainbowtrout (Oncorhynchus mykiss). Wildlife Internationl, Ltd., Easton,MD, USA. Project No. 289A-121 (unpublished).

7.4.1.2(1) – Acute toxicity toinvertebrates (Daphniamagna)

D6(LON 1787)

LeLievre, M.K. (1990) Evaluation of didecyldimethylammoniumchloride (DDAC) in a static acute toxicity test with daphnids,Daphnia magna. Springborn Laboratories, Inc., Wareham, MA,USA. Report No. 89-10-3112 (unpublished).

7.4.1.2(2) – Acute toxicity toinvertebrates (Daphniamagna)

D67(LON 2939)

Swigert, J.P., Graves, W.C. and M.A. Mank (1995) An evaluationof didecyldimethylammoniumchloride (DDAC) in a 48-hour flowthroughacute toxicity study with the cladoceran (Daphnia magna).Wildlife International Ltd., Easton, MD, USA. Project No. 289A-122 (unpublished).

7.4.1.2 – Acute toxicity toinvertebrates (Mysidopsisbahia)

D8(LON 1789)

LeLievre, M.K. (1990) Evaluation of didecyldimethylammoniumchloride (DDAC) in a static acute toxicity test with mysid shrimp,Mysidopsis bahia. Springborn Laboratories, Inc., Wareham, MA,USA. Report No. 90-2-3233 (unpublished).

7.4.1.2 – Acute toxicity toinvertebrates (Crassostreavirginica)

D59 Dionne, E. (1994) Didecyldimethylammoniumchloride (DDAC):Evaluation in a static (recirculated) acute toxicity test with Easternoysters (Crassostrea virginica) using [14C]-DDAC. Springborn

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Laboratories, Inc., Environmental Sciences Division, Wareham,MA, USA. Report No: 93-12-5079 (unpublished).

7.4.1.2 – Acute toxicity toinvertebrates (Crassostreavirginica)

D58(LON 3167)

Dionne, E. (1994) Didecyldimethylammoniumchloride (DDAC):Evaluation in a static (recirculated) acute toxicity test with Easternoysters (Crassostrea virginica) using [14C]-DDAC. SpringbornLaboratories, Inc., Environmental Sciences Division, Wareham,MA, USA. Report No. 93-6-4854 (unpublished).

7.4.1.3(1) – Growthinhibition test on algae(Selenastrum capricornutum)

D57(LON 3433)

Desjardins, D., Kendall, T.Z., Van Hoven, R.L. and H.O. Krueger(2003) Bardac 2280: A 96-hour toxicity test with the freshwateralga (Selenastrum capricornutum). Wildlife International, Ltd.,Easton, MD, USA. Project No. 289A-152 (unpublished).

7.4.1.3(2) – Growthinhibition test on algae(Scenedesmus subspicatus)

D115(LON 3011)

Scheerbaum, D. (1998) Bardac 22: Alga, growth inhibition test(72hr). Dr.U.Noack-Laboratorium fur Angewandte Biologie,Sarstedt, Germany. Study No. SS061301 (unpublished).

7.4.1.3(3) – Growthinhibition test on algae(Selenastrum capricornutum)in Natural Surface Water

D66(LON 3659)

Desjardins, D., Kendall, T.Z., Van Hoven, R.L. and H.O. Krueger(2003) Bardac 2280: A 96-hour toxicity test with the freshwateralga (Selenastrum capricornutum) using natural surface water.Wildlife International, Ltd., Easton, MD, USA. Project No. 289A-153 (unpublished).

7.4.1.4 – Inhibition tomicrobiological activity

D117(LON 3330)

Mead, C. (2001) LZ1043 (Didecyldimethylammounium chloride):Assessment of the inhibitory effect on the respiration of activatedsewage sludge. Safepharm Laboratories Ltd., Derby, England.Project No. 102-369 (unpublished).


D116(LON 1265)

Vonk, J.W. (1989) Biodegradability of Bardac-22. NetherlandsOrganization for Applied Scientific Research, TNO Division ofTechnology for Society, Delft, The Netherlands. Report No.R89/252 (unpublished).

7.4.3.2 – Reproduction andgrowth in fish (Brachydaniorerio)

D118(LON 3373)

Hooftman, R.N., de Vette, H.Q.M. and B. Borst (2001) Early lifestage test under intermittent flow-through conditions withdidecyldimethylammounium chloride and the fish species,Brachydanio rerio (OECD Guideline No. 210). TNO Chemistry,

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Delft, The Netherlands. Report No. V99.1173 (unpublished).7.4.3.3.1 – Bioaccumulationin fish(Lepomis machrochirus)

D43(LON 1790)

Fackler, P.H. (1990) Bioconcentration and elimination of 14Cresiduesby bluegill (Lepomis machrochirus) exposed todidecyldimethylammonium chloride (DDAC). SpringbornLaboratories, Inc., Wareham, MA, USA. Report No. 89-7-3043(unpublished).

7.4.3.4 – Reproduction andgrowth in invertebrates(Daphnia magna)

D7(LON 3323)

Hooftman, R.N. and H.Q.M. de Vette (2001) Intermittent flowthroughreproduction test with didecyldimethylammonium chlorideand Daphnia magna. TNO Nutrition and Food Research,Department of Environmental Toxicology, Delft, The Netherlands.Report No. V99.1171 (unpublished).

7.4.3.4 – Reproduction andgrowth in invertebrates(Daphnia magna)

D121(LON 1953)

Jonas, W. (1992) Bardac 2270: Reproduktionstest an Daphniamagna. (unpublished).

7.4.3.5.1 – Effects onsediment dwelling organisms(Chironomus tentans)

D63(LON 2941)

England, D.C. and T. Leak (1995) Chronic toxicity of sedimentincorporateddidecyldimethylammoniumchloride (DDAC) toChironomus tentans. ABC Laboratories, Columbia, MO, USA.Report No. 41005 (unpublished).


D119(LON 3378)

DeVette, H.Q.M., Hanstveit, R. and J.A. Schoonmade (2001) Theassessment of the ecological effects of didecyldimethylammouniumchloride (Guidelines OPPTS 850.5100 Soil MicrobialCommunity Test, OECD 216 and OECD 217 and CTB SectionH.4.1). TNO Chemistry, Delft, The Netherlands. Study No. IMW-99-9048-05 (unpublished).

7.5.1.2(1) – Acute toxicity toearthworms

D88(LON 3153)

Henzen, L. (1999) The acute toxicity of DDAC to the wormspecies Eisenia fetida in a 14-day test (OECD Guideline No. 207).TNO Nutrition and Food Research Institute, Delft, TheNetherlands. Report No. V99.160 (unpublished).

7.5.1.2(2) – Acute toxicity toearthworms

D133(LON 3799)

Rodgers, M.H. (2004) N-Alkyl (C12-16)-N,N-dimethyl-Nbenzylammoniumchloride (ADBAC): Acute toxicity (LC50) to theearthworm. Huntingdon Life Sciences, Huntingdon,Cambridgeshire, England. Report No. ADB/023 033976(unpublished).

7.5.1.3 – Acute toxicity toplants

D114(LON 3811)

Gray, J. (2004) N,N-Didecyl-N,N-dimethylammonium chloride(DDAC): Acute toxicity to terrestrial plants. Huntingdon LifeSciences, Huntingdon, Cambridgeshire, England. Study No.DKG/014 (unpublished).

7.5.3.1.1 – Acute oraltoxicity (Bobwhite Quail)

D1(LON 1784)

Campbell, S., Hoxter, K.A. and G.J. Smith (1991)Didecyldimethylammonium chloride: An acute oral toxicity

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studywith the northern bobwhite. Wildlife International Ltd., Easton,MD, USA. Project No. 289-103A (unpublished).

7.5.3.1.2(1) – Short-termtoxicity (Bobwhite Quail)

D2(LON 1785)

Long, R.D., Hoxter, K.A. and G.J. Smith (1991)Didecyldimethylammonium chloride: A dietary LC50 Study withthe northern bobwhite. Wildlife International Ltd., Easton, MD,USA. Project No. 289-101 (unpublished).

7.5.3.1.2(2) – Short-termtoxicity (Mallard duck)

D3(LON 1783)

Long, R.D., Hoxter, K.A. and G.J. Smith (1991)Didecyldimethylammoniumchloride: A dietary LC50 study with themallard. Wildlife International Ltd., Easton, MD, USA. ProjectNo. 289-102 (unpublished).

Other Non-Key Report(s)Included in This Submission

D53(LON 3815)

Bestari, K. (2001) Determination of the leachability of Bardac2280 from treated wood. Centre for Toxicology, University ofGuelph, Guelph, Ontario, Canada. Study No. 200-CT-WL-B22(unpublished).

References SupportingSummaries Found inDocument III-A, Section 5

D138 Ruddick, J.N.R. (1984) Appendix C – Alkylammonium compoundsas wood preservatives. Proc. Am. Wood. Pres. Assn. 80, 191-204and Appendix D – Field testing of alkylammonium woodpreservatives, pp. 206-210.


D140 Creffield, J.W. (1993) A study on the effectiveness of DDAC toprotect wood from attack by termites. IRG Document No.IRG/WP/93-30009.

D141 Graf, E. (1987) Determination of the protective effectiveness ofBardac 22 against wood destroying basidiomycetes after leachingprocedure. Swiss Federal Laboratories for Materials Testing andResearch, EMPA St. Gallen, Switzerland. Report No. 2311491(unpublished). [Ref. No. D132 (LON 3819), English translation ofthe German original test report (Bestimmung derWirksamkeitsgrenze von Bardac 22 gegen holzzerstörendeBasidiomyceten) attached as Annex.

D142 Linfield, W.M. (1969) In E. Jungermann, Ed., “CationicSurfactants”, Marcel Dekker, New York, N.Y. Chapter 2,“Straight-Chain Alkylammonium Compounds, pages 9-70.

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D144 Molnar, S., Dickinson, D.J. and R.J. Murphy (1996) Acceleratedtesting for out-of-ground contact using natural biologicalpreconditioning. International Research Group on WoodPreservation Document No. IRG/WP 96-20088.

D145 Molnar, S., Dickinson, D.J. and R.J. Murphy (1997a) Acceleratedtesting for out-of-ground contact using natural biologicalpreconditioning. International Research Group on WoodPreservation Document No. IRG/WP 97-20108.

D146 Molnar, S., Dickinson, D.J. and R.J. Murphy (1997b) Microbialecology of treated lap-joints at Hilo, Hawaii for 24 months.International Research Group on Wood Preservation DocumentNo. IRG/WP 97-20107.

D147 Preston, A.F., McKaig, P.A. and P.J. Walcheski (1986) Termiteresistance of treated wood in an above ground field test.International Research Group on Wood Preservation DocumentNo. IRG/WP 1300.

D148 Preston, A.F., Walcheski, P.J., McKaig, P.A. and D.D. Nicholas(1987) Recent research on alkylammonium compounds in the U.S.Proc. Am. Wood Pres. Assn. 83, 331-347.

D149/D150 Walker, L.E. (1999) Waterproofing and preservative compoundsand preparation thereo. U.S. Patent 5,855,817; and Walker L.E.(1998) Waterproofing and preservative composition for wood. U.S.Patent 5,833,741.

D151 Wazny, J. and L.J. Cookson (1993) A comparison of Coniophoraolivacea and Coniophora puteana test strains. InternationalResearch Group on Wood Preservation Document No.IRG/WP/20004.

D152 Wazny, J. and L.J. Cookson (1994) Comparison of the agar blockand soil block methods used for evaluation of fungitoxic value ofQAC and CCA wood preservatives. International Research Groupon Wood Preservation Document No. IRG/WP/20039.

D153 Zahora, A., Jin, L., Cui, F., Walcheski, P. and K. Archer (2000)E-mail communication of June 9, 2000 and attached memo toAWPA Formosan Subterranean Task Force.

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Document III B

Endpoint ReferenceNo.

ReferenceNon-Key Studies are italicized.

3.5(1) – Acidity/alkalinityand if necessary pH value(1% in water)

D156(LON 4006)

Sydney, P. (2006) BC-25: Physicochemical properties.Huntingdon Life Sciences Ltd., Huntingdon, Cambridgeshire,England. Report No. DKG0018/062229 (unpublished).

3.6(1) – Relative Density D156(LON 4006)


3.8(1) – Technicalcharacteristics of the biocidalproduct: Persistent foaming

D156(LON 4006)


3.10.2(1) – Viscosity D156(LON 4006)


References SupportingSummaries Found inDocument III-B, Section 5


D143 Moffat, A.R. (1994) A determination of the toxic level ofACQ2100 wood preservative for the powder post borer Lyctusbrunneus (Stephens). International Research Group on WoodPreservation Document No. IRG/WP 94-20029.

D144 Molnar, S., Dickinson, D.J. and R.J. Murphy (1996) Acceleratedtesting for out-of-ground contact using natural biologicalpreconditioning. International Research Group on WoodPreservation Document No. IRG/WP 96-20088.

D145 Molnar, S., Dickinson, D.J. and R.J. Murphy (1997a) Acceleratedtesting for out-of-ground contact using natural biologicalpreconditioning. International Research Group on WoodPreservation Document No. IRG/WP 97-20108.

D146 Molnar, S., Dickinson, D.J. and R.J. Murphy (1997b) Microbialecology of treated lap-joints at Hilo, Hawaii for 24 months.International Research Group on Wood Preservation DocumentNo. IRG/WP 97-20107.

D148 Preston, A.F., Walcheski, P.J., McKaig, P.A. and D.D. Nicholas(1987) Recent research on alkylammonium compounds in the U.S.Proc. Am. Wood Pres. Assn. 83, 331-347.

D153 Zahora, A., Jin, L., Cui, F., Walcheski, P. and K. Archer (2000)E-mail communication of June 9, 2000 and attached memo toAWPA Formosan Subterranean Task Force.

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Appendix IV: List of standard terms and abbreviations

Stand. term / Abbreviation

Explanation

A AmpereACh AcetylcholineAChE AcetylcholinesteraseADBAC Alkyldimethylbenzylammonium ChlorideADI acceptable daily intakeADME administration distribution metabolism and excretionADP adenosine diphosphateAE acid equivalentAF assessment factorAFID alkali flame-ionisation detector or detectionA/G albumin/globulin ratioai active ingredientALD50 approximate median lethal dose, 50%ALT alanine aminotransferase (SGPT)Ann. AnnexAOEL acceptable operator exposure levelAMD automatic multiple developmentANOVA analysis of varianceAP alkaline phosphataseapprox ApproximateARC anticipated residue contributionARfD acute reference doseas active substanceAST aspartate aminotransferase (SGOT)ASV air saturation valueATP adenosine triphosphateBAF bioaccumulation factorBCF bioconcentration factorbfa body fluid assayBOD biological oxygen demandbp boiling pointBPD Biocidal Products DirectiveBSAF biota-sediment accumulation factorBSE bovine spongiform encephalopathyBSP bromosulfophthaleinBUN blood urea nitrogenbw body weightc centi- (x 10 –2 )°C degrees Celsius (centigrade)CA controlled atmosphereCAD computer aided designcd candelaCDA controlled drop(let) applicationcDNA complementary DANN

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Explanation

CEC cation exchange capacitycf confer, compare toCFU colony forming unitsChE cholinesteraseCI confidence intervalCL confidence limitscm centimetreCNS central nervous systemCOD chemical oxygen demandConc ConcentrationCPK creatinine phosphatasecv coefficient of variationCv ceiling valued day(s)DDAC Didecyldimethylammonium ChlorideDES diethylstilboestrolDIS draft international standard (ISO)DMSO dimethylsulfoxideDNA deoxyribonucleic aciddna designated national authorityDO dissolved oxygenDOC dissolved organic carbondpi days post inoculationDRP detailed review paper (OECD) DT50(lab) period required for 50 percent dissipation (under laboratory conditions) (define

method of estimation)DT90(field) period required for 90 percent dissipation (under field conditions) (define

method of estimation)dw dry weightDWQG drinking water quality guidelines decadic molar extinction coefficientEASE Estimation and Assessment of Substance ExposureEC50 median effective concentrationECD electron capture detectorED50 median effective doseEDI estimated daily intakeEINECS European inventory of existing commercial substancesELINCS European list of notified chemical substancesELISA enzyme linked immunosorbent assaye-mail electronic mailEMDI estimated maximum daily intakeEN European normEPMA electron probe micro-analysisERL extraneous residue limitESD Emission Scenario DocumentESPE46/51 evaluation system for pesticides

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Explanation

EUSES European Union system for the evaluation of substancesF FieldF0 parental generationF1 filial generation, firstF2 filial generation, secondFBS full base setFELS fish early-life stageFIA fluorescence immuno-assayFID flame ionisation detectorFmol fractional equivalent of the metabolite´s molecular weight compared to the

active substanceFOB functional observation batteryfoc organic carbon factor (compartment dependent) fp freezing pointFPD flame photometric detectorFPLC fast protein liquid chromatographyg gram(s)gd gestation dayGAP good agricultural practiceGC gas chromatographyGC-EC gas chromatography with electron capture detectorGC-FID gas chromatography with flame ionisation detectorGC-MS gas chromatography-mass spectrometryGC-MSD gas chromatography with mass-selective detectionGEP good experimental practiceGFP good field practiceGGT gamma glutamyl transferaseGI gastro-intestinalGIT gastro-intestinal tractGL guideline levelGLC gas liquid chromatographyGLP good laboratory practiceGM geometric meanGMO genetically modified organismGMM genetically modified micro-organismGPC gel-permeation chromatographyGPS global positioning systemGSH GlutathioneGV Granulosevirush hour(s)H Henry’s Law constant (calculated as a unitless value) ha hectare(s)Hb HaemoglobinHC5 concentration which will be harmless to at least 95 % of the species present with

a given level of confidence (usually 95 %)HCG human chorionic gonadotropin

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Explanation

Hct HaematocritHDT highest dose testedhL HectolitreHEED high energy electron diffractionHID helium ionisation detectorHPAEC high performance anion exchange chromatographyHPLC high pressure liquid chromatography or high performance liquid

chromatographyHPLC-MS high pressure liquid chromatography - mass spectrometryHPPLC high pressure planar liquid chromatographyHPTLC high performance thin layer chromatographyHRGC high resolution gas chromatographyHS Shannon-Weaver indexHt HaematocritHUSS human and use safety standard I IndoorI50 inhibitory dose, 50%IC50 median immobilisation concentration or median inhibitory concentration 1ICM integrated crop managementID ionisation detectorIEDI international estimated daily intakeIGR insect growth regulatorim intramuscularinh inhalationINT 2-p-iodophenyl-3-p-nitrophenyl-5-phenyltetrazoliumchloride testing methodip intraperitonealIPM integrated pest managementIR infraredISBN international standard book numberISSN international standard serial numberIUCLID International Uniform Chemical Information Databaseiv intravenousIVF in vitro fertilisationk (in combination) kilok rate constant for biodegradationK Kelvin Ka acid dissociation constantKb base dissociation constantKads adsorption constantKdes apparent desorption coefficientkg kilogramKH Henry´s Law constant (in atmosphere per cubic metre per mole)Koc organic carbon adsorption coefficientKom organic matter adsorption coefficientKow octanol-water partition coefficientKp solid-water partition coefficient

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Explanation

kPa kilopascal(s)l, L litreLAN local area networkLASER light amplification by stimulated emission of radiationLBC loosely bound capacityLC liquid chromatographyLC-MS liquid chromatography- mass spectrometryLC50 lethal concentration, medianLCA life cycle analysisLC-MS-MS liquid chromatography with tandem mass spectrometryLD50 lethal dose, median; dosis letalis mediaLDH lactate dehydrogenaseln natural logarithmLOAEC lowest observable adverse effect concentrationLOAEL lowest observable adverse effect levelLOD limit of detectionLOEC lowest observable effect concentrationLOEL lowest observable effect levellog logarithm to the base 10LOQ limit of quantification (determination)LPLC low pressure liquid chromatographyLSC liquid scintillation counting or counterLSD least squared denominator multiple range testLSS liquid scintillation spectrometryLT lethal thresholdm MetreM Molarµm micrometre (micron)MAC maximum allowable concentration MAK maximum allowable concentration MC moisture contentMCH mean corpuscular haemoglobinMCHC mean corpuscular haemoglobin concentrationMCV mean corpuscular volumeMDL method detection limitMFO mixed function oxidaseµg microgrammg milligramMHC moisture holding capacityMIC minimum inhibitory concentration min minute(s)MKC minimum killing concentrationmL millilitreMLT median lethal timeMLD minimum lethal dosemm millimetre

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Explanation

MMAD mass median aerodynamic diametermo month(s)MOE margin of exposuremol mole(s)MOS margin of safetymp melting pointMRE maximum residue expectedMRL maximum residue level or limitmRNA messenger ribonucleic acidMS mass spectrometryMSDS material safety data sheetMTD maximum tolerated doseMT material testMW molecular weightn.a. not applicablen- normal (defining isomeric configuration)n number of observationsNAEL no adverse effect levelnd not detectedNEDI national estimated daily intakeNEL no effect levelNERL no effect residue levelng Nanogramnm NanometreNMR nuclear magnetic resonanceno, n° NumberNOAEC no observed adverse effect concentrationNOAEL no observed adverse effect levelNOEC no observed effect concentrationNOED no observed effect doseNOEL no observed effect levelNOIS notice of intent to suspendNPD nitrogen-phosphorus detector or detectionNPV nuclear polyhedrosis virusNR not reportedNTE neurotoxic target esteraseOC organic carbon contentOCR optical character recognitionODP ozone-depleting potentialODS ozone-depleting substancesOEL occupational exposure limit OH HydroxideOJ Official JournalOM organic matter contentPa PascalPAD pulsed amperometric detection

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Explanation

2-PAM 2-pralidoximepc paper chromatographyPCV haematocrit (packed corpuscular volume)PEC predicted environmental concentrationPECA predicted environmental concentration in airPECS predicted environmental concentration in soilPECSW predicted environmental concentration in surface waterPECGW predicted environmental concentration in ground waterPED plasma-emissions-detectorpH pH-valuePHED pesticide handler’s exposure dataPIC prior informed consentpic phage inhibitory capacityPIXE proton induced X-ray emissionpKa negative logarithm (to the base 10) of the acid dissociation constantpKb negative logarithm (to the base 10) of the base dissociation constantPNEC predicted no effect concentration (compartment to be added as subscript)po by mouthPOP persistent organic pollutantsppb parts per billion (10-9 )PPE personal protective equipmentppm parts per million (10-6 )PPP plant protection productppq parts per quadrillion (10-24 )ppt parts per trillion (10-12 )PSP phenolsulfophthaleinPrT prothrombin timePRL practical residue limitPT product typePT(CEN) project team CENPTDI provisional tolerable daily intakePTT partial thromboplastin timeQA quality assuranceQAU quality assurance unit(Q)SAR quantitative structure-activity relationshipr correlation coefficientr 2 coefficient of determinationRA risk assessmentRBC red blood cellREI restricted entry intervalRENI Registry Nomenclature Information SystemRf retardation factorRfD reference doseRH relative humidityRL50 median residual lifetimeRNA ribonucleic acid

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Explanation

RP reversed phaserpm revolutions per minuterRNA ribosomal ribonucleic acidRRT relative retention timeRSD relative standard deviations SecondS SolubilitySAC strong adsorption capacitySAP serum alkaline phosphataseSAR structure/activity relationshipSBLC shallow bed liquid chromatographysc Subcutaneoussce sister chromatid exchangeSCAS semi-continuous activated sludgeSCTER smallest chronic toxicity exposure ratio (TER)SD standard deviationse standard errorSEM standard error of the meanSEP standard evaluation procedureSF safety factorSFC supercritical fluid chromatographySFE supercritical fluid extractionSIMS secondary ion mass spectroscopyS/L short term to long term ratioSMEs small and medium sized enterprisesSOP standard operating proceduressp species (only after a generic name)SPE solid phase extractionSPF specific pathogen freespp subspeciesSSD sulphur specific detectorSSMS spark source mass spectrometrySTEL short term exposure limitSTER smallest toxicity exposure ratio (TER)STMR supervised trials median residueSTP sewage treatment plantt tonne(s) (metric ton)t½ half-life (define method of estimation)T3 tri-iodothyroxineT4 thyroxineT25 tumorigenic dose that causes tumours in 25% of the test animals TADI temporary acceptable daily intakeTBC tightly bound capacityTCD thermal conductivity detectorTG technical guideline, technical groupTGD Technical guidance document

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July 2007


Explanation

TID thermionic detector, alkali flame detectorTDR time domain reflectrometryTER toxicity exposure ratioTERI toxicity exposure ratio for initial exposureTERST toxicity exposure ratio following repeated exposureTERLT toxicity exposure ratio following chronic exposuretert tertiary (in a chemical name)TEP typical end-use productTGGE temperature gradient gel electrophoresisTIFF tag image file formatTLC thin layer chromatographyTlm median tolerance limitTLV threshold limit valueTMDI theoretical maximum daily intakeTMRC theoretical maximum residue contributionTMRL temporary maximum residue limitTNsG technical notes for guidanceTOC total organic carbonTremcard transport emergency cardtRNA transfer ribonucleic acidTSH thyroid stimulating hormone (thyrotropin)TTC 2,3,5-triphenylterazoliumchloride testing methodTWA time weighted averageUDS unscheduled DNA synthesisUF uncertainty factor (safety factor)ULV ultra low volumeUR unit riskUV UltravioletUVC unknown or variable composition, complex reaction productsUVCB undefined or variable composition, complex reaction products in biological

materialv/v volume ratio (volume per volume)vis VisibleWBC white blood cellwk Weekwt Weightw/v weight per volumeww wet weightw/w weight per weightXRFA X-ray fluorescence analysisyr year< less than less than or equal to> greater than greater than or equal to

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