Chemistry Scoring Index -...

Review of Halliburton Energy Services, Inc. (HESI)Chemistry Scoring Index

Prepared forHalliburton Energy Services, Inc.

P.O. Box 42806Houston, TX 77242-2806

December 30, 2009

~ -~ Grad=ent

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Table of Contents

1 Introduction ..............................................................................................................1

2 The CSI Approach is Scientifically Defensible .......................................................32.1 Review Criteria ...................................................................................................................32.2 Description of the CSI ........................................................................................................42.3 Assessment of the Primary Review Criteria .......................................................................5

2.3.1 Selection of Hazard Categories: The CSI generally reflects acomprehensive approach to hazard identification ..................................................5

2.3.2 Selection of a Concentration Cut-Off Value: The CSI reflects an inclusiveapproach to concentration cut-offs .........................................................................6

2.3.3 Assignment of Hazard Categories: The CSI reflects a comprehensiveapproach to assigning hazards ...............................................................................6

2.3.4 Data Sources: The CSI relies on a widely used and generallycomprehensive primary data source .......................................................................7

2.4 Assessment of the Secondary Review Criteria ................................................................... 72.4.1 Scoring of Chemicals with No Data Available: The CSI approach assigns

a higher hazard score when data are not available .................................................72.4.2 Weighting of Health vs. Environmental vs. Physical Safety Hazard

Criteria: The CSI’s approach to weighting its three hazard criteria isappropriate for genetic hazard scoring ..................................................................8

2.4.3 Weighting of Scores Between Hazard Categories Within a Criterion: TheCSI’s scoring is logical, and technically supportable .............................................8

2.4.4 Weighting Within a Hazard Category Based on Concentration: The CSIscoring approach is logical, and technically supportable .......................................8

2.5 Summary .............................................................................................................................9

3

4

5

The CSI Approach is Comparable to Several Existing Ranking Systems .............103.1 Detailed Comparison ........................................................................................................11

3.1.1 Green Screen ........................................................................................................123.1.2 US EPA’s CHAMP ...............................................................................................143.1.3 US EPA’s DIE General Screen for Safer Ingredients ..........................................16

3.2 Summary ...........................................................................................................................17

Implementation and Use of the CSI will Enhance HESI’s CorporateSustainability Strategies .........................................................................................18

Summary and Conclusions .....................................................................................19

References .........................................................................................................................20

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List of Tables

TableTableTableTableTableTableTableTable

2.1a2.1b2.1c2.2a2.2b2.2c2.32.4

Table 3.1Table 3.2Table 3.3

CSI - Health CriterionCSI - Physical Safety CriterionCSI - Environmental CriterionCSI Scoring Scheme - Health CriterionCSI Scoring Scheme - Physical Safety CriterionCSI Scoring Scheme - Environmental CriterionComparison of CSI and GHS Cut-Off ValuesTotal Possible Score per Hazard Criteria for a Single Chemical

CPA Green Screen for Safer ChemicalsUS EPA CHAMPUS EPA DIE General Screen for Safer Ingredients

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List of Abbreviations

ACGIHBCFCEPACHAMPCPACPSIACSIDARTDIEDSLECOSARE-FASTEUGHSHHAPHBPHESIHPVHSDBHWPIRCHSIRISLLOLIMMPVMSDSOECDOPPTOSHAPBTPVCQSARRBPREACHRollSRSEISCRAMSIDSTRITSCAUSUS EPAVVOCsWMPT

American Conference of Industrial HygienistsBioconcentration FactorCanada Environmental Protection AgencyChemical Assessment and Management ProgramClean Production ActionConsumer Product Safety Improvement ActChemistry Scoring IndexDecision Analysis by Ranking TechniquesDesign for the EnvironmentDomestic Substances ListEcological Structure Activity RelationshipsExposure and Fate Assessment Screening ToolEurope UnionGlobally Harmonized SystemHighHazardous Air PollutantHazard-Based PrioritizationHalliburton Energy Services, Inc.High Production VolumeHazardous Substances Data BankHazardous Water PollutantIndiana Relative Chemical Hazard ScoreIntegrated Risk Information SystemLowList Of ListsModerateMedium Production VolumeMaterial Safety Data SheetOrganization for Economic Cooperation and DevelopmentOffice of Pollution Prevention and ToxicsOccupational Safety and Health AdministrationPersistent, Bioaccumulative ToxicsPolyvinyl ChlorideQuantitative Structure Activity RelationshipRisk-Based PrioritizationRegistration, Evaluation, Authorisation and Restriction of Chemical SubstancesRestriction of Hazardous SubstancesRisk-Screening Environmental IndicatorsScoring and Ranking Assessment ModelScreening Information Data SetToxics Release InventoryToxic Substances Control ActUnited StatesUnited States Environmental Protection AgencyVery HighVolatile Organic CompoundsWaste Minimization Prioritization Tool


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1 Introduction

Gradient was retained by Halliburton Energy Services, Inc. (HESI) to review a comprehensive

hazard evaluation system, which was developed by HESI, and is hereafter referred to as "the Chemistry

Scoring Index," or "CSI." HESI personnel described the CSI during several conference calls with

Gradient, and provided Excel spreadsheets to Gradient containing eight product use groups consisting of a

total of 127 products comprised of 300-400 chemicals. This information formed the basis for Gradient’s

evaluation of the CSI approach.

HESI formulates a variety of products with specific properties and performance characteristics,

which include various chemicals in a range of concentrations. The CSI compiles and ranks intrinsic

chemical hazard properties for products designed for the same use so that products can be compared

based on their relative potential health, physical safety, and environmental hazards. HESI undertook

development of the CSI primarily to satisfy internal needs that included a desire to:

Consider relative hazards in selecting products for use in operations;

Review and assess HESI’s current product portfolio; and

Consider relative hazards in formulating new products.

In addition to the internal drivers that led to its development, the CSI is responsive to certain

external influences, including a larger societal movement towards the use of "green products" and

legislative and regulatory changes. For example, various innovative retailers (e.g., Walmart, SC Johnson,

BASF) are adopting product and chemical management systems to better understand hazards associated

with chemical ingredients in the products they sell, and to find safer (e.g., less toxic or hazardous)

alternatives to chemicals of concern. These systems range from a reliance on restricted substance lists, to

proprietary evaluation systems, to product design strategies (Green Chemistry & Commerce Council,

2009). Further, legislation in the United States (US) and the European Union (EU) is increasingly

affecting industrial and consumer product and retailing companies. Two key pieces of legislation in the

EU are the 2006 Restriction of Hazardous Substances (RollS Directive, 2009), which restricts the use of

certain metals and flame retardants in electronic and electrical equipment imported into Europe, and the

2007 Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) Directive

(ECHA, 2009), which requires detailed information on each chemical’s uses and toxicity from

manufacturers and importers of chemicals into the EU. In the US, several states have passed legislation

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affecting chemical management (e.g., California’s Safe Drinking Water and Toxic Enforcement Act,

which requires labeling of products containing chemicals known to cause cancer, mutagenic, or

reproductive effects, and California’s Green Chemistry Program and draft Proposal for "Safer Alternatives

for Consumer Products" Rule). The most noticeable federal legislative initiatives in recent years have

been the 2008 Consumer Product Safety Improvement Act (CPSIA) (US Congress, 2008) and the United

States Environmental Protection Agency’s 2009 proposal to reform the 1976 Toxic Substances Control

Act (TSCA) (US EPA, 2009f). This general backdrop of increased interest in understanding more about

the safety and/or toxicity of chemical ingredients in products provides further impetus for development of

chemical management approaches such as that offered by the CSI.

Gradient’s review of the CSI began by the establishment of a set of driving principles:

The approach must be scientifically defensible;

The implementation must be transparent; and

The intended and actual use must be appropriate; that is, it must be consistent with thegoals of the CSI to identify and rank relative potential hazards for of products in the sameproduct use group.

The review of the CSI described here focuses on the CSI approach. Section 2 describes our

criteria and conclusions for assessing the scientific defensibility of the approach. Section 3 compares the

CSI to other similar ranking tools in the public domain. Section 4 focuses on expected implementation

and use of the CSI. Section 5 presents a summary and our conclusions.

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2 The CSI Approach is Scientifically Defensible

To review the scientific defensibility of the approach used by the CSI, Gradient considered a

number of components necessary for assessing relative hazards of chemicals or products. These include

the selection of hazard categories, the assignment of hazard categories to chemicals, and the data sources

that are relied upon. Gradient also reviewed the approach for evaluating chemicals with no data, and the

relative weighting of different types of hazards in assigning a total hazard score. In this section, we

describe the review criteria we selected to evaluate these components, the general approach of the CSI,

and how we evaluated the CSI against the review criteria.

2.1 Review Criteria

To review the scientific defensibility of the CSI approach, Gradient defined a set of primary and

secondary technical review criteria. Primary technical review criteria assess the approach for assigning

hazards to a chemical; that is, the appropriateness, adequacy, and accuracy of hazard assignment.

Secondary technical review criteria assess the scoring and ranking of products based on the chemical

hazards that have been assigned to its chemical components. Put differently, Gradient assumed that it was

primarily important for a hazard evaluation system to correctly and conservatively assign hazards to a

product (i.e., while a system might identify hazards too conservatively, we would not want it to

underestimate or fail to identify chemical hazards), while it was secondarily important for those hazards

to be combined into an appropriate product score/rank.

Our primary technical review criteria include the following:

Selection of hazard categories;

Selection of a concentration cut-off value for scoring of a chemical component;

Assignment of hazard categories to chemicals; and

Data sources.

Our secondary technical review criteria include the following:

Scoring of chemicals with no data available;

Weighting of health vs. environmental vs. physical safety hazard criteria;

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Weighting of scores between hazard categories within a criterion; and

Weighting within a hazard category based on concentration.

2.2 Description of the CSI

The CSI compiles and scores intrinsic chemical hazard properties for products designed for the

same use so that products can be compared to other products in the same product use group based on their

potential health, physical safety, and environmental hazards. A primary distinction between the CSI and

other available hazard ranking tools is that the CSI was developed to rank products (which may contain

one or more chemicals), while other tools are focused on individual chemicals. In the CSI, a health

hazard score, an environmental hazard score, and a physical safety hazard score are given to each of the

product chemical components and these scores are added together to compile a total hazard score for the

product. Products that score lowest within a product use group have a lower intrinsic hazard and can

potentially be considered as more environmentally responsible.

As a formulator, HESI relies on the chemical information provided by its suppliers. After

defining the component make-up of a product, to the extent practical, the CSI compiles information for

each chemical component of a product on three hazard criteria - health, environmental, and physical

salty. In contrast to some systems, the CSI defines the health hazard criterion as addressing worker

health, whereas the environmental hazard criterion addresses ecological health as well as population-

based human health. This is a broader definition of the environmental hazard criterion than found

elsewhere. Each criterion consists of several hazard categories, including those defined in the United

Nations’ Globally Harmonized System (GHS) of Classification and Labeling of Chemicals (UN, 2007)

system, supplemented with additional non-GHS hazard categories. The following hazard categories are

included within each criterion in the CSI:

Health Criterion: carcinogenicity, mutagenicity, reproductive toxicity, endocrinedisruptors, sensitizers, acute toxicity, corrosivity, acute target organ toxicity, chronictarget organ toxicity, and aspiration;

Environmental Criterion: acute aquatic toxicity, chronic aquatic toxicity, ozonedepletion, volatile organic compounds (VOCs), hazardous air pollutants (HAPs),hazardous water pollutants (HWPs), biodegradation, and bioaccumulation; and

Physical Safety Criterion: explosive, pyrotechnic, flammable gas, oxidizing gas, gasesunder pressure, flammable liquid, flammable solid, self-reactive substance, pyrophoric,self-heating substance, emit flammable gas in contact with water, oxidizing liquid,oxidizing solid, organic peroxide, corrosive to metals.

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Each of the hazard categories is associated with a set of definitions, shown in Tables 2. la-c. To

assign hazard categories consistent with these definitions, the CSI relies on the List Of Lists (LOLI)

Database,1 which contains over 3,100 regulatory lists from around the world, including those that

summarize environmental, health, and safety regulations, international regulations, chemical inventories,

and reference material necessary for Material Safety Data Sheet (MSDS) preparation. After hazard

categories are assigned to each of the product chemical components, hazard scores are assigned based on

the CSI’s scoring matrix (shown in Table 2.2a-c). The scoring matrix specifies maximum scores for each

hazard category and reflects the relative weighting between hazard categories within a hazard criterion as

well as between hazard criteria. Within each hazard category, hazard scores are assigned based on the

percentage of the chemical component in the product, i.e., higher percentage ranges of the chemical in the

product can result in a higher hazard score.

After assigning scores in each hazard category to each chemical product component, hazard

scores are added for each criterion. This results in a health hazard score, an environmental hazard score,

and a physical safety hazard score. The product hazard score is the sum of the three hazard criteria

scores, and is used to rank products within a product use group, as well as comparatively against each

other. In the CSI, a higher score implies a product with a greater intrinsic hazard.

2.3 Assessment of the Primary Review Criteria

This section describes the application of our primary review criteria to the CSI.

2.3.1 Selection of Hazard Categories: The CSI generally reflects a comprehensive approach to

hazard identification

Proper hazard category selection is a key component of total hazard ranking, requiring a balance

between comprehensiveness and redundancy. HESI has primarily based its hazard category selection on

the GHS, but has added several additional hazard categories, reflecting a more comprehensive approach

to hazard identification. Additional categories included in the CSI but not considered under the GHS are

endocrine disruptors, HAPs, HWPs, ozone depletors, VOCs, and two separate biodegradability hazard

1 The LOLI Database is the property of ChemADVISOR, Ine, and provides a pay-for-use service, including extensive GHS-

related regulatory data (http://www.chemadvisor.com/) (ChemADVISOR, Inc., 2009).


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categories. The inclusion of these additional hazard categories allows for a more inclusive identification

of potential hazards.

2.3.2 Selection of a Concentration Cut-Off Value: The CSI reflects an inclusive approach to

concentration cut-offs

The CSI assesses hazard potential, based, in part, on the concentration of each chemical in the

finished product. Use of a concentration cut-off value means that chemicals present in a product at

concentrations below the cut-off value would not be identified as hazardous, regardless of the chemical’s

intrinsic properties. Lower cut-off values allow for more chemicals to be "screened in" to the hazard

evaluation, while higher cut-off values mean that more chemicals are excluded. All of the cut-off values

currently used in the CSI are either equally or more stringent than the cut-offs used by GHS (i.e., more

compounds were screened into the CSI assessment). A comparison of the CSI and GHS cut-offs is

presented in Table 2.3.

While the CSI’s concentration cut-off criteria are more inclusive than those used in the GHS,

Gradient understands that the HESI will go a step further by requesting that its suppliers provide full

analytical disclosure of all product constituents in the future. This information will be used to include all

known chemicals in a product in future hazard evaluations, effectively as if there were no concentration

cut-off. This step will make the CSI far more comprehensive than the GHS approach in that many more

chemicals at low concentrations will potentially be included in the hazard assessment.

2.3.3 Assignment of Hazard Categories: The CSI reflects a comprehensive approach to assigning

hazards

The inclusion criteria used by the CSI to assign chemicals to a certain hazard category is also

largely based on the GHS. Departures from the GHS categories reflect a comprehensive approach aimed

at maximizing the number of identified hazards. This methodology was generally evident in the

evaluations of health, environmental, and physical safety hazards.

In the health criterion, for example, some of the GHS categories that had a tiered classification

(i.e., classification based on degrees of toxicity) were rolled up into one category in the CSI. Specifically,

while the GHS differentiated between Category I and II reproductive toxins, the CSI treated all

reproductive toxins as equally toxic. Similarly, mutagens were divided into two distinct classes under the


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GHS scheme, while the CSI assumed toxic equivalency for all identified mutagens. The CSI also

combined GHS-Class II and III irritants into one category.

In the environmental assessment, the cut-off for defining a chemical as bioaccumulative

[bioconcentration factor (BCF) > 500] in the CSI is set conservatively low. For instance, a BCF cut-off

of 1,000 is used in PBT Profiler, a tool developed for US EPA’s Office of Pollution Prevention and

Toxics (OPPT).2

In the physical safety hazards assessment, the categories evaluated by the CSI mirror those

defined by the GHS, with a single minor exception. The GHS considers explosives as a general category,

and includes pyrotechnic chemicals; the CSI evaluates these as separate categories.

2.3.4 Data Sources: The CSI relies on a widely used and generally comprehensive primary data

source

The accuracy of the hazard evaluation is highly dependent on the reliability of the data sources

and the consistent application of that information to the chemicals which comprise the product. The CSI

relies on the LOLl database (ChemAdvisor, 2009), which is a comprehensive source of worldwide

regulatory lists including environmental, health, and safety, international regulations, chemical

inventories, and reference material necessary for MSDS preparation. This is an acceptable primary data

source. HESI may choose to augment this source with additional data sources.

2.4 Assessment of the Secondary Review Criteria

This section describes the application of our secondary review criteria to the CSI.

2.4.1 Scoring of Chemicals with No Data Available: The CSI approach assigns a higher hazard

score when data are not available

The CSI approach documents lack of chemical information on a chemical-specific basis, and

assigns a numerical score that is added to the product’s total hazard score. This ensures that products will

not be identified as non-hazardous solely on the basis of a lack of chemical data.

2 PBT Profiler. Persistent, Bioaeeumulative, and Toxic Profiles Estimated for Organic Chemicals On-Line.

http://www.pbtprofiler.net/(ESC, 2006).


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2.4.2 Weighting of Health vs. Environmental vs. Physical Safety Hazard Criteria: The CSI’s

approach to weighting its three hazard criteria is appropriate for generic hazard scoring

Under the current scheme, a single chemical can potentially receive the highest total hazard score

in the environmental hazard criterion, followed by the physical safety and health hazard criteria (see

Table 2.4), in the unlikely event that the chemical receives the maximum possible score in every hazard

category within the criteria. We consider this acceptable given that the environmental hazard criterion

includes hazards to both the general population and to ecological systems. Other than the somewhat

uneven total possible score for each hazard criterion, all hazard criteria are weighted equally when added

together, i.e., no hazard criteria score is added in multiples. Situations may arise, however, where more

interest in a certain hazard may be warranted. Overall, the approach to weighting health vs.

environmental vs. physical hazards in the CSI is appropriate for generic hazard scoring (i.e., when no

hazard criterion is implicitly assumed to be of greater concern because of a specific use setting).

2.4.3 Weighting of Scores Between Hazard Categories Within a Criterion: The CSI’s scoring is

logical, and technically supportable

Within each hazard criterion, HESI made professional judgments about the relative importance of

certain hazard categories by assigning different maximum scores. For example, the maximum score

assigned to a known human carcinogen is 100, twice the maximum score assigned to a reproductive toxin

(see Table 2.2a-c). These same types of relative scoring judgments also extend across hazard criteria.

For example, a chemical assigned to the bioaccumulative environmental hazard category can receive a

maximum score of 50. This is twice the maximum score that can be received by a gas under pressure

under the physical safety criterion. Despite the professional judgment involved in assigning these relative

weights, the impact of alternative weightings on total hazard scores does not appear to be significant.

That is, it is unlikely that a different product would be identified as substantially less hazardous on the

basis of a change in the maximum score received by a human carcinogen from 100 to 200. Overall, we

agree that there is logic in prioritizing certain hazards above others.

2.4.4 Weighting Within a Hazard Category Based on Concentration: The CSI scoring approach

is logical, and technically supportable

The use of weighting within a hazard category implies a defined quantitative relationship between

chemical concentration and degree of hazard. For example, in the chronic aquatic toxin category, the CSI


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scoring approach assumes that a chemical present at 5-9.9% is four times more hazardous than a chemical

present at 0.001 to 0.09%. Although a defined quantitative relationship between chemical concentration

and degree of hazard is a function of chemical-specific toxicity information and properties, the generic

approach taken in the CSI is preferable to assuming that a chemical’s hazard is equal at all concentrations.

This approach allows for distinctions to be made between products that contain a high concentration of a

hazardous chemical and those containing a very low concentration of the same chemical.

2.5 Summary

The CSI approach is sufficiently based on existing chemical hazard identification systems.

Specifically, the choice to rely on the GHS approach is sound. The GHS system is globally recognized,

and the result of an extensive harmonization effort by a multitude of countries, international

organizations, and stakeholders. Furthermore, the CSI approach is more comprehensive than the GHS in

its hazard identification by inclusion of additional hazard categories (i.e., VOCs, HWPs, HAPs, ozone

depletors, endocrine disruptors, and a second biodegradability category), by using concentration cut-off

values that are set equal to or lower than those defined in the GHS, by striving to include all identified

chemicals without regard to a concentration cut-off, and by assigning hazard scores when data are not

available. We conclude that the CSI’s overall approach is scientifically defensible, and as comprehensive,

or more comprehensive, in its hazard identification step than the GHS on which it is based.

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3 Comparable to Several Existing RankingThe CSI Approach is

Systems

As a further approach to ascertaining the scientific defensibility of the CSI, Gradient identified

approximately 25 other existing hazard and/or risk-based ranking, scoring and assessment systems or

tools currently in development or use, from which we chose three for a detailed comparison with the CSI.

This list of assessment systems described below is not comprehensive.

Although the systems we identified exhibit many similarities to each other, they encompass

several different categories of approaches, including the following:

Guidance/decision tree approaches that provide a framework for chemical evaluation. Ingeneral, these are transparent, fully-documented decision tree approaches to evaluatingchemicals that involve comparing chemical toxicity information to established criteria.Due to their transparency and documentation, these systems are among the easiest tocompare to the CSI approach. Examples include:

US EPA’s Design for the Environment (DIE) General Screen for SaferIngredients (US EPA, 2009a);

US EPA’s Chemical Assessment and Management Program (CHAMP)methodology (US EPA, 2009b);

US EPAAJniversity of Tennessee Method for Ranking and Scoring Chemicals(Davis et al., 1994); and

Organization for Economic Cooperation and Development’s (OECD) HighProduction Volume (HPV) Chemical Evaluation/Screening Information Data Set(SIDS) Analysis (OECD 2000, 2003, 2005, 2006, 2008, 2009a, b).

Automated software/database ranking and scoring tools that provide chemical-specificnumerical ranking based on hazards. Most of these tools require some level of manualdata input/entry (e.g., chemical properties, toxicity information) into spreadsheets orother data platforms, then automatically generate a chemical score or rank relative toother chemicals. Some of the tools we identified include the following:

Canada Environmental Protection Agency’s (CEPA) Domestic Substances List(DSL) search engine (CEPA, 2006);

Scoring and Ranking Assessment Model (SCRAM) (Snyder et al., 2000a, b,c,d);

Indiana Relative Chemical Hazard Score (IRCHS) (Whaley, 1996);

EU’s Decision Analysis by Ranking Techniques (DART) (Pavan and Worth,2008); and

US EPA’s Waste Minimization Prioritization Tool (WMPT) (US EPA, 1997).

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"Green Chemistry" labeling and product/life cycle assessment tools’, which are used todetermine whether a chemical is safe or "green," and/or evaluate resource consumptionand environmental burdens associated with product chemicals at every point during theproduct’s life. Some of the tools we identified implement automated processes, whileothers are documented guidance or decision tree approaches.following:

Examples include the

Green Screen (CPA, 2007);

EU’s Eco Label program (EP, 2000);

SC Johnson’s proprietary tool Green List (Five Winds International, Undated-a);

Cradle to Cradle Protocol (MBDC, 2009); and

Eco-Efficiency (BASK 2008; Five Winds International, Undated-b; Saling et al.,2002).

Data generation tools’ that provide predictive and/or risk-based assessment for chemicals.These tools also consider toxicity and other factors, but generate new information or datafor chemicals being assessed. For example:

US EPA’s PBT Profiler (ESC, 2006) estimates persistence, bioaccumulation, andtoxicity for chemicals that lack existing experimental data;

US EPA’s Exposure and Fate Assessment Screening Tool (E-FAST) (Versar,Inc., 200) calculates human potential dose rates for a wide variety of chemicalexposure routes and estimates the number of days per year that a concentrationcorresponding to an aquatic ecotoxicity concern will be exceeded for organismsin the water column;

US EPA’s Ecological Structure Activity Relationships (ECOSAR) tool (US EPA,2009c) estimates a chemical’s acute toxicity and chronic toxicity to aquaticorganisms such as fish, aquatic invertebrates, and aquatic plants by usingstructure activity relationships;

CalTox (McKone and Enoch, 2002) is a risk assessment model that calculates theemissions of a chemical, the concentration of a chemical in soil, and the risk ofan adverse health effect due to a chemical; and

US EPA’s Risk-Screening Environmental Indicators (RSEI) (US EPA, 2009e) isa computer-based screening tool that analyzes risk factors to put Toxics ReleaseInventory (TRI) release data into a chronic health context.

3.1 Detailed Comparison

Of the ranking/assessment systems identified, we selected three for a more detailed comparison to

the CSI to further evaluate overall soundness and scientific defensibility of the approach. The selected

systems are Clean Production Action’s (CPA) Green Screen (CPA, 2007), US EPA’s CHAMP (US EPA

2009b,e), and US EPA’s DfE General Screen for Safer Ingredients (US EPA, 2009a). In general, these

systems were selected because they consider hazard criteria similar to those evaluated by the CSI (i.e.,

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health, environmental, and physical safety) and include transparent documentation and/or guidance.

Gradient relied on the primary and secondary technical review criteria established above, as well as

several other attributes, to evaluate the ranking schemes and compare them, in general terms, to the CSI.

Tables 3.1 through 3.3 provide details regarding each of the systems.

Other systems were excluded from consideration for a detailed comparison for one or more

reasons. For example, a number of systems are proprietary and are not publicly available [e.g., SC

Johnson GreenList (2004), BASF EcoEfficiency (Lawson et al., 2002; Lee et al., 1998), Walmart

GreenWercs (The Wercs Ltd. Co., 2009)]; thus, a more detailed comparison with the CSI was not

possible. Other systems provided very limited information regarding approach and evaluation criteria;

thus, a more detailed comparison was not possible [e.g., the EU EcoLabel (EP, 2000)]. Finally, some of

the systems do not consider each of the three hazard criteria evaluated by the CSI (health, environmental,

and physical safety); thus, an in-depth comparison to the CSI would be less useful [for example, the

Offshore Chemical Notification Scheme (Cefas, 2009a,b) was not selected for comparison because the

system is focused primarily on ecological hazards].

3.1.1 Green Screen

CPA’s Green Screen (CPA, 2007) (see Table 3.1) is a publicly available, hazard-based screening

method used to evaluate individual chemicals (and their byproducts) in consumer/industrial products.

Green Screen was selected for comparison to the CSI because it defines a comprehensive list of categories

and criteria for health, environmental, and physical safety hazards; thus, it is very similar in approach to

the CSI. Also, like the CSI, hazard categories and evaluation criteria are largely based on the UN’s GHS

(UN, 2007), as well as US EPA’s DfE program (US EPA, 2009a), thus the approach may be considered

scientifically sound. Finally, the Green Screen is documented in a transparent written guidance, with

well-defined hazard categories, evaluation criteria, and data sources, facilitating a more detailed

comparison review.

Green Screen was developed recently (2007) and its use is not yet widespread. However, it has

been used by some prominent companies. For example, according to the CPA website (CPA, 2009),

Green Screen was used by Walmart to develop their "GreenWercs" software tool (this program analyzes

the composition of individual products from ingredient data entered by manufacturers, examining its

potential impact on human health and the environment and plotting its combined score). In addition,

Hewlett-Packard is using the Green Screen to assess alternatives to brominated flame retardants and

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polyvinyl chloride (PVC) plastics. The state of Washington has used the Green Screen as an alternatives

assessment tool to determine if safer alternatives to Deca-BDE, a flame retardant used in television

casings and upholstery, existed on the market.

Green Screen’s approach is based on US EPA’s DIE program (US EPA, 2009d), and defines four

Benchmarks to indicate whether chemicals used in products are safe. Green Screen defines "threshold

values" for all chemical hazards evaluated (e.g., carcinogenicity, bioaccumulation, flammability). Based

on a comparison to the threshold values, chemicals AND their breakdown products/metabolites are

categorized as Very High (V), High (H), Moderate (M), or Low (L) for each of the hazards evaluated.

Chemicals are then placed within one of the four Benchmarks based on their categorization for each of

the hazards and the standards or criteria established for each of the Benchmarks. These Benchmarks are

as follows:

Benchmark 1 - Avoid, Chemical of High Concern: chemicals categorized as high/veryhigh PBT and human toxicity hazards;Benchmark 2 - Use, but search for safer substitutes: chemicals categorized asmoderate/high PBT, human toxicity, flammable, or explosive hazards;Benchmark 3 - Use, but still opportunity for improvement: chemicals categorized asmoderate PBT, ecotoxicity, or flammable, or explosive hazards; orBenchmark 4 - Prefer, Safer Chemical: encompasses those chemicals categorized ashaving low inherent toxicity to humans and wildlife.

Thus, if a chemical and its breakdown products were characterized as Low for each of the hazards

evaluated, that chemical would be placed in Benchmark 4. However, if the chemical was categorized as

Moderate for one of the hazards, that chemical might be placed in Benchmark 3. One aspect of Green

Screen that differs from the CSI is that each chemical AND its breakdown products/metabolites are used

to assign a chemical to a Benchmark. For example, a chemical might fall into the Benchmark 4 category

based on its own properties, but into the Benchmark 3 category when its breakdown products are

considered. In addition, in contrast with the CSI, there is no actual "scoring" of chemicals.

Green Screen’s hazard evaluation categories and criteria are based largely on those defined in US

EPA’s DIE as well as the UN GHS (UN, 2007). The hazard categories evaluated during Green Screen are

similar to those evaluated by the CSI, with some discrete differences.

Health: Green Screen evaluates neurotoxicity and immunotoxicity as separate categories,while the CSI considers select endpoints for these categories under chronic toxicity.

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HESI301999

Aspiration hazards are not considered in Green Screen, although they are a hazardcategory under the GHS and are evaluated by the CSI.

Environmental: Green Screen and the CSI both consider acute and chronic aquatictoxicity, persistence (biodegradation), and bioaccumulation. Green Screen does notconsider several CSI environmental categories, i.e., VOCs, HAPs, HWPs, and ozonedepletion.

Physical Safety Hazards’: Green Screen considers only flammability and explosivity aspart of the physical safety hazard screen. The CSI considers all GHS physical safetyhazard categories.

Regarding data gaps and resources, the Green Screen recommends several approaches. It favors

what is called a "Comprehensive Data Approach," using existing experimental data to identify levels of

concern for as many hazards as possible, then using Quantitative Structure Activity Relationship (QSAR)

analyses to fill as many data gaps as possible. Another approach defined by Green Screen assesses

"Common Sense Data Sources" such as MSDSs, the Hazardous Substances Data Bank (HSDB), the

Integrated Risk Information System (IRIS), etc. A third approach used in Green Screen is the "Limited

Set of Hazards Approach," by which chemicals would be benchmarked based on a few hazards for which

experimental and QSAR data are available. This approach is useful when one is concerned with only

certain types of hazards as might be appropriate in some use settings. Note that chemicals for which there

are insufficient data are flagged and, in certain cases, may not be evaluated/benchmarked.

3.1.2 US EPA’s CHAMP

US EPA’s CHAMP (US EPA, 2009b,e) outlines guidance for qualitative Risk-Based Prioritization

(RBP) of HPV chemicals, as well as Hazard-Based Prioritization (HBP) for Medium Production Volume

(MPV) chemicals (see Table 3.2). The RBP and HBP screening evaluate most of the same hazard

categories; however, the RBP evaluates environmental fate (mobility, volatility, hydrolysis, photo- and

bio-degradation), and physical properties. These are not evaluated during the HBP. CHAMP was selected

for comparison to the CSI because it is a publicly available approach to hazard screening, documented in

a fairly transparent written guidance, with defined hazard categories, evaluation criteria, and data sources.

For this evaluation we compare the CSI to the RBP because the RBP incorporates physical

properties of chemicals and environmental fate, while HBP does not. During an RBP, chemicals undergo

qualitative hazard, risk, and exposure screenings based on US EPA-defined evaluation criteria. RBPs are

developed for chemicals for which adequate hazard and exposure/use information is available, while

HBPs are developed for MPVs which are less likely to have information available to develop exposure


HESI302000

and risk characterizations to support an RBP. The findings of the screenings are summarized in written

reports. US EPA’s OPPT uses the findings to prioritize chemicals as low (follow-up action not suggested

at this time), medium (available information suggests possible concerns that might be resolved if

additional data were available), or high priority (available information suggests that these chemicals

appear to have more serious potential risk concerns; US EPA will encourage voluntary actions to

understand/mitigate risk and will also determine if regulatory actions are needed).

The hazard categories defined in CHAMP are based on OECD SIDS. Although the overall

approach to CHAMP is different than the CSI, the hazard categories evaluated during CHAMP are quite

similar to those evaluated by the CSI. Comparing ChAMP’s categories to the CSI, we find the following:

Health: CHAMP evaluates neurotoxicity and immunotoxicity as separate categories,while the CSI considers select endpoints for neurotoxicity and immunotoxicity under thechronic toxicity category. Aspiration and corrosivity hazards are not considered inChAMP, although they are evaluated by the CSI.

Environmental: CHAMP includes several environmental fate criteria not specificallyconsidered by the CSI - these include mobility, hydrolysis, and photo degradation.ChAMP also considers volatility, ready/environmental biodegradation, persistence,bioaccumulation, and aquatic toxicity, which are considered by the CSI. CHAMP doesnot consider several CSI environmental categories - i.e., HAPs, HWPs, ozone depletion -as specific categories.

Physical Hazards’: CHAMP evaluates only two properties under physical hazards - vaporpressure and water solubility. The CSI considers all GHS physical hazard categories.

For the "hazard" screening portion of the RBP, CHAMP relies upon the National Library of

Medicine Databases, which allow searches of numerous data sources and databases, including PubMed,

the Hazardous Substances Database Bank, Science Direct, etc. A primary difference between the CSI

approach and ChAMP is that CHAMP does not rely on a single database for information, and also

expands its searches/review beyond regulatory boundaries. CHAMP is thus more comprehensive in its

research/review of data sources. The ChAMP RBP guidance document outlines an extensive list of

public sources searched by US EPA to obtain physical/chemical properties, hazard, and

exposure/use/release information.

As discussed above, RBPs are developed for chemicals for which adequate hazard and

exposure/use information is available. While HBPs are not the focus of our detailed comparison, it is

important to point out that chemicals evaluated during an HBP are generally not as well-characterized,

therefore, the available data are flagged for data adequacy. For example, the data are summarized in


HESI302001

tables, and "measured" data values are clearly flagged as such, while "experimental" data are flagged with

symbols indicating whether they are categorized as either a "value from guideline study, clear weight of

evidence, or evaluated database," a "value from non-guideline but reliable experimental study," or a

"value reported without supporting details." Estimated data are also flagged/identified. When data are

not available, OPPT uses expert judgment and may use one or more estimation approaches (e.g.,

QSARS). Lack of available data may influence the prioritization of a chemical - i.e., a chemical with

data gaps may be categorized as a medium, not low, priority.

3.1.3 US EPA’s DfE General Screen for Safer Ingredients

US EPA’s General Screen for Safer Ingredients (US EPA, 2009d) is a publicly-available system

developed under US EPA’s DfE Program that is designed to delineate the safer or "low-concern" end of

the ingredient spectrum for chemicals used in consumer products, and to guide and ensure best-in-class

ingredient choices for DfE-recognized products (see Table 3.3). The DfE was selected for comparison

with the CSI because it is an established US EPA program that is widely recognized, highly regarded, and

currently implemented. Many well known consumer product companies such as SC Johnson and

Colgate-Palmolive have established partnerships with US EPA’s DfE program, and numerous consumer

products meeting the screening process carry the DfE label. GreenBlue has partnered with US EPA DfE

to develop the "CleanGredients" software tool, which used the DfE approach as the basis for evaluating

and verifying the surfactant and solvent chemicals contained in its database. In addition, the DfE screen

has a fairly transparent written guidance with clearly-defined evaluation criteria for comparison,

facilitating a more detailed comparison. Finally, like the CSI, DfE uses toxicological thresholds defined

in the GHS (UN, 2007), but also uses some thresholds defined in CHAMP.

Determinations using the DfE General Screen distinguish safer chemicals, and are not

classifications. The DfE also calls on the expertise of US EPA’s OPPT. It differs from the CSI in that

DfE is a pass/fail approach - there is no "scoring" per se - and chemicals are either considered DfE-

approved or not DfE-approved depending on whether they meet threshold criteria within all of the

categories evaluated. For example, a chemical classified as an IARC Group 1 carcinogen will not pass

the DfE General Screen. In addition to the DfE General Screen, customized screens and standards have

been developed for select industries and consumer products (e.g., household cleaning products).

The DfE’s hazard categories and evaluation criteria are based on CHAMP (US EPA, 2009d) and

the UN GHS (UN, 2007). The DfE General Screen also defines preferred and acceptable test methods for

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HESI302002

the categories evaluated. DIE’s General Screen considers health, environmental, and physical safety

hazard categories that overlap with the CSI approach. Comparing DIE to the CSI, we find the following:

Health: The DIE considers neurotoxicity as a separate category, while the CSI considersselect endpoints for neurotoxicity under the chronic toxicity category.

Environmental: Similar to the CSI, the DIE considers acute aquatic toxicity, persistence(biodegradation), and bioaccumulation potential. While the CSI also considers chronicaquatic toxicity, DIE does not. DIE also does not consider several HESI environmentalcategories - i.e., HAPs, HWP, ozone depletion - as specific categories.

Physical Hazards’: Although physical safety hazards are not addressed in the GeneralScreen, several of the customized screening protocols and standards do include this as anevaluation category. The CSI considers all GHS physical safety hazard categories.

3.2 Summary

Our general comparison of the CSI to other ranking and scoring systems demonstrates that most

existing systems are fairly consistent with regard to approach and the hazard categories evaluated. The

CSI shares many similarities with some of those systems, indicating that the overall approach is sound

and scientifically defensible.

Our detailed comparison of the CSI approach to three of these systems (Green Screen, US EPA’s

CHAMP, and US EPA’s DIE) also indicates significant similarities in approach, as well as some

differences. Some of the other systems we identified consider a broader suite of data sources to evaluate

and score hazards (i.e., they rely on data sources beyond what is compiled in the LOLI). It is unclear if

the reliance on these additional data sources would have a significant impact on the scoring of chemicals

contained within HESI’s current product portfolio. There are clear advantages in relying on a single broad

data compilation source such as the LOLI database in that it allows for quick hazard scoring and ranking,

the LOLI database is automatically updated, hazard scores can be more easily automated and

implemented, and the effort is less labor-intensive.


HESI302003

4 Implementation and Use of the CSI will Enhance HESI’s

Corporate Sustainability Strategies

Final implementation of the CSI will include a manual that describes the development and

appropriate use of the system. This manual will describe the approach, and technical and professional

judgment decisions that led to the implemented hazard scoring matrix. Uncertainties will be disclosed

and described. Data sources relied upon by the CSI will be identified and prioritized, with a decision tree

that describes the hazard assignment process. The system will undergo a thorough quality control check.

Use of specialized software will ensure the consistent application of databases and assignment of hazard

categories and scores to chemicals. A protocol for revisions will be developed so that updates to chemical

information will be made as new data become available.

The CSI is a hazard ranking tool, and does not at this time provide risk ranking ability. Although

hazard and risk ranking may give similar results, one can imagine that a hazard ranking system might give

equal rank to two chemicals that are assigned to the same hazard category and have the same

concentration, while a risk ranking system might give different rank based on the relative toxicity of the

two chemicals. Documentation will describe to all potential users the differences between relative hazard

and relative risk and make clear that the CSI is a hazard ranking tool. The appropriate use of the CSI is to

identify the presence of a hazard, thus identifying the subsequent potential need to minimize exposure and

resulting risk.

Based on our review, we believe that the CSI will allow HESI to meet its original goals:

To assist in selecting less hazardous products for use in HESI’s operations;

To review and assess intrinsic hazards associated with HESI’s current chemical/productportfolio; and

To assist in formulating new, less hazardous, products.

Consistent use of the CSI could enhance HESI’s product management and corporate sustainability

strategies.

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5 Summary and Conclusions

On the basis of our detailed review of the CSI approach, Gradient concludes that the CSI

approach is scientifically defensible and provides a very credible means of comparing the intrinsic

hazards of chemical products in a product use group. The CSI approach is sufficiently based on existing

chemical hazard identification systems, specifically, the GHS approach, which is globally recognized, and

the result of an extensive harmonization effort by a multitude of countries, international organizations,

and stakeholders. Furthermore, we believe the CSI is more comprehensive than the GHS in its hazard

identification because of its inclusion of additional hazard categories.

Comparison of the CSI to other ranking and scoring systems shows a general consistency with

regard to approach and the hazard categories chosen for evaluation. The CSI shares many similarities

with some of those systems, further augmenting our conclusion that the overall approach is sound and

scientifically defensible. Our detailed comparison of the CSI approach to three of these systems (Green

Screen, US EPA’s CHAMP, and US EPA’s DfE) indicated significant similarities, and a few differences,

in the approach to hazard identification. Gradient concludes that the CSI is more comprehensive than

these other systems in the areas of environmental and physical safety hazards because the CSI includes

more hazard categories in these criteria. While the other systems we evaluated included a few additional

health hazard categories not explicitly considered by HESI, the CSI does consider select endpoints for

these categories. We therefore conclude that the CSI is comprehensive in its health hazard analysis as

well.

Based on the scientific defensibility of the approach, and the comparability to other ranking

systems, we believe that the CSI will aid HESI in meeting its goals of selecting and developing less

hazardous products for use in its operations. Furthermore, consistent use of the CSI could enhance

HESI’s product chemicals management and corporate sustainability strategies.


HESI302005

References

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Clean Production Action (CPA). 2007. "The Green Screen for Safer Chemicals: Evaluating FlameRetardants for TV Enclosures." 82p., March.

Clean Production Action (CPA). 2009. "What is the Green Screen for Safer Chemicals?" 7p.

Davis, GA; Kincaid, L; Swanson, M; Schultz, T; Bartmess, J; Griffith, B; Jones, S. 1994. "ChemicalHazard Evaluation for Management Strategies: A Method for Ranking and Scoring Chemicals byPotential Human Health and Environmental Impacts. User’s Manual for RSEI Version 2.2.0 [1996 - 2006TRI Data]." University of Tennessee, Center for Clean Products and Clean Technologies (Knoxville,TN); Report to US EPA, Office of Research and Development, Risk Reduction Engineering Laboratory.EPA/600/R-94/177, 120p., September.

Environmental Science Center (ESC). 2006. "PBT Profiler Methodology." Report to US EPA, Office ofPollution Prevention and Toxics. Accessed onNovember 18, 2009 athttp://www.pbtprofiler.net/methodology.asp, 15p., September 21.

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European Parliament (EP). 2000. "Regulation (EC) No. 1980/2000 of the European Parliament and of theCouncil of 17 July 2000 on a revised Community eco-label award scheme." Council of the EuropeanCommunities. Off J. Eur. Comm. L(237): 1-12, September 21.

Five Winds International. Undated-a. "Greening the Supply Chain at SC Johnson." 9p.

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Green Chemistry & Commerce Council; University of Massachusetts Lowell; Lowell Center forSustainable Production; Green Chemistry & Commerce Council; Torrie, Y; Buczek, M; Morose,G; Tickner, J. 2009. "Best Practices in Product Chemicals Management in the Retail Industry:Moving Business Toward Safer Alternatives." Accessed on December 29, 2009 athttp://www.greenchemistryandcommerce.org/downloads/uml-rptbestpracl209.pdf, 44p., December.


HESI302006

Lawson, GW; Van Winkle, LS; Toskala, E; Senior, RM; Parks, WC; Plopper, CG. 2002. "Mouse strainmodulates the role of the ciliated cell in acute tracheobronchial airway injury-distal airways." Am. J.Pathol. 160(1):315-327.

Lee, C; Watt, KC; Chang, AM; Plopper, CG; Buckpitt, AR; Pinkerton, KE. 1998. "Site-selectivedifferences in cytochrome P450 isoform activities. Comparison of expression in rat and rhesus monkeylung and induction in rats." Drug Metab. Dispos. 26(5):396-400.

McDonough Braungart Design Chemistry, LLC (MBDC). 2009. "The Cradle to Cradle Design Protocol."Accessed on November 18, 2009 at http://www.mbdc.com/c2c_mbdp.htm, 2p.

McKone, TE; Enoch, KG. 2002. "CalTOX: A Multimedia Total Exposure Model Spreadsheet User’sGuide, Version 4.0 (Beta)." Lawrence Berkeley National Laboratory; University of California, School ofPublic Health (Berkeley, CA); Report to US EPA. LBNL - 47399.45p., August.

Organisation for Economic Co-operation and Development (OECD). 2000. "Manual for Investigation ofHPV Chemicals. Chapter 3.3: Guidance for the Use of Structure Activity Relationships (SAR) in theHPV Chemicals Programme." Environment Directorate, HPV Chemicals Programme. Accessed onNovember 9, 2009 at http://www.oecd.org/document/7/0,3343,en_2649_34379_1947463 1 1 1 1,00.html, 22p.,July.

Organisation for Economic Co-operation and Development (OECD). 2003. "Manual for Investigation ofHPV Chemicals. Chapter 4.3: Guidance for the Initial Assessment of Health Effects." EnvironmentDirectorate, HPV Chemicals Programme. Accessed on November 9, 2009athttp://www.oecd.org/document/7/0,3343,en_2649_34379_1947463 1 1 1 1,00.html, 9p., October.

Organisation for Economic Co-operation and Development (OECD). 2005. "Manual for Investigation ofHPV Chemicals. Chapter 6.1: Description of Post-SIDS Activities and Procedures." EnvironmentDirectorate, HPV Chemicals Programme. Accessed on November 9, 2009 athttp://www.oecd.org/document/7/0,3343,en_2649_34379_1947463 1 1 1 1,00.html, 3p.,December.

Organisation for Economic Co-operation and Development (OECD). 2006. "Manual for Investigation ofHPV Chemicals. Chapter 2: SIDS, The SIDS Plan and the SIDS Dossier." Environment Directorate, HPVChemicals Programme. Accessed on November 9, 2009 athttp://www.oecd.org/document/7/0,3343,en_2649_34379_1947463 1 1 1 1,00.html, 20p.,August.

Organisation for Economic Co-operation and Development (OECD). 2008. "Manual for Investigation ofHPV Chemicals. Chapter 1: Procedures, Including the Use of the Electronic Discussion Groups and theOn-Line HPV Database." Environment Directorate, HPV Chemicals Programme. Accessed on November9, 2009 at http://www.oecd.org/document/7/0,3343,en_2649_34379_1947463 1 1 1 1,00.html, 12p.,August.

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SC Johnson. 2004. "Easing our Ecological Footprint." 3p.

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United States Environmental Protection Agency (US EPA). 2009a. "DfE General Screen for SaferIngredients." Design for Environment Program, 15p., February 3.

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Tables

HESI302010

Table 2.1aCSI - Health Criterion

Hazard CategoryCarcinogenicity Cat. 1(Known HumanCarcinogen)

Carcinogenicity Cat. 2(Suspected HumanCarcinogen)

Mutagenicity

I DefinitionsAccording to criteria (weigbt of the evidence), the substance is known or presumed to have carcinogenic potential inhumaaas.IARC Group 1 aaad Group 2AACGIH Categor~ A1NTP - Known Human CaxcinogensEU - Dangerous Substaaaces Directive - Carcinogens Category 1 and Category 2Substance is present at > 0.1% in the product and is on one of these lists:ACGIH - Threshold Limit Values - Carcinogens (Categor~ A1)IARC - Group 1 (Carcinogenic to Humaaas)IARC - Group 2A (Probably Carcinogenic to Humaaas)NTP (National Toxicology Program) - Report on Carcinogens - Known Humaaa CarcinogensEU - CLP (1272/2008) - Annex VI - Table 3.2 - Caxcinogens Category 1EU - CLP (1272/2008) - Annex VI - Table 3.2 - Caxcinogens Categor~ 2Australia - GHS - Carcinogenicity (Priority Existing Chemical Assessment Reports)Japan - GHS - CarcinogenicityUS - California - Proposition 65 - Carcinogens ListUS - OSHA - Specifically Regulated Carcinogens (1910.1001 to 1910.1096)According to criteria (weight of evidence), the substaaace is suspected to have carcinogenic potential in humans.

IARC Group 2BACGIH Category A2 and A3NTP - Reasonably Anticipated to be Humaaa CarcinogensEU - Dangerous Substaaaces Directive - Carcinogens Cate~or~ 3Substance is present at > 0.1% in the product and is on one of these lists:ACGIH - Threshold Limit Values - Carcinogens (Categor~ A2 and A3;IARC - Group 2B (Possibly Carcinogenic to Humaaas)NTP (National Toxicology Program) - Report on Caxcinogens - Reasonably Anticipated to be Human Carcinogens

EU - CLP (1272/2008) - Annex VI - Table 3.2 - Caxcinogens Category 3According to criteria (weight of evidence), the substaaace is known to induce or is suspected to induce heritablemutations.Cat 1A: Chemicals known to induce heritable mutations in germ cell of humans. Positive evidence from humanepidemiological studiesCat 1B: Chemicals which should be regarded as if they induce heritable mutations in the germ cells of humaaas(a) Positive result(s) from in vivo heritable germ cell mutagenicity tests in mammals; or(b) Positive result(s) from in vivo somatic cell mutagenicity tests in mammals, in combination with some evidence thatthe substance has potential to cause mutation to germ cells. This supporting evidence may, for example, be derived frommutagenicity/genotoxic test in germ cells in vivo, or by demonstrating the ability of the substance or its metabolite(s) tointeract with the genetic material of germ cells; or(c) Positive result(s) from test showing mutagenic effects in the germ cells of humaaas, without demonstration oftransmission to progeny; for example, an increase in the frequency of aneuploidy in sperm cells of exposed people

Cat 2: Chemicals which cause concern for humaaas owing to the possibility that they may induce heritable mutations inthe germ cells of humansPositive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments obtainedfrom:(a) Somatic cell mutagenicity tests in vivo, in mammals; or(c) Other in vivo somatic cell genotoxicity test which are supported by positive results from in vitro mutagenicity assaysNOTE: Chemicals which are positive in in vitro mammaliaaa mutagenicity assays, and which also show- chemicalstructure activity relationship to known germ cell mutagens, should be considered for classification as Category 2mutagens.

Mutagenicity Test Method in germ cells: OECD 483Genotoxicity Test Methods in germ cells: Sister Chromatic Exchange SEC aaaalysis in spermatogonia and UDS intesticular cellsGenotoxicity Test Methods in somatic cells: OECD 486 and Mammalian bone marrow- SCEMutagenicity Test Method in vitro : OECD 473, OECD 476, and OECD 471Mutagenicity Test Method in vivo heritable germ cell: OECD 478 and OECD 485Mutagenicity Test Method in vivo somatic cell: OECD 475, OECD 484, and OECD 474

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Page 1 of 21 Gradient

HESI302011


Hazard Category

Reproductive Toxicity

Endocrine Disruptors

I DefinitionsSubstance is present at > 0.1% in the product and is on one of these lists:Australia - GHS - Mutagenicity (Priority Existing Chemical Assessment Reports)Austria - Prohibited Chemicals - MutagensBulgaria - Occupational Exposure Limits - MutagensEU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Germ Cell MutagenicityEU - CLP (1272/2008) - Annex VI - Table 3.2 - Mntagens Category 1EU - CLP (1272/2008) - Annex VI - Table 3.2 - Mutagens Category 2EU - CLP (1272/2008) - Annex VI - Table 3.2 - Mntagens Category 3Japan - ISHL Mutagens - Existing ChemicalsJapan - GHS - Germ Cell MntagenicityKorea - MOL - GHS - Germ Cell Mutagenicit~Norway - Occupational Exposure Limits - MutagensSwitzerland - Occupational Exposure Limits - MutagensUnited Kingdom - Dangerous Substances and Preparations - Muta~ens Cate~or~ 2According to criteria (weight of evidence), the substance is a known or suspected reproductive toxicantSexual Function and Fertility: Adverse effects on sexual function and fertility including alterations to the reproductivesystems, effects on the onset of puberty, gamete production and transport, reproductive cycle normality, sexual behavior,fertility, parturition, pregnancy outcomes, premature reproductive senescence, or modifications in other functions thatare dependent on the integrity of the reproductive system. Adverse effects on orvia lactation are also included inreproductive toxicity, but are treated separately.Development of Ott~pring: Developmental toxicity includes any effect which interferes with normal development ofth~conceptus, either before or after birth, and resulting from exposure of either parent prior to conception, or exposure ofthe developing ott~pring during prenatal development, or postnatally, to the time of sexual maturation including death ofdeveloping organism, structural abnormality, altered growth and functional deficiency.

Evidence Criteria includes maternal mortality, mating index, fertility index, gestation length, body weight and bodyweight change, food and water consumption, clinical evaluations, post-mortem data, and aaaimal and experimental data(e.~g., OECD 421 aaad OECD 422).Substance is present at > 0.1% in the product and is on one of these lists:Austria - Prohibited Chemicals - Reproductive ToxinsBulgaria - Occupational Exposure Limits - Toxic to ReproductionCanada - British Columbia - Occupational Exposure Limits - Substances with Reproductive Critical EffectsCzech Republic - Prohibited or Restricted Hazardous Substances - Reproductive ToxinsEU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Reproductive ToxicityEU - CLP (1272/2008) - Annex VI - Table 3.2 - Reproductive Category 1EU - CLP (1272/2008) - Annex VI - Table 3.2 - Reproductive Category 2EU - CLP (1272/2008) - Annex VI - Table 3.2 - Reproductive Category 3France - Occupational Exposure Limits - Reproductive ToxinsGermany - TRGS 905 - Reproductive ToxinsJapan - GHS - Toxic to ReproductionKorea - MOL - GHS - Reproductive ToxicityNetherlands - List of Reproductive ToxinsNorway - Occupational Exposure Limits - Reproductive HazardsPeru - Occupational Exposure Limits - Toxic for ReproductionSlovenia - Occupational Exposure Limits - Reproductive ToxinsUS - California - Proposition 65 - Reproductive Toxicity - FemaleUS - California - Proposition 65 - Reproductive Toxicity - MaleUnited Kingdom - Dangerous Substances and Preparations - Toxic for Reproduction Category 1United Kingdom - Dangerous Substances and Preparations - Toxic for Reproduction Cate~o~ 2According to criteria (weight of evidence), the substance is a endocrine disruptor.Disruption of the endocrine system can occur in various ways. Some chemicals mimic a natural hormone, fooling thebody into over-responding to the stimulus (e.g., a growth hormone that results in increased muscle mass), or respondingat inappropriate times (e.g., producing insulin when it is not needed). Other endocrine disrupting chemicals block theeffects of a hormone from certain receptors (e.g., growth hormones required for normal development). Still othersdirectly stimulate or inhibit the endocrine system and cause overproduction or underproduction of hormones (e.g., anover or underactive thyroid). Certain drugs are used to intentionally cause some of these effects, such as birth controlpills. In many situations involving environmental chemicals, however, an endocrine effect is not desirable.

Substance is present at > 0.1% in the product and is on one of these lists:Denmark - List of Substances with Documented Endocrine Disruption EffectsEU - Endocrine Disrupters - Raaaked Priority List - Human Health CategorizationsEU - Endocrine Disrupters - Raaaked Priority List - Overall CategorizationsEU - Endocrine Disrupters - Ranked Priority List - Wildlife Categorizations

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HESI302012


Hazard CategorySensitizers

Acute Toxicity Cat. 1

I DefinitionsHuman or animal evidence of respiratory or skin sensitizationA respiratory sensitizer is a substance that will lead to hypersensitivity of the airways following inhalation of thesubstance.A skin sensitizer is a substaaace that will lead to an allergic response following skin contact.Human Experience(a) size of population(b) extent of exposure(c) clinical history

(i) in vivo immunological test (e.g., skin prick test)(ii) in vitro immunological test (e.g., serological analysis)(iii) studies that may indicate other specific hypersensitivity reactions (e.g., repeated low-level irritation,

phaxmacologically mediated effects)(d~ data from no~itive bronchial challenge te~t~Animal Studies(a) measurement of Immunoglobulin E (igE) and other specific immunological parameters

(b) specific pulmonary responses in guinea pigsSubstance is present at > 0.1% in the product and is on one of these lists:ACGIH - Threshold Limit Values - Sensitization (SEN) NotationsArgentina - Occupational Exposure Limits - SensitizersAustralia - GHS - Skin Sensitizers (Priority Existing Chemical Assessment Reports)Austria - Occupational Exposure Limits - Respiratory SensitizersAustria - Occupational Exposure Limits - SensitizersAustria - Occupational Exposure Limits - Skin SensitizersEU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Respiratory or Skin SensitizationGermany - TRGS 907 - Table of SensitizersJapan - GHS - Respiratory SensitizersJapan - GHS - Skin SensitizersKorea - MOL - GHS - Respiratory SensitizationKorea - MOL - GHS - Skin SensitizationNorway - Occupational Exposure Limits - SensitizersSouth Africa - Mine Safety - Occupational Exposure Limits - SensitizersSouth Africa - Occupational Exposure Limits - SensitizersOral LD50 < 5 m~/k~Dermal LD50 < 50 mg/kgInhalation (Gas) LC50 < 100 ppmInhalation (Vapor) LC50 < 0.5 mg/1Inhalation (Dust/Mist) LC50 < 0.05 mg/1

Substance is present at > 0.1% in the product and is on one of these lists:Australia - GHS - Acute Toxicity - Dermal (Priority Existing Chemical Assessment Reports)Australia - GHS - Acute Toxicity - Inhalation (Priority Existing Chemical Assessment Reports/Australia - GHS - Acute Toxicity - Oral (Priority Existing Chemical Assessment Reports)EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - DermalEU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - InhalationEU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - OralJapan - GHS - Acute Toxicity - DermalJapan - GHS - Acute Toxicity - Inhalation - Dust and MistJapan - GHS - Acute Toxicity - Inhalation - GasJapan - GHS - Acute Toxicity - Inhalation - VaporJapan - GHS - Acute Toxicity - OralKorea - MOL - GHS - Acute Toxicity - DermalKorea - MOL - GHS - Acute Toxicity - Inhalation - Dust and MistKorea - MOL - GHS - Acute Toxicity - Inhalation - GasKorea - MOL - GHS - Acute Toxicity - Inhalation - VaporKorea - MOL - GHS - Acute Toxicity - Oral

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HESI302013


Hazard CategoryAcute Toxicity Cat. 2



I DefinitionsOral LD50 > 5 < 50 m~/kgDermal LD50 > 50 < 200 mg/kgInhalation (Gas) LC50 > 100 < 500 ppmInhalation (Vapor) LC50 > 0.5 < 2.0 mg/1Inhalation (Dust/Mist) LC50 > 0.05 < 0.5 mg/1Substance is present at > 0.1% in the product and is on one of these lists:Australia - GHS - Acute Toxicity - Dermal (Priority Existing Chemical Assessment Reports)Australia - GHS - Acute Toxicity - Inhalation (Priority Existing Chemical Assessment Reports)Australia - GHS - Acute Toxicity - Oral (Priority Existing Chemical Assessment Reports)EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - DermalEU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - InhalationEU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - OralJapan - GHS - Acute Toxicity - DermalJapan - GHS - Acute Toxicity - Inhalation - Dust and MistJapan - GHS - Acute Toxicity - Inhalation - GasJapan - GHS - Acute Toxicity - Inhalation - VaporJapan - GHS - Acute Toxicity - OralKorea - MOL - GHS - Acute Toxicity - DermalKorea - MOL - GHS - Acute Toxicity - Inhalation - Dust and MistKorea - MOL - GHS - Acute Toxicity - Inhalation - GasKorea - MOL - GHS - Acute Toxicity - Inhalation - VaporKorea - MOL - GHS - Acute Toxicity - OralOral LD50 > 50 < 300 mg/kgDermal LD50 > 200 < 1000 mg/kgInhalation (Gas) LC50 > 500 < 2500 ppmInhalation (Vapor) LC50 > 2.0 < 10 mg/1Inhalation (Dust/Mist) LC50 > 0.5 < 1 mg/1Substance is present at > 0.1% in the product and is on one of these lists:Australia - GHS - Acute Toxicity - Dermal (Priority Existing Chemical Assessment Reports)Australia - GHS - Acute Toxicity - Inhalation (Priority Existing Chemical Assessment Reports)Australia - GHS - Acute Toxicity - Oral (Priority Existing Chemical Assessment Reports)EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - DermalEU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - InhalationEU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - OralJapan - GHS - Acute Toxicity - DermalJapan - GHS - Acute Toxicity - Inhalation - Dust and MistJapan - GHS - Acute Toxicity - Inhalation - GasJapan - GHS - Acute Toxicity - Inhalation - VaporJapan - GHS - Acute Toxicity - OralKorea - MOL - GHS - Acute Toxicity - DermalKorea - MOL - GHS - Acute Toxicity - Inhalation - Dust and MistKorea - MOL - GHS - Acute Toxicity - Inhalation - GasKorea - MOL - GHS - Acute Toxicity - Inhalation - VaporKorea - MOL - GHS - Acute Toxicity - OralOral LD50 > 300 < 2000 m~/kgDermal LD50 > 1000 < 2000 mg/kgInhalation (Gas) LC50 > 2500 < 20000 ppmInhalation (Vapor) LC50 > 10 < 20 mg/1Inhalation (Dust/Mist) LC50 > 1 < 5 mg/1Substance present at > 0.1% in the product and on one of these lists:Australia - GHS - Acute Toxicity - Dermal (Priority Existing Chemical Assessment Reports)Australia - GHS - Acute Toxicity - Inhalation (Priority Existing Chemical Assessment Reports)Australia - GHS - Acute Toxicity - Oral (Priority Existing Chemical Assessment Reports)EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - DermalEU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - InhalationEU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Acute Toxicity - OralJapan - GHS - Acute Toxicity - DermalJapan - GHS - Acute Toxicity - Inhalation - Dust and MistJapan - GHS - Acute Toxicity - Inhalation - GasJapan - GHS - Acute Toxicity - Inhalation - VaporJapan - GHS - Acute Toxicity - Oral



HESI302014


Hazard Category

Corrosivity Cat. 1

Corrosivity Cat. 2 (Irritant~

I DefinitionsKorea - MOL - GHS - Acute Toxicity - DermalKorea - MOL - GHS - Acute Toxicity - Inhalation - Dust and MistKorea - MOL - GHS - Acute Toxicity - Inhalation - GasKorea - MOL - GHS - Acute Toxicity - Inhalation - VaporKorea - MOL - GHS - Acute Toxicity - Oral)H< 2> 11.5Irreversible daanage to skin or eyes.Skin Corrosion - produces destruction of skin tissue, visible necrosis through the epidermis and into the dermis, in atleast 1 of 3 tested animals after exposure up to a 4 hour duration. Reactions include ulcers, bleeding, bloody scabs and,by the end of observation at 14 days, by discoloration due to blanching of the tissue, complete area of alopecia and scars.

Eye Corrosion - produces destruction of eye tissue, or serious physical decay of vision, following application of a testsubstance to the anterior surface of the eye, which is not fully reversible within 21 days of application.(a) at least one animal effect on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversedwithin an observation period normally 21 days; and/or(b) at in 2 of 3 tested animals, a positive response of:

(i) corneal opacity > 3; and/or(ii) iritis > 1.5calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material

Corrosive to metals - corrosion rate on either steel or aluminum surfaces exceeding 6.25 mm per year at a testtemperature of 55 C when tested on both materials.Substance is present at > 1% in the product and is on one of these lists:Australia - GHS - Skin Corrosion/Irritation (Priority Existing Chemical Assessment Reports)Australia - GHS - Serious Eye Damage/Eye Irritation (Priority Existing Chemical Assessment Reports;EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Serious Eye Damage/Eye IrritationEU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Skin Corrosion/IrritationHong Kong - Dangerous Goods - Categor~ 3 - Corrosive SubstancesJapan - GHS - Skin Corrosion/IrritationJapan - GHS - Serious Eye Damage/IrritationJapan - ISHL Corrosive LiquidsKorea - MOL - GHS - Serious Eye Damage or Irritatio~Korea - MOL - GHS - Skin Corrosion or IrritationSingapore - Corrosive and Explosive Substances - Corrosive SubstancesReversible damage to skin or eyesSkin Irritation(1) Mean value of > 2.3 < 4.0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24,48 and 72 hours after patch removal or, if reaction are delayed, form grades on 3 consecutive days after the onset of skinreaction; or(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularlytaking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or(3) In some cases where there is pronounced variability of response among animals, with very definitive positive effectsrelated to chemical exposure in a single animal but less than the criteria above.Eye Irritation(1) at least in 2 of 3 tested animals a positive response of:(a) corneal opacity > 1; and/or(b) iritis > 1; and/or(c) conjunctival redness > 2; and/or(d) conjunctival oedema (Chemosis) >2calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which[’ullv reverses within an observation neriod of normally 21 davs.



HESI302015


Hazard Category

Acute Target OrganToxicity

Chronic Target OrganToxicity

Aspiration Hazard

I DefinitionsSubstance is present at > 1% in the product and is on one of these lists:Australia - GHS - Skin Corrosion/Irritation (Priority Existing Chemical Assessment Reports)Australia - GHS - Serious Eye Damage/Eye Irritation (Priority Existing Chemical Assessment Reports’,EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Serious Eye Damage/Eye IrritationEU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Skin Corrosion/IrritationJapan - GHS - Skin Corrosion/IrritationJapan - GHS - Serious Eye Damage/IrritationKorea - MOL - GHS - Serious Eye Damage or Irritatio~Korea - MOL - GHS - Skin Corrosion or IrritationFollowing a single exposure, the substance can produce significant toxicity to humans or the substance can be presumedto have potential for harm to human health based on experimental studies with animals.Substance is present at > 1% in the product and is on one of these lists:Australia - GHS - Specific Organ Systemic Toxicity Following Single Exposure (Priority Existing Chemical AssessmentReports)EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Specific Target Organ Toxicity - Single ExposureKorea - MOL - GHS - Specific Tay~et Organ Toxicity - Single ExposureFollowing repeated exposures, the substance can produce significant toxicity to humans or the substance can be)resumed to have potential for harm to human health based on experimental studies with animals.

Substance is present at > 1% in the product and is on one of these lists:Australia - GHS - Specific Organ Systemic Toxicity Following Repeated Exposure (Priority Existing ChemicalAssessment Report)EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Specific Target Orga~a Toxicity - Repeated Exposure

Korea - MOL - GHS - Specific Tay~et Organ Toxicit~¢ - Repeated ExposurePractical experience in humans from reliable and good quality evidence that the substance can produce aspirationhazard.Cat 1: Hydrocarbon with a kinematic viscosity < 20.5 mm2/s measured at 40 C.Cat 2: On the basis of existing animal studies and expert judgment that takes into account surface tension, watersolubility, boiling point, and volatility, substances, other than those classified in Cat 1, which have a kinematic viscosity< 14 mm2/s, measured at 40 C.Substance is present at > 1% in the product and is on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Aspiration HazardJapan - GHS - Aspiration HazardsKorea - MOL - GHS - Aspiration Hazard

Note." All tabulated information provided to Gradient by HESLThe same list may be cited under different hazard categories, indicating that specific information in that list is used tofurther assign the chemical to a specific hazard category.



HESI302016

Table 2.1bCSI - Physical Safety Criterion

Hazard CategoryExplosive

Pyrotechnic

Flammable Gas

Oxidizing Gas

Gases Under Pressure

Flammable Liquid Cat. 1(Extremely FlammableLiquid)

I Def’mitionsSolid or Liquid substance or mixture which, by chemical reaction, is in itself capable of producing gas at such atemperature and pressure and at such a speed as to cause damage to surroundingsPart I of the UN Recommendation on the Transport of Dangerous Goods’, Manual of Tests and Criteria (Test Series 1-8)Substance is present at > 0.1% in the product and is on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - ExplosiveHong Kong - Dangerous Goods - Category 1 - Explosives and Blasting AgentsIndonesia - Explosives - Quantity Limit ValuesJapan - GHS - ExplosivesKorea - MOL - GHS - ExplosivesKorea - NEMA - GHS - ExplosivesLuxembourg - Explosives Convention - Powerful ExplosivesNew- Zealand - HSNO - Explosives - GHS ClassificationsSingapore - Arms and Explosives Act - Detection Agents (First Schedule)Singapore - Arms and Explosives Act - Explosive Precursors (Second Schedule)South Africa - Explosives Act - High ExplosivesSouth Africa - Mine Safety - Occupational Exposure Limits - Explosion HazardsUS - BATF - List of Explosive MaterialsUS - State Department - Munitions List Cate~o~ V - Explosives and Energetic MaterialsSubstance/mixture designed to produce an effect by heat, light, sound, gas or smoke or a combination of these as theresult ofnon-detonative self-sustaining exothermic chemical reaction.Part I of the UN Recommendation on the Transport of Dangerous Goods’, Manual of Tests and Criteria (Test Series 1-8)Gas having a flammable range with air at 20 C and standaxd pressure of 101.3 kPaTest Method: ISO 10156:1996Substance is present at > 1% in the product and is on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Flammable GasJapan - GHS - Flammable GasesKorea - MOL - GHS - Flammable GasesKorea - NEMA - GHS - Flammable GasesEU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Flammable AerosolAny gas which may, generally by providing oxygen, cause or contribute to the combustion of other material more thanair does.Test Method: ISO 10156:99 and ISO 10156-2:2005Substance is present at > 1% in the product and is on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Oxidizing GasJapan - GHS - Oxidizing GasesKorea - MOL - GHS - Oxidizin~ GasesGases contained in a receptacle at a pressure of 200 kPa (gauge) or more, or which are liquefied or liquefied andrefrigerated.Compressed Gas: A gas which when packaged under pressure is entirely gaseous at -50 ; including all gases with acriticaltemperature* < -50CLiquefied Gas: A gas which when packaged under pressure is partially liquid at temperature above -50 C(a) High Pressure Liquefied Gas - a gas with a critical temperature* between -50 C and +65 C(b) Low- Pressure Liquefied Gas - a gas with a critical temperature* above +65 CRefrigerated Gas: A gas which when packaged is made partially liquefied because of its low- temperatureDissolved Gas: A gas which when packaged under pressure is dissolved in a liquid phase solvent*Critical temperature is the temperature above which a pure gas cannot be liquefied; regardless of the degree ofcompressionSubstance is present at > 1% in the product and is on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Gases under PressureJapan - GHS - Gases Under PressureKorea - MOL - GHS - Gases Under PressureKorea - NEMA - GHS - Gases Under PressureLiquid with a Flash Point < 23 C and initial boilin~ point < 35CSubstance is present at > 1% in the product and is on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Flammable LiquidJapan - GHS - Flammable LiquidsKorea - MOL - GHS - Flammable LiquidsKorea - NEMA - Dangerous Substances - Class 4 Flammable LiquidsKorea - NEMA - GHS - Flammable LiquidsUS - CAA (Cleaaa Air Act) - Accidental Release Prevention - Flammable Substaaaces

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HESI302017


Hazard CategoryFlammable Liquid Cat. 2(Highly Flaa~mableLiquid)

Flammable Liquid Cat. 3Flammable Liquid)

Flammable Liquid Cat. 4Combustible Liquid)

Flammable Solid

Self-Reactive Substance

Pyrophoric (Liquids andSolids)

I Def’mitionsLiquid with a Flash Point < 23 C and initial boilin~ point > 35CSubstance is present at > 1% in the product and is on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Flammable LiquidJapan - GHS - Flammable LiquidsKorea - MOL - GHS - Flammable LiquidsKorea - NEMA - Dangerous Substances - Class 4 Flammable LiquidsKorea - NEMA - GHS - Flammable LiquidsUS - CAA (Clean Air Act) - Accidental Release Prevention - Flammable Substances

Liquid with a Flash Point > 23 C and < 60 CSubstance is present at > 1% in the product and is on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Flammable LiquidJapan - GHS - Flammable LiquidsKorea - MOL - GHS - Flammable LiquidsKorea - NEMA - Dangerous Substances - Class 4 Flammable LiquidsKorea - NEMA - GHS - Flammable LiquidsUS - CAA (Clean Air Act) - Accidental Release Prevention - Flammable SubstancesLiquid with a Flash Point > 60 C and < 93 CSubstance is present at > 1% in the product and is on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Flammable LiquidJapan - GHS - Flammable LiquidsKorea - MOL - GHS - Flammable LiquidsKorea - NEMA - Dangerous Substances - Class 4 Flammable LiquidsKorea - NEMA - GHS - Flammable LiquidsUS - CAA (Clean Air Act) - Accidental Release Prevention - Flammable SubstancesSolids which are readily combustible, or may cause or contribute to fire through friction.Test method N. 1 : see Part III, sub-section 33.2.1 of UNManual of Test and CriteriaCat. 1 Burning Rate Test:Substance or mixture other than metal powders:(a) wetted zone does not stop fire; and(b) burning time < 45 s or burning rate > 2.2 mm/s

Metal powders: burnin~ time < 5 minCat. 2 Burning Rate Test:Substance or mixture other than metal powders:(a) wetted zone stops fire for at least 4 min.; and(b) burning time < 45 s or burning rate > 2.2 mm/s

Metal powders: burning time > 5 min and < 10 minSubstance is present at > 1% in the product and is on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Flammable SolidJapan - GHS - Flammable SolidsKorea - MOL - GHS - Flammable SolidsKorea - NEMA - Dangerous Substances - Class 2 Flammable SolidsKorea - NEMA - GHS - Flammable SolidsThermally unstable liquid or solid substance or mixture liable to undergo a strongly exothermic decomposition evenwithout participation of oxygen (air). Excludes explosives, organic peroxides, and oxidizers.Part II of the UN Recommendation on the Transport of Dangerous Goods’, Manual of Tests and Criteria (Test SeriesA-H)Substance present at > 1% in the product and on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Self-Reactive Substance or MixtureJapan - GHS - Self-Reactive Substamces and MixturesKorea - MOL - GHS - Self-Reactive Substances and MixturesKorea - NEMA - Dangerous Substances - Class 5 Self-Reactive SubstancesKorea - NEMA - GHS - Self-Reactive Substances and MixturesLiquids/solids which, even in small quantities ~e liable to ignite within five minutes after coming into contact with air.

Liquids: Test method N.3 (Paxt III, sub-section 33.3.1.5 of UNManual of Test and Criteria)Solids: Test method N.4 (Part III, sub-section 33.3.1.6 of UNManual qfTest and Criteria)Substance is present at > 1% in the product and is on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Pyrophoric LiquidEU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Pyrophoric SolidJapan - GHS - Pyrophoric LiquidsJapan - GHS - Pyrophoric SolidsKorea - NEMA - GHS - Pyrophoric LiquidsKorea - NEMA - GHS - Pyrophoric Solids



HESI302018


Hazard CategorySelf-Heating Substance

Emit Flammable Gases inContact with Water

Oxidizing Liquid

Oxidizing Solid

Organic Peroxide

Corrosive to Metals

Note."

I Def’mitionsA solid or liquid substance or mixture, other than pyrophoric liquid or solid, which, by reaction with air and withoutenergy supply, is liable to self-heat. These substances will ignite only when in large amounts (kg) and after long3eriods of time (hours or days).Test method N.4 (Part III, sub-section 33.3.1.6 of UNManual of Test and Criteria)Substance is present at > 1% in the product and is on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Self-Heating Substance or MixtureJapan - GHS - Self-Heating Substances aaad MixturesKorea - MOL - GHS - Self-Heatin~ Substances and MixturesSubstances or mixtures which, in contact with water, emit flammable gases are solid or liquid substances or mixtureswhich, by interaction with water, are liable to become spontaneously flammable or to give off flammable gases indangerous quantities.Test method N.5 (Part III, sub-section 33.4.1.4 of UNManual of Test and Criteria)Substance is present at > 1% in the product and is on one of these lists:EU - CLP (1272/2008) -Annex VI-Table 3.1-Classifications-Substance or Mixture which in Contact with Water EmitsFlammable GasJapan - GHS - Substances and Mixtures Which in Contact with Water Emit Flammable GasesKorea - MOL - GHS - Substances and Mixtures which in Contact with Water Emit Flammable GasesKorea - NEMA - GHS - Substances and Mixtures Which in Contact with Water Emit Flammable GasesA liquid which, while in itself nor necessarily combustible, may, generally by yielding oxygen, cause, or contribute to,the combustion of other material.Test method 0.2 (Part III, sub-section 34.4.2 of UNManual of Test and Criteria)Substance is present at > 1% in the product and is on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Oxidizing LiquidJapan - GHS - Oxidizing LiquidsKorea - MOL - GHS - Oxidizing LiquidsKorea - NEMA - Dangerous Substances - Class 6 Oxidizing LiquidsKorea - NEMA - GHS - Oxidizing LiquidsA solid which, while in itself nor necessarily combustible, may, generally by yielding oxygen, cause, or contribute to,the combustion of other material.Test method O. 1 (Part III, sub-section 34.4.1 of UNManual of Test and Criteria)Substance is present at > 1% in the product and is on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Oxidizing SolidJapan - GHS - Oxidizing SolidsKorea - MOL - GHS - Oxidizing SolidsKorea - NEMA - Dangerous Substances - Class 1 Oxidizing SolidsKorea - NEMA - GHS - Oxidizin~ SolidsLiquid or solid organic substances which contain the bivalent -O-O- structure and may be considered derivative ofhydrogen peroxide, where one or both of the hydrogen atoms have been replaced by orgaaaic radicals.

Test series A to H (Part II of UNManual of Test and Criteria)Substance is present at > 1% in the product and is on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Organic PeroxideJapan - GHS - Organic PeroxidesKorea - MOL - GHS - Organic PeroxidesKorea - NEMA - GHS - Organic PeroxidesUS - DOT (Department of Traaasportation) - Organic Peroxides TableSubstance of a mixture which by chemical action will materially damage, or even destroy, metals at a rate exceeding6.25 mm/year at a temperature of 55 C.Tests in Part II, sub-section 37.4 of UNManual q[’Test and Criteria)Substance is present at > 1% in the product and is on one of these lists:EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Substance or Mixture Corrosive to MetalsJapan - GHS - Corrosive to MetalsKorea - MOL - GHS - Corrosive to MetalsKorea - NEMA - GHS - Corrosive to Metals

All tabulated information provided to Gradient by HESLThe same list may be cited under different hazard categories, indicating that specific information in that list is used tofurther assign the chemical to a specific hazard category



HESI302019

Table 2.1cCSI - Environmental Criterion

Hazard CategoryAcute Aquatic ToxicityCat. 1

Acute Aquatic ToxicityCat. 2

Acute Aquatic ToxicityCat. 3

Chronic Aquatic ToxicityCat. 1



I Def’mitions96 hr LCs0 (fish) < 1 mg/1

48 hr ECs0 (crustacea) < 1 mg/172 or 96 hr ErCs0 (algae or other aquatic plants) < 1 rag/1

Substance is present at > 1% in the product and is on one of these lists:Australia - GHS - Acute Hazards to the Aquatic Environment (Priority Existing Chemical Assessment Reports)EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Hazardous to the Aquatic EnvironmentJapan - GHS - Acute Hazards to the Aquatic EnvironmentKorea - MOL - GHS - Hazardous to the Aquatic Environment - Acute96 hr LCs0 (fish) > 1 rag/1 a~d < 10 rag/148 hr ECs0 (crustacea) > 1 rag/1 and < 10 rag/172 or 96 hr ErCs0 (algae or other aquatic plants) > 1 rag/1 and < 10 rag/1

Substance is present at > 1% in the product and is on one of these lists:Australia - GHS - Acute Hazards to the Aquatic Environment (Priority Existing Chemical Assessment Reports)

EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Hazardous to the Aquatic EnvironmentJapan - GHS - Acute Hazards to the Aquatic EnvironmentKorea - MOL - GHS - Hazardous to the Aquatic Environment - Acute96 hr LCs0 (fish) > 10 rag/1 and < 100 rag/148 hr ECs0 (crustacea) > 10 rag/1 and < 100 rag/172 or 96 hr ErCs0 (algae or other aquatic plants) > 10 rag/1 and < 100 rag/1

Substance is present at > 1% in the product and is on one of these lists:Australia - GHS - Acute Hazards to the Aquatic Environment (Priority Existing Chemical Assessment Reports)EU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Hazardous to the Aquatic EnvironmentJapan - GHS - Acute Hazards to the Aquatic EnvironmentKorea - MOL - GHS - Hazardous to the Aquatic Environment - Acute96 hr LCs0 (fish) < 1 rag/148 hr ECs0 (crustacea) < 1 rag/172 or 96 hr ErCs0 (algae or other aquatic plants) < 1 rag/1

Lacks the potential to rapidly degrade (OECD 306 or 301 Biodegradation < 20%)Has the potential to bioaccumulate (BCF > 500 or if absent, log Kow > 4)Chronic NOEC(s) is < 1 rag/1Substance is present at > 0.1% in the product and is on one of these lists:Australia - GHS - Chronic Hazards to the Aquatic Environment (Priority Existing Chemical Assessment Reports)Japan - GHS - Chronic Hazards to the Aquatic EnvironmentKorea - MOL - GHS - Hazardous to the Aquatic Environment - Chronic96 hr LCs0 (fish) > 1 rag/1 a~d < 10 rag/148 hr ECs0 (crustacea) > 1 rag/1 and < 10 rag/172 or 96 hr ErCs0 (algae or other aquatic plants) > 1 rag/1 and < 10 rag/1Lacks the potential to rapidly degrade (OECD 306 or 301 Biodegradation < 20%)Has the potential to bioaccumulate (BCF > 500 or if absent, log Kow > 4)If Chronic NOEC(s) is < 1 rag/1 then it is Chronic Aquatic Toxicity Cat. 1Substance is present at > 0.1% in the product and is on one of these lists:Australia - GHS - Chronic Hazards to the Aquatic Environment (Priority Existing Chemical Assessment Reports)Japan - GHS - Chronic Hazards to the Aquatic EnvironmentKorea - MOL - GHS - Hazardous to the Aquatic Environment - Chronic96 hr LCs0 (fish) > 10 rag/1 and < 100 rag/148 hr ECs0 (crustacea) > 10 rag/1 and < 100 rag/172 or 96 hr ErCs0 (algae or other aquatic plants) > 10 rag/1 and < 100 rag/1

Lacks the potential to rapidly degrade (OECD 306 or 301 Biodegradation < 20%)Has the potential to bioaccumulate (BCF > 500 or if absent, log Kow > 4)If Chronic NOEC(s) is < 1 rag/1 then it is Chronic Aquatic Toxicity Cat. 1Substance is present at > 0.1% in the product and is on one of these lists:Australia - GHS - Chronic Hazards to the Aquatic Environment (Priority Existing Chemical Assessment Reports)Japan - GHS - Chronic Hazards to the Aquatic EnvironmentKorea - MOL - GHS - Hazardous to the Aquatic Environment - Chronic

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Hazard CategoryChronic Aquatic ToxicityCat. 4

Ozone Depletion

I Def’mitionsPoorly soluble with no acute toxicityLacks the potential to rapidly degrade (OECD 306 or 301 Biodegradation < 20%)Has the potential to bioaccumulate (BCF > 500 or if absent, log Kow > 4)If Chronic NOEC(s) is < 1 m~/1 then it is Chronic Aquatic Toxicity Cat. 1Substance is present at > 0.1% in the product and is on one of these lists:Australia - GHS - Chronic Hazards to the Aquatic Environment (Priority Existing Chemical Assessment Reports)Korea - MOL - GHS - Hazardous to the Aquatic Environment - ChronicA substance which, on the basis of the available evidence concerning its properties and its predicted or observedenvironmental fate and behavior, may present a danger to the structure aa~d/or the functioning of the stratospheric ozonelayer. Ozone Depletors are determined from regulatory lists.Substance is present at > 0.1% in the product and is on one of these lists:Australia - Ozone Protection Act - Scheduled SubstancesBrazil - Prohibited Ozone Depleting SubstancesBrazil - Restricted Commercial Use of Ozone Depleting SubstancesCanada - Ozone Depleting Substances - Schedule 2Canada - Ozone Depleting Substances - Schedule 3Canada - Ozone Depleting Substances - Schedule 4China - Ozone Depleting Substances - First ScheduleChina - Ozone Depleting Substances - Fourth ScheduleChina - Ozone Depleting Substances - Second ScheduleChina - Ozone Depleting Substances - Third ScheduleCroatia - Ozone Depleting Substances - Annex A, Group ICroatia - Ozone Depleting Substances - Annex A, Group IICroatia - Ozone Depleting Substances - Annex B, Group ICroatia - Ozone Depleting Substances - Annex B, Group IICroatia - Ozone Depleting Substances - Annex B, Group IIICroatia - Ozone Depleting Substances - Annex C, Group ICroatia - Ozone Depleting Substances - Annex C, Group IICroatia - Ozone Depleting Substances - Annex C, Group IIICroatia - Ozone Depleting Substances - Annex E, Group IDjibouti - Ozone Depleting Substances - Importation RestrictionsE1 Salvador - List of Ozone Depleting SubstancesEU - CLP (1272/2008) - Annex VI - Table 3.1 - Classifications - Hazardous for the Ozone LayerEU - Ozone Depleting Substances Regulation (2037/2000)GCC - Ozone Depleting Substances - Annex A - Group IGCC - Ozone Depleting Substances - Annex A - Group IIGCC - Ozone Depleting Substances - Annex B - Group IGCC - Ozone Depleting Substances - Annex B - Group IIGCC - Ozone Depleting Substances - Annex B - Group IIlGCC - Ozone Depleting Substances - Annex C - Group IGCC - Ozone Depleting Substances - Annex C - Group IIGCC - Ozone Depleting Substances - Annex C - Group IIlGCC - Ozone Depleting Substances - Annex E - Group IHong Kong - Ozone Depleting SubstancesIndia - Ozone Depleting Substances - Schedule IIndonesia - Ozone Depleting Substances - Annex IIndonesia - Ozone Depleting Substances - Annex IIIndonesia - Ozone Depleting Substances - Annex IIlIndonesia - Prohibition on the Production of Ozone Depleting SubstancesJapan - Ozone Depleting Substances - Annex A Group IJapan - Ozone Depleting Substances - Annex A Group IIJapan - Ozone Depleting Substances - Annex B Group IJapan - Ozone Depleting Substances - Annex B Group IIJapan - Ozone Depleting Substances - Annex B Group IIlJapan - Ozone Depleting Substances - Annex C Group IJapan - Ozone Depleting Substances - Annex C Group IIJapan - Ozone Depleting Substances - Annex C Group IIlJapan - Ozone Depleting Substances - Annex EJapan - Prevention of Marine Pollution and Disaster - Ozone Depleting SubstancesLatvia - Ozone Depleting SubstancesNew- Zealand - Ozone Depleting SubstancesNorway - Ozone Depleting SubstancesOman - Ozone Depleting SubstancesPhilippines - Ozone Depleting Substances - Annex A - Group I

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Hazard Categor.~

VOCs

Hazardous Air Pollutants(HAPs)

I Def’mitionsPhilippines - Ozone Depleting Substances - AnnexPhilippines - Ozone Depleting Substances - AnnexPhilippines - Ozone Depleting Substances - AnnexPhilippines - Ozone Depleting Substances - AnnexPhilippines - Ozone Depleting Substances - AnnexPhilippines - Ozone Depleting Substances - AnnexPhilippines - Ozone Depleting Substances - AnnexSingapore - Ozone Depleting Substances - AnnexSingapore - Ozone Depleting Substances - AnnexSingapore - Ozone Depleting Substances - AnnexSingapore - Ozone Depleting Substances - AnnexSingapore - Ozone Depleting Substances - AnnexSingapore - Ozone Depleting Substances - AnnexSingapore - Ozone Depleting Substances - AnnexSingapore - Ozone Depleting Substances - AnnexSingapore - Ozone Depleting Substances - AnnexSwitzerland - Chemical Risk Reduction OrdinanceTaiwan - Ozone Depleting SubstancesTurkey - Ozone Depleting Substances - Group ITurkey - Ozone Depleting Substances - Group IITurkey - Ozone Depleting Substances - Group II]Turkey - Ozone Depleting Substances - Group IVTurkey - Ozone Depleting Substances - Group VTurkey - Ozone Depleting Substances - Group VITurkey - Ozone Depleting Substances - Group VII

BBCCCE

A - Group IIB - Group IB - Group IIB - Group IIlC - Group IC - Group IIE

A - Group IA - Group IIB - Group I

- Group II- Group IIl- Group I- Group II- Group IIl

- Ozone Depleting Substances

Turkey - Ozone Depleting Substances - Substaaaces under ControlUS - CAA (Cleaaa Air Act) - Class I Ozone DepletorsUS - CAA (Cleaaa Air Act) - Class II Ozone DepletorsUS - California - Ozone Depleting Compounds Prohibited in Antiperspirants and DeodorantsUNEP - Montreal Protocol Ozone Depletors - Annex A - Group ]UNEP - Montreal Protocol Ozone Depletors - Annex A - Group I]UNEP - Montreal Protocol Ozone Depletors - Annex B - Group 1UNEP - Montreal Protocol Ozone Depletors - Annex B - Group I]UNEP - Montreal Protocol Ozone Depletors - Annex B - Group II]UNEP - Montreal Protocol Ozone Depletors - Annex C - Group 1UNEP - Montreal Protocol Ozone Depletors - Annex C - Group I]UNEP - Montreal Protocol Ozone Depletors - Annex C - Group II]UNEP - Montreal Protocol Ozone Depletors - Annex EVOCs are chemicals that evaporate easily at room temperature. VOCs have a high vapor pressure and low- watersolubility. The term "organic" indicates that the compounds contain carbon. VOC compounds are determined fromregulatory listsSubstance is present at > 0.1% in the product and is on one of these lists:Cyprus- Air Quality- Ozone Precursors (VOCs)Korea - MOE - Substaaaces Regulated as VOCsSwitzerland - VOCsUS - CAA (Clean Air Act) - VOCs in SOCMIToxic air pollutants, also known as HAPs, are those pollutants that are known or suspected to cause cancer or otherserious health effects, such as reproductive efl’ects or birth defects, or adverse environmental efl’ects. HAPs aredetermined by regulatory lists.Substance is present at > 0.1% in the product and is on one of these lists:Cambodia - Pollutants in Ambient Air - Maximum Allowable Concentrations Emitted from Stationary SourcesJapan - Air Pollution Control Law- - Emission Standards for Air PollutantsJapan - Air Pollution Control Law- - HAPsKorea - MOE - Cleaaa Air Conservation Act - Air PollutantsKorea - MOE - Cleaaa Air Conservation Act - Specified HAPsPhilippines - Air Quality - Source Specific Air PollutantsSaudi Arabia - Royal Commission - HAPsUS - CAA (Cleaaa Air Act) - 1990 HAPsUS - CAA (Cleaaa Air Act) - High Risk HAPsUS - CAA (Clean Air Act) - HON Rule - Organic HAPs



HESI302022


Hazard CategoryHazardous WaterPollutants (HWPs)

Biodegradation -Persistent

Biodegradation - InherentBioaccumulation

Note."

I Def’mitionsPollutants that reduce the usefulness of water to humans and other organisms in nature. HWPs are determined byregulatory lists.Substance is present at > 0.1% in the product and is on one of these lists:EU - Groundwater Directive (2006/118/EC) - Minimum List of Pollutants aaad IndicatorsJapan - Environmental Quality Standards - Water Pollutants - Public Water - Monitored Substances & Guideline Values

Japan - Environmental Quality Standards - Water Pollutants - Public Water - Protection of Human HealthUS - California - Priority Toxic Pollutants - Freshwater CriteriaUS - California - Priority Toxic Pollutants - Human Health CriteriaUS - California - Priority Toxic Pollutants - Saltwater CriteriaUS - CWA (Cleaaa Water Act) - Priority PollutantsUS - DOT (Department of Traaasportation) - Severe Maxine Pollutants (regulated at 1% or greater) - (Appendix B)

Lacks the potential to rapidly degrade (OECD 306 or 301 Biodegradation < 20%)Substance is present at > 1% in the product and is on one of these lists:Canada - Saskatchewaaa - Dangerous Goods - Environmental Persistent or Chronic Hazardous SubstancesEU - Persistent Organic Pollutants (850/2004) - Annex I - Substances Subject to ProhibitionsEU - Persistent Organic Pollutants (850/2004) - Annex III- Substances Subject to Release Reduction ProvisionsEU - Persistent Organic Pollutants (Decision 2006/507/EC) - Stockholm ConventionIndia - Persistent Organic Pollutants (POPs)Thailand - Banned Persistent Organic Pollutants (POPs)US - Washington - Persistent Bioaccumulative ToxinsUNEP - Persistent Organic Pollutants (POP)Lacks the potential to rapidly degrade (OECD 306 or 301 Biodegradation > 20 <60 %)Has the potential to bioaccumulate (BCF > 500 or if absent, log Kow > 4)Substance is present at > 1% in the product and is on one of these lists:US - California - 22 CCR - Total Threshold Conc. (TTLC)-Persistent Bioaccumulative Substances - ExtremelyHazardous WastesUS - California - 22 CCR-Total Threshold Limit Conc. (TTLC) Values-Persistent and Bioaccumulative ToxicSubstancesUS - CWA (Cleaaa Water Act) - Bioaccumulative Chemicals of Concern (BCCs)US - Washington - Persistent Bioaccumulative Toxins

All tabulated information provided to Gradient by HESLThe same list may be cited under different hazard categories, indicating that specific information in that list is used tofurther assign the chemical to a specific hazard category.



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Table 2.3Comparison of CSI and GHS Cut-Off Values

CSI Hazard Categories CSI Cut-Offs (%) GHS Cut-Offs (%)Environmental HazardAcute Aquatic Toxicity Cat. 1 0.001 1 [1]Acute Aquatic Toxicity Cat. 2 0.1 1 [1]Acute Aquatic Toxicity Cat. 3 1 1 [1]Chronic Aquatic Toxicity Cat. 1 0.001 1 [1]Chronic Aquatic Toxicity Cat. 2 0.001 1 [1]Chronic Aquatic Toxicity Cat. 3 0.001 1 [1]Chronic Aquatic Toxicity Cat. 4 0.1 1 [1]Ozone Depletion 0.001 NAVOCs 0.001 NAHAPs 0.001 NAHWPs 0.001 NABiodegradation - Persistent 0.001 --Biodegradation - Inherent 0.001 NABioaccumulation 0.001 --Physical Safety HazardExplosive 0.001 --Pyrotechnic 0.001 --Flammable Gas 0.001 --Oxidizing Gas 0.001 --Gases Under Pressure 0.001 --Flammable Liquid Cat. 1 (Extremely Flammable Liquid)Flammable Liquid Cat. 2 (Highly Flammable Liquid)Flammable Liquid Cat. 3 (Flammable Liquid)Flammable Liquid Cat. 4 (Combustible Liquid)Flammable SolidSelf-Reactive SubstancePyrophoric (Liquids and Solids)Self-Heating SubstanceEmit Flammable Gases in Contact with WaterOxidizing LiquidOxidizing SolidOrganic Peroxide

Corrosive to MetalsHealth Hazard

0.001 --0.1 --

0.001 --

0.1 --0.001 --0.001 0.5 or 1 I21

Carcinogenicity Cat. 1 (Known Human Carcinogen) 0.001 0.1Carcinogenicity Cat. 2 (Suspected Human Carcinogen) 0.001 0.1Mutagenicity 0.001 0.1 or 1.0 [3]Reproductive Toxicity 0.001 0.1Endocrine Disruptors 0.001 NASensitizers 0.001 0.1Acute Toxicity Cat. 1 0.001 1Acute Toxicity Cat. 2 0.001 --Acute Toxicity Cat. 3 0.1 --Acute Toxicity Cat. 4 1 --Corrosivity Cat. 1 0.1 3 (eye), 5 (skin)Corrosivity Cat. 2 (Irritant) 1 1Acute Target Organ Toxicity 0.001 1Chronic Target Organ Toxicity 0.001 1Aspiration Hazard 5 --Notes:All tabulated CSI criteria and cutoffs provided to Gradient by HESLNA: Not applicable. The UN GHS (2007) does not consider this hazard category.-- Cut-offs are not defined by GHS for this hazard category.[1] The GHS defines a generic cut-off of >_ 1.0%for chemicals that are ’Hazardous to the aquatic environment.

[2] < 1% available 0 2 from organic peroxides when >_ 1.0% H 2 0 ~ or < 0.5% available 0 ~ from organic peroxidewhen > 1.0% to < 7% H~0 ~.[3] > O. 1% for Category 1 mutagen; > 1.0% for Category 2 mutagen.

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Table 2.4Total Possible Score per Hazard Criteria for a Single Chemical

Hazard Criteria Total Possible Score12

Environmental 635Physical Safety 5503Health 510

Notes:1Assumes the highest possible score in each hazard category, and uses the highestscore value when there are multiple classes within a category (e.g., scored acutetoxicity as Category 1 acute toxin).:Total possible score information derived from CSI scores presented in Tables 2.2a-cof this report.3The total score for physical safety hazards is dependent upon the phase of thechemical. Thus, the highest possible score for liquid chemicals is 550, and thehighest possible score for solids and gases is 475, and 350, respectively.

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Table 3.1

CPA Green Screen for Safer Chemicals

Parameter CommentsGeneral Overview Hazard-based screening method, based on US EPA’s DfEI21 program, that defines criteria for four (4)

Benchmark levels to indicate whether chemicals used in products are safe. Differs from the CSI inthat criteria are defined for each Benchmark that each chemical AND its breakdownproducts/metabolites must pass.

Publicly Available? Yes.

Use/applicability? Individual chemicals (and their byproducts) in consumer/industrial products

Used by? State of Washington Department of Ecology, Walmart (in developing their internal tool, GreenWercs),Hewlett-Packard

Primary Review CriteriaHazard Categories Evaluated Health, Environmental, and Physical safety hazards (limited)

Hazard Category Comparison Health: Green Screen includes two categories not explicitly considered by the CSI, however, the CSIconsiders select endpoints for these categories under chronic toxicity.Environmentah Green Screen and the CSI both consider acute and chronic aquatic toxicity,persistence (biodegradation), and bioaccumulation. Green Screen does not consider several CSIenvironmental categories - i.e., VOCs, fLAPs, HWPs, and ozone depletion.Physical Safety Hazards: Green Screen considers only flammability and explosivity as part of thephysical hazards screen, while CSI considers all GHS categories.

Based largely on those defined in US EPA’s DIE[21 as well as the UN GHS.[31Hazard CategoryResources/Databases Used

Secondary Review Criteria

Scoring/~Veighting of Chemicals Chemicals are not assigned hazard scores, but based on presence of chemical and its by-products/metabolites, chemicals are assigned to a particular Green Screen Benchmark.

Are Data Gaps Addressed? Yes. Data are qualified/flagged if data are not available. Green Screen also recommends the use ofQSARs to fill data gaps.

Other Attributes

Platform Process (software, Traaasparent written guidance document that is not automated. Chemicals undergoing Green Screenflowchart, etc. ) assessment are summarized in a comprehensive written report.

Are Data Qualifiers Used? Yes. For example, Green Screen will identify aaad flag chemicals when Benchmarks are based onactual experimental data versus estimated/predicted results. Also, when data are unavailable for aparticular endpoint/category, this will be flagged during the Green Screen assessment.

Chemical Identifier (i e., CAS CAS numbernumber?)

Is there a "No Hazard Category"? No. However, Green Screen defines criteria for "low- hazards." Chemicals passing Benchmark 4 areHow is it Defined? considered "Safer Chemicals."

Notes:CAS - Chemical Abstract Service Number

]~@reFices:

[1] CPA, 2007.[2] US EPA, 2009a.[31 UN, 200Z

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Table 3.2

US EPA CHAMPIll

Parameter CommentsGeneral Overview CHAMP outlines guidaaace for qualitative RBP of HPV chemicals, as well as HBP for MPV

chemicals. During RBP, chemicals undergo qualitative hazard, risk and exposure screenings based onUS EPA-defined evaluation criteria (the RBP hazard screening is most relevaaat for our comparison).


Use/applicability? Prioritization of individual HPV and MPV chemicals for further assessment.

Used by? US EPA, for purposes of chemical prioritization. Will be superseded by another program, but CHAMPreports have been published as recently as September 2009.

Primary Review Criteria

Hazard Categories Evaluated Health, Environmental (Toxicity and Fate Characterization), aaad Physical Safety Hazards (limited)

Hazard Category Comparison Health: CHAMP considers two categories not explicitly considered by the CSI, however, the CSIconsiders select endpoints for these categories under chronic toxicity.Environmental: CHAMP includes several environmental hazard categories not specificallyconsidered by the C SI, while CHAMP does not consider several C SI environmental categories -i.e.,HAPs, HWPs, ozone depletion.Physical Safet~ Hazards: CHAMP evaluates only two properties under physical hazards - vaporpressure and water solubility; the CSI evaluates all GHS categories.

Hazard CategoryResources/Databases Used

Hazard categories are based on OECD SIDS. For the "hazard" screening portion of RBP (consideredmost relevant to the CSI comparison because the RBP approach also considers physical properties),CHAMP relies upon the National Library of Medicine Databases which allows searches of numerousdata sources and databases, including PubMed, the Hazardous Substances Database Ba~k, etc.


Scoring/~Veighting of Chemicals Chemicals undergoing CHAMP RBP are not scored, but are assigned low-, medium, or high prioritybased on qualitative evaluation of hazard criteria.

Are Data Gaps Addressed? When data are not available, expert judgment aaad one or more estimation approaches (i. e., QSARS)may be used. Lack of data may influence the prioritization of a chemical.

Other Attributes

Platform Process (software, Outlined in a fairly traaasparent written guidance document and is not automated. OPPT professionalflowchart, etc. ) judgment is used to evaluate data quality aaad endpoint information. Output is a comprehensive written

report (HBP) or reports (RBP, for the various screening aaaalysis reports and final decision).

Are Data Qualifiers Used? Yes, data are flagged for data adequacy. "Measured" data values are clearly flagged as such, while"experimental" data are flagged with symbols indicating they are categorized as either a "value fromguideline study, clear weight of evidence, or evaluated database," a "value from non-guideline butreliable experimental study," or a "value reported without supporting details." Estimated data are alsoflagged/identified.CAS number and chemical formula/structureChemical Identifier (i e., CAS

number?)Is there a "No Hazard Category"? No; however, there are low- priority chemicals for which "follow-up action not suggested at this time."How is it Defined?


J~@rences:

[1] US EPA, 2009b, d

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Table 3.3US EPA DfE General Screen for Safer Ingredients [11

Parameter

General OverviewCommentsThe DIE is a screening system developed under US EPA’s Design for the Environment (DIE) Program.Differs from the CSI in that DIE is a pass/fail approach - there is no "scoring" perse - mad chemicalsare screened out if they do not meet certain threshold criteria within any of the categories evaluated.Customized screens and stmadards have been developed for select industries and consumer products(e .g., household cleaning products).


Use/applicability? Designed to delineate the safer or "low-concern" end of the ingredient spectrum for chemicals used inconsumer products, to guide and ensure best-in-class ingredient choices for DIE-recognized products.Products meeting the DIE screening process may be labeled with the DIE symbol.

Used by? Mmay well-known consumer product companies such as SC Johnson and Colgate-Palmolive haveestablished partnerships with US EPA’s DIE program. In addition, GreenBlue’s CleanGredients[4]

database was developed based on the DIE.

Primary Review Criteria

Hazard Categories Evaluated Health, Environmental, and Physical Safety Hazards (limited)

Hazard Category Comparison Health: The DIE considers an additional category not explicitly considered by the CSI; however, theCSI considers select endpoints for this category under chronic toxicity.Environmental: Similar to the CSI, the DIE considers acute aquatic toxicity, persistence(biodegradation), and bioaccumulation potential. While the CSI also considers chronic aquatictoxicity, DIE does not. DIE also does not consider several CSI environmental categories - i.e., HAPs,HWPs, ozone depletion - as specific categories.Physical Safety Hazards: Although physical hazards are not addressed in the General Screen,several of the customized screening protocols mad standards do include this as an evaluation category,but for limited categories. The CSI considers all GHS physical hazards.The DIE’s categories and evaluation criteria are based on CHAMPI21 and the UN GHS.[3] The DIEGeneral Screen also defines preferred and acceptable test methods for the categories evaluated.

Hazard CategoryResources/Databases Used


Scoring/~Veighting of Chemicals The DIE does not score chemicals, rather, chemicals are screened out based on hazard evaluationcriteria.

Are Data Gaps Addressed? QSAR mad other estimation models are used when data are unavailable.

Other Attributes

Platform Process (software, The DIE General Screen is documented in a fairly transparent written guidance. The output is a, [4]flowchart, ete ) written report. Note that GreenBlue s software tool CleanGredients lists chemicals that have been

approved via use of the DIE screen (the database includes solvents and surfactmats only at this time,but will be expanded to include fragrmaces and chelating agents).

Are Data Qualifiers Used? No.

Chemical Identifier (i e., CAS CAS numbernumber?)

Is there a "No Hazard Category"? No, however, chemicals that pass the screen are considered to be of "low- concern."How is it Defined?


J~@reHcesJ

[1] US EPA, 2009a.[2] US EPA, 2009b, d[3] UN, 2007.

G:~PROJECTS\209095Fr acFluids~D eliverables\Shor tRepoO\Tables\Tables 3 1 to 3 3.xlsx\3 3 DIE Printed: 12/30/2009


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