SAFETY REPORT OF Trutvalla Cerat For Camilla of Sweden AB · The SED was calculated for all...

SAFETY REPORT OF Trutvalla Cerat

For Camilla of Sweden AB

2017-02-21

2

Table of content Table of content ..................................................................................................................................... 2

Part A: Cosmetic product safety information ...................................................................................... 3

1. Quantitative and qualitative composition of the cosmetic product .............................................. 3

2. Physical/chemical characteristics and stability of the cosmetic product ..................................... 4

3. Microbiological quality ................................................................................................................. 4

4. Impurities, traces, information about the packaging material ..................................................... 4

5. Normal and reasonably foreseeable use .................................................................................... 5

6. Exposure to the cosmetic product .............................................................................................. 5

7. Exposure to the substances ....................................................................................................... 5

8. Toxicological profile of the substances ....................................................................................... 6

9. Undesirable effects and serious undesirable effects .................................................................. 6

10. Information on the cosmetic product......................................................................................... 6

Part B: Cosmetic product safety assessment ..................................................................................... 7

1. Assessment conclusion .............................................................................................................. 7

2. Labelled warnings and instructions of use .................................................................................. 7

3. Reasoning ................................................................................................................................... 7

Appendix 1 .................................................................................................................................... 11

3

Part A: Cosmetic product safety information Product: Trutvalla Cerat Responsible person: Camilla of Sweden AB, Kristineholmsvägen 10F, 441 39 Alingsås, Sweden Manufacturer: Camilla of Sweden AB, Kristineholmsvägen 10F, 441 39 Alingsås, Sweden

1. Quantitative and qualitative composition of the cosmetic product

All raw materials are purchased from Naturkosmetikkompaniet.

Råvara INCI name CAS no Conc % (w/w)Function in the

product

Riskli Oryza Sativa Bran

Oil 68553-81-1 42,86 EMOLLIENT

Jojoba-olja Simmondsia

Chinensis Seed Oil

90045-98-0 18,43 EMOLLIENT

SKIN

CONDITIONING

Bivax Cera alba 8012-89-3 26,79 EMOLLIENT

Ullfett Lanolin 8006-54-0 5,36 EMOLLIENT

EMULSIFYING

SKIN

CONDITIONING

Karnaubavax Copernicia Cerifera

Wax

8015-86-9 1,25 EMOLLIENT

SKIN

CONDITIONING

Benzoin Styrax Benzoin Gum

Extract

9000-05-9. 0,18 PERFUMING

Vaniljpulver Vanilla Planifolia

Seed Powder

8024-06-4 / 84650-

63-5

0,05 PERFUMING

E-vitamin Tocopherol 10191-41-0 5,09 ANTIOXIDANT

SKIN

CONDITIONING

4

2. Physical/chemical characteristics and stability of the cosmetic product

Finished product: Product type: Lip balm Physical form: Solid Allergens: Benzyl benzoate, Benzyl alcohol and Benzyl cinnamate are present in the product at concentrations >0.001%. Stability According to the manufacturer the shelf-life of the unopened product is 24 months. After opening the shelf-life of the product is 6 months.

3. Microbiological quality

The product does not contain water and is therefore classified as a low risk product according to ISO 29621. According to the rapport “Hudkrämer och liknande produkter” Tillsynsrapport från enheten för kosmetika och hygienprodukter 2011-04-13 (Reviderad 2011-05-17) from the Swedish medical Agency it is not relevant to perform challenge testing on water free products.

4. Impurities, traces, information about the packaging material

For ingredients see table 2. The raw material is mainly certified organic, i.e. the content of impurities has been check by certification bodies. Considering the concentrations of impurities that are expected in certified organic raw materials, the concentrations of impurities in the cosmetic product are negligible. The primary packaging is intended for lip balms and is of plastic.

INCI name CAS no Conc % (w/w)Purity/ Conc in

raw material

Certificate/additivies

/ImpuritiesAllergens Classification

Oryza Sativa Bran

Oil 68553-81-1 42,86 eco

Simmondsia

Chinensis Seed Oil

90045-98-0 18,43 100% eco

Cera alba 8012-89-3 26,79 100% eco

Lanolin 8006-54-0 5,36 100% Pesticide max 3 ppm

Copernicia Cerifera

Wax

8015-86-9 1,25 100% eco

Styrax Benzoin

Gum Extract

9000-05-9. 0,18 50% 50% Dipropylene

glycol

Benzyl benzoate,

Benzyl alcohol,

and Benzyl

cinnamate at

concentration

>0.001%

H315, H317, H319

Vanilla Planifolia

Seed Powder

8024-06-4 / 84650-

63-5

0,05 100% Eco

Tocopherol 10191-41-0 5,09 >97% H317

5

5. Normal and reasonably foreseeable use

Lip balm for daily lip care.

6. Exposure to the cosmetic product

a) The site of application: Lips

b) The surface area of application: 4.6 cm2

c) The amount of product applied: 0.057 g/application

d) The duration and frequency of use: 4 times/day

e) The normal and reasonably foreseeable exposure route(s): dermal

f) Retension factor: 1

g) The targeted (or exposed) population(s): Adults

Exposure: 0.057/60 kg x 1 =0.95 mg/kg/day Impact due to particle size (nano): No raw materials in nano form.

7. Exposure to the substances

See table 3. The systematic exposure dose (SED) of each ingredient per kg bw (tot body weight = 60 kg) and day has been calculated. The SED was low for all ingredients. None of the ingredients had available NOAEL values, i.e. a margin of safety (MOS) could not be calculated. Table 3. SED and MOS-values for the ingredients

INCI name CAS noConc %

(w/w)

SED

mg/kg

bw/day at

100%

absorption

Total:

0.95

mg/kg/day

lowest

reported

NOAEL

mg/kg

bw

Margin of

Safety

(MOS)/

comments

Oryza Sativa Bran

Oil 68553-81-1 42,86 0,41 Safe

according

to CIRCera alba 8012-89-3 26,79 0,25 Safe

according

to EFSASimmondsia

Chinensis Seed Oil

90045-98-0 18,43 0,18 Safe

according

to CIRLanolin 8006-54-0 5,36 0,05

6

8. Toxicological profile of the substances

Gathered information is presented in Appendix 1.

The following data bases and sources have been consulted for compiling toxicity data for the ingredients: CosIng, http://ec.europa.eu/consumers/cosmetics/cosing/ CIR (Cosmetic Ingredients Review) opinions Bibra, http://www.bibra-information.co.uk/ SCCS (Scientific Committee of Consumer Safety) opinions IUCLID (International Uniformed Chemical Information Database) datasets ECHA (European Chemicals Agency) EFSA (European Food Safety Authority HERA (Human and Environmental Risk Assessment on ingredients of household cleaning products) HSDB (Hazardous Substances Databank) Toxline, database SIDS (Screening Information Dataset) EPA (United States Environmental Protection Agency) FDA (United States Food and Drug Administration) INCHEM (International Program on Chemical safety) NICNAS (National Industrial Chemicals Notification and Assessment Scheme, Australian Government Department of Health and Ageing) C&L (Classification and Labeling) inventory CosmeticsINFO http://www.cosmeticsinfo.org/ PubMed http://www.ncbi.nlm.nih.gov/pubmed

9. Undesirable effects and serious undesirable effects

No undesired effects have been reported. Responsible person has set up a system to collect document, establish causality and manage the undesirable effects caused by the product.

10. Information on the cosmetic product

No additional information

Tocopherol 10191-41-0 5,09 0,05 Safe

according

to CIRCopernicia Cerifera

Wax

8015-86-9 1,25 0,01 Safe

according

to BIBRAStyrax Benzoin

Gum Extract

9000-05-9. 0,09 0,001

Dipropylene glycol 110-98-5/

25265-71-8

0,09 0,001 Safe

according

to CIRVanilla Planifolia

Seed Powder

8024-06-4 /

84650-63-5

0,05 0,001 Food stuff

http://www.ncbi.nlm.nih.gov/pubmed

7

Part B: Cosmetic product safety assessment

1. Assessment conclusion

Based on the information provided by the manufacturer and the toxicity data compiled for the ingredients, it can be concluded that the Trutvalla Cerat is unlikely to produce abnormally high number of adverse effects if used under normal or reasonably foreseeable conditions of use. The product will give users the level of safety that can reasonably be expected.

2. Labelled warnings and instructions of use

No warnings are needed. Benzyl benzoate, Benzyl alcohol and Benzyl cinnamate should be included in the ingredient list of the product since the concentrations are >0.001%.

3. Reasoning

The Trutvalla Cerat contains well-known ingredients extensively used in different cosmetic products. None of the products indicate any specific worries (Tab 1, Part B). The Styrax Benzoin Gum Extract is classified H315 (Causes skin irritation) and H317 (May cause an allergic skin reaction), H319 (Causes serious eye irritation). The concentration of the Styrax Benzoin Gum Extract is low and the risk for adverse skin or eye effects when using the product is very low. The finished product contains Benzyl benzoate, Benzyl alcohol and Benzyl cinnamate at concentrations >0.001%, i.e these allergens should be listed on the product. The product does not contain water and is therefore classified as low risk products according to ISO 29621, i.e. challenge testing is not needed. Information on packaging material is given from the manufacturer and interaction between the primary packaging material and the product is not expected. The raw material is mainly certified organic, i.e. the content of impurities has been check by certification bodies. Considering the concentrations of impurities that are expected in certified organic raw materials, the concentrations of impurities in the cosmetic product are negligible. The manufacturing of the product should follow a quality controlled standardised procedure. The SED was calculated for all ingredients and MOS was calculated for the ingredient with available NOAEL value. The SEDs were low for all ingredients. Since no NOAEL values were available, MOS value could not be calculated. The ingredients without NOAEL values were considered safe by CIR, EFSA or BIBRA.

8

Table 1, Part B

Danderyd 2017-02-21

Cecilia Clemedson, Ph.D., ERT AdvocoTox AB Danderyds Campus, Mörby Centrum, plan 7 SE-182 31 Danderyd, Sweden www.advocotox.se [email protected] Mobile +46(0)70 601 91 89

mailto:[email protected]

9

CURRICULUM VITAE of

Cecilia Clemedson

Title Ph. D. in Toxicology, ERT Birthplace Danderyd, Sweden Date of birth November 30, 1960 Business address: AdvocoTox AB, Danderyds Campus Mörby Centrum, plan 7 SE-182 31 Danderyd, Sweden Mobile +46-70-601 91 89 E-mail [email protected] ACADEMIC EXAMINATIONS 1985 Bachelor of Science, microbiology, molecular biology, and chemistry, University of Uppsala. 1989 Licentiate of Philosophy, Department of Neurochemistry and Neurotoxicology, University of Stockholm. 1992 Doctoral Thesis at Department of Neurochemistry and Neurotoxicology, University of Stockholm. 2015 European Registered Toxicologist EDUCATION 1980 Course in ecology and environmental technology, 7 weeks, Royal

Technical High School (KTH), Stockholm. 1985 Course in Toxicology, 20 weeks, Karolinska Institutet, Stockholm. 1987 Course in ”Ion channels: structure, function and the methodology to study them”, 5 weeks, University of Stockholm. 1989 Course in ”The structure and function of the nervous system”, 7 weeks,

Karolinska Institutet, Stockholm. 1989 Course in Scientific Writing, University of Stockholm. 1990 Course in ”Reproductive toxicology”, Karolinska Institutet, Stockholm. 1991 Course in ”Neurotoxicology”, Karolinska Institutet, Stockholm. 1999 Course in ”Toxicokinetics”, Karolinska Institutet, Stockholm. 1999 Course in Principles, practices and problems in preparing The

Toxicological Expert Report, Pre-clinical and regulatory perspectives, Management Forum, London, UK.

2000 Course in ”Drug toxicology”, Karolinska Institutet, Stockholm.

10

POSITIONS IN THE PROFESSION 1980-1982 Trainee at the Dept. of Neurochemistry & Neurotoxicology, University of

Stockholm. 1986-1992 Ph.D. student at the Dept. of Neurochemistry & Neurotoxicology,

University of Stockholm. 1992-1995 Programme Secretary of the MEIC programme, Department of

Pharmaceutical Biosciences, Division of Toxicology 1995-1997 Maternal leave 1997-2000 Managing director of NICA-Nordic Information Centre for Alternative

Methods, Stocksund, Sweden 1997- Managing director of CCTox Consulting, Stocksund, Sweden 2001-2010 Part owner of Expertrådet ECB Miljökompetens AB, Sollentuna, Sweden 2001- 2009 Board member of Expertrådet ECB Miljökompetens AB, Sollentuna,

Sweden 2001-2005 Coordinator of the EDIT programme 2005- 2010 Scientific Coordinator of ACuteTox, an Integrated Project under the

EU6FP. 2007-2009 Coordinator of Forinvitox, a project under the EU6FP 2009- Managing director and part owner of AdvocoTox AB, Danderyd, Sweden

11

Appendix 1

Cera Alba CAS NO 8012-89-3

1. Acute toxicity

Beeswax didn’t produce acute animal toxicity (Lanigan et al 2001).

2. Skin irritation and corrosivity

Beeswax didn’t produce skin irritation (Lanigan et al 2001).

3. Eye irritation

Beeswax didn’t produce ocular irritation (Lanigan et al 2001).

4. Skin sensitisation

Beeswax didn’t produce skin sensitization (Lanigan et al 2001).

5. Dermal/percutaneous absorption

Not available

6. Repeated dose toxicity

Not available

7. Mutagenicity/genotoxicity

Not available

8. Carcinogenicity

Not available

9. Reproductive toxicity

Not available

10. Endocrine disruptors

Not available

11. Other

No data available

12. Conclusions

An EFSA Committee considered that the data on beeswax itself were insufficient to establish

an ADI, but concluded that the safety of beeswax could be assessed, based on available

scientific literature on the main constituents of beeswax and plant waxes showing chemical

structural similarities to beeswax. They could not reach a conclusion about the potential

allergenicity of beeswax as the available information was very limited. However, the

committee concluded that the use of beeswax as an additive for the existing food uses is not

of safety concern. (EFSA 2007).

13. NOAEL

No data available

14. References

Lanigan RS, Yamarik TA; Cosmetic Ingredient Review Expert Panel (2001) Final report on

the safety assessment of PEG-6, -8, and -20 sorbitan beeswax. Int J Toxicol. 20 Suppl 4:27-

38.

12

PesticideInfo: http://www.pesticideinfo.org/Detail_Chemical.jsp?Rec_Id=PC33785

Beeswax (E 901) as a glazing agent and as carrier for flavours. Scientific Opinion of the

Panel on Food additives, Flavourings, Processing aids and Materials in Contact with Food

(AFC). The EFSA Journal (2007) 615, 1-28: EFSA

http://www.efsa.europa.eu/en/efsajournal/doc/615.pdf

http://www.pesticideinfo.org/Detail_Chemical.jsp?Rec_Id=PC33785

13

Copernicia Cerifera Cera CAS NO 8015-86-9

1. Acute toxicity

The no-untoward-effect level for carnauba wax in the diet of rats was 10%, which

represented a mean intake of approximately 8.8 and 10.2 g/kg body weight/day in males and

females, respectively (Rowland et al 1982).


Has not caused skin irritation (BIBRA 2006).

3. Eye irritation

No indication of eye irritancy in rabbits (BIBRA 2006).


Is a rare skin sensitizer in man (BIBRA 2006).


Not available


On repeated administration in the diet it did not produce any notable toxic effects in rats or

dogs (BIBRA 2006).


Carnauba wax failed to induce chromosome damage in mammalian cells in culture and

showed no convincing genotoxic activity in bacterial assays (including the Ames test) or in

yeast (BIBRA 2006).

8. Carcinogenicity

Not available


There was no indication of reproductive or developmental toxicity in rats (BIBRA 2006). The

reproductive performance of Wistar rats fed carnauba wax at levels of 0.1, 0.3 or 1% in the

diet and the effects of subchronic administration of carnauba wax at these dose levels on the

resultant progeny have been studied. Serum free fatty acid levels were found to be

decreased in male and female rats fed carnauba wax at dietary levels of 0.3 and 1.0%. No

other effects of feeding carnauba wax at levels up to 1.0% of the diet were observed (Parent

et al 1983).


Not available

11. Other

No data available

12. Conclusions

No data available

13. NOAEL

No data available

14. References

BIBRA (2006) http://www.bibra-information.co.uk/profile-32.html

14

Dipropylene glycol CAS NO 110-98-5 / 25265-71-8

1. Acute toxicity

The results of acute, subchronic, and chronic oral toxicity studies indicated a low order of

toxicity for these glycols. Results of parenteral injection, inhalation, and acute and subchronic

cutaneous toxicity studies likewise supported a low order of toxicity (CIR 2006).


A number of product formulations containing these glycols at concentrations up to 21.4%

have been tested in various human skin irritation test. The degree of irritation produced

depended upon the particular product. There was no correlation between the degree of

irritation and the concentration of the glycol present in the product (CIR 2006).

3. Eye irritation

The glycols produced mild to severe ocular irritation with Hexylene Glycol producing the most

severe irritation (CIR 2006).


There were no reactions indicative of skin sensitization to these glycols in any skin

sensitization assays and no suggestions of phototoxicity or photosensitization (CIR 2006).


No data available


The results of acute, subchronic, and chronic oral toxicity studies indicated a low order of

toxicity for these glycols. Results of parenteral injection, inhalation, and acute and subchronic

cutaneous toxicity studies likewise supported a low order of toxicity (CIR 2006).


Propylene glycol and dipropylene glycol were tested for mutagenic or genotoxic potential and

found to be negative in a battery of studies: a bacterial gene mutation assay using

Salmonella typhimurium, and in vitro Chinese hamster ovary (CHO) mutation assay, an in

vitro Chinese hamster ovary (CHO) chromosomal aberration assay and an in vitro sister

chromatid exchange assay (EPA 2006).

8. Carcinogenicity

Propylene glycol and dipropylene glycol to be negative for carcinogenicity in studies (EPA

2006).


No data available


No data available

11. Other

The FDA permits Butylene Glycol to be used as a synthetic flavoring and adjuvant for direct

addition to food. Butylene Glycol, Hexylene Glycol and Dipropylene Glycol are allowed to be

used as indirect food additives. For example, Butylene Glcyol may be used in polymeric

coatings in contact with food, and Hexylene Glycol and Dipropylene Glycol may be used in

adhesives in contact with food (CosmeticsINFO 2014).

12. Conclusions

The CIR Expert Panel evaluated the scientific data and concluded that Butylene Glycol,

Hexylene Glycol, Ethoxydiglycol and Dipropylene Glycol are safe for use in cosmetics and

personal care products (CIR 2006).

15

13. NOAEL

No data available

14. References

EPA (2006) http://www.epa.gov/pesticides/reregistration/REDs/propylene_glycol_red.pdf

CIR (2006) http://online.personalcarecouncil.org/jsp/CIRList.jsp?id=452

CosmeticsINFO (2014) http://www.cosmeticsinfo.org/ingredient/butylene-glycol-and-related-

ingredients

16

Lanolin CAS NO 8006-54-0

1. Acute toxicity

LD50 Rat oral >16000 mg/kg (HSDB 2012) Probable oral lethal dose (human) above 15 g/kg

(HSDB 2012)


No data available

3. Eye irritation

Lanolin is non-irritating when applied to the eye (CosmeticINFO 2012).


Tests for skin sensitization are negative. Extensive clinical experience indicates that there is

a low incidence of sensitivity. However, although there have been numerous patch test

studies performed on lanolin since the 1950s, the prevalence of allergy to lanolin remains

controversial; perhaps in part because of the heterogeneity of substances making up lanolin

and probably more importantly to the level of purification performed (HSDB 2012).


No data available


No data available


No data available

8. Carcinogenicity

No data available


No data available


No data available

11. Other

No data available

12. Conclusions

No data available

13. NOAEL

No data available

14. References

HSDB (2012) http://toxnet.nlm.nih.gov/cgi- bin/sis/search/f?./temp/~B3Y9Oh:1

CosmeticsINFO (2012)

http://www.cosmeticsinfo.org/ingredient_details.php?ingredient_id=435

17

Oryza Sativa Bran Oil CAS NO 68553-81-1

1. Acute toxicity

No data available


Not irritant (CIR 2010)

3. Eye irritation

Undilated Oryza Sativa Bran Oil was minimally irritant to eyes (CIR 2010)


Non-sensitizing and not phototoxic in animal studies (CIR 2010).


No data available


No data available


No data available

8. Carcinogenicity

No data available


No data available


No data available

11. Other

No data available

12. Conclusions

No data available

13. NOAEL

No data available

14. References

CIR (2010) http://www.cir-safety.org/sites/default/files/117_draft_oils.pdf

18

Simmondsia Chinensis Seed Oil CAS NO 90045-98-0

1. Acute toxicity

Oral mouse and rat LD50 was greater than 5.0 g/kg (CIR 2008, 1992).


Simmondsia Chinensis (Jojoba) Seed Oil was non- to slightly irritating when instilled into the

eyes of white rabbits (CIR 2008, 1992).

3. Eye irritation

Undiluted Simmondsia Chinensis (Jojoba) Seed Oil was not a skin irritant. Tests of topical

products containing Simmondsia Chinensis (Jojoba) Seed Oil found them to be nonirritants to

humans. (CIR 2008, 1992).


In a maximization test, no sensitization reactions were observed with Jojoba Alcohol. Tests of

topical products containing Simmondsia Chinensis (Jojoba) Seed Oil found them to be

nonsensitizers to humans. Sensitization to undiluted Jojoba Oil was not observed (CIR 2008,

1992).


Based on the large molecular weight of the components of the Jojoba Oil ingredients, the CIR

Expert Panel concluded that they would not penetrate the skin (CIR 2008, 1992).


No data available


Jojoba Alcohol and mixture of Jojoba Oil and Hydrogenated Jojoba Oil were not mutagenic in

bacterial assays (CIR 2008, 1992).

8. Carcinogenicity

No data available


No data available


No data available

11. Other

No data available

12. Conclusions

The CIR Expert Panel evaluated the scientific data and based on the available information

concluded that Jojoba Oil and the related ingredients were safe for use as cosmetic

ingredients (CIR 2008, 1992).

13. NOAEL

No data available

14. References

CIR (2008, 1992) http://online.personalcarecouncil.org/jsp/CIRList.jsp?id=3116

19

Styrax Benzoin Gum Extract CAS NO 9000-05-09

1. Acute toxicity

Oral LD50 rat: 10 g/kg.

Dermal LD50 rabbit: 8.87 g/kg (SDS 2015).


Concentrated product can cause skin irritation. Tested without irritation at 8% solution (SDS

2014).

3. Eye irritation

Can cause eye irritation (SDS 2014).


May cause sensitization and contact dermatitis at skin contact to high concentrations.

Tested without sensitization at 0.03% solution (SDS 2015).


No data available


No data available


No data available

8. Carcinogenicity

No data available


No data available


No data available

11. Other

No phototoxic reaction is reported (SDS 2014).

12. Conclusions

13. NOAEL

No data available

14. References

SDS (2014) Naturkosmetikkompaniet

20

15.

Tocopherol CAS NO 54-28-4 / 16698-35-4 / 10191-41-0 / 119-13-1 / 1406-18-4 / 1406-66-2 / 2074-53-5 / 59-02-9 / 7616-22-0

1. Acute toxicity

In rats, the dermal LD50 is >3 g/kg for tocopherol. The oral LD50 of tocopherol greater than 4

g/kg. In mice, the oral LD50 of tocopherol is >25 ml/kg (CIR 2014).


Tocopherol was not an irritant (CIR 2014).

3. Eye irritation

No data available


Tocopherol was not a sensitizer (CIR 2014).


Dermally applied tocopherols do penetrate the skin (CIR 2014).


In rats, tocopherol was not toxic in a 60-day study. In a 90-day study, rats dosed orally with

2000 mg/kg d-α-tocopherol died in 9 to 11 wks because of internal hemorrhage; other signs

of toxicity were observed in a dose-dependent manner. High doses of tocopherol has a

hemorrhagic activity (CIR 2014).


Anti-mutagenic activity attributed to these compounds was consistent with their antioxidant

properties (CIR 2014).

8. Carcinogenicity

Carcingenicity studies were negative (CIR 2014).


Reproductive toxicity studies were negative


No data available

11. Other

The FDA includes Tocopherol on its list of nutrients considered Generally Recognized As

Safe (GRAS). Tocopherol is also on FDA's list of GRAS food preservatives (CosmeticsINFO

2015).

12. Conclusions

The safety of Tocopherol and related ingredients (Dioleyl Tocopheryl Methylsilanol,

Potassium Ascorbyl Tocopheryl Phosphate, Tocophersolan, Tocopheryl Acetate, Tocopheryl

Linoleate, Tocopheryl Linoleate/Oleate, Tocopheryl Nicotinate, Tocopheryl Succinate) has

been assessed by the CIR Expert Panel. The CIR Expert Panel evaluated the scientific data

and concluded that Tocopherol and the related ingredients were safe as used in cosmetics

and personal care products (CIR 2014).

13. NOAEL

No data available

14. References

CosmeticsINFO (2015) http://www.cosmeticsinfo.org/ingredient/tocopherol-and-related-

21

ingredients

CIR (2014) http://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/FR667.pdf

http://online.personalcarecouncil.org/ctfa-static/online/lists/cir-pdfs/FR667.pdf

22

Vanilla planifolia seed CAS NO 8024-06-4 / 84650-63-5

1. Acute toxicity

For vanillin LD50 oral is reported to be 1400-3976 mg/kg for different species and dermal

LD50 for rabbit is rapported to be 5010 mg/kg (INCHEM 1998).


Two skin irritation studies were both negative (INCHEM 1998).

3. Eye irritation

Only vanillin powder was irritating to the eye due to mechanical stress from crystals (INCHEM

1998).


In the skin sensitisation testing with vanillin, 5 out of 10 tests showed positive results

indicating that vanillin has an allergenic potential. The other tests were negative, including the

only test conducted according to GLP (INCHEM 1998).


No data available


In a 26-27 week dog study NOEL was 100 mg/kg/day for Vanillin (INCHEM 1998).


The testing for genetic toxicity of vanillin in vivo is negative in all systems tested and gave no

indication of any genotoxicity (INCHEM 1998).

8. Carcinogenicity

A full 2 years oral feeding carcinogenicity study has been conducted in rats with a negative

result. There was no indication of vanillin being an experimental carcinogen. The other tests

conducted confirm this finding and some tests even indicate that vanillin reduces the

tumourgenicity of carcinogenic treatments (INCHEM 1998).


No data available


No data available

11. Other

The use of vanillin as a food additive is approved by authorities world wide, and FDA has

granted GRAS status to its use (INCHEM 1998).

12. Conclusions

No data available

13. NOAEL

100

14. References

INCHEM (1998) http://www.inchem.org/documents/sids/sids/121335.pdf

SAFETY REPORT OF Trutvalla Cerat For Camilla of Sweden AB · The SED was calculated for all...

Documents

Transcript of SAFETY REPORT OF Trutvalla Cerat For Camilla of Sweden AB · The SED was calculated for all...