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
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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
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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.
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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
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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
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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
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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).
2. Skin irritation and corrosivity
Has not caused skin irritation (BIBRA 2006).
3. Eye irritation
No indication of eye irritancy in rabbits (BIBRA 2006).
4. Skin sensitisation
Is a rare skin sensitizer in man (BIBRA 2006).
5. Dermal/percutaneous absorption
Not available
6. Repeated dose toxicity
On repeated administration in the diet it did not produce any notable toxic effects in rats or
dogs (BIBRA 2006).
7. Mutagenicity/genotoxicity
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
9. Reproductive toxicity
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).
10. Endocrine disruptors
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).
2. Skin irritation and corrosivity
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).
4. Skin sensitisation
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).
5. Dermal/percutaneous absorption
No data available
6. Repeated dose 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).
7. Mutagenicity/genotoxicity
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).
9. Reproductive toxicity
No data available
10. Endocrine disruptors
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)
2. Skin irritation and corrosivity
No data available
3. Eye irritation
Lanolin is non-irritating when applied to the eye (CosmeticINFO 2012).
4. Skin sensitisation
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).
5. Dermal/percutaneous absorption
No data available
6. Repeated dose toxicity
No data available
7. Mutagenicity/genotoxicity
No data available
8. Carcinogenicity
No data available
9. Reproductive toxicity
No data available
10. Endocrine disruptors
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
2. Skin irritation and corrosivity
Not irritant (CIR 2010)
3. Eye irritation
Undilated Oryza Sativa Bran Oil was minimally irritant to eyes (CIR 2010)
4. Skin sensitisation
Non-sensitizing and not phototoxic in animal studies (CIR 2010).
5. Dermal/percutaneous absorption
No data available
6. Repeated dose toxicity
No data available
7. Mutagenicity/genotoxicity
No data available
8. Carcinogenicity
No data available
9. Reproductive toxicity
No data available
10. Endocrine disruptors
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
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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).
2. Skin irritation and corrosivity
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).
4. Skin sensitisation
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).
5. Dermal/percutaneous absorption
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).
6. Repeated dose toxicity
No data available
7. Mutagenicity/genotoxicity
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
9. Reproductive toxicity
No data available
10. Endocrine disruptors
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).
2. Skin irritation and corrosivity
Concentrated product can cause skin irritation. Tested without irritation at 8% solution (SDS
2014).
3. Eye irritation
Can cause eye irritation (SDS 2014).
4. Skin sensitisation
May cause sensitization and contact dermatitis at skin contact to high concentrations.
Tested without sensitization at 0.03% solution (SDS 2015).
5. Repeated dose toxicity
No data available
6. Dermal/percutaneous absorption
No data available
7. Mutagenicity/genotoxicity
No data available
8. Carcinogenicity
No data available
9. Reproductive toxicity
No data available
10. Endocrine disruptors
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).
2. Skin irritation and corrosivity
Tocopherol was not an irritant (CIR 2014).
3. Eye irritation
No data available
4. Skin sensitisation
Tocopherol was not a sensitizer (CIR 2014).
5. Dermal/percutaneous absorption
Dermally applied tocopherols do penetrate the skin (CIR 2014).
6. Repeated dose toxicity
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).
7. Mutagenicity/genotoxicity
Anti-mutagenic activity attributed to these compounds was consistent with their antioxidant
properties (CIR 2014).
8. Carcinogenicity
Carcingenicity studies were negative (CIR 2014).
9. Reproductive toxicity
Reproductive toxicity studies were negative
10. Endocrine disruptors
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
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).
2. Skin irritation and corrosivity
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).
4. Skin sensitisation
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).
5. Dermal/percutaneous absorption
No data available
6. Repeated dose toxicity
In a 26-27 week dog study NOEL was 100 mg/kg/day for Vanillin (INCHEM 1998).
7. Mutagenicity/genotoxicity
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).
9. Reproductive toxicity
No data available
10. Endocrine disruptors
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
1
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