SAFETY REPORT OF Trutvalla Cerat For Camilla of Sweden AB

Transcription

1 SAFETY REPORT OF Trutvalla Cerat For Camilla of Sweden AB

2 Table of content Table of content... 2 Part A: Cosmetic product safety information Quantitative and qualitative composition of the cosmetic product Physical/chemical characteristics and stability of the cosmetic product Microbiological quality Impurities, traces, information about the packaging material Normal and reasonably foreseeable use Exposure to the cosmetic product Exposure to the substances Toxicological profile of the substances Undesirable effects and serious undesirable effects Information on the cosmetic product... 6 Part B: Cosmetic product safety assessment Assessment conclusion Labelled warnings and instructions of use Reasoning... 7 Appendix

3 Part A: Cosmetic product safety information Product: Trutvalla Cerat Responsible person: Camilla of Sweden AB, Kristineholmsvägen 10F, Alingsås, Sweden Manufacturer: Camilla of Sweden AB, Kristineholmsvägen 10F, Alingsås, Sweden 1. Quantitative and qualitative composition of the cosmetic product Riskli Råvara INCI name CAS no Conc % (w/w) Jojoba-olja Oryza Sativa Bran Oil Simmondsia Chinensis Seed Oil Function in the product ,86 EMOLLIENT ,43 EMOLLIENT SKIN CONDITIONING Bivax Cera alba ,79 EMOLLIENT Ullfett Lanolin ,36 EMOLLIENT EMULSIFYING SKIN CONDITIONING Karnaubavax Copernicia Cerifera Wax ,25 EMOLLIENT SKIN CONDITIONING Benzoin Styrax Benzoin Gum ,18 PERFUMING Extract Vaniljpulver Vanilla Planifolia / ,05 PERFUMING Seed Powder 63-5 E-vitamin Tocopherol ,09 ANTIOXIDANT SKIN CONDITIONING All raw materials are purchased from Naturkosmetikkompaniet. 3

4 2. Physical/chemical characteristics and stability of the cosmetic product INCI name CAS no Conc % (w/w) Purity/ Conc in raw material Certificate/additivies /Impurities Allergens Classification Oryza Sativa Bran ,86 eco Oil Simmondsia ,43 100% eco Chinensis Seed Oil Cera alba ,79 100% eco Lanolin ,36 100% Pesticide max 3 ppm Copernicia Cerifera ,25 100% eco Wax Styrax Benzoin ,18 50% 50% Dipropylene Benzyl benzoate, H315, H317, H319 Gum Extract glycol Benzyl alcohol, and Benzyl cinnamate at concentration >0.001% Vanilla Planifolia / ,05 100% Eco Seed Powder 63-5 Tocopherol ,09 >97% H317 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 According to the rapport Hudkrämer och liknande produkter Tillsynsrapport från enheten för kosmetika och hygienprodukter (Reviderad ) 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. 4

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 cm 2 c) The amount of product applied: 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 no Conc % (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 ,86 0,41 Safe according to CIR Cera alba ,79 0,25 Safe according to EFSA Simmondsia Chinensis Seed Oil ,43 0,18 Safe according to CIR Lanolin ,36 0,05 5

6 Tocopherol ,09 0,05 Safe according to CIR Copernicia Cerifera Wax Styrax Benzoin Gum Extract Dipropylene glycol / Vanilla Planifolia Seed Powder ,25 0,01 Safe according to BIBRA ,09 0, / ,09 0,001 Safe according to CIR 0,05 0,001 Food stuff 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, CIR (Cosmetic Ingredients Review) opinions Bibra, 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 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 6

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. 7

8 Table 1, Part B Danderyd Cecilia Clemedson, Ph.D., ERT AdvocoTox AB Danderyds Campus, Mörby Centrum, plan 7 SE Danderyd, Sweden cecilia.clemedson@advocotox.se Mobile +46(0)

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 Danderyd, Sweden Mobile cecilia.clemedson@advocotox.se ACADEMIC EXAMINATIONS 1985 Bachelor of Science, microbiology, molecular biology, and chemistry, University of Uppsala Licentiate of Philosophy, Department of Neurochemistry and Neurotoxicology, University of Stockholm Doctoral Thesis at Department of Neurochemistry and Neurotoxicology, University of Stockholm European Registered Toxicologist EDUCATION 1980 Course in ecology and environmental technology, 7 weeks, Royal Technical High School (KTH), Stockholm Course in Toxicology, 20 weeks, Karolinska Institutet, Stockholm Course in Ion channels: structure, function and the methodology to study them, 5 weeks, University of Stockholm Course in The structure and function of the nervous system, 7 weeks, Karolinska Institutet, Stockholm Course in Scientific Writing, University of Stockholm Course in Reproductive toxicology, Karolinska Institutet, Stockholm Course in Neurotoxicology, Karolinska Institutet, Stockholm Course in Toxicokinetics, Karolinska Institutet, Stockholm Course in Principles, practices and problems in preparing The Toxicological Expert Report, Pre-clinical and regulatory perspectives, Management Forum, London, UK Course in Drug toxicology, Karolinska Institutet, Stockholm. 9

10 POSITIONS IN THE PROFESSION Trainee at the Dept. of Neurochemistry & Neurotoxicology, University of Stockholm Ph.D. student at the Dept. of Neurochemistry & Neurotoxicology, University of Stockholm Programme Secretary of the MEIC programme, Department of Pharmaceutical Biosciences, Division of Toxicology Maternal leave Managing director of NICA-Nordic Information Centre for Alternative Methods, Stocksund, Sweden Managing director of CCTox Consulting, Stocksund, Sweden Part owner of Expertrådet ECB Miljökompetens AB, Sollentuna, Sweden Board member of Expertrådet ECB Miljökompetens AB, Sollentuna, Sweden Coordinator of the EDIT programme Scientific Coordinator of ACuteTox, an Integrated Project under the EU6FP Coordinator of Forinvitox, a project under the EU6FP Managing director and part owner of AdvocoTox AB, Danderyd, Sweden 10

11 Appendix 1 Cera Alba CAS NO 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 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 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:

12 PesticideInfo: 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 12

13 Copernicia Cerifera Cera CAS NO 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 12. Conclusions 13. NOAEL 14. References BIBRA (2006) 13

14 Dipropylene glycol CAS NO / 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 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 10. Endocrine disruptors 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). 14

15 13. NOAEL 14. References EPA (2006) CIR (2006) CosmeticsINFO (2014) 15

16 Lanolin CAS NO 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 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 6. Repeated dose toxicity 7. Mutagenicity/genotoxicity 8. Carcinogenicity 9. Reproductive toxicity 10. Endocrine disruptors 11. Other 12. Conclusions 13. NOAEL 14. References HSDB (2012) bin/sis/search/f?./temp/~b3y9oh:1 CosmeticsINFO (2012) 16

17 Oryza Sativa Bran Oil CAS NO Acute toxicity 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 6. Repeated dose toxicity 7. Mutagenicity/genotoxicity 8. Carcinogenicity 9. Reproductive toxicity 10. Endocrine disruptors 11. Other 12. Conclusions 13. NOAEL 14. References CIR (2010) 17

18 Simmondsia Chinensis Seed Oil CAS NO 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 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 9. Reproductive toxicity 10. Endocrine disruptors 11. Other 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 14. References CIR (2008, 1992) 18

19 Styrax Benzoin Gum Extract CAS NO 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 6. Dermal/percutaneous absorption 7. Mutagenicity/genotoxicity 8. Carcinogenicity 9. Reproductive toxicity 10. Endocrine disruptors 11. Other No phototoxic reaction is reported (SDS 2014). 12. Conclusions 13. NOAEL 14. References SDS (2014) Naturkosmetikkompaniet 19

20 15. Tocopherol CAS NO / / / / / / / / 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 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 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 14. References CosmeticsINFO (2015) 20

21 ingredients CIR (2014) 21

22 Vanilla planifolia seed CAS NO / Acute toxicity For vanillin LD50 oral is reported to be 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 6. Repeated dose toxicity In a 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 10. Endocrine disruptors 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 13. NOAEL References INCHEM (1998) 22

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