SAFETY REPORT OF After Sun For Camilla of Sweden AB

Transcription

1 SAFETY REPORT OF After Sun 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... 6 Appendix

3 Part A: Cosmetic product safety information Product: After Sun 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 Råvara INCI name CAS no Jojoba-olja Simmondsia Chinensis Seed Oil Content (kg) Conc % (w/w) Function in the product ,18 EMOLLIENT SKIN CONDITIONING Lavendel Lavandula angustifolia flower oil ,14 PERFUMING E-vitamin Tocopherol ,57 ANTIOXIDANT SKIN CONDITIONING Rosmarin Rosmarinus Officinalis Leaf Extract ,11 PERFUMING The raw materials are purchased from Naturkosmetikkompaniet 2. Physical/chemical characteristics and stability of the cosmetic product INCI name Simmondsia Chinensis Seed Oil Lavandula angustifolia flower oil CAS no Conc % (w/w) Purity/ Conc in raw material Certificate ,18 100% Organic Allergens ,14 100% Limonene & Linalool present in concentratons >0.001% Classifica tion H304, H315, H317 Tocopherol ,57 >97% H317 Rosmarinus Officinalis Leaf Extract ,11 100% in Helianthus Annuus Seed Oil (CAS ) Organic, Food grade Finished product: Product type: After sun oil Physical form: Oil Perfume: Yes (etheric oil), Limonene and Linalool present at concentrations > 0.001%. Stability: According to the manufacturer the shelf-life of the finished product is at least 6 months. 3

4 3. Microbiological quality The product does not contain water and is therefore classified as low risk products 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 The raw materials are food stuff or certified organic, i.e. the content of impurities has been check by certification bodies. Considering the concentrations of impurities that are expected in food stuff and certified organic raw materials, the concentrations of impurities in the cosmetic product are negligible. The primary packing material is Copolyster EB062 from Eastman. It doesn t contain any harmful substances and it is intended for use in contact with food stuff. 5. Normal and reasonably foreseeable use Body oil to be used daily (see below). 6. Exposure to the cosmetic product a. The site of application: body and head. b. The surface area of application: cm 2 c. The amount of product applied: 7.82 g/day d. The duration and frequency of use: 2.28 times/day e. The normal and reasonably foreseeable exposure route(s): dermal f. The targeted (or exposed) population(s): Adults g. Retention factor: 1.0 Exposure: Adult: 7.82 g/60 kg = mg/kg/day According to the SCCS's Notes of Guidance for the testing of cosmetic substances and their safety evaluation, 9th Revision Impact due to particle size (nano): The product contains no nano material 7. Exposure to the substances See table 3. The amount applied of each ingredient per kg bw (tot body weight = 60 kg) and day has been calculated (SED). The SED was low for all 4

5 ingredients. For ingredients with available NOAEL values a margin of safety (MOS) have been calculated. As a worst case scenario 100% absorption has been used for all ingredients. Table 3. SED and MOS-values for the ingredients of the product INCI name Simmondsia Chinensis Seed Oil Lavandula angustifolia flower oil CAS no Conc % (w/w) SED mg/kg bw/day at 100% absorption Total: mg/kg/day lowest reported NOAEL mg/kg bw Margin of Safety (MOS)/ comments ,18 127,93 Safe according to CIR ,14 1,48 Safe in this concentration Tocopherol ,57 0,74 Safe according to CIR Rosmarinus Officinalis Leaf Extract Helianthus Annuus Seed Oil ,11 0, ,11 0,14 Safe according to CIR 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) 5

6 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 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. 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 After Sun 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. Linalool and Limonene must be included in the ingredient list of the product. 3. Reasoning The After Sun is a body oil that contains well-known ingredients extensively used in different cosmetic products. The complied toxicity data on the ingredients do not indicate any specific worries for any of the ingredients (Table 1, Part B). Lavandula angustifolia flower oil is classified H315 (Causes skin irritation) and H317 (May cause an allergic skin reaction). The concentration of the etheric oil is low and the risk for an adverse skin effect when using the product is very low. The finished product contains Limonene and Linalool at concentrations >0.001% which should be included in the ingredient list 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 has been provided. It doesn t contain any harmful substances. Interaction between the primary packaging material and the product is not expected. The raw material is mainly certified organic, i.e. the 6

7 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 (ISO 22716). 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, except for Simmondsia Chinensis Seed Oil. The calculated MOS value for Tocopherol was over 100, i.e. no reason for concern. The ingredients without NOAEL values were considered safe by CIR. Table 1, Part B INCI name CAS no Conc % (w/w) SED mg/kg bw/day at 100% absorption Total: mg/kg/day lowest reported NOAEL mg/kg bw Margin of Safety (MOS)/ comments Simmondsia Chinensis Seed Oil ,18 127,93 Safe according to CIR Lavandula angustifolia flower oil ,14 1,48 Safe in this concentration Tocopherol ,57 0,74 Safe according to CIR Rosmarinus Officinalis Leaf Extract Helianthus Annuus Seed Oil ,11 0, ,11 0,14 Safe according to CIR Danderyd Cecilia Clemedson, Ph.D., ERT AdvocoTox AB Danderyds Campus, Mörby Centrum, plan 7 SE Danderyd, Sweden cecilia.clemedson@advocotox.se Mobile +46(0)

8 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. 8

9 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 9

10 Appendix 1. HELIANTHUS ANNUUS SEED EXTRACT CAS NO / Acute toxicity 2. Skin irritation and corrosivity Not a skin irritant (CIR 2011). 3. Eye irritation 4. Skin sensitisation Not a skin sensitizer (CIR 2011). 5. Dermal/percutaneous absorption 6. Repeated dose toxicity 7. Mutagenicity/genotoxicity 8. Carcinogenicity 9. Reproductive toxicity 10. Endocrine disruptors 11. Other The FDA includes sunflower seed oil and its triglycerides or fatty acids on its list of indirect food additives. These ingredients may be used as components of resinous and polymeric coatings having incidental contact with food (CosmeticsINFO 2014). 12. Conclusions The CIR Expert Panel has evaluated scientific data of sunflower seed oil and its triglycerides or fatty acids. Based on a history of safe use in food, the composition of the oils, and data indicating these ingredients were not dermal irritants or sensitizers, the CIR Expert Panel concluded that they are safe as used in cosmetic products. Botanical and botanically derived ingredients used in the formulation of cosmetics are generally mild and safe. There is a considerable body of information about the safety of Botanical ingredients and a well established history of use (CosmeticsINFO 2014). 13. NOAEL 14. References CosmeticsINFO (2014) Notes 10

11 CAS NO Acute toxicity Lavandula angustifolia flower oil 2. Skin irritation and corrosivity 3. Eye irritation 4. Skin sensitisation 5. Dermal/percutaneous absorption 6. Repeated dose toxicity 7. Mutagenicity/genotoxicity 8. Carcinogenicity 9. Reproductive toxicity 10. Endocrine disruptors 11. Other 12. Conclusions Is thought to be non-toxic (Shenet 2014) 13. NOAEL 14. References Shenet (2014) Notes 11

12 Rosmarinus Officinalis Leaf Extract CAS NO Acute toxicity The acute toxicity of Rosmarinus officinalis (rosemary)-derived ingredients is not very remarkable. The dermal LD50 of Rosmarinus officinalis leaf oil is > 10 ml/kg. The oral LD50 of Rosmarinus officinalis leaves is >2 g/kg, of Rosmarinus officinalis leaf extract is >8.5 g/kg, and of Rosmarinus officinalis leaf oil is 5.5 g/kg (CIR 2013). 2. Skin irritation and corrosivity An ointment containing 4.4% Rosmarinus officinali leaf oil, applied at concentrations up to 40%, was not irritating to rat skin. However, in a rabbit study, occlusive application to intact and abraded skin produced moderate irritation. In an in vitro study using the reconstituted human epidermis model, rosmarinic acid was not predicted to be irritating. In clinical testing, Rosmarinus officinalis leaves produced irritation in 44 of 234 patients with contact dermatitis or eczema. Rosmarinus officinalis leaf oil, 10% in petrolatum, was not an irritant in a 48-h closed patch test (CIR 2013). 3. Eye irritation 4. Skin sensitisation Rosmarinus officinalis leaf oil, 10% in petrolatum, was not a sensitizer in a maximization study. However, several cases of allergic reactions to Rosmarinus officinalis have been reported (CIR 2013). 5. Dermal/percutaneous absorption In an in vitro transdermal permeation study using full-thickness dorsal rat skin, rosmarinic acid had good permeability through the skin (CIR 2013). 6. Repeated dose toxicity Doses as high as 14.1 g/kg bw Rosmarinus officinalis leaf extract were tested (5 days by gavage), and studies were performed for up to 3 months (dietary). Increases in absolute and relative liver-to-body weights were observed in many of the studies, independent of the extraction method; these changes were shown to be reversible, and no other signs of toxicity were observed. Oral administration of Rosmarinus officinalis leaf oil also affected liver weights. No signs of toxicity were observed when 0.3% rosmarinic acid was fed to mice for 8 wks. In a clinical 21-day study, daily oral treatment with 50 or 200 mg rosmarinic acid did not produce any adverse effects. The LOEL was 300 mg/kg bw/day s.c. rosmarinic acid (CIR 2013). 7. Mutagenicity/genotoxicity Rosmarinus officinalis leaf extract was not genotoxic when tested in vitro in an Ames test, in a chromosomal aberration assay in human lymphocytes, or in a gene-locus mutation assay in human lymphocytes, and it was not genotoxic when tested in vivo in a chromosomal aberration assay or micronucleus test (CIR 2013). 8. Carcinogenicity No indications of carcinogenicity (CIR 2013). 9. Reproductive toxicity No indications of reprotoxicity (CIR 2013). 10. Endocrine disruptors 11. Other The FDA includes Rosmarinus officinalis on its list of spices and other natural seasonings and flavorings considered Generally Recognized As Safe (GRAS). Rosmarinus officinalis leaf 12

13 extract and rosmarinic acid have been shown to have anti-inflammatory activity (CosmeticsINFO 2014). 12. Conclusions Botanical and botanically-derived ingredients used in the formulation of cosmetics are generally mild and safe. There is a considerable body of information about the safety of botanical ingredients and a well-established history of use (CosmeticsINFO 2014). 13. NOAEL References CosmeticINFO (2014) CIR (2013) 13

14 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) 14

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. References CosmeticsINFO (2015) CIR (2014) 1