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Safety Assess12.446Rev3 The Elms · Oxford Rd · Chieveley · Newbury · RG20 8RT· United Kingdom Telephone: +44 1635 248830 Fax: +44 1635 247206 Email: [email protected] SAFETY REPORT/ SAFETY ASSESSMENT Product Name: simplehuman Moisturizing Liquid Hand Soap PART A, SAFETY REPORT The following Safety Assessment is carried out according to the Council Directive 76/768/EEC, on the Safety of Cosmetic Products and as amended by Commission Directives 2003/15/EC (7th Amendment), 2003/83/EC (30th Amendment), and 2003/80/EC (31st Amendment) The Assessment is conducted in accordance with the principles of Good Laboratory Practice referred to in Article 1 of Council Directive 2004/10/EC on the applications of the principles of good laboratory practice and the verification of their application for tests on chemical substances. This assessment takes account of: a) the general toxicological profile of each ingredient used: b) the chemical structure of each ingredient: c) the level of exposure of each ingredient; d) the specific exposure characteristics of the areas on which the cosmetic product will be applied; e) the specific exposure characteristics of the class of individuals for whom the cosmetic product is intended. Review of Ingredients. All of the ingredients have a history of use in cosmetic and toiletry products. Ingredients that are: • Prohibited under the Cosmetics Directive • Restricted when used beyond the allowed authorised conditions • With toxicological data incompatible with the intended concentration and use • Which have insufficient toxicological data nor safety in use experience • Which are not properly characterised with regard to purity and analytical composition 1 Are excluded. ASSESSMENT Assessment is based on ingredient safety review and information on the final formulations, including the intended and reasonably foreseeable use, the physico-chemical and microbiological specifications of the raw materials and the finished product, stability and a history and record of any reported undesirable effects linked to the use of the product. DESCRIPTION OF THE PRODUCT This is a rinse-off product for application to the hands. It is for use by the whole family above age 3 years. The product may typically be used 1-5 times daily. QUANTITATIVE COMPOSITION OF THE PRODUCT Ingredients are listed below. Detailed information on the safety and toxicology of ingredients is appended. Ingredient INCI names %w/w (as 100% Supplier/Trade Name active) Aqua 85.1529 Sodium Laureth Sulphate 6.75 Stepan, Steol CS-230 PCK Cocoamidopropyl betaine 3 Pilot, Caltaine C-35 Sodium Lauryl Sulfate 2.9 Stepan, Stepanol WA-Extra PCK Glycerin 1 Univar, Glycerin 99.7% Sodium Chloride 0.6 Univar Lavandula Angustifolia Oil 0.22 ING Soutions, Lavender Oil Trisodium Ethylenediamine 0.037 Innospec-Argan, Natriquest E30 Disuccinate Panthenol 0.05 DSM, DL Panthenol 50L Tocopheryl Acetate 0.0001 DL-Alpha Tocopheryl Acetate Benzophenone-4 0.05 BASF, Uvinul MS-40 *Methylchloroisothiazolinone 0.07** Thor, Microcare ITL *Methylisothiazolinone Thor, Microcare ITL Sodium PCA 0.005 Ajinimoto, Ajidew NL 50 CI 60730 (0.1% solution) 0.15 Sensient, Ext D&C Violet No 2 CI 14700 (0.1% solution) 0.015 Sensient, FD&C Red No 4 2 EU Ingredients Labelling Aqua Sodium Laureth Sulfate Cocoamidopropyl betaine Sodium Lauryl Sulfate Glycerin Sodium Chloride Panthenol Tocopheryl Acetate Lavandula Angustifolia oil Benzophenone-4 Trisodium Ethylenediamine Disuccinate Sodium PCA Methylchloroisothiazolinone Methylisothiazolinone CI 60730 CI 14700 Linalool PHYSICAL/CHEMICAL CHARACTERISTICS The raw material Specifications and the Finished Product Specifications are to be available. RAW MATERIAL QUALITY/ PURITY All raw materials are from reputable sources of supply and are considered to meet current standards of purity and quality. The physical and chemical properties and microbiological of the raw materials have been reviewed. It is noted that all are to current standards and there are no banned or restricted materials present. The raw materials meet current good standards for quality and purity. Manufacturers Material data sheets/ Certificates are to be available. STABILITY The product is stable under normal and foreseeable conditions of use. MICROBIAL QUALITY INGREDIENTS It is a requirement that all raw materials/ ingredients meet a microbial quality of < 1000 cfu/ gram for Adult products 3 FINSHED PRODUCT It is a requirement that the Finished Product meets a microbial quality of < 1000 cfu/ gram for Adult products and zero harmfuls. CHALLENGE TEST DATA The product passes a Microbial Challenge Test PACKAGING The product is packaged as described below: a. POUCH (1 litre refill pouch) Country of Origin: South Korea Stand Up Pouch / 3 SIDE SEAL/ / SPOUT(10mm I.D.DIA) / ROUND CORNER Pouch Composition: MATTCOAT/PET(12)/PRN(4)/ADH/ONY(15)/ADH/WHITE OCTENE- LLDPE(135) Spout Composition: HDPE Size: 177mm x 245mm + 90mm (7.0'' x 9.6'' + 3.5'') Gauge: 162 mic ( 6.4 mil) Print: 4 Colors Give away 0.2 litre sample pouches. Description: Stand Up Pouch / NO ZIPLOCK/3 SIDE SEAL/ / TEAR NOTCH / ROUND CORNER / Composition: MATT-COAT/PET(12)/PRN(4)/ADH/ONY(15)/ADH/WHITE OCTENE-LLDPE(95) Size: 110mm x 170mm + 50mm (4.3'' x 6.7'' + 2.0'') Gauge: 122 mic ( 4.8 mil) Print: 4 Colors b. PET BOTTLE Country of Origin: China Pump (stem/ stem guide/SS spring/spring guide/bottle cap/piston seal/ glass ball/pump housing/foam washer/ straw/ polypropylene cover) Metal cap (stainless steel/ polypropylene) Collar lock (polypropylene) The packaging material is to meet an acceptable standard of purity. Consideration has been given to interaction between the product and the packaging. It is considered there is no adverse interaction between product and packaging as regards safety to the consumer. 4 DESCRIPTION OF INTENDED AND REASONABLY FORESEEABLE USE The product may reasonably be typically used 1-5 times daily. EXPOSURE TO THE PRODUCT & MARGINS OF SAFETY Based on the available toxicological literature or on “read-across” data Margins of Safety have been calculated for both topical and systemic effects. The procedure is as described in: THE SCCS NOTES OF GUIDANCE, FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION, 7th REVISION, 2010. Dermal Absorption reported as a % of the substance applied: The calculation of the SED is as follows: SED = A (g/day) x 1000mg/g x C (%)/100 x DAp (%)/100 60 kg SED (mg/kg bw/day) = Systemic Exposure Dosage A (g/day) = Amount of the cosmetic product applied daily: see the daily exposure values for different cosmetic product types C (%) = the Concentration of the ingredient under study in the finished cosmetic product on the application site DAp (%) = Dermal Absorption expressed as a percentage of the test dose assumed to be applied in real life conditions 60 kg = default human body weight The calculation of Margin of Safety (MOS): NOAEL SED NOAEL data is derived from published literature where available. Estimated Daily Exposure Levels: Data for Estimated daily exposure levels is taken from the current Colipa data as presented in THE SCCS NOTES OF GUIDANCE, FOR THE TESTING OF COSMETIC INGREDIENTS AND THEIR SAFETY EVALUATION, 7th REVISION, 2010. Estimated daily exposure levels for different cosmetic product types according to Colipa data [SCCNFP/0321/02; Hall et al. 2007, 2011]. Product type Estimated Relative Retention Calculated Calculated daily amount factor 1 daily relative daily amount applied exposure exposure applied (mg/kg (g/day) (mg/kg bw/day bw/day) 5 Bathing, showering Shower gel 18.67 g 279.20 0.01 0.19 2.79 Hand wash soap 20.00 g 0.01 0.20 3 3.33 2 - Hair care Shampoo 10.46 g 150.49 0.01 0.11 1.51 Hair conditioner 3.92 g - 0.01 0.04 0.60 Hair styling 4.00 g 57.40 0.1 0.04 5.74 products Semi-permanent 35 ml - 0.1 Not - hair (per calculated dyes (and application) lotions) 2 Oxidative/perma 100 ml - 0.1 Not - nent (per calculated 4 hair dyes 2 application) Skin care Body lotion 7.82 g 123.20 1.0 7.82 123.20 Face cream 1.54 g 24.14 1.0 1.54 24.14 Hand cream 2.16 g 32.70 1.0 2.16 32.70 Make-up Liquid foundation 0.51 g 7.90 1.0 0.51 7.90 Make-up 5.00 g - 0.1 0.50 8.33 remover 2 Eye shadow 2 0.02 g - 1.0 0.02 0.33 Mascara 2 0.025 g - 1.0 0.025 0.42 Eyeliner 2 0.005 g - 1.0 0.005 0.08 Lipstick, lip salve 0.057 g 0.90 1.0 0.057 0.90 Deodorant Deodorant non- 1.50 g 22.08 1.0 1.50 22.08 spray Deodorant 1.43 g 20.63 1.0 1.43 20.63 aerosol spray (ethanol-based) 5 Deodorant spray 0.69 g 10.00 1.0 0.69 10.00 (not ethanol- based) Oral hygiene Toothpaste 2.75 g 43.29 0.05 0.138 2.16 (adult) Mouthwash 21.62 g 325.40 0.10 2.16 32.54 1 The retention factor was introduced by the SCCNFP to take into account rinsing off and dilution of finished products by application on wet skin or hair (e.g. shower gels, shampoos, …) [SCCNFP/0321/00] 2 Product types not covered by the Colipa studies: existing daily application amounts are divided by the mean human body weight of 60 kg. 3 Danish Ministry of the Environment, Environmental Protection Agency: Survey of liquid hand soaps, including health and environmental assessments. 4 Daily exposure value not calculated due to the low frequency of exposure (see also 3-8.3.1). 5 Steiling et al. (publication in preparation); results presented to the SCCS. ‘Ethanol-based’ are products containing ethanol as principal ingredient. 6 It was concluded that all ingredients, when considered both individually and in combination have an adequate Margin of Safety, ie > 100.
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