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Directorate-General for Health and Food Safety
Executive Summary
1. General data
1.1 Identity of the ingredient : Benzylidene malonate polysiloxane
1.2 CAS n° : 207574-74-1
1.3 Use : Cosmetics & toiletries, e.g. sunscreen products, skin care products
concentration : max. 10 %
2. Terms of reference
2.1 Context of the question
The adaptation to technical progress of the Annexes to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products.
Request for inclusion of S74 in Annex VII, part 1 - List of UV filters which Cosmetic Products may contain - to Council Directive 76/768/EEC.
2.2 Request to the SCCNFP
The SCCNFP is requested to answer the following questions :
* Is S74 safe for use in cosmetic products?
* Does the SCCNFP propose any restrictions or conditions for its use in cosmetic products?
3. Toxicological Evaluation & Characterisation
3.1 Acute toxicity (dermal, oral, i.v., i.p.) : No clinical abnormalities were observed
3.2 Chronic/sub-chronic toxicity : No dose related clinical abnormalities were noted. NOAEL = 1.000 mg/kg bw/day
3.4 Photo-toxicity : No evidence of a photo-toxic effect associated with the substance
3.3 Reproductive toxicity : No data
3.4. Percutaneous absorption : Appears to be about 2%
3.5 Irritation and corrosivity : No evidence of having irritant action.
3.6 Sensitisation : The substance showed no capacity to produce sensitisation
3.8 Photo-allergenicity : No potential to produce photo-allergy
3.9 Genotoxicity/mutagenicity : The substance is not mutagenic or photo- mutagenic
4. Opinion
The SCCNFP is of the opinion that Benzylidene malonate polysiloxane is safe for use in cosmetic products as a UV light absorber at a maximum concentration of 10%.
The SCCNFP proposes no further restrictions or conditions for its use in cosmetic products.
5. Statement on the toxicological evaluation
The SCCNFP is the scientific advisory body to the European Commission in matters of consumer protection with respect to cosmetics and non-food products intended for consumers.
The Commission's general policy regarding research on animals supports the development of alternative methods to replace or to reduce animal testing when possible. In this context, the SCCNFP has a specific working group on alternatives to animal testing which, in co-operation with other Commission services such as ECVAM (European Centre for Validation of Alternative Methods), evaluates these methods.
SCCNFP opinions include evaluations of experiments using laboratory animals; such tests are conducted in accordance with all legal provisions and preferably under chemical law regulations. Only in cases where no alternative method is available will such tests be evaluated and the resulting data accepted, in order to meet the fundamental requirements of the protection of consumer health.
1. General data
1.1 Identity of the ingredient : Benzylidene malonate polysiloxane
1.2 CAS n° : 207574-74-1
1.3 Use : Cosmetics & toiletries, e.g. sunscreen products, skin care products
concentration : max. 10 %
2. Terms of reference
2.1 Context of the question
The adaptation to technical progress of the Annexes to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products.
Request for inclusion of S74 in Annex VII, part 1 - List of UV filters which Cosmetic Products may contain - to Council Directive 76/768/EEC.
2.2 Request to the SCCNFP
The SCCNFP is requested to answer the following questions :
* Is S74 safe for use in cosmetic products?
* Does the SCCNFP propose any restrictions or conditions for its use in cosmetic products?
3. Toxicological Evaluation & Characterisation
3.1 Acute toxicity (dermal, oral, i.v., i.p.) : No clinical abnormalities were observed
3.2 Chronic/sub-chronic toxicity : No dose related clinical abnormalities were noted. NOAEL = 1.000 mg/kg bw/day
3.4 Photo-toxicity : No evidence of a photo-toxic effect associated with the substance
3.3 Reproductive toxicity : No data
3.4. Percutaneous absorption : Appears to be about 2%
3.5 Irritation and corrosivity : No evidence of having irritant action.
3.6 Sensitisation : The substance showed no capacity to produce sensitisation
3.8 Photo-allergenicity : No potential to produce photo-allergy
3.9 Genotoxicity/mutagenicity : The substance is not mutagenic or photo- mutagenic
4. Opinion
The SCCNFP is of the opinion that Benzylidene malonate polysiloxane is safe for use in cosmetic products as a UV light absorber at a maximum concentration of 10%.
The SCCNFP proposes no further restrictions or conditions for its use in cosmetic products.
5. Statement on the toxicological evaluation
The SCCNFP is the scientific advisory body to the European Commission in matters of consumer protection with respect to cosmetics and non-food products intended for consumers.
The Commission's general policy regarding research on animals supports the development of alternative methods to replace or to reduce animal testing when possible. In this context, the SCCNFP has a specific working group on alternatives to animal testing which, in co-operation with other Commission services such as ECVAM (European Centre for Validation of Alternative Methods), evaluates these methods.
SCCNFP opinions include evaluations of experiments using laboratory animals; such tests are conducted in accordance with all legal provisions and preferably under chemical law regulations. Only in cases where no alternative method is available will such tests be evaluated and the resulting data accepted, in order to meet the fundamental requirements of the protection of consumer health.
