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Directorate-General for Health and Food Safety
Executive Summary
1. General data
1.1 Identity of the ingredient : Musk Ketone
1.2 CAS n° : 81-14-1
1.3 Use : Fragrance ingredient
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.
Change in Annex III, part 1, no 12 to Council Directive 76/768/EEC to set limits for Musk Xylene in cosmetic products.
2.2 Request to the SCCNFP
The SCCNFP is requested to answer the following questions :
* Is Musk Ketone safe for use in cosmetic products?
* Does the SCCNFP propose any restrictions or conditions for its use in cosmetic products?
3. Safety Assessment & Classification
The assessment followed the Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 1 for the intended use.
Evaluation of acute toxicity (oral, dermal), skin and mucous membrane irritation, sub-chronic toxicity (oral, dermal), reproductive toxicity (oral), genotoxicity, percutaneous absorption have shown that the Musk Ketone can be safely used under the conditions stated in the Opinion.
4. Opinion
On review of the information presently available, it is the opinion of the SCCNFP that Musk Ketone can be safely used in cosmetic products, excluding oral care products, up to a maximum daily absorbed dose of about 14 m g/kg/day.
The opinion that consumer exposure to Musk Ketone should be reduced is based on the findings of long retention of the substance in human fat and its excretion in human milk.
Long term toxicity studies are needed.
It is estimated that exposure to Musk Ketone from cosmetic use is about 200 m g/kg/day. This equates to about 28 m g/kg/day absorbed.
It is recommended that exposure to Musk Ketone should be reduced to about 14 m g/kg/day (theoretically absorbed dose). This can be achieved following the same approaches as suggested for Musk Xylene.
The above has been formulated only on review of the cosmetic use of Musk Ketone. For the full safety assessment of Musk Ketone, it is necessary to consider other sources of consumer exposure from non-food products e.g., laundry 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.
The extend to which these validated methods are applicable to cosmetic products and its ingredients is a matter of the SCCNFP.
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 : Musk Ketone
1.2 CAS n° : 81-14-1
1.3 Use : Fragrance ingredient
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.
Change in Annex III, part 1, no 12 to Council Directive 76/768/EEC to set limits for Musk Xylene in cosmetic products.
2.2 Request to the SCCNFP
The SCCNFP is requested to answer the following questions :
* Is Musk Ketone safe for use in cosmetic products?
* Does the SCCNFP propose any restrictions or conditions for its use in cosmetic products?
3. Safety Assessment & Classification
The assessment followed the Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 1 for the intended use.
Evaluation of acute toxicity (oral, dermal), skin and mucous membrane irritation, sub-chronic toxicity (oral, dermal), reproductive toxicity (oral), genotoxicity, percutaneous absorption have shown that the Musk Ketone can be safely used under the conditions stated in the Opinion.
4. Opinion
On review of the information presently available, it is the opinion of the SCCNFP that Musk Ketone can be safely used in cosmetic products, excluding oral care products, up to a maximum daily absorbed dose of about 14 m g/kg/day.
The opinion that consumer exposure to Musk Ketone should be reduced is based on the findings of long retention of the substance in human fat and its excretion in human milk.
Long term toxicity studies are needed.
It is estimated that exposure to Musk Ketone from cosmetic use is about 200 m g/kg/day. This equates to about 28 m g/kg/day absorbed.
It is recommended that exposure to Musk Ketone should be reduced to about 14 m g/kg/day (theoretically absorbed dose). This can be achieved following the same approaches as suggested for Musk Xylene.
The above has been formulated only on review of the cosmetic use of Musk Ketone. For the full safety assessment of Musk Ketone, it is necessary to consider other sources of consumer exposure from non-food products e.g., laundry 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.
The extend to which these validated methods are applicable to cosmetic products and its ingredients is a matter of the SCCNFP.
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.
