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Directorate-General for Health and Food Safety
Executive Summary
1. General data
1.1 Identity of the ingredient : Hexahydro-hexamethyl-cyclopenta (g )-2-benzopyran
1.2 CAS n° : 1222-05-5
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.
2.2 Request to the SCCNFP
The SCCNFP is requested to answer the following questions :
* Is Hexahydro-hexamethyl-cyclopenta (g )-2-benzopyran safe for use in cosmetic products?
* Does the SCCNFP propose any restrictions or conditions for its use in cosmetic products?
Safety Assessment & Classification
The assessment followed the Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 3. The requested data must be available within 12 months.
4. Opinion
Information on the purity of the substance and its possible isomers must be provided.
The SCCNFP had made a series of recommendations on the assays to be performed in assessing potential hazards of cosmetic ingredients in different areas including percutaneous absorption and photo-toxicity.
Percutaneous absorption was insufficiently assessed. A new in vitro penetration study has to be provided, in accordance with the SCCNFP Notes of Guidance (SCCNFP/0119/99).
The absence of photo-toxicity should be confirmed using the in vitro 3T3 Neutral Red Uptake Photo-toxicity Test.
The above has been formulated only on review of the cosmetic use of HHCB. For the full safety assessment of HHCB, 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 : Hexahydro-hexamethyl-cyclopenta (g )-2-benzopyran
1.2 CAS n° : 1222-05-5
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.
2.2 Request to the SCCNFP
The SCCNFP is requested to answer the following questions :
* Is Hexahydro-hexamethyl-cyclopenta (g )-2-benzopyran safe for use in cosmetic products?
* Does the SCCNFP propose any restrictions or conditions for its use in cosmetic products?
Safety Assessment & Classification
The assessment followed the Notes of Guidance under scientifically based premises of consumer safety and leads to a classification 3. The requested data must be available within 12 months.
4. Opinion
Information on the purity of the substance and its possible isomers must be provided.
The SCCNFP had made a series of recommendations on the assays to be performed in assessing potential hazards of cosmetic ingredients in different areas including percutaneous absorption and photo-toxicity.
Percutaneous absorption was insufficiently assessed. A new in vitro penetration study has to be provided, in accordance with the SCCNFP Notes of Guidance (SCCNFP/0119/99).
The absence of photo-toxicity should be confirmed using the in vitro 3T3 Neutral Red Uptake Photo-toxicity Test.
The above has been formulated only on review of the cosmetic use of HHCB. For the full safety assessment of HHCB, 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.
