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Directorate-General for Health and Food Safety
Summary sheet on Commission
Review (ref. XXIV/1991/97)
Ingredient : a-{4-[4-Dimethylamino-4'-(N-ethyl-3-sulfobenzylamino)-benzhydrylidene]-(N-ethyl-2,5-cyclohexylideneammonio)}3-tolylsulfonate
CAS n° : 1694-09-3
Function and max in use concentration : previously used as a colour classified food additive
Relevant toxicity data :
Assessment of carcinogenicity : carcinogenic in rats following oral and subcutaneous administration. Increased incidence of benign mammary tumours in female rats following ambient exposure.
Assessment of carcinogenicity : some evidence of mutagenicity in Salmonella.
Human data : no data available
Classification : 2a (See Classification of Substances)
CI 42640 was previously assessed by the SCC (SCC/313/83)
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.
Ingredient : a-{4-[4-Dimethylamino-4'-(N-ethyl-3-sulfobenzylamino)-benzhydrylidene]-(N-ethyl-2,5-cyclohexylideneammonio)}3-tolylsulfonate
CAS n° : 1694-09-3
Function and max in use concentration : previously used as a colour classified food additive
Relevant toxicity data :
Assessment of carcinogenicity : carcinogenic in rats following oral and subcutaneous administration. Increased incidence of benign mammary tumours in female rats following ambient exposure.
Assessment of carcinogenicity : some evidence of mutagenicity in Salmonella.
Human data : no data available
Classification : 2a (See Classification of Substances)
CI 42640 was previously assessed by the SCC (SCC/313/83)
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.
