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Directorate-General for Health and Food Safety
Opinion of the Scientific Committee on Cosmetic and non-food products concerning Benzoic acid, 4,4-{[6-[[[(1,1-dimethyl)amino]carbonyl]phenyl] amino]-1,3,5-triazine-2,4-diyl)diimino}bis-, bis(2-ethylhexyl)ester adopted by the plenary session of January 21, 1998
Ingredient : Benzoic acid, 4,4-{[6-[[[(1,1-dimethyl)amino]carbonyl]phenyl] amino]-1,3,5-triazine-2,4-diyl)diimino}bis-, bis(2-ethylhexyl)ester
CAS n° : 154702-15-5
Function and maximum use concentration : UV filter, 10 %
Assessment of acute toxicity : oral toxicity very low.
Assessment of sub-chronic toxicity (oral): very low.
Assessment of capacity to produce skin irritation and photo-irritation : negative.
Assessment of capacity to produce sensitisation : negative, found to be non-irritant and hypoallergenic following repeated application in human volunteers.
Assessment of capacity to produce photo-sensitisation: negative.
Assessment of capacity to irritate mucous membranes: negative.
Test for degree of percutaneous absorption. Radioactive compound was used on living human skin samples ex vivo: the results suggest that absorption is very low.
Tests for mutagenic and clastogenic activity in suitable bacterial and tissue culture systems were negative, as were similar tests for photo-mutagenicity and photo-clastogenicity.
Stability of the compound over a period of some 3 years, and its stability when exposed to ultraviolet radiation, were satisfactorily demonstrated.
Analysis of the above data led to the conclusion that the compound exhibited a sufficiently high margin of safety.
Classification: 1 (See "Classification of Substances")
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.
Summary sheet of Commission Review (XXIV/1873/97, rev. 12/97)
Ingredient : Benzoic acid, 4,4-{[6-[[[(1,1-dimethyl)amino]carbonyl]phenyl] amino]-1,3,5-triazine-2,4-diyl)diimino}bis-, bis(2-ethylhexyl)ester
CAS n° : 154702-15-5
Function and maximum use concentration : UV filter, 10 %
Assessment of acute toxicity : oral toxicity very low.
Assessment of sub-chronic toxicity (oral): very low.
Assessment of capacity to produce skin irritation and photo-irritation : negative.
Assessment of capacity to produce sensitisation : negative, found to be non-irritant and hypoallergenic following repeated application in human volunteers.
Assessment of capacity to produce photo-sensitisation: negative.
Assessment of capacity to irritate mucous membranes: negative.
Test for degree of percutaneous absorption. Radioactive compound was used on living human skin samples ex vivo: the results suggest that absorption is very low.
Tests for mutagenic and clastogenic activity in suitable bacterial and tissue culture systems were negative, as were similar tests for photo-mutagenicity and photo-clastogenicity.
Stability of the compound over a period of some 3 years, and its stability when exposed to ultraviolet radiation, were satisfactorily demonstrated.
Analysis of the above data led to the conclusion that the compound exhibited a sufficiently high margin of safety.
Classification: 1 (See "Classification of Substances")
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.
