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Directorate-General for Health and Food Safety
Summary sheet on Commission
Review (Ref XXIV/1640/97)
Ingredient: Phenol,2-(2H-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1,3,3,3- tetramethyl-1-(trimethylsilyl)oxy)-disiloxanyl)propyl)
CAS n° : 155633-54-8
Function and max in use concentration:UV filter, 15 %
Assessment of acute toxicity (dermal, oral, i.v., i.p.)
- oral toxicity low
Assessment of irritation & corrosivity:
- appropriate experiments were with favourable results
Assessment of chronic/subchronic toxicity:
- Repeated dose toxicity (90d)
- oral application: within a reasonable NOAEL
Assessment of reproductive toxicity:
- no signs of embryotoxicity or teratogenicity within reasonable dose ranges
Assessment of genotoxicity/carcinogenicity:
- no evidence of mutagenic or photo-mutagenic potentials
- in several appropriate tests
Assessment on allergenicity/sensitization:
- in appropriate testing no evidence of neither allergenicity
- nor photoallergenicity activities
Percutaneous absorption:
- very low, leading to an appropriate "safety margin"
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.
Ingredient: Phenol,2-(2H-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1,3,3,3- tetramethyl-1-(trimethylsilyl)oxy)-disiloxanyl)propyl)
CAS n° : 155633-54-8
Function and max in use concentration:UV filter, 15 %
Assessment of acute toxicity (dermal, oral, i.v., i.p.)
- oral toxicity low
Assessment of irritation & corrosivity:
- appropriate experiments were with favourable results
Assessment of chronic/subchronic toxicity:
- Repeated dose toxicity (90d)
- oral application: within a reasonable NOAEL
Assessment of reproductive toxicity:
- no signs of embryotoxicity or teratogenicity within reasonable dose ranges
Assessment of genotoxicity/carcinogenicity:
- no evidence of mutagenic or photo-mutagenic potentials
- in several appropriate tests
Assessment on allergenicity/sensitization:
- in appropriate testing no evidence of neither allergenicity
- nor photoallergenicity activities
Percutaneous absorption:
- very low, leading to an appropriate "safety margin"
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.
