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Directorate-General for Health and Food Safety
Summary sheet on Commission
Review (Ref XXIV/1289/97)
Ingredient: 2-hydroxyethylamino-5-nitroanisole (INCI)
CAS n°: 66095-81-6
Function and max in use concentration: semipermanent (non oxidative) hair dye; max 1 %
Assessment of acute toxicity (dermal, oral, i.v., i.p.):
Acute oral toxicity low
Assessment of irritation & corrosivity:
Slight irritations on mucous membranes; no irritative effects on the skin
Assessment of chronic/subchronic toxicity:
Repeated dose toxicity
- 28 d oral application: reasonable NOAEL
Assessment of reproductive toxicity:
Beside a slight maternotoxic effect in the high test dose, neither embryotoxic nor teratogenic effects in reasonable dose ranges
Assessment of genotoxicity/carcinogenicity:
No signs of mutagenicity in in vitro and in vivo experiments
Assessment of allergenicity/sensitization:
Not sensitizing
Percutaneous absorption:
Low absorption rate leading to a high "safety margin"
Classification: 1
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 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: 2-hydroxyethylamino-5-nitroanisole (INCI)
CAS n°: 66095-81-6
Function and max in use concentration: semipermanent (non oxidative) hair dye; max 1 %
Assessment of acute toxicity (dermal, oral, i.v., i.p.):
Acute oral toxicity low
Assessment of irritation & corrosivity:
Slight irritations on mucous membranes; no irritative effects on the skin
Assessment of chronic/subchronic toxicity:
Repeated dose toxicity
- 28 d oral application: reasonable NOAEL
Assessment of reproductive toxicity:
Beside a slight maternotoxic effect in the high test dose, neither embryotoxic nor teratogenic effects in reasonable dose ranges
Assessment of genotoxicity/carcinogenicity:
No signs of mutagenicity in in vitro and in vivo experiments
Assessment of allergenicity/sensitization:
Not sensitizing
Percutaneous absorption:
Low absorption rate leading to a high "safety margin"
Classification: 1
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 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.
