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Directorate-General for Health and Food Safety
Summary sheet on Commission
Review (Ref XXIV/1288/97)
Ingredient: 1-amino-2-nitro-4-(ß-hydroxyethyl)amino-5-chloro-benzene
Function and max in use concentration: oxidative (permanent) – max 2 %; 1 % with H2O2 – and semipermanent (non-oxidative) – max 2 % - hair dye
Assessment of acute toxicity (dermal, oral, i.v., i.p.):
Oral toxicity low
Assessment of irritation & corrosivity:
No irritative or corrosive effects on the skin or mucous membranes in low concentrations
Assessment of chronic/subchronic toxicity:
Repeated dose toxicity
- 90 d oral application: reasonable NOAEL
- 18-months dermal skin painting study: no increased tumour frequencies
Assessment of reproductive toxicity:
No signs of maternal toxicity, embryotoxicity or teratogenicity within reasonable dose ranges
Assessment of genotoxicity/carcinogenicity:
No mutagenic properties in appropriate in vitro tests
Assessment of allergenicity/sensitization:
No sensitization or primary irritation was observed
Percutaneous absorption:
In vitro testing revealed a low penetration rate, leading to an appropriate "safety margin". Also the in vivo investigations (with radiolabelled test substance) showed after oral or dermal applications acceptable results.
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: 1-amino-2-nitro-4-(ß-hydroxyethyl)amino-5-chloro-benzene
Function and max in use concentration: oxidative (permanent) – max 2 %; 1 % with H2O2 – and semipermanent (non-oxidative) – max 2 % - hair dye
Assessment of acute toxicity (dermal, oral, i.v., i.p.):
Oral toxicity low
Assessment of irritation & corrosivity:
No irritative or corrosive effects on the skin or mucous membranes in low concentrations
Assessment of chronic/subchronic toxicity:
Repeated dose toxicity
- 90 d oral application: reasonable NOAEL
- 18-months dermal skin painting study: no increased tumour frequencies
Assessment of reproductive toxicity:
No signs of maternal toxicity, embryotoxicity or teratogenicity within reasonable dose ranges
Assessment of genotoxicity/carcinogenicity:
No mutagenic properties in appropriate in vitro tests
Assessment of allergenicity/sensitization:
No sensitization or primary irritation was observed
Percutaneous absorption:
In vitro testing revealed a low penetration rate, leading to an appropriate "safety margin". Also the in vivo investigations (with radiolabelled test substance) showed after oral or dermal applications acceptable results.
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.
