Summary sheet on Commission
Review (Ref XXIV/1287/97)
Ingredient: 4-N,N-bis(ß-hydroxyethyl)-2-nitro-p-phenylenediamine
84 % in the commercial product "Kardinalrot" together with 13 % 1-(ß-hydroxyethyl-amino-2-nitro-4-bis-(ß-hydroxyethyl)-amino-benzene
Function and max in use concentration: oxidative (permanent) – max 2.5 %, 1.5 % with H2O2 – and semipermanent (non oxidative) – max 2.5 % - hair dye
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 (90 d)
- oral application: reasonable NOAEL
Assessment of reproductive toxicity:
No signs of maternal toxicity, fetal toxicity or teratogenic effects within reasonable dose ranges
Assessment of genotoxicity/carcinogenicity:
No evidence of mutagenicity in different endpoints
Assessment of allergenicity/sensitization:
No harmful effects were observed; in concl.: "non sensitizer"
Percutaneous absorption:
In vitro testing revealed a very low absorption rate, leading to an appropriate "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: 4-N,N-bis(ß-hydroxyethyl)-2-nitro-p-phenylenediamine
84 % in the commercial product "Kardinalrot" together with 13 % 1-(ß-hydroxyethyl-amino-2-nitro-4-bis-(ß-hydroxyethyl)-amino-benzene
Function and max in use concentration: oxidative (permanent) – max 2.5 %, 1.5 % with H2O2 – and semipermanent (non oxidative) – max 2.5 % - hair dye
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 (90 d)
- oral application: reasonable NOAEL
Assessment of reproductive toxicity:
No signs of maternal toxicity, fetal toxicity or teratogenic effects within reasonable dose ranges
Assessment of genotoxicity/carcinogenicity:
No evidence of mutagenicity in different endpoints
Assessment of allergenicity/sensitization:
No harmful effects were observed; in concl.: "non sensitizer"
Percutaneous absorption:
In vitro testing revealed a very low absorption rate, leading to an appropriate "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.