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Directorate-General for Health and Food Safety
Summary sheet on Commission
Review (Ref XXIV/1290/97)
Ingredient: 1-(2-hydroxyethyloxy)-3-methylamino-4-nitrobenzene
CAS n°: 59820-63-2
Function and max in use concentration: semipermanent (non-oxidative) hair dye, max 1 %
Assessment of acute toxicity (dermal, oral, i.v., i.p.):
Oral toxicity low
Assessment of irritation & corrosivity:
Slight temporary irritation on mucous membranes, no irritating effects observed on the skin
Assessment of chronic/subchronic toxicity:
Repeated dose toxicity
- 28 d oral application: reasonable NOAEL
Assessment of reproductive toxicity:
Apart from slight to moderate maternal toxicity in higher dose ranges no signs of embryotoxicity or teratogenicity within appropriate dose ranges were observed
Assessment of genotoxicity/carcinogenicity:
No evidence of mutagenicity in in vitro and in vivo studies
Assessment of allergenicity/sensitization:
Not sensitizing
Percutaneous absorption:
In vitro experiments – with presence or absence of hair – showed low penetration rates, 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: 1-(2-hydroxyethyloxy)-3-methylamino-4-nitrobenzene
CAS n°: 59820-63-2
Function and max in use concentration: semipermanent (non-oxidative) hair dye, max 1 %
Assessment of acute toxicity (dermal, oral, i.v., i.p.):
Oral toxicity low
Assessment of irritation & corrosivity:
Slight temporary irritation on mucous membranes, no irritating effects observed on the skin
Assessment of chronic/subchronic toxicity:
Repeated dose toxicity
- 28 d oral application: reasonable NOAEL
Assessment of reproductive toxicity:
Apart from slight to moderate maternal toxicity in higher dose ranges no signs of embryotoxicity or teratogenicity within appropriate dose ranges were observed
Assessment of genotoxicity/carcinogenicity:
No evidence of mutagenicity in in vitro and in vivo studies
Assessment of allergenicity/sensitization:
Not sensitizing
Percutaneous absorption:
In vitro experiments – with presence or absence of hair – showed low penetration rates, 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.
