Registration Dossier
Registration Dossier
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EC number: 202-431-1 | CAS number: 95-55-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
A reproduction study on three generations with dermal application of formulations containing a final concentration of 0.15% of the test substance showed no effect on the reproduction systems of rats. However, the dose administered was too low for hazard assessment.
Short description of key information:
A reproduction study on three generations (non GLP, non OECD guideline) with dermal application of a hair dye formulation containing a final concentration of 0.15% of the test substance showed no effect on the reproduction systems of rats. The dose administered was too low for hazard assessment.
Effects on developmental toxicity
Description of key information
The test item showed a certain toxicity in hens egg test but no teratogenicity. Intraperitoneal application of the substance to pregnant hamsters resulted in developmental toxicity at all dose levels. Oral administration of the test material to female rats caused discoloration of the urine in all treatment groups. Maternal and developmental toxicity was restricted to animals of the high dose group.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 70 mg/kg bw/day
Additional information
o-Aminophenol was moderately toxic in an in vivo hen’s egg test and had no teratogenic potential in this test. o-Aminophenol administered intraperitoneally on day 8 of gestation to Syrian golden hamsters at 100, 150, 200 mg/kg bw was found to be teratogenic at all doses tested. o-Aminophenol was tested for teratogenicity by oral gavage to groups of 20 pregnant SD (OFA) rats on days 6 – 15 of gestation at 20, 70, 250 mg/kg bw/d. A brown discoloration of urines occurred in all treated animals 24 hours after the first administration of the test substance; pathological findings were only observed in 250 mg/kg treated group. Thus the NOAEL for maternal toxicity and for foetal development (embryotoxicity) was 70 mg/kg bw/d.
Justification for classification or non-classification
These data from secondary sources are not suiteable to derive or to change the current classification and labelling of the substance according the dangerous substance directive (67/548/EEC) or theClassification, Labeling, and Packaging Regulation (EC) No. 1272/2008.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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