Registration Dossier
Registration Dossier
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EC number: 202-431-1 | CAS number: 95-55-6
Endpoint summary
Administrative data
Description of key information
Two subacute oral toxicity studies in rats were performed with o-aminophenol. In study 1 with treatment over 30 days at daily doses 0, 20, 80, 320 mg/kg bw, none of the three tested doses could be considered as a NOAEL. In study 2 with doses of 0, 2. 5 and 15 mg/kg bw/d, a NOAEL of 5 mg/kg bw/d was derived based on the thyroid weight changes observed.
Both subchronic toxicity studies are considered to be inconclusive.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 5 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Two subacute oral toxicity studies in rats were performed with o-aminophenol. In study 1 with treatment over 30 days at daily doses 0, 20, 80, 320 mg/kg bw, none of the three tested doses could be considered as a NOAEL. Increased liver and kidney weight as well as mottled kidneys and renal tubular lesions were observed in the mid and high dose group. In addition, an increase in blood urea nitrogen and in urinary proteins were seen in the high dose group. In study 2 with doses of 0, 2. 5 and 15 mg/kg bw/d, a NOAEL of 5 mg/kg bw/d was derived based on the thyroid weight changes observed. Reduced body weight in the high dose group and in females of the mid and low dose group was also abserved.
A three-month oral toxicity study was performed in rats. As only a single dose level of 50 mg/kg bw/d was tested, the results are inconclusive. The value of the 13-week dermal toxicity study of a hair dye formulation in rabbits is limited due to the low dose applied (topical application of an oxidation hair-dye mixture with a final concentration of 0.15%). No study on sub-chronic toxicity according to the Notes of Guidance was submitted. Both subchronic toxicity studies are considered as inconclusive due to single dose testing and inappropriate dose level.
Repeated dose toxicity: via oral route - systemic effects
(target organ) urogenital: kidneys
Justification for classification or non-classification
These data from secondary sources are not suiteable to derive a classification or labelling of the substance according the dangerous substance directive (67/548/EEC) or the Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008.
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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