Registration Dossier
Registration Dossier
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EC number: 210-236-8 | CAS number: 610-81-1
Endpoint summary
Administrative data
Description of key information
Based on the result of the key study (Clouzeau, OECD 401, Klimisch 1, GLP), the LD50 value of the test article 4-amino-3-nitrophenol was between the range of 500 mg/kg and 1000 mg/kg.
Hence, according to the CLP regulation, the test item was classified as Category 4 for Acute Oral Hazard.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 500 mg/kg bw
Additional information
Clouzeau, OECD 401, Klimisch 1, GLP:
The test substance was administered by gavage to 3 groups of 10 fasted Sprague-Dawley rats (5 males and 5 females) at the dose levels of 500, 1000 and 1500 mg/Kg. The test item was administered in suspension in 1,2 -propanediol, 99% at a volume of 10 mL/Kg. They were observed for mortality, clinical signs and bodyweight for 14 days observation period and were subjected to necropsy at day 15 for macroscopic examination of the main organs. Death were mainly noted between 1 and 2 hours post-treatment. Mortality rates were 10%, 70% and 70% in rats at 500, 1000 and 1500 mg/Kg respectively. No sex-related difference was noted. The body weight gain of the surviving animals was not influenced by the treatment. Macroscopic post-mortem examination revealed no abnormalities in the animals sacrificed at the end of the study. Orange or dark red colouration of the tissues and organs was observed in all animals found dead during the study at all dose levels. Under these experimental conditions, the LD50 of the test item administered by oral route in rats was higher than 500 mg/Kg and less than 1000 mg/Kg.
Justification for classification or non-classification
Based on the result of the key study (Clouzeau, OECD 401, Klimisch 1, GLP), the LD50 value of the test article 4-amino-3-nitrophenol was between the range of 500 mg/kg and 1000 mg/kg. Hence, according to the CLP regulation, the test item was classified as Category 4 for Acute Oral Hazard.
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