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Administrative data

Description of key information

The acute oral toxicity was tested on rats in two non-GLP studies. Both tests were perrformed either in accordance with or following the corresponding EU- and OECD-test guidelines.
- 1st study (Wallace, 1976): LD50 = 1070 mg/kg for males; 1310 mg/kg for females
- 2nd study (Monnot, 1983): LD50 = 332 mg/kg for males and 705 mg/kg for females
The LD50 of 332 mg/kg was identified as key value for the the chemical safety assessment.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
332 mg/kg bw

Additional information

The test of 1983 (Monnot) was performed according to OECD- and EU-testing guidelines, therefore it was identified as key study. The second test (Wallace, 1976) was conducted following a comparable test design, before the corresponding test guidelines were available, hence it was identified as supporting study. Both tests were not performed in accordance with GLP, therefore they were considered to have Klimisch 2.

Justification for classification or non-classification

The GHS criteria for classifying a substance as Category 4 acute toxicity hazard is triggered when the acute toxicity estimate is between 300 and 2000 mg/kg body weight. Since the lowest LD50 is 332 mg/kg body weight, the test material is within range for classification as a Category 4 acute toxicity hazard.