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Administrative data

Description of key information

In an acute oral toxicity study with rats, as well as in an acute dermal toxicity study with rats, an LD50 >2000 mg/kg bw was determined. No mortality occurred in these studies.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Oral

The substance was evaluated for acute oral toxicity in five-week old male and female Crj:CD(SD) rats at a dose level of 2000 mg/kg bw in corn oil. No death occured in rats of either sex, and no abnormalities were detected either in the clinical signs and body weight changes during the study period or in autopsy findings at the end of the study period. It was concluded that the LD50 value of the test substance was >2000 mg/kg bw in male and female rats.

Dermal

An acute dermal toxicity study was performed with the substance in accordance with OECD 402 (1987) and according to GLP principles. Five male and five female rats were exposed to 2000 mg/kg bw for 24 hours under occlusive conditions. No mortality occurred. Lethargy was noted in 1 male on day 1. Macroscopic examination of the animals did not reveal any abnormalities. The LD50 of MD/CHA/ODA/DCHA was concluded to be >2000 mg/kg bw. There was no skin irritation observed.

Justification for classification or non-classification

Based on the results of an acute oral and an acute dermal toxicity study, the substance does not need to be classified for acute oral and acute dermal toxicity in accordance with the CLP Regulation.