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Administrative data

Description of key information

Acute oral toxicity in rats: LD50 >5000 mg/kg bw in a test similar to OECD TG 401.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute oral toxicity

A study was performed to assess the acute oral toxicity of the substance to the rat according to a protocol similar to OECD TG 401. A group of four fasted rats (two of each sex) was given a single dose by gavage of the substance, as supplied, at a dose level ranging from 6.4 to 16.0 g/kg bw. All animals were observed for 14 days and necropsied.

Clinical signs observed were ptosis, lethargy, pilo-erection, ataxia, abnormal body carriage, abnormal gait, a decreased respiratory rate, pallor of the extremities and increased salivation. Reduced body weight gains were seen in one male and one female at 6.4 g/kg during the first week of observation and in one female at 10.0 g/kg during the second week of observation, compared to the controls. Body weight gains of the remaining animals were normal throughout the two-week observation period. The acute oral LD50 in rats was determined to be between 6400 and16000  mg/kg bw.

In a supporting study similar to OECD TG 401, the LD50 was assessed to be greater than 5000 mg/kg bw (Moreno, 1982). Clinical signs observed were ptosis, diarrhoea, lethargy, piloerection, ataxia, flaccid muscle tone, chromorhinorrhea, and brown staining of the anogenital area. Gross observations at necropsy were normal for all rats. The substance is not acute orally toxic: LD50 > 5000 mg/kg bw and no acute oral classification is needed.

Acute dermal toxicity

A dermal study is available, demonstrating the LD50 greater than 5000 mg/kg bw (Moreno, 1982). No death occurred at this dose in any of the 10 animals used.

This information does not lead to a different C&L.

Justification for classification or non-classification

The substance does not need to be classified for acute oral (and dermal) toxicity according to EU CLP (EC No. 1272/2008 and its amendments).