Registration Dossier

Diss Factsheets

Administrative data

Description of key information

acute oral toxicity, LD50 >5110 mg/kg bw (OECD guideline 401)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
5 110 mg/kg bw

Additional information

Acute oral toxicity was evaluated in a study performed under GLP according to OECD guideline 401, in which five male and five female Wistar rats received an application of 5110 mg/kg bw in distilled water by gavage (Asta Medica AG, 1992). Since no mortality was observed during the 16 day observation period, the LD50 is >5110 mg/kg bw. Signs of toxicity were hypokinesia, restrained gait, sunken sides and piloerection. The signs were recorded in all animals and were present between 30 minutes and two days after treatment. No abnormalities at necropsy were observed.

Justification for classification or non-classification

Based on the results of the acute oral toxicity study, the substance does not need to be classified according to Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.