Registration Dossier

Administrative data

Description of key information

An oral LD50 between >2000 mg/kg bw was determined in an acute oral toxicity study (OECD 423, GLP).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an acute toxic class method (OECD 423 guideline study, GLP) the test substance was administered to female Wistar rats oral gavage (BASF 2009). One group of three female rats were exposed to 300 mg/kg bw followed by two groups of three female rats exposed to 2000 mg/kg bw. After an observation period of 14 days surviving animals were necropsied. No mortality was observed in all exposed animals. Impaired and poor general state, dyspnoea, piloerection, none and reduced feces, staggering, ataxia, chromodacryorrhea, lacrimation and smeared fur were observed in the 2000 mg/kg bw dose group. No clinical effects were observed in animals exposed to 300 mg/kg bw. The LD50 was therefore determined to be above 2000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
One acute oral toxicity study is available. This study is adequate for covering this endpoint.

Justification for classification or non-classification

Based on oral LD50 of >2000 mg/kg bw classification for acute oral toxicity is not warranted in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.