Registration Dossier

Administrative data

Description of key information

An oral LD50 of >2000 mg/kg 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 GLP compliant study performed according to OECD guideline 423, six female rats per dose were exposed to 300 or 2000 mg/kg bw of the test substance dissolved in 0.5% CMC solution in doubly distilled water (BASFR 2003). After an observation period of 14 days the surviving animals were necropsied. No mortality occurred. No clinical signs were observed and gross pathology of the organs showed no particular findings.


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.