Registration Dossier

Administrative data

Description of key information

According to Regulation (EC) No. 1907/2006, Annex VIII, 8.6.1, column 2, this short-term toxicity study (28 days) does not need to be conducted if a reliable sub-chronic (90 days) study is available.

A reliable sub-chronic (90 days) has been performed with the test substance, applying 0 (control), 100, 300 and 1000 mg/kg bw/d per oralis to rats. In lack of any adverse treatment-related effects observed during the treatment period and the recovery period the No Observed Effect Level (NOEL) in this study was set to 1000 mg/kg bw/d (highest dose tested in this study).

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the results of an oral subchronic repeated dose toxicity study, not revealing any effects when dosed up to 1000 mg/kg bw/d (p.o.), the substance is not subject to classification and labelling for STOT repeat exposure according to CLP (Regulation EC No. 1272/2008).