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Description of key information

A single repeated dose toxicity study was conducted in accordance with OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents) and GLP.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
1 000 mg/kg bw/day
Study duration:

Additional information

No 90-day repeated dose toxicity study was conducted as specified in the waiver presented in Section 7.5.1.

Justification for classification or non-classification

No treatment related effects were observed in the presented repeated dose toxicity study. No classification for repeated dose toxicity (e.g. STOT) is therefore required in accordance with Regulation (EC) No 1272/2008.