Registration Dossier

Administrative data

Description of key information

Repeated dose oral. OECD 422. No adverse effects observed up to 1000 mg/kg/day, the highest dose tested. Reliability = 1.
No repeated dose dermal data available. No toxicity in dermal irritation or sensitisation study and dermal route not more acutely toxic than oral.
No repeated dose inhalation data available. Inhalation route not more acutely toxic than oral.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

No evidence of systemic toxicity was observed following repeated dose exposure by oral gavage. The NOAEL was 1000 mg/kg/day.

Justification for classification or non-classification

Based on the lack of adverse effects in the repeat dose study and in the acute oral, dermal, and inhalation exposures, the substance does not need to be classified for repeated dose toxicity according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.