Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

No effects on fertility were observed in a one generation reproduction toxicity study (OECD 422), at doses up to 1000 mg/kg/day. 


Short description of key information:
Oral: OECD 422. No evidence of reproductive/fertility effects observed up to 1000 mg/kg/day, the highest dose tested. Reliability = 1.

Dermal: Not specifically tested for this endpoint. However, no adverse effects noted in reproductive organs in acute dermal toxicity study and no reproductive effects observed by oral route. Not mutagenic or clastogenic.

Inhalation: Not specifically tested for this endpoint. However, no adverse effects noted in reproductive organs in acute inhalation toxicity study and no reproductive effects observed by oral route. Not mutagenic or clastogenic.

Effects on developmental toxicity

Description of key information
Oral: OECD 422. No evidence of reproductive/developmental toxicity effects up to 1000 mg/kg/day, the highest dose tested. Reliability = 1.
Dermal: Not specifically tested for this endpoint. However, no adverse effects noted in reproductive organs in acute dermal toxicity study and no reproductive/developmental toxicity effects observed by oral route. Not mutagenic or clastogenic.
Inhalation: Not specifically tested for this endpoint. However, no adverse effects noted in reproductive organs in acute inhalation toxicity study and no reproductive/developmental toxicity effects observed by oral route. Not mutagenic or clastogenic.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

No effects on developmental toxicity were observed in a one generation reproduction toxicity study (OECD 422), at doses up to 1000 mg/kg/day.

Justification for classification or non-classification

The substance did not produce any observed effects on the developing foetus in an OECD 422 study in rats, in which offspring were exposed to the substance from conception through post-natal day 3, either trans-placentally or in milk. The substance did not produce any genetic damage when tested in cell cultures or in laboratory animals. Additionally, no tissue damage or systemic effects were observed during a repeated oral toxicity-one generation reproduction study, up to the highest dose tested (1000 mg/kg bw/day). Therefore, the substance is not considered to be a reproductive toxin. The substance does not need to be classified for reproductive toxicity according to the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Additional information