Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via inhalation route
Dose descriptor:
NOAEC
36 081 mg/m³
Additional information

The test substance did not adversely affect reproductive function at any concentration tested. Maternal effects were the same central nervous system effects as those observed in acute studies involving non-pregnant animals.


Short description of key information:
Oral: Inhalation is the most plausible route for repeated exposures.
Dermal: Inhalation is the most plausible route for repeated exposures.
Inhalation: OECD 415; rat. No adverse effects on fertility or reproductive function were observed at any exposure concentration. Clinical signs (central nervous system) occurred at 36081 mg/m3, but not at 20618 mg/m3. The central nervous system toxicity was similar to that observed in the acute studies. Not classified as a reproductive toxin. Reliability = 1.

Effects on developmental toxicity

Description of key information
Oral: Inhalation is the most plausible route for repeated exposures.  
Dermal: Inhalation is the most plausible route for repeated exposures.
Inhalation: OECD 414, rat. No developmental toxicity was observed at any doses that were not maternally toxic. Maternal toxicity (central nervous system) was observed at 20618 mg/m3 and higher, but not at 5154 mg/m3. Maternal toxicity was similar to that observed in acute inhalation studies. Not classified as a reproductive developmental toxin. Reliability = 1.
Effect on developmental toxicity: via inhalation route
Dose descriptor:
NOAEC
20 618 mg/m³
Additional information

The test substance was not uniquely toxic to the developing foetus at any concentration tested. Maternal effects were the same as the central nervous system effects observed in acute studies involving non-pregnant animals.

Justification for classification or non-classification

The test substance did not adversely affect reproductive function and was not uniquely toxic to the developing foetus. The substance does not need to be classified for reproductive toxicity according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.