Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Male and female rats were exposed to 0 or 10000 ppm of the substance via inhalation for 90 days. No histopathological or weight changes were observed in reproductive organs. Based on this information, the NOAEL for effects on reproductive organs was 10000 ppm, which was the highest concentration tested.

Male and female dogs were exposed to 0 or 5000 ppm of the substance via inhalation for 90 days. No histopathological or weight changes were observed in reproductive organs. Based on this information, the NOAEL for effects on reproductive organs was 5000 ppm, which was the highest concentration tested.

Effects on developmental toxicity

Additional information

In a developmental toxicity study, pregnant rats were exposed by inhalation to 0, 5000, 20000 or 50000 ppm of the test substance for 6 hours per day, on days 7-21 of gestation. The maternal and developmental no-observed-effect level (NOEL) was 50000 ppm, which was the highest concentration tested. 

Justification for classification or non-classification

The test substance did not adversely affect reproductive organs in 90-day studies in rats and dogs, and did not produce adverse developmental effects at any dose level tested in a rat prenatal developmental toxicity study. The substance does not need to be classified for developmental toxicity according to the EU Directive 67/548/EEC. However, due to the lack of a dedicated reproductive toxicity study, the substance cannot be classified for reproductive toxicity according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Additional information