Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via inhalation route
Dose descriptor:
NOAEC
4 550 mg/m³
Additional information

The key reproductive toxicity study (OECD 422 screening study) is the only study available for this endpoint. The test was carried out in accordance with an OECD test guideline and in compliance with GLP, and was therefore assigned Reliability 1.


Short description of key information:
Only one study examining toxicity to reproduction was included in this dataset (DCC, 2002). This study was a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422) in which the test material was administered via the inhalation route to rats. This screening study identified an NOAEC for reproductive effects of 500 ppm (4.55 mg/l) for the parental and foetal generations. The higher concentration, 2500 ppm (22.8 mg/l), which caused effects on maternal body weight, reduced litter size and number of implantation sites, was identified as the LOAEC (parental and foetal).

Effects on developmental toxicity

Description of key information
The key developmental toxicity study was the same rat inhalation combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422) described above (DCC, 2002). The LOAEC and NOAEC for maternal toxicity and foetal effects are also as above, 500 ppm (4.55 mg/l) and 2500 ppm (22.8 mg/l), respectively. These values are based on effects on maternal weight gain and reduced litter size and weight (effects on foetal development). This screening study did not identify any gross external abnormalities among the foetuses.
Effect on developmental toxicity: via inhalation route
Dose descriptor:
NOAEC
4 550 mg/m³
Additional information

The key developmental toxicity study (OECD 422 screening study) is the only study available for this endpoint. The test was carried out in accordance with an OECD test guideline and in compliance with GLP, and was therefore assigned Reliability 1.

Justification for classification or non-classification

The available data do not support classification for reproductive or developmental toxicity.