Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

American Biogenic Corporation (1986) reported a 2-generation study with rats in doses ranging from 250 - 1000 ppm. The test substance was given via inhalation for 6 h/d. The NOAEL for parental animals was 1000 ppm, for F1 animals was 500 ppm and for the F2 animals 500 ppm. The authors concluded that inhalation exposure to 1000 ppm through one generation and exposure to 250 or 500 ppm through two consecutive generations did not adversely affect the growth, development and reproductive performance of rats.

Effects on developmental toxicity

Additional information

An OECD guideline study (No. 414) carried out at BASF (1994) with gavage administration to rabbits in doses of 50 - 500 mg/kg showed a NOAEL of 250 mg/kg for maternal toxicity and a NOAEL of 500 mg/kg for teratogenicity. Some overt signs of maternal toxicity were found at 500 mg/kg (reduced food consumption, impaired body weight gain and unsteady gait), but was not toxic to the does at 50 and 250 mg/kg. There occurred no substance-related adverse effects on the gestational parameters and on the fetuses up to and including the highest dose level (500 mg/kg); at all dose levels no indications for substance-induced teratogenic effects were observed.

Biodynamics Inc. reported 1984 that cyclohexanone administered to pregnant rats by the inhalation route at exposure levels of 300 and 650 ppm was not considered maternally toxic, embryotoxic or teratogenic. At the highest dose level (1400 ppm), maternal toxic effects were evident (reduced body weight data, and at physical in-life evaluation an increased incidence of lacrimation, lethargy and nasal discharge) and embryotoxicity (reduced fetal weight data, increase in ossification variation data); however, no teratogenicity was evident at this same dose level.

Biodynamic Inc. (1984) reported that cyclohexanone administered to pregnant mice by the inhalation route at an exposure level of 1400 ppm (= about 5.6 mg/l) was maternally toxic, embryotoxic and fetotoxic, but was not considered teratogenic.

Justification for classification or non-classification

Classification for reproduction toxicity is not warranted.

Since no malformations were found in the above described studies and maternal toxicity were only found in high-dosed animals, classification for developmental toxicity is not warranted.