Registration Dossier
Registration Dossier
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EC number: 201-159-0 | CAS number: 78-93-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
According to the data provided in the REACH dossier of butanone, dissiminated on the ECHA homepage, a structurally related test substance, i.e. secondary butyl alcohol, administered in drinking water to rats over two generations did not affect reproductive parameters or cause fetotoxicity up to a concentration of 1.0% (1644 – 1771 mg/kg bw/day). A decrease in pup viability was seen above the limit dose, i.e. 3.0% (5089 - 4571 mg/kg bw/day) and a slight decrease in fetal body weight was seen at 2.0% (approx. 3000 mg/kg bw/day).
Effects on developmental toxicity
Additional information
According to the data provided in the REACH dossier of butanone, dissiminated on the ECHA homepage, inhalation of 3000 ppm butanone induced a significant decrease in delayed ossification of interparietal bones and significant increase in the incidence of extra lumbar ribs in developing rats. Furthermore, maternal body weights and weight gain was significantly decreased in this dose group.
Pregnant Swiss (CD-1) mice appear to be relatively insensitive to the toxic effects of butanone, but showed a treatment related increase in relative liver and kidney weights indicative for maternal toxicity. The offspring of the mice exhibited significant signs of toxicity at the 3000-ppm exposure level. Neither maternal nor developmental toxicity were observed at 1000 ppm butanone or below.
The overall conclusion from these studies is that butanone produces a low level of developmental toxicity at maternally toxic levels but is not selectively teratogenic in laboratory animals.Justification for classification or non-classification
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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