Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on developmental toxicity

Description of key information
The subject chemical was not a selective developmental toxicant in either rats or rabbits.
Effect on developmental toxicity: via inhalation route
Dose descriptor:
NOAEC
1 733 mg/m³
Additional information

The subject chemical was not a developmental toxicant in pregnant rats exposed for 6 hours/day at concentrations as high as 400 ppm on gestation days 6 through 15. Common variations in certain skeletal elements and incidence of supernumerary ribs were increased at maternally toxic dose levels. The NOEL for teratogenicity was 400 ppm. Similarly, no significant developmental toxicity was recorded in pregnant rabbits exposed by inhalation for 6 hours/day at concentrations as high as 500 ppm on gestation days 6 through 15. None of the incidences of malformations noted were statistically significantly different from control values. The NOEL for teratogenicity was 500 ppm.

Justification for classification or non-classification

The surrogate test material, 2 -butoxyethanol, was not a selective reproductive toxicant in mice at a dose level of 720 mg/kg bwt/day in a 2 -generation study using a continuous breeding protocol. In sub-chronic and sub-acute inhalation studies in rats, the subject chemical had no effects on the reproductive organs. The subject chemical was also not a selective developmental toxicant in either rats or rabbits exposed by inhalation. Based on the evidence presented, the subject chemical would not be classified for Reproductive Toxicity according to Directive 67/548/EEC, EU CLP (Regulation (EC) No. 1272/2008, and UN GHS. Similarly, based on minimal effects (variations in ossification and supernumerary ribs) noted in the presence of maternal effects, the subject chemical is not classified for Developmental Toxicity according to Directive 67/548/EEC, EU CLP (Regulation (EC) No. 1272/2008, and UN GHS