Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information
Short description of key information:
A two generation rat feeding study was conducted on the L-2-Chloropropionic acid. The substance decreased growth rate and food consumption and caused neurotoxic effects. The high dose was terminated due to maternal toxicity probably reflecting an increased consumption rate during lactation.

Toxicity to reproduction: other studies

Additional information

There were no effects on fertility of offspring parameters at birth but there was a high incidence of F1A pup mortality from about day 14 at 1500 ppm. This was judged to be due to maternal toxicity rather than a direct effect of L-CPA on pup development and almost certainly reflects the increased effective dose rate for these dams caused by the increased feed consumption during the lactation period. The no observed effect level was 500 ppm L-CPA. As definitive effects were evident in the parental animals during the pre-mating period this can be calculated to reflect a received dose rate of at least 37 mg/kg/day (males) or 42 mg/kg/day (females). These values are conservative as they are calculated on week 10 bodyweight and consumption. Initial rates would be substantially higher and those during lactation much higher (about double). Clear signs of toxicity were seen in male and female rats diets containing 1500ppm L-CPA in the form of neurotoxicity with associated brain lesions and reductions in bodyweight gain and food consumption. There were no effects on fertility of offspring parameters at birth but there was a high incidence of F1A pup mortality at 1500ppm which was due to maternal toxicity rather than a direct effect of L-CPA on pup development. The no observed effect level was 500ppm L-CPA.

Justification for classification or non-classification

Based on this study there are no reproductive effects of L-CPA but the neurotoxic potential of the compound is confirmed in the parental animals. Classification for neurotoxic effects resulting from repeated exposure is considered necessary and this is described in section 7.5.