Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
150 mg/kg bw/day
Additional information

This substance causes adverse effects on reproduction in rats only at maternally toxic doses when tested in accordance with OECD Guideline 421. Exposure of the parents to the high dose (750 mg/kg/day then reduced to 500 mg/kg/day on day 5) for fifty six consecutive days caused a statistically significant reduction in cumulative body weight gain in males during the first two weeks of treatment and a statistically significant reduction in body weight gain in females during the final week of gestation. A non-statistically significant increase in the incidence of hypertrophy/vacuolation of the interstitial glands of the ovaries also was evident at the high dose females. The only statistically significant effect was a decrease in the live birth index at the high dose level. There were no statistically significant increases in pre- and post implantation loss and no treatment-related effects on conception rates. The NOAEL for reproductive effects in the absence of maternal toxicity is 150 mg/kg/day. The no observed effect level (NOEL) for reproductive toxicity considering non-statistically significant changes is considered to be 15 mg/kg/day.


Short description of key information:
Reproduction toxicity study in accordance with OECD Guideline 421.is available for the test substance

Effects on developmental toxicity

Description of key information
Reproduction toxicity data is available for the test substance, and  it causes adverse effects on reproduction in rats only at maternally toxic doses when tested in accordance with OECD Guideline 421.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
150 mg/kg bw/day
Additional information

This substance does not cause adverse effects on development in rats when tested in accordance with OECD Guideline 421. Exposure of the parents to the high dose (750 mg/kg/day then reduced to 500 mg/kg/day on day 5) for fifty six consecutive days caused a statistically significant reduction in cumulative body weight gain in males during the first two weeks of treatment and a statistically significant reduction in body weight gain in females during the final week of gestation. A non-statistically significant increase in the incidence of hypertrophy/vacuolation of the interstitial glands of the ovaries also was evident at the high dose females. Offspring bodyweight gain was significantly reduced between Day 1 and Day 4 in the high dose group.  The NOAEL for developmental effects in the absence of maternal toxicity is 150 mg/kg/day. The no observed effect level (NOEL) for developmental toxicity considering non-statistically significant changes is considered to be 15 mg/kg/day.

Justification for classification or non-classification

In accordance to Directive 67/548/EEC and EU CLP (Regulation (EC) No. 1272/2008), classification of this substance is not required for reproduction toxicity.