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Key value for chemical safety assessment

Effects on fertility

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

Based on the results of this screening study, the NOAEL for systemic parental toxicity was considered to be 50 mg/kg/d. No effects on mating and fertility were observed in this study up to the highest dose level tested of 125 mg/kg bw/d, and thus the NO(A)EL for mating and fertility was considered to be equal to or greater than 125 mg/kg bw/d.


Short description of key information:
An oral reproduction/developmental toxicity screening study in rats described in Davies (2009) (OECD 421; GLP compliant) is considered to be reliable without restrictions.

Effects on developmental toxicity

Description of key information
A screening study in pregnant female rats (compliant to OECD 414 and GLP) described in Davies (2009) is considered to be reliable without restrictions. 
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
200 mg/kg bw/day
Additional information

In the screening developmental toxicity/ teratogenicity study, clinical signs of maternal toxicity were observed dose-dependently at 60 and 200 mg/kg bw/d. At 20 mg/kg bw/d, no effects beside an initial lower body weight were observed, and this dose level was therefore regarded as NOAEL for maternal toxicity. No effects on the development of pups and no external abnormalities were detected at any dose level up to 200 mg/kg bw/d. Therefore, this dose level can be considered as preliminary NOAEL for developmental toxicity, with the restriction that it is based only on external examinations.

Toxicity to reproduction: other studies

Additional information

Parental/maternal toxicity was observed in the reproduction developmental toxicity screening study in rats and in the preliminary developmental toxicity study with the lowest NOAEL of 20 mg/kg bw/d. In the reproduction screening study, no effects on fertility, reproduction and offspring development were observed up to the highest dose level of 125 mg/kg bw/d. There were also no effect on offspring development, and no external abnormalities were seen in the preliminary developmental toxicity study up to the highest dose level tested of 200 mg/kg bw/d. Therefore, based on these screening/preliminary studies, no effects of the test item SymWhite 377 on fertility, reproduction and offspring development are to be expected.

Justification for classification or non-classification

Based on the negative results of the reproduction developmental toxicity screening study in rats and the preliminary developmental toxicity study in rats, no classification and labelling of the test item SymWhite 377 is considered necessary at this point in time.

Additional information