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Key value for chemical safety assessment

Effects on fertility

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

In a GLP-study - conducted with DVB-96 - according to OECD guideline 422 doses of 30, 100, 300, and 1,000 mg/kg bw/day were administered to rats by oral gavage. Clear evidence of maternal toxicity was observed at the highest dose, which likely exceeded the maximum tolerated dose: 22% decrease in female bw and 44% decrement in bw gains; 50% decrease in female thymus weight. Fertility was unaffected up to the highest dose level tested. With regard to pups, decreased body weights of both sexes at birth were seen in the 100 mg/kg or more groups. Decreased numbers of live pups born, live birth index and viability index, and decreased body weights of both sexes on day 4 after birth were seen in the 1000 mg/kg/group, Hence, the NOEL for fertility is 1000 mg/kg bw/day for male and 300 mg/kg bw/day for female rats.

Based on the consistent results obtained for the different grades of the reaction mass of divinylbenzene and ethylstyrene in the acute as well as in the repeated dose toxicity studies it can be concluded that the results from this study with DVB-96 are representative for the different grades of the reaction mass.


Short description of key information:
A GLP-study in rats (oral gavage administration) according to OECD guideline 422 is available for DVB-96.

Effects on developmental toxicity

Description of key information
A GLP-study in rats (oral gavage administration) according to OECD guideline 422 is available for DVB-96. 
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
30 mg/kg bw/day
Additional information
In a GLP-study - conducted with DVB-96 - according to OECD guideline 422 doses of 30, 100, 300, and 1,000 mg/kg bw/day were administered to rats by oral gavage. Clear evidence of maternal toxicity was observed at the highest dose, which likely exceeded the maximum tolerated dose: 22% decrease in female bw and 44% decrement in bw gains; 50% decrease in female thymus weight. Once born, 7 out of 9 dams lost all pups at the highest dose. By post-natal day 4 the average pup bw significantly decreased (2.2 g for high dose vs 14.5 g for control). Effects for the two mid-doses (300 and 100 mkd) were minimal, with no increase in embryo/fetal losses, no pup losses, and minimal differences in pup bw. Clear NOEL for all endpoints (including the pups) is 30 mg/kg bw/day.

Based on the consistent results obtained for the different grades of the reaction mass of divinylbenzene and ethylstyrene in the acute as well as in the repeated dose toxicity studies it can be concluded that the results from this study with DVB-96 are representative for the different grades of the reaction mass.

Justification for classification or non-classification

Based on the findings in the OECD 422 study - considering the lack of significant effects at several lower dose levels and the occurrence of the severe effects (fetal toxicity; decreased pup survival) only at the highest dose (1,000 mkd of 96.2% DVB) which elicited significant maternal toxicity (22% bw and 44% bw gain deficits) and clearly exceeded the maximum tolerable dose - the classification as Reproductive Toxin EU Category 3 (R63: Possible risk of harm to the unborn child) and/or GHS Class 2 is proposed for of all grades of the reaction mass of divinylbenzene and ethylstyrene.

Additional information