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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

Isopropenyl acetate (purity 99.3%) was administered to male rats for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 pups reached day 4 post partum according to OECD Guideline 421. The following dose levels were applied: 0 (control group), 50, 200 and 1000 mg/kg body weight/day. A standard dose volume of 5 mL/kg body weight with a daily adjustment to the actual body weight was used. Control animals were dosed with the vehicle alone (corn oil).

No deaths occurred in parent animals before scheduled termination. No test item-related adverse clinical signs were observed during the study at any dose level. At the dose levels of 200 and 1000 mg/kg/day, salivation was observed in males and females. This observation was considered to be a sign of discomfort caused by the test item but not an adverse effect. Food consumption was not affected by the treatment with the test item at any dose level neither in males nor in females. Body weights and body weight gain were not affected by the treatment with the test item at any dose level neither in males nor in females. Except for one female at the dose level of 50 mg/kg/day, all females were mated, became pregnant and gave birth. Mating performance, fertility, gestation and parturition were not affected by the treatment with the test item at any dose level. Weights of testes and epididymides were not affected by the treatment with the test item at any dose level. No gross lesions attributed to treatment with the test item were noted at any dose level. No test item-related histopathology findings were noted neither in males nor in females treated with the test item at the highest dose. No test item-related histopathology findings were noted during examination of reproductive organs of female which did not become pregnant and its male partner at the dose level of 50 mg/kg/day.

Number of pups at first litter check and viability of pups up to day 4 post partum were considered not to be affected by the treatment with the test item at any dose level. Sex ratios at first litter check and on day 4 post partum were considered not to be affected by the treatment with the test item at any dose level. No abnormal findings were noted at first litter check and during the first 4 days post partum at any dose level. Pups body weights and body weight gain to day 4 post partum were not affected by the treatment with the test item at any dose level. No findings were noted at macroscopic examination of pups at any dose level.

Under the conditions described for this study, the general NOAEL (No Observed Adverse EffectLevel) for parental organism was considered to be 1000 mg/kg body weight/day.The NOEL (No Observed Effect Level) for reproduction/developmental toxicity was considered to be 1000 mg/kg body weight/day.


Short description of key information:
In a OECD 421 reporoduction screening test the NOAEL (No Observed Adverse EffectLevel) for parental organism was considered to be 1000 mg/kg body weight/day.The NOEL (No Observed Effect Level) for reproduction/developmental toxicity was consideredto be 1000 mg/kg body weight/day.

Justification for classification or non-classification

Additional information