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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
Study duration:

Toxicity to reproduction: other studies

Additional information

This study was designed to investigate the potential toxic effects of n-butyl-3 -hydroxybutyrate, using data from a related ether alcohol, isopropyl-3 -hydroxybutyrate (IPHB), when administered to rats for 28 days and to evaluate the potential of the test item to affect male and female reproductive performance such as gonadal function, mating behavior, conception, parturition, and early postnatal development. Under the conditions of this screening study, no test item-related effects on reproductive performance, gestation length, parturition, reproductive organs, or neurobehavioral parameters were noted at any dosage level. Based on these results, a dosage level of 1000 mg/kg/day was considered to be the no-observed-adverse-effect level (NOAEL) for reproductive toxicity of Isopropyl-3-Hydroxybutyrate when administered orally by gavage to Crl:CD(SD) rats. Test item-related lower mean body weight gains and reduced mean food consumption were observed for the 1000 mg/kg/day group males during the first week of treatment, but were considered to be transient and not adverse as absolute mean body weights were not affected. There were no test item-related clinical findings noted for males or females at any dosage level and no effects on mean body weights, body weight gains, and food consumption for males at 250 or 500 mg/kg/day or females at 250, 500, or 1000 mg/kg/day. In addition, there were no test item-related effects on clinical pathology, organ weights, and macroscopic and histopathological findings at any dosage level. Hence, the NOAEL for systemic toxicity was considered to be 1000 mg/kg/day. In the absence of effects on the general physical condition of the F1 pups, the NOAEL for neonatal toxicity was 1000 mg/kg/day.

Justification for classification or non-classification

Additional information