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Administrative data

Description of key information

Minor effects observed at 250 mg/kg/day were judged to have no adverse health effect consequences Therefore the NOAEL for this oral 90-day rat study is 250 mg/kg/day. 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
250 mg/kg bw/day

Additional information

The objective of the study was to determine the toxicity of the test article, Bisphenol F DiGlycidyl Ether, following oral (gavage) administration to rats for at least 13 weeks. One high dose female was killed in extremis during Week 12 of the study and considered incidental.

Generally, the test article Bisphenol F DiGlycidyl Ether, was well tolerated when dosed orally by gavage for 13 weeks at 10, 50 and 250 mg/kg/day. Most of the clinical signs were observed in all dose groups, including controls, with the exception of the high stepping gait which was seen in high dose animals only. The significance of this clinical sign in isolation is unclear especially without microscopic findings. The significance of the changes in activity are also unclear since there is a reduction as well as an increase, also there is no relation to dose levels and no microscopic findings. The reduction in body weight gain during the first seven weeks in the high dose males was probably linked with the decreased food consumption. Thus, the effects on high dose male body weights and food consumptions are considered to be minor. The increased liver weight in both sexes was not accompanied by any microscopic changes and was probably caused by increased metabolism in an attempt to metabolize and eliminate the test article. In the absence of any other findings in high dose females, the toxicological importance of the lower adrenal weights than controls is unclear.

Minor effects observed at 250 mg/kg/day were judged to have no adverse health effect consequences Therefore the NOAEL for this oral 90-day rat study is 250 mg/kg/day.

Justification for classification or non-classification