2,2,6,6-tetramethylpiperidin-4-ol

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

NOEL (P, male) > 600 mg/kg/day, NOEL (P, female) = 200mg/kg/day and NOEL (F1) = 200mg/kg/day, GLP-OECD Guideline Study, MHW, 1998

Toxicity to reproduction: other studies

Additional information

Only the results from one study are available. The OECD repeat dose and reproductive toxicity study [OECD TG 422] was reported (MHW, Japan, 1998). This study was identified to be well conducted and reported. With regards to the reproductive performance, no effects were detected in males. However, at estrous cycle examination, continuous diestrous was observed in three females of the 600 mg/kg group and the mean estrous cycle of this group showed extension compared with the control group. There were no effects of the test substance on the copulation or fertility indices. Pathological examinations did not show significant abnormalities in the reproductive organs of the parental animals. With regard to the effects on neonates, viability on day 4 of lactation was decreased in the 600 mg/kg group, and male and female pups of the 600 mg/kg group showed lower body weights on day 4 of lactation. There are no significant differences in the delivery index and live birth index. Also, no exteral and visceral abnormalities related to the test substance were detected in any of the offspring.

Conclusion: On the basis of these findings, the NOEL of 2,2,6,6 -tetramethylpiperidin-4 -ol for reproductive toxicity to parental rats was considered to be > 600 mg/kg/day for males, and 200 mg/kg/day for females. Moreover, the NOEL of the test substance to F1 offspring was established to be 200 mg/kg/day.

Justification for classification or non-classification

Due to the lack of toxicity on reproduction, there is no need to classify 2,2,6,6 -tetramethylpiperidin according to this endpoint.