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Toxicological information

Toxicity to reproduction

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Administrative data

extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the extended one-generation reproductive toxicity study does not need to be conducted because there are no results from available repeated dose toxicity studies that indicate adverse effects on reproductive organs or tissues, or reveal other concerns in relation with reproductive toxicity

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Executive summary:

It was not considered necessary to conduct a study to fulfil this data point. The waiver request is based on the availability of results from a repeated administration oral 90-day toxicity study conducted on Cycloaliphatic Epoxy Resin in rats (Padgett, E.L., 2001 - see 7.5.1). Effects on the reproductive system were examined in both males and females. There were no adverse effects observed on the oestrous cycle of females and no test article related effects on spermatogenic endpoints (including sperm motility, sperm production rate and epididymal sperm numbers). Extrapolating from these results, no effect on fertility is expected. The developmental toxicity study presented in 7.8.2 also gave no indications of adverse toxicological reactions in the conceptus at dose levels up to 125 mg/kg bw/day. Maternal effects were apparent in this study but no effects likely to adversely affect fertility or reproductive performance. In addition to this, as no fertility toxicity is expected, to conduct further testing on animals would be considered a breach of the REACH Regulation EC No. 1907/2006, where one of the aims is to reduce and refine the testing on vertebrate animals.