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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:
Justification for type of information:
A study on the Reproduction toxicity is required by REACH for dossier of FR-513. At this point we request to waive this investigation. For the following justification: A 28- day oral repeat dose toxicity study in the rat with a 14 day recovery period was conducted including investigation of some important reproduction endpoints (completed 2015). The results showed no systemic toxicity effects and the No Observed Adverse Effect level (NOAEL) was determined as >500 mg/kg/day (highest dose tested). No treatment related changes in sperm count and motility were observed (data are attached in Table 7 and Appendix 8). Vaginal lavages which were taken early morning during the 3 week period from all females, prior to termination of the animals showed no treatment related changes in the oestrus cycle (data are attached as Appendix 8, in 7. X of the IUCLID file). In addition, there were no dose related changes in organ weight of ovaries, seminal vesicles, testis, ureter, uterus, vagina in comparison to control animals. From the generated scientific data it can be concluded that subacute repeated exposure to FR-513, does not seem to induce adverse effect on the fertility nor cause systemic toxicity or affect the reproductive organs.

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion