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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:
The registrants request to refrain from performing the (EOGRT) based on the following arguments:
According to the REACH Regulation Annex IX section 8.7.3, EOGRT should be performed “If the available repeated dose toxicity studies (e.g. 28-day or 90-day studies, OECD 421 or 422 screening studies) indicate adverse effects on reproductive organs or tissues or reveal other concerns in relation with reproductive toxicity.
A 28- day oral repeat dose toxicity study in the rat with a 14 day recovery period was conducted according to OECD 407 testing guideline under GLP conditions (Dhinsa, 2013). This study, did not observe adverse effect on reproductive organs or tissues. There were no dose related changes in organ weight of ovaries, and testes and no changes treatment related changes were found in the histopathology investigation of seminal vesicles, testis, vagina, uterus and Cervix in comparison to control animals. The No Observed Adverse Effect level (NOAEL) was determined as >1000mg/kg/day.
Therefore, since no adverse effect on reproductive organs or tissues were observed we believe that performing the EOGRT is not justified.

Data source

Materials and methods

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion