Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Applicant's summary and conclusion

No effects on reproductive organs were found in the 90-day OECD TG 408 study as summarized elsewhere in this dossier. In addition, there were no developmental effects reported in the OECD TG 414 study conducted with the test material. These results suggest a low risk for reproductive toxicity; therefore, we are waiving the requirement for an OECD TG 443 (EOGRTS) study.

Throughout the process of adoption of the Contested Decision, the registrants have submitted additional information demonstrating that the available information on the Substance did not
substantiate (i) the existence of a potential reproductive toxicity hazard or (ii) that a potential hazard (and thus risk) needed to be clarified. In that context, the registrants have proposed to investigate the alleged concern, relied upon by the Agency to request the EOGRTS, by performing a study according to an extended version of the OECD TG 421, with a 10-week pre-mating period in view of the male fertility endpoint. Based on the broad range of investigations covered by an extended OECD TG 421 (including, amongst others, the thyroid weight, pathology and hormone measurements), the results of that study would allow to determine whether there is a concern which would trigger an EOGRTS at the level of Annex IX requirement, or not.