Registration Dossier

Diss Factsheets

Administrative data

extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because relevant human exposure can be excluded as demonstrated in the relevant exposure assessment

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Executive summary:

Draft report is due in August 2022. We anticipate to receive the final report in February 2023 with a dossier submission in March 2023. Extra work has been initiated to include histopathology of low and intermediate dose levels for select tissues. This has delayed the study by a number of months.