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:

An unaudited draft report was received for the main study in August 2022, audited in September. We anticipate to receive the unaudited report for the T3/T4 analysis in December and the audited draft in February 2023. However, personnel changes at the contracted lab has resulted in a delay of the draft report on the dose solution analysis portion of the study. The audited draft report is scheduled to be received by the end of April 2023. This has delayed the final report until June 2023.