Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
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
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Annex IX, the extended one-generation reproductive toxicity study does not need to be conducted at this tonnage band (100-1000 tpy) because there are no results from available repeated dose toxicity studies (28-day and 90-day repeated dose toxicity studies together with a pre-natal developmental toxicity study) 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

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

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