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Administrative data

Endpoint:
carcinogenicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
A carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if:
- the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure, and
- the substance is classified as germ cell mutagen category 2 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.
Since the substance is not classified as a germ cell mutagen and there are no indications from all available study data that the substance is able to induce hyperplasia and/or pre-neoplastic lesions no carcinogenicity study is required.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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