Registration Dossier

Toxicological information

Carcinogenicity

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Administrative data

Description of key information

In accordance with column 2 of REACH Annex X, a carcinogenic study is not needed as the test substance is not genotoxic and there is no evidence from the repeated dose studies that the test substance is able to induce hyperplasia and/or pre-neoplastic lesions.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records
Reference
Endpoint:
carcinogenicity, other
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Additional information

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

Based on the available data, classification for carcinogencity is not triggerd according to Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.