Registration Dossier

Administrative data

Description of key information

No carcinogenicity study is required, since the substance is not mutagenic and no hyperplasia or pre-neoplastic lesions were observed in any of the available repeated dose studies.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are no carcinogenicity studies available for Atmer 163.

According to the REACH regulation (1907/2006/EC), 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 mutagen category 3 or there is evidence from repeated dose studies that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.

There is no evidence that Atmer 163 causes carcinogenicity by a direct genotoxic mechanism, as the results of all genotoxicity studies were negative. Furthermore, in all available repeated dose toxicity studies, no evidence for hyperplasia or preneoplastic lesions was seen.

Thus, a proposal for a carcinogenicity study is scientifically neither required nor justified.


Justification for classification or non-classification

Based on expert judgement, a testing proposal for a carcinogenicity study for Atmer 163 is not scientifically justified. The conclusion with regard to classification and labelling according to Regulation (EC) 1272/2008 for carcinogenicity is "data lacking".