Registration Dossier

Diss Factsheets

Administrative data

Description of key information

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

Justification for classification or non-classification

Additional information

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 2,2-bis[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 25811-35 -2) cause carcinogenicity by a direct genotoxic mechanism, as the results of all genotoxicity studies were negative. Furthermore, in all available repeated dose toxicity studies and developmental studies, no evidence for hyperplasia or preneoplastic lesions was seen. Thus, a proposal for a carcinogenicity study is scientifically neither required nor justified.

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