Registration Dossier

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

A waiver is proposed for this endpoint.

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

e-caprolactone is non mutagenic in the Ames test (OECD 471) and the HPRT test (OECD476). No clastogenicity was found in a chromosomal aberration test (OECD 473). Beyond this in-vivo mutagenicity data is negative as well for the read-across substance adipic acid.

Therefore e-caprolactone is considered to be clearly non mutagenic. According to Column 2 of Annex X of the REACH Regulation it is not necessary to conduct a carcinogenicity study. Beyond this there are no hints for a possible secondary cancer mechanism; e-caprolactone therefore is expected to be non carcinogenic.

Justification for classification or non-classification

e-caprolactone is non mutagenic in the Ames test (OECD 471) and the HPRT test (OECD476). No clastogenicity was found in a chromosomal aberration test (OECD 473). Beyond this in-vivo mutagenicity data is negative as well. Therefore e-caprolactone is considered to be clearly non mutagenic.