Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Justification for type of information:
The positive findings in vitro where Ethoxy ethoxy ethyl acrylate (CAS No. 7328-17-8) demonstrated marked toxicity and induced statistically significant increases in the frequency of cells with chromosome aberrations, in both the absence and presence of a liver enzyme metabolizing system (S9) and thus was considered to be clastogenic to human lymphocytes in vitro, needs to be further evaluated in vivo. In accordance to ECHA guidance R7A (version 6.0, 2017); in case of negative OECD 471 and positive OECD 473, no OECD 476 (HPRT) is needed, and a testing proposal should be proposed (appropriate in vivo study). Thus an in vivo chromosome aberration test (OECD 474) is proposed.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Version / remarks:
Testing proposal based on positive findings in vitro (OECD 473)

Results and discussion

Applicant's summary and conclusion