Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Negative results were produced in three key in vitro studies; a regulatory Ames test (OECD 471) conducted with 1,3-Dimethyl-3-phenylbutyl acetate; a mouse lymphoma assay (OECD 476) and a chromosome aberration test in human lymphocytes (OECD 473) both conducted with the read-across substance, 4-Methyl-4-phenylpentan-2-ol.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Additional information from genetic toxicity in vitro:

Justification for selection of genetic toxicity endpoint
One key genetic toxicity study was conducted with the test substance, 1,3-Dimethyl-3-phenylbutyl acetate, a reverse mutation study in bacterial cells. Two further key in vitro genetic toxicity studies have been conducted with the read-across substance, 4-methyl-4-phenylpentan-2-ol, an in vitro mutagenicity studies in mammalian cells and a cytogenicity study in human lymphocytes. All key and supporting studies had a negative outcome.

Justification for classification or non-classification

Negative results were produced in an in vitro reverse mutation test in bacterial cells with the test substance 1,3-Dimethyl-3-phenylbutyl actetate as well as in an in vitro cytogenicity study in mammalian cells and in a gene mutation study in mammalian cells for read-across substance 4-methyl-4-phenylpentan-2 -ol.

Therefore, no classification is required for this endpoint for 1,3-dimethyl-3-phenylbutyl acetate.