Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Three GLP-compliant in vitro tests with reaction mass of 2,2'-oxybisbutane (DSBE), DIPE, SBA and 2-methylpropan-2-ol (TBA), a bacterial reverse mutation assay (Ames test), a mammalian chromosome aberration test, and a mammalian cell gene mutation test, were conducted.

The reported data of the bacterial reverse mutation assay show that under the experimental conditions applied, the substance did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.

In the mammalian chromosome aberration test, the substance did not induce structural chromosome aberrations in this test in Chinese Hamster lung cells, both with and without metabolic activation.

In the mammalian cell gene mutation test, the substance did not induce gene mutations in presence and absence of metabolic activation in the cultured mammalian cells (L5178Y TK+/- 3.7.2 C mouse lymphoma cell line) used.

Hence, in all three different tests, the gene toxicity of reaction mass of 2,2'-oxybisbutane (DSBE), DIPE, SBA and 2-methylpropan-2-ol (TBA) was evaluated "negative". The substance can be regarded as not mutagenic.


Short description of key information:
The genetic toxicity of reaction mass of 2,2'-oxybisbutane (DSBE), DIPE, SBA and 2-methylpropan-2-ol (TBA) has been assessed in 3 GLP compliant in vitro studies, including a bacterial reverse mutation assay, a mammalian chromosome aberration test and a mammalian cell gene mutation test. Negative results were reported in all studies in the presence and/or absence of metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The criteria for classification as mutagenic were not met.