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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

The absence of point mutation-inducing activities was demonstrated by the negative outcome in a Bacerial Reverse Mutation Test. In contrast induction of structural chromosome aberrations were identified in an In Vitro Chromosome Aberration Test. However in a higher-tier in vivo mutagenicity study (i.e. the Mammalian Erythocyte Micronucleus Test) a negative result was obtained. Consequently testing of DOBA revealed no evidence of mutagenic activity in living mammalian organisms. Therefore the test item was not considered to be mutagenic.

Justification for selection of genetic toxicity endpoint
Due to the available studies and its outcome, selection of a single reference in order to cover genetic toxicity is not sufficient. Therefore an appropriate set of genetic toxicity studies was selecte.

Short description of key information:
In this Bacerial Reverse Mutation Test (AMES-Test), with and without metabolic activation, the test item did not induce genmutation in the genom of the tester strains used. Therefore the test item is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.

In this In Vitro Mammalian Chromosome Aberration Test significantly increased rates of aberrant cells were observed in the absence of S9 mix at 45.8 and 91.6 µg/mL and in the presence of S9 mix at 732 µg/mL. In the absence of S9 mix clastogen effects were observed at concentrations showing beginning precipitation. In the presence of S9 mix clastogen effects were observed in a concentration range being far above the limit of solubility, but showing relevant cytotoxicity.
In conclusion, it can be stated that the test item is considered to be clastogenic in this chromosome aberration test in the absence and presence of metabolic activation.

Due to the positive result in the In Vitro Mammalian Chromosome Aberration Test an appropriate in vivo follow up test was performed in particular the Mammalian Erytthrocyte Micronucleus Test. In this test the mean values of micronuclei observed after treatment with the test item were below or near to the value of the vehicle control group and all within the historical vehicle control data range.
In conclusion, it can be stated that the test item did not induce micronuclei as determined by this micronucleus test in the bone marrow cells of the mouse.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test substance yield negative results in an Bacerial Reverse Mutation Test and positive results in an in vitro Chromosome Aberrartion Test. However the latter could not be confirmed by a higher-tier in vivo Micronucleus Test from which negative results were obtained.

Since these findings do not meet the criteria for classification according to the rules laid down in Directive 67/548/EEC and in Regulation (EC) No 1272/2008, classification is not warrantable.