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Administrative data

Key value for chemical safety assessment

Additional information

The ability of DOI to induce genetic damage was assessed in several in vitro and in vivo studies performed either with the test item or the analogous substance DEI:

In a bacterial reverse mutation test performed according to OECD guideline 471 and GLP, DOI was applied on five strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA102 and TA100) up to 5 µL/plate, with and without metabolic activation. Under the experimental conditions, DOI is concluded to be non mutagenic.

Another bacterial reverse mutation assay with DOI on Salmonella typhimurium strains TA 1535, TA 97a, TA 98, TA 100 and TA 102 was also negative. This result is supported by negative results obtained with the analogous substance DEI:

- In an in vivo micronucleus test in rat performed according to OECD guideline 474 and GLP, DEI was applied .

- In a mammalian gene mutation test performed according to OECD guideline 476 and GLP, DEI

induced no mutagenic activity being demonstrated at the TK locus in L5178Y mouse lymphoma cell culture, in absence or in presence of metabolic activation.

- In an in vivo micronucleus test in rat performed according to OECD guideline 474 and GLP, DEI is concluded to be non genotoxic.

From the results described above, it can be concluded that DOI did not induce any genotoxicity and therefore should not be classified for genetic toxicity.


Short description of key information:
No indication of genetic toxicity was observed in an in vitro bacterial reverse mutation (Ames) assay performed with DOI.
Additionally, no effects were observed in in-vitro assays (Ames test and gene mutation assay in mammalian cells) and in-vivo assays (micronucleus assays) performed on the analogous substance DEI.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the classification criteria of Annex VI Directive 67/548/CEE or UN/EU GHS, and considering the negative results in the genetic toxicity tests using DOI or the analogous substance DEI, no classification for mutagenicity is required.