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Key value for chemical safety assessment

Additional information

In vitro studies:

Ames test - The key study for in vitro genetic toxicity (Bowles, 2010) was conducted to OECD Guideline 471 (Bacterial Reverse Mutation Assay). The study was conducted in line with GLP. A reliability rating of 1 was assigned according to the criteria of Klimisch, 1997.

Chromosome aberration - The key study for in vitro genetic toxicity (Shivaram, 2006) was conducted to OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test). The study was conducted in line with GLP. A reliability rating of 1 was assigned according to the criteria of Klimisch, 1997.

In vivo study:

In the key study for in vivo genetic toxicity (review article by BG Chemie) the study was conducted according to OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test).

The reliability rating for this study is 2, according to the criteria of Klimisch, 1997 as it is secondary source peer reviewed literature data with limited information available, however it was conducted in accordance with OCED guidelines.


Short description of key information:
There are 2 key endpoints required for in vitro genetic toxicity:

Ames test - The genetic toxicity of DNBP was examined in a bacterial reverse mutation assay (Ames test), in accordance with OECD 471 and EU method B.13/14. Salmonella typhimurium stains TA1535, TA 1537, TA98 and TA100, along with Escherichia coli strain WP2uvrA- were tested with and without S9 rat liver fraction metabolic activation.
The test material was considered to be non-mutagenic under the conditions of the test.

Chromosome aberration - From the results of the study, it is concluded that the test item 2-sec butyl-4,6 dinitrophenol (CAS RN: 88-85-7) is clastogenic in CHO cells at the tested concentrations and under the conditions of testing employed.

In vivo:
In a micronucleus test (in accordance with OECD guideline No. 474), 5 male and 5 female NMRI mice (strain Hoe: NMRkf (SPF71); weight 24 to 38 g) were given the test substance (technical product, 96.9% pure) orally in a 2% starch slurry at doses of 0 (negative controls), 10, 25 and 40 mg/kg body weight, Positive controls were treated with 50 mg cyclophosphamide/kg body weight. The bone marrow was processed 24, 48 and 72 hours after dosing. There was no increase in the occurrence of micronuclei compared with the negative controls. The ratio of polychromatic to normochromatic erythrocytes was unaffected. Thus the substance was not mutagenic in this study.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The results for the key parameters chosen for genetic toxicity were negative and so the criteria set out in Directive 67/548/EEC and Regulation (EC) no 1272/2008, do not apply. Classification for genetic toxicity is not considered to be necessary.