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One study was well conducted and negative effects both with and without S9 were observed indicated that the test material did not cause point mutation in bacterial reverse mutation test according to OECD TG 471 and 472 (Thompson, 1997) .

The genotoxicity was investigated by Durward in 1997 via chromosome aberration test in CHL cells in vitro and the results indicated that test material did not have clastogenic effects under the conditions of the study.

In Vitro Mammalian Cell Gene Mutation Test (CHO/HPRT) for BDP was conducted according to OECD Testing Guideline 476 and negative result was observed with and without S9.

An in vivo polychromatic erythrocyte micronucleus test was conducted under GLP, the result of which shows the test substance can not cause the frequency of micronuclealed immalure erythrocytes increasing in high dose (up to 5000 mg/kg).

Moreover, the laboratory facilities which comply with OECD Principles of Good Laboratory Practice were utilized in order to ensure the consistency and reliability for the results.

These three studies were utilized as key studies in substance genetic toxicity evaluation due to their high adequation, reliability and relevance to this element.

Overall, in genotoxicity studies, the test chemical was not mutagenic in bacteria and in Chinese Hamster Ovary cells, nor did it induce an increased incidence of chromosomal aberrations in Chinese hamster lung cells in vitro. In addition, it can not induce the frequency of micronuclealed immalure erythrocytes increasing.

Therefore, the BDP does not have genetic toxicity potential in vitro tests as well as in vivo tests.


Short description of key information:
In vitro:
Negative result in bacteria (Salmonella typhimurium and Escherichia coli) with and without metabolic activation (OECD TG 471)
Negative result in chromosomal aberrations (Chinese hamster lung cells)with and without metabolic activation.(OECD TG 472)

In vivo
Negative result in Mammalian Erythrocyte Micronucleus Test (OECD TG 472)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to the existing studies in vitro and in vivo tests which included bacterial reverse mutation test, mammalian chromosome aberration test (Chinese hamster lung cells ) and frequency of micronuclealed immalure erythrocy test were all provided negative results, which displayed the BDP was not mutagenic in bacteria, nor did it induce an increased incidence of chromosomal aberrations neither frequency of micronuclealed immalure erythrocytes increase.