Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Twostudieswerewell conducted, ofwhich thenegativeresultswith and without S9indicated that the test material did not causegenemutation in bacterialandmammalian cells in vitro.Additionally,achromosome aberration test in CHL cells in vitrowas conductedand the results indicated that test material did not have clastogenic effects under the conditions of the study.

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

Overall, in genotoxicity studies, the test chemical was not mutagenic in bacteriaandmammalian cells, nor did it induce an increased incidence of chromosomal aberrations in Chinese hamster lung cells in vitro. In vivo tests were not provided.


Short description of key information:
negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to the existingin vitro testsincludingbacterial reverse mutation test, mammalian cell gene mutationtestand mammalian chromosome aberration test,negative results displayedthatBDP was not mutagenic invitro.Thus,in vivo tests were not provided andcurrently,further studydoesnot need tobe considered.