Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

6,6'-[[3,3',5,5'-tetrakis(1,1-dimethylethyl)-[1,1'- biphenyl]-2,2'-diyl] bis(oxy)]bis-dibenzo[d,f][1,3,2]-dioxaphosphepin was tested in ames and chromosomal aberration assay. The results of the Salmonella-Escherichia coli/Mammalian-Microsome Reverse Mutation Assay Preincubation Method with a Confirmatory Assay with test material indicate that under the conditions of this study, the test article did not cause a positive increase in the mean number of revertants per plate with any of the tester strains either in the presence or absence of microsomal enzymes prepared from Aroclor™-induced rat liver (S9). There were no significant increases in the frequencies of cells with aberrations in either the absence or presence of S9 activation. Cultures treated with the positive control chemicals (i.e.,mitomycin C without S9 and cyclophosphamide with S9) had significantly higherincidences ofabnormal cells inall assays. Baseduponthese results, the test materialwas considered to be non-genotoxic in thisin vitrochromosomal aberration assayutilizing rat lymphocytes.