Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Gene Mutation in vitro

Bacteria

The substance (1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate (CAS No. 5945-33-5) was tested in three in vitro gene mutation study in bacteria (Reverse Mutation Assay, Ames Test). Two guideline assays tested up to 5000ug/plate however precipitation was noted at 100ug/plate and 1000ug/plate. The assay chosen as the key study was performed in accordance with GLP and according to OECD 471 guidelines. Precipitation of the substance was noted at 500ug/plate. None of the strains tested (S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2uvrA) showed evidence of mutagenic activity, either in the absence or in presence of S9 mix.

Mammalian cells in vitro

Chromosome aberration

The substance (1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate (CAS No.5945-33-5) was tested in three in vitro chromosome abberration assays in mammalian cells (in vitro mamamalian cytogenicity assay). In the key study was tested in human lymphocytes with and without S9. There were no significant increases in structural chromosomeal aberrations were seen following 21 hour non-activated treatments or 3 hour treatments with S-9. The substance did not display clastogenic activity in this assay.

Gene mutation in vitro mammalian cell

Gene mutation

The substance 1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate (CAS No. 5945-33-5) was tested in one in vitro gene mutation study in mammalian cells. In this assay (OECD 476/GLP), mouse lymphoma L5178Y cells cultured in vitro were exposed to the test substance in DMSO at concentrations of 5.0 to 200 µg/mL in the presence and absence of mammalian metabolic activation (Aroclor-induced rat liver S9). There was no concentration-related increase in mutant frequency. The colony sizing for the MMS and DMBA positive controls yielded the expected increase in small colonies and large colonies. Under the conditions of this study, the substance was concluded to be negative.


Short description of key information:
In vitro:
Gene Mutation (Bacterial Reverse Mutation Assay/Ames test): (1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate (CAS No. 5945-33-5) did not show mutagenic activity using S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and and E. coli WP2uvrA in the presence or absence of metabolic activation (OECD 471/GLP).

Chromosome aberration (Mammalian in vitro cytogenicity): (1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate (CAS No. 5945-33-5) did not display clastogenic activity in this assay (Annex V; GLP).

Gene mutation (in vitro mammalian cell gene mutation test): the substance 1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate (CAS No. 5945-33-5) does not induce gene mutations in mouse lymphoma L5178Y cells in the presence or absence of S9 metabolic activation (OECD 476, GLP);

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available information in the dossier, the substance (1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate (CAS No. 5945-33-5) does not need to be classified for genetic toxicity when the criteria outlined in Annex I of 1272/2008/EC is applied.