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EC number: 249-828-6 | CAS number: 29761-21-5
For this endpoint 3 in vitro tests, performed similar to OECD test guidelines, were selected as key studies:
- One Bacterial Reverse Mutation Assays (Ames test).The concentrations used were 0.01, 0.1, 1.0, 5.0, and 10 ul/plate. The results of the tests conducted on IDDPP in the absence and in the presence of a metabolic activation system were all negative. IDDPP did not demonstrate genetic activity in any of the assays conducted in this evaluation and was considered not mutagenic under these test conditions.
- In the in vitro mammalian Chromosome Aberration test, CHO cells were treated at 30.5, 61, and 3905 ug/ml for 4 and 20 hours in the non-activated test system, and for 4 hours in the S9-activated test system. All cells were harvested 20 hours after treatment initiation. The percentage of cells with structural or numerical aberrations in all exposure groups was not (biologically) significantly increased above that of the solvent control at any dose level. Based on these results IDDPP was concluded to be negative for the induction of structural and numerical chromosome aberrations in CHO cells in both the non-activated and the S9-activated test systems.
- In the in vitro Mammalian Cell Gene Mutation Test cells derived from the mouse lymphoma cell line L5178Y were grown in culture media containing IDDPP at concentrations of 0.004, 0.008, 0.016, 0.031, and 0.063 ul/ml, with and without microsomal activation. IDDPP did not induce an increase in mutations at the TK locus in these cells at all concentrations tested with and without microsomal activation. As no evidence of mutagenic activity was obtained in this study, IDDPP was not mutagenic for mouse lymphoma L51784, TK+/- cells under the conditions of this evaluation.
One Bacterial Reverse Mutation Assays (Ames test) was considered a supporting study. Dose levels used in the mutation assays were: 10000, 3333, 1000, 333 and 100 ug/plate. No substantial increases in revertant colony numbers of any of the test strains were observed following treatment with IDDPP at any dose level, in the presence or absence of S-9 mix, in this mutation test. It is concluded that IDDPP shows no evidence of mutagenic activity in this bacterial system.
In all genetic toxicity in vitro studies (3 key and 1 supporting) IDDPP did not show any genotoxic potential. Therefore, it can be concluded that the substance is not mutagenic, and does not need to be classified for mutagenicity according to the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC
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