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EC number: 606-396-7 | CAS number: 198904-86-8
Bacterial gene mutation study
A bacterial gene mutation study was carried out for BMS 233101-01. The bacterial strains were exposed to concentrations of 50, 150, 500, 1500 and 5000 ug/plate substance per plate, both with and without metabolic activation. This study validly found the test substance to be non-mutagenic according to the specified guidelines.
Mouse lymphoma assay
The results of a genotoxicity study, performed according to OECD guideline 490 and GLP principles, showed that BMS-233101-01 was positive in the 3-hour treatment with S9 and negative in the 3-hour and 24-hour treatments without S9 in the In Vitro Mammalian Cell Gene Mutation Test (L5178Y TK+/- Microwell Assay).
In Vitro Chromosomal Aberration study
A study was performed to assess the ability of BMS 233101-01 to induce chromosomal aberrations in human lymphocytes cultured in vitro. It is concluded that BMS 233101-01 has shown no evidence of clastogenic activity in this in vitro cytogenetic test system.
A study was performed to assess the ability of BMS 233101-01 to induce chromosomal aberrations in human lymphocytes cultured in vitro.
Human lymphocytes, in whole blood culture, were stimulated to divide by addition of phytohaemagglutinin, and exposed to the test substance both in the presence and absence of S9 mix derived from rat livers. Solvent and positive control cultures were also prepared. Two hours before the end of the incubation period, cell division was arrested using Colcemid", the cells harvested and slides prepared, so that metaphase cells could be examined for chromosomal damage.
In order to assess the toxicity of BMS 233101-0 I to cultured human lymphocytes, the mitotic index was calculated for all cultures treated with the test substance and the solvent control. On the basis of these data, the following concentrations were selected for metaphase analysis:
Without S9 mix - 3 hours treatment, 18 hours recovery: With S9
160, 80 and 40 µg/ml.
With S9 mix - 3 hours treatment, 18 hours recovery:
Without S9 mix - 21 hours continuous treatment:
160, 80 and 40 µg/ml.
160, 80 and 40 µg/ml.
In both the absence and presence of S9 mix, BMS 233101-0 I caused no statistically significant increase in the proportion of metaphase figures containing chromosomal aberrations, at any dose level, when compared with the solvent control, in either test.
A quantitative analysis for polyploidy was made in cultures treated with the negative control and highest dose level. No statistically significant increases in the proportion of polyploid cells were seen. All positive control compounds caused large, statistically significant increases in the proportion of aberrant cells, demonstrating the sensitivity of the test system and the efficacy of the S9 mix.
It is concluded that BMS 233101-01 has shown no evidence of clastogenic activity in this in vitro cytogenetic test system
The test article BMS-233101-01 was evaluated as negative under the conditions of a mouse micronucleus study.
Three in vitro mutagenicity tests (bacterial mutation and mouse lymphoma assay and Chomosomal abberation) returned one positive results on potential for mutagenicity of BMS 233101-01. One in vivo test in rats (micronucleus assay), showed negative results. Based on a weight of evidence approach the material has the potential to be non- genotoxic
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