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EC number: 444-810-6 | CAS number: -
No substantial increases in revertant colony numbers of any of the tester strains were observed following treatment with CP-163,625-BV at any dose level, in the presence or absence of S9 mix, in either mutation test. The mean revertant colony counts for the solvent controls were within the historical range. The concurrent positive controls demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations by causing increases over double the concurrent solvent control.
In this in vitro assessment of the mutagenic potential of CP-163,625-BV, histidine dependent auxotrophic mutants of Salmonella typhimurium (strains TA 1535, TA 1537, TA98 and TA100) and a tryptophan dependent mutant of Escherichia coil . (strain CM891) were exposed to the test substance diluted in dimethyl sulphoxide, which was also used as a negative control. Two independent mutation tests were performed in the presence and absence of liver preparations from Aroclor 1254-induced rats (S9 mix). The first was a standard plate incorporation assay, the second involved a pre-incubation stage. Dose levels of up to 5000 µg/plate were tested in the mutation tests. This is the standard limit dose recommended in the regulatory guidelines this assay follows. Other dose levels used were a series of ca half-log10 dilutions of the highest concentration. Toxicity was observed towards the tester strains in the first mutation test at 5000 µg/plate and at 5000 and 1500 µg/plate in the second mutation test. No evidence of mutagenic activity was seen at any dose level of CP-163,625-BV in either mutation test. The concurrent positive controls demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations. It is concluded that, when tested in dimethyl sulphoxide, CP-163,625-BV shows no evidence of mutagenic activity in this bacterial system.
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