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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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