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EC number: 442-300-8
CAS number: -
PCE = Polychromatic erythrocytes
NCE = Normochromatic erythrocytes
SD = Standard deviation
*** = P < 0.001
The test article’s potential to produce
damage to chromosomes or aneuploidy when administered to mice was
assessed in a micronucleus assay following OECD guideline 474 and in
compliance with GLP. A range-finding study was performed to find
suitable dose levels of the test material and investigate to see if
there was a marked difference in toxic response between the sexes. There
was no marked difference in test material toxicity between the sexes,
therefore the main study was performed using only male mice. The
micronucleus study was conducted using the intraperitoneal route in
groups of seven mice (males) at the maximum recommended dose (2000 mg/kg
bw) with 1000 and 500 mg/kg bw as the two lower dose levels. Animals
were killed 24 or 48 hours later, the bone marrow extracted and smear
preparations made and stained. Polychromatic (PCE) and normochromatic
(NCE) erythrocytes were scored for the presence of micronuclei. Further
groups of mice were given a single intraperitoneal dose of arachis oil
(7 mice) or dosed orally with cyclophosphamide (5 mice), to serve as
vehicle and positive controls respectively. Vehicle control animals were
killed 24 or 48 hours later, and positive control animals were killed
after 24 hours. No statistically significant decreases in the PCE/NCE
ratio were observed in the 24 or 48-hour test material dose groups when
compared to their concurrent control groups. There was no evidence of a
significant increase in the incidence of micronucleated polychromatic
erythrocytes in animals dosed with the test material when compared to
the concurrent vehicle control groups. The positive control material
induced a marked increase in the frequency of micronucleated
polychromatic erythrocytes and the test system was therefore considered
to be functional. In conclusion, the test material was considered to be
non-genotoxic under the conditions of the test.
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