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EC number: 246-562-2
CAS number: 25013-15-4
study was conducted to determine the cytogenicity and chromosome
aberration potential of the test substance according to a method similar
to OECD Guideline 478. Three groups of 10 male Sprague Dawley rats were
given the test substance by oral gavage for 5 consecutive days at doses
of 0.15, 0.5 or 1.5 mL/kg bw/day. A further group of 10 males was given
olive oil (negative control) by oral gavage at 1.0 mL/kg bw/day for 5
consecutive days. A fifth group of 10 males was given a single dose of
the positive control (triethylenemelamine) at 0.5 mg/kg bw by
intraperitoneal injection. Three days after the last dose, each male was
mated with 2 virgin females over a 5 d period. Males were then allowed
to rest for 2 d. Subsequently, the mating process was repeated with
additional virgin females until the males had been mated for 7 weeks, 2
females per week. Fourteen to fifteen days from the mid-point of the
mating period, the females were sacrificed by CO2 asphyxiation. The
abdominal cavity was exposed and the membrane removed from each ovary.
The corpora lutea were counted for each ovary and recorded separately.
The uterine contents were examined and the number of live and dead
implants was recorded for each uterine horn. The criteria for a living
foetus were viability at necropsy, general colour, and absence of
maceration; a dead implant was that present at the implantation site as
a non-viable foetus reduced in size or as a necrotic embryonic mass.
Males were sacrificed after completion of the mating period, but no
necropsies were performed. The pregnancy data for females mated with
males previously dosed with the positive control revealed expected
findings. Comparison of the pregnancy data for females mated with males
previously dosed with the test substance with that of females mated with
males given the negative control did not reveal any differences
attributable to treatment with the test substance. Under the study
conditions, treatment of males with the test substance and their
subsequent mating over a 7 week period (covering the spermatogenic
cycle) with untreated virgin females did not result in any evidence of
mutagenic potential (Putman, 1980).
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