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EC number: 944-817-9
CAS number: 244626-73-1
Result tables are included in "Attached
a Reproduction / Developmental Toxicity Screening Test conducted
according to OECD Guideline 421 and in compliance with GLP, test item
was administered to groups of Crl:CD(SD)
at 0, 100, 300 and 1000 mg/kg bw/day by oral (gavage). Males were
treated 15 days before pairing up to necropsy after a minimum of four
consecutive weeks. Females were treated for 15 days before pairing,
throughout mating and gestation, until Day 6 of lactation. The F1
generation received no direct administration of the test substance; any
exposure was in utero or via the milk. A control group of ten males and
ten females was dosed with vehicle alone (corn oil). Clinical signs,
body weight change, food and water consumption were monitored during the
study. All animals were subjected to a gross necropsy examination,
selected organs were weighed and histopathological evaluation of
selected tissues was performed. The clinical condition of offspring,
litter size and survival, sex ratio and offspring bodyweight were
assessed and macroscopic pathology investigations were undertaken.
Oral administration of the test
material at dose levels up to and including 1000 mg/kg bw/day was well
tolerated. There were no deaths, no treatment-related clinical signs or
dosing signs observed and no treatment-related effects on bodyweight
performance or food intake of males. Females receiving 1000 mg/kg bw/day
consumed slightly more food and gained more weight during the second
week of treatment compared with Controls, and as a consequence, absolute
bodyweights of these females during gestation and lactation were
slightly greater than in Controls; these findings were not adverse.
Oestrous cycle length, mating
performance, fertility, reproductive capacity and gestation length were
unaffected by treatment with the test material at all dose levels
investigated. The weights of the reproductive organs were unaffected,
and there were no treatment-related macroscopic or microscopic
Bodyweight gain, survival and
development of the offspring to Day 7 of age was considered unaffected
by parental treatment. In the 1000 mg/kg bw/day group, the weight gain
of offspring between Day 4 and Day 7 of age was slightly lower than
Control; differences were small, and may reflect the slightly higher
litter size in this group, however, and in the absence of any changes in
clinical condition or offspring survival, these minor differences in
weight gain were considered not to be adverse.
the test conditions, the NOAEL for fertility and development (foetal and
pup growth until day 6) is 1000 mg/kg bw/day in the rat.
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