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EC number: 214-881-6
CAS number: 1205-17-0
The test item was evaluated for its
developmental toxicity in a study equivalent to OECD guideline 414 in
Sprague-Dawley rats (25/group; cesarean-sectioning identified 21 to 25
pregnant rats/group). Oral dosages of 0 (corn oil), 62, 125, or 250
mg/kg/day were administered by gavage on days 7 through 17 of gestation
(GDs 7 through 17). Rats were observed for viability, clinical signs,
body weights, and feed consumption. Necropsy and cesarean sectioning
occurred on GD 21. Uteri were examined for number and distribution of
implantations, live and dead fetuses, and early and late resorptions.
Numbers of corpora lutea were also recorded. Fetuses were weighed and
examined for gender, gross external changes, and soft tissue or skeletal
alterations. Analysis of dosage preparations verified calculated dosages
±10%. No deaths occurred. Excessive salivation occurred in all groups,
but the incidence was increased at 250 mg/kg/day. The 250 mg/kg/day
dosage also was associated with a significant increase in the incidences
of a clear, red or yellow perioral and/or red perivaginal substance and
significant reductions in mean feed consumption and body weight gains
(11.6% and 7.4%, respectively) during the entire dosage period. No gross
changes attributable to the test item were observed at necropsy.
Cesarean section or litter parameters, as well as fetal alterations,
were not affected by the test item at 250 mg/kg/day or either of the
lower dosages tested. Based on these data, maternal and developmental
no-observable-effect levels (NOAELs) of 125 and > 250 mg/kg/day,
respectively, were established for the test item. lt is concluded that
the test item is not a developmental toxicant in rats under the
conditions of this study and dosing regimen.
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