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EC number: 800-172-4
CAS number: 398141-87-2
ANALYSES OF DOSING FORMULATIONS
- The analysed dosing formulations were
within Charles River SOP range for suspensions (85% to 115%) and were
- The test substance was not detected in
the analysed vehicle formulation that was administered to the control
group (Group 1).
- Results of the analyses of dosing
formulations are summarised in the table attached.
The objectives of the study were to
determine the potential of the test substance to induce developmental
toxicity after maternal exposure from implantation to 1 day prior to
expected parturition, to characterize maternal toxicity at the exposure
levels tested, and to determine a no-observed-adverse-effect level
(NOAEL) for maternal toxicity and developmental toxicity. The protocol
was designed in general accordance with the United States EPA Health
Effects Test Guidelines: OPPTS 870.3700, Prenatal Developmental Toxicity
Study, Aug 1998, and the OECD Guideline for the Testing of Chemicals
Guideline 414, Prenatal Developmental Toxicity Study, 22 Jan 2001.
Test substance in the vehicle (corn
oil) was administered orally by gavage to 4 groups of 25 bred female
Crl:CD(SD) rats once daily from Gestation Days 6–19.
Dosage levels were 175, 350, 600, and 1000 mg/kg/day administered at a
dose volume of 5 mL/kg. A concurrent control group composed of 25 bred
females received the vehicle on a comparable regimen. The females were
approximately 13 weeks of age at the initiation of dose administration.
All animals were observed twice daily for mortality and moribundity.
Clinical observations, body weights, and food consumption were recorded
at appropriate intervals. On
Gestation Day 20, a
laparohysterectomy was performed on each female. The uteri, placentae,
and ovaries were examined, and the numbers of fetuses, early and late
resorptions, total implantations, and corpora lutea were recorded.
Gravid uterine weights were recorded, and net body weights and net body
weight changes were calculated. The fetuses were weighed, sexed, and
examined for external, visceral, and skeletal malformations and
All females in the control, 175,
350, 600, and 1000 mg/kg/day groups survived to the scheduled necropsy
on Gestation Day 20. Test substance-related clinical findings of red and
clear material around the mouth were noted in a dose-related manner in
the 350, 600, and 1000 mg/kg/day groups approximately 1 hour following
dose administration; these findings were noted sparingly in the 350
mg/kg/day group. The observations generally did not persist to the daily
clinical examinations and therefore, were not considered adverse. No
other test substance-related clinical findings were noted.
Test substance-related lower mean
body weight gains were noted in the 600 and 1000 mg/kg/day groups during
Gestation Days 6–9
and in the 1000 mg/kg/day group during Gestation Days 15–20,
resulting in lower mean body weights in the 1000 mg/kg/day group on
Gestation Day 9 (4.5%) and 20 (5.0%). Corresponding effects on food
consumption were noted for females in the 1000 mg/kg/day group during
Gestation Days 6–9.
Mean body weights in the 600 mg/kg/day group were similar to the control
group throughout the study. Therefore, the lower mean body weight gain
observed in the 600 mg/kg/day group during Gestation Days 6–9
was not considered adverse. No other test substance-related effects were
noted on mean body weights, body weight gains, gravid uterine weights,
net body weights, and net body weight gains. No test substance-related
maternal macroscopic findings were noted at the scheduled necropsy on
Gestation Day 20. Intrauterine growth and survival and fetal morphology
were unaffected by maternal test substance administration.
Based on the adverse effects on body
weight, body weight gain, and food consumption at 1000 mg/kg/day, a
dosage level of 600 mg/kg/day was considered to be the
no-observedadverse-effect level (NOAEL) for maternal toxicity. Due to
the lack of effects at any dosage level, a dosage level of 1000
mg/kg/day, the highest dosage level evaluated, was considered to be the
NOAEL for embryo/fetal development when test item was administered
orally by gavage to bred Crl:CD(SD) rats.
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