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EC number: 935-411-2
CAS number: -
CHEMICAL ANALYSES OF THE DOSE FORMULATIONS
The test item concentrations in the administered dose formulations analyzed on Day 5 p.c.and Day 20 p.c. remained within an acceptable range of variations (-3.3% to -0.2%) when compared to the nominal values (± 10% of the nominal concentrations).
No test item was detected in the control dose formulation.
The objective of this study was to evaluate the potential toxic effects of the test item, Reaction products of 4,4'-isopropylidenediphenol, ethoxylated and methacrylic acid, on the pregnant female rat and on the developing organism, following daily oral administration (gavage) from Day 5 to Day 20 post-coitum (p.c.) inclusive.
Three groups of 24 time-mated female Sprague-Dawley rats received the test item, Reaction products of 4,4'-isopropylidenediphenol, ethoxylated and methacrylic acid, once daily by the oral route (gavage) at dose levels of 100, 300 or 1000 mg/kg/day from Day 5 to Day 20 p.c. inclusive. A control group of
24 time-mated females received the vehicle (corn oil), under the same experimental conditions. A constant dosage volume of 5 mL/kg/day was used. The animals were checked daily for mortality and clinical signs. Body weight and food consumption were recorded at designated intervals. At termination, thyroid hormones (TSH, T3 and T4) were determined for all females. On Day 21 p.c., the females were euthanized and a macroscopic post-mortem examination was performed. Thyroids with parathyroids were weighed and examined microscopically. Hysterectomies were performed and the numbers of corpora lutea, implantation sites, early and late resorptions, and live and dead fetuses
were recorded. Placentas were observed and weighed. The fetuses were weighed, examined for external abnormalities and sexed by internal examination of the gonads. The anogenital distance was measured. The fetuses were subjected to detailed external, soft tissue and skeletal examinations.
At hysterectomy on Day 21 p.c., 20/24, 24/24, 21/24 and 24/24 females were pregnant with live fetuses in the groups treated at 0, 100, 300 and 1000 mg/kg/day, respectively. No unscheduled deaths occurred during the study. Ptyalism was observed especially in most females at 1000 mg/kg/day. This sign, commonly noted when a test item is administered by gavage, was not considered to represent an adverse effect.
Body weight, body weight change and food consumption were unaffected by the test item treatment. At necropsy of the dams, no test item-related macroscopic findings were observed. Gravid uterus weight, carcass weight, net body weight change and gestation parameters were not impacted by the test item treatment. Thyroid hormone analysis and thyroid gland examination did not reveal any disturbances at any
dose level. No effects on the fetal body weight, placental weight, sex ratio or anogenital distance were noted at any dose level. At external, soft tissue or skeletal examination of the fetuses, no variations or malformations attributable to the test item treatment were noted.
The test item, Reaction products of 4,4'-isopropylidenediphenol, ethoxylated and methacrylic acid, was administered daily to time-mated female Sprague-Dawley rats by the oral route (gavage) at dose levels of 100, 300 or 1000 mg/kg/day from Day 5 to Day 20 p.c., inclusive.
Based on the results obtained in this study:
. the No Observed Adverse Effect Level (NOAEL) for maternal parameters was considered to be 1000 mg/kg/day,
. the No Observed Effect Level (NOEL) for embryo-fetal development was considered to be 1000 mg/kg/day.
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