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EC number: 203-742-5
CAS number: 110-16-7
The objective of this prenatal developmental toxicity study was to evaluate the potential effects of the test item, Maleic Acid, on pregnancy and on embryo-foetal development in rats following daily oral (gavage) administration at doses 20, 60 and 140 mg/kg body weight/day from implantation to the day prior to scheduled caesarean section (day 5 to day 19 post-mating inclusive).There were slight adverse clinical manifestations observed in highest dose group (140 mg/kg), such as vocalization and piloerection at the beginning of treatment. All females were schedule sacrificed on gestation day 20. The final body weight of pregnant females was slightly decreased in the 20 and 140 mg/kg dose groups (by 3.57% and 2.02% compared to the control group). However these changes were not statistically significant.However, body weight gain in the 20 mg/kg group was statistically reduced compared to controls. The final body weight of pregnant females was not influenced by administration of tested substance and similarly the weight gain did not differ compared to control females except in the low dose group, where the body weight gain was reduced at the end of treatment (p<0.01). However, the netto weight of females (without uterus) or uterine weight was not changed in any treatment group compared to control group.Pre-implantation and post-implantation loss was similar in all groups with no statistical significance among groups. The weight of thyroid gland was not influenced by the treatment of tested substance and significant differences among groups were seen in thyroidal hormones (T3, T4 and TSH). Histological examination of thyroid gland did not reveal obvious histomorphological changes.The mean total body weight of fetuses was slightly decreased in low and high dose group (5.9% and 4.8%) compared to the control value without statistical significance. Similar findings were observed in the mean placental weight (ranging from 5.4% to 7.1% reduction), again without statistical significance. No changes in anogenital distance was noted in both sexes. The percentage of male fetuses was not changed compared to control group).There were no test item related external malformations in foetuses. Analysis of skeletal malformations revealed delayed ossification of the cervical vertebrae in all dose groups, less than 4 metacarpal ossification centers present in all dose groups and delayed ossification metatarsal centers, pelvic bone, caudal vertebrae and sternebrae in low treatment group. These anomalies might be connected to slightly lower body weight of foetuses in treatment groups. Increased incidence of visceral anomalies was not observed in either treatment group.Based on the results, the NOAEL for maternal toxicity was determined to be 140 mg/kg body weight/day (actual dose received). Although we did not find any malformations and abnormalities of skeletal and visceral development, but rather transient changes and anomalies in development, the NOAEL for developmental toxicity was determined to be ≤20 mg/kg body weight/day (actual dose received) due to presence of delayed ossification and unsignificant growth delay observed in low and high treatment groups.
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