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EC number: 224-809-5
CAS number: 4500-29-2
see attached background materials in "Overall remarks, attachements".
The objective of this study was to evaluate the developmental toxicity of Genamin CH 020 in pregnant female Wistar rats and developing embryos/fetuses consequent to treatment of Genamin CH 020 in pregnant rats by oral gavage from gestation day (GD) 5 to 19. This study was intended to provide a rational basis for risk assessment in humans and to establish a No Observed Adverse Effect Level (NOAEL) for maternal and developmental toxicity in rats.
A total of 96,Day 0 pregnant ratswere randomly divided into different groups according to the study design as follows:
Dosage volume (mL/kg)
No. of Day 0 pregnant rats
The following parameters and endpoints were evaluated in this study: Clinical signs, body weights, body weight gains, food consumption, gross pathology, gravid uterine weights, intrauterine growth and survival,number of corpora lutea, and fetal parameters [sex, weight and anogenital distance, and external, visceral and skeletal observations].Approximately half the number of the fetuses from each litter were examined for visceral malformations and variations and the remaining half were evaluated for skeletal malformations and variations. In addition, from each dam, the thyroid was weighed and subjected to microscopic evaluation. Thyroid hormones levels were determined from the blood samples collected at terminal sacrifie (on GD 20).
Results of the study are summarized below:
· Clinical signs and gross necropsy changes: There were no clinical signs, or mortalities in treated rats at any of the doses tested.
Grossly, at necropsy no abnormalities were detected.
· Maternal Parameters: No treatment-related effects on maternal body weights and food consumption up to the highest tested dose of 180 mg/kg/day. The other maternal parameters comprising of uterine weight, implantations and early and late resorptions, post implantation loss were comparable to vehicle control group up to the high dose of 180 mg/kg/day. Gross evaluation of placenta revealed no remarkable findings.
· Litter Parameters: No treatment-related effects on litter parameters comprising of total number of fetuses, fetal weights, anogenital distance in male and female fetuses, were observed.
· Fetal examination: External, visceral and skeletal examinations revealed no teratogenic effects attributed to the test item.
· Thyroid hormone levels (T3, T4 and TSH), thyroid weights, and thyroid histology were unaffected by treatment.
Based on the above findings, it is concluded that, No Observed Adverse- Effect Level (NOAEL) for
• Maternal toxicity is 180 mg/kg/day as the maternal body weight and weight gain, corrected body weight gain and food consumption was unaffected up to 180 mg/kg/day.
• Fetal developmental toxicity and Teratogenicity is 180 mg/kg/day as fetal resorptions or post implantation loss were comparable to the control, no effects on fetal body weights and further the fetal external, visceral and skeletal examinations revealed no signs of teratogenicity or developmental toxicity up to 180 mg/kg/day.
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