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EC number: 423-630-1 | CAS number: -
Status of gestation: 29 young adult nulliparous female rats in each group were successfully mated but the actually pregnant numbers in each group were between 23-27 (Table 3). The embryonic resorptions in low-, medium- and high-level groups were significantly increased, while the viable foetuses were decreased (P<0.05 or P<0.01). In medium- and high-dose groups, the foetal deaths were observed to be higher than that of the control(尸<0.01). Compared with those of the control, the increased embryonic resorption rate, increased foetal deaths and decreased viable foetus rate in the positive group were significantly different (P<0.01). There were no differences between sex ratio of the foetuses in all dose groups.
Foetus growth: Compared with those of the control, the body weight, body length and tail length of the foetuses in the high dose group and in the positive group were significantly decreased (P<0.01)
Foetuses external alterations:Short-tailed, kinked-tailed, acaudate and malrotated-foot foetuses were found in the positive group (P<0.01). Some signs were also found in dose groups but without any signicant difference with the contros(P>0.05)
Foetuses soft tissue alterations:No soft tissue alterations were observed in all dose groups. One case of ventriculomegaly was found in the high dose group but without difference with the controls (P>0.05). Some malformations were found in the positive group(尸<0.05 or尸<0.01), showing N,N'-Methylene bis -(2 -amino -1,3,4 -thiadiazole) could induce soft tissue alterations in rats
Foetuses skeletal alterations:Some types of malformations were found in the high dose group, which partly were significantly different with those of the control (^O.OS or尸<0.01). The skeletal alterations were mainly including enlarged fontanel, abnormal upper occipital morphology, dysostosis of parietal bones and os incae, bipartite ossification of cervical arch and sternum, and abnormal metacarpal ossification (Table 7).
Some malformations were found in the positive group with high incidence(尸<0.05 or P<0.01), showing N,N'-Methylene bis -(2 -amino -1,3,4 -thiadiazole) could induce skeletal alterations in rats.
Evaluation of Results:
(1) Maternal toxic response: No obvious maternal toxic response was observed under designed dose levels.
(2) Embryonic toxic response: Definite embryonic toxic responses were observed at the low-, medium- and high-dose groups under the existing test conditions.
(3) Teratogenicity: Under the existing test conditions, 632.0mg/kgethyl tetrahydrofurfuryl etherelicited the increase of skeletal malformations. The minimum teratogenic dose was 632.0mg/kg and theNo Observed Adverse Effect Level (NOAEL)ofethyl tetrahydrofurfuryl ether(supplied by Thomas Swan&Co. Ltd.) was 126.4mg/kg on SPF SD rats. Based onThe Guidelines for the Testing of Chemicals (No. 414’ Teratogenicity)of the State Environmental Protection Administration of China, theTeratogenicity Indexwas calculated to be 5 (3160mg/kg/632.0mg/kg), indicating this test material was categorized as "Basically Non-teratogenic".
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