Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 613-645-3 | CAS number: 646505-36-4
In a prenatal developmental toxicity study performed according to OECD TG 414 mated female Wistar rats were assigned to four dose groups, each containing twenty-two animals. The test item was administered once daily by gavage from Day 6 to 20 post-coitum at doses of 100, 300 and 1000 mg/kg bw/day. The rats of the control group received the vehicle, Polyethylene glycol 400, alone.
One female of the 300 mg/kg bw group and three females of the 1000 mg/kg bw group showed laboured respiration concurrent with other signs of ill health, including hunched posture and decreased body weight gain. For two of these females (one in each dose group) macroscopic examination showed a distended GI tract filled with gas and a small spleen, which was confirmed by a low spleen weight in both animals. Although at low incidence, the distended GI tract filled with gas was considered to be of toxicological relevance due to similar findings in a repeated-dose oral toxicity study (OECD 407) with the test item.
No treatment-related effects on the fetal development were observed in all Desmorapid 01 treatment groups. In detail, litter size, sex-ratio, fetal body weight, and fetal morphological examinations (external, visceral and skeletal) were not affected by the treatment. In conclusion, based on the results in this prenatal developmental toxicity study the maternal No Observed Adverse Effect Level (NOAEL) for the test item was established as being 100 mg/kg bw/day. The developmental NOAEL was established as being at least 1000 mg/kg bw/day.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Close Do not show this message again