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EC number: 939-253-5
CAS number: 68424-85-1
The test substance
was not teratogenic in rabbits.
- LO(A)EL maternal toxic effects:
10 mg/kg bw/d, based on necropsy findings in 5/22 animals.
Incidence was increased to 8/22 at 30 mg/kg bw/day (dilated
gallbladder 3/22, accentuated lobular pattern liver 3/22).
Foci (reddish/brownish) in the lung was also observed in 2
females, but also in view of findings in range finding study and
parallel study with comparable compound, this can be caused
by inadvertent presence of substance into the airways and
not attributable to systemic toxicity. Incidence was not
increased in the top-dose group. There is an indication of
lower body weight gain, correlating to a lower food
consumption, but that was not statistical significant and in
the high-dose goup not different from the mid-dose group.
Blackish content in stomack and intestines is indicative of
local corrosive effects of test substance.
- NO(A)EL maternal toxic effects:
3 mg/kg bw/day. There seems to be a dose-response related increase
in necropsy findings in stomach, intestine and liver.
Dilated gallbladder incidence was not increased in highest
dose group compared to mid-dose.
- LO(A)EL embryotoxic / teratogenic effects:
Based on the number of foetuses presenting malformations or
variations and in the absence of a treatment-related
increase of such observation, the embryo-fetal development
was not considered to be affected by treatment.
- NO(A)EL embryotoxic / teratogenic effects:
30 mg/kg bw/day, being the highest tested dose.
A study was conducted to determine the
developmental toxicity and teratogenicity of the test substance
according to OECD Guideline 414 and US EPA OPPTS 870.3700, in compliance
with GLP. The substance was administered to pregnant rabbits by gavage
from Day 6 to 28 post-coitum at the dose-levels of 3, 10 or 30 mg
a.i./kg bw/day. The dose of 30 mg a.i./kg bw/day caused the death of
three females, severe clinical condition or abortion in two other
females and transient, lower maternal body weight gain. Necropsies
revealed in 8/22 females accentuated lobular patterns in the liver,
whitish areas and/or blackish deposits in the stomach mucosa and dilated
intestines. At 10 mg/kg bw/day, relevant necropsy findings were noted in
5/22 females (dilated gall bladder, accentuated lobular pattern, pale
liver, brownish or reddish foci on the lungs, blackish deposit on the
stomach mucosa). No maternal toxicity or effects on litter data
parameters or embryo-foetal development were noted at 3 mg/kg bw/day.
Moreover, there were no effects on litter data parameters and no
treatment-related findings upon external, visceral or
skeletal observation in any of the dose groups up to 30 mg a.i./kg
bw/day. Under the study conditions, the rabbit NOAEL for maternal
toxicity was 3 mg a.i./kg bw/day while the rabbit NOAEL for
embryo-foetal development was considered to be 30 mg a.i./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.
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