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EC number: 233-520-3
CAS number: 10213-78-2
The study was designed to investigate the effects of the test item
on embryonic and fetal development following repeated administration by
gavage to the pregnant female during gestation including the period of
The study was designed to comply with the following guidelines:
EPA Health Effects Test Guideline OPPTS 870.3700, ‘Prenatal
Developmental Toxicity Study’ (August 1998)
Ministry of Agriculture, Forestry and Fisheries Testing guidelines for
Toxicology studies, 12 NohSan No 8147, (24 November 2000)
Guidelines for Testing of Chemicals, No 414, ‘Prenatal Developmental
Toxicity Study’ (adopted 22 January 2001)
Regulation (EC) No 440/2008 of 30 May 2008 test methods pursuant to
Regulations (EC) No 1907/2006 of the European Parliament and of the
Council on the Registration, Evaluation, Authorisation and Restriction
of Chemicals (REACH)
The test item was administered by gavage
to three groups each of twenty-four time mated Sprague-Dawley Crl:CD®(SD)
IGS BR strain rats, between Days 5 and 19 of gestation inclusive at dose
levels 15, 50, and 150 mg/kg bw/day. A further group of twenty-four time
mated females was exposed to the vehicle only (Arachis oil) over the
same treatment period to serve as a control.
Clinical signs, body weight change, food
and water consumptions were monitored during the study.
All females were terminated on Day 20 of gestation and subjected
to gross necropsy including examination of the uterine contents. The
number of corpora lutea, number, position and type of implantation,
placental weights, fetal weight, sex and external and internal
macroscopic appearance were recorded. Half of each litter were examined
for detailed skeletal development and the remaining half were subjected
to detailed visceral examination.
There were no unscheduled deaths during the study.
Clinical sign did not indicate any effect of treatment at 15, 50
or 150 mg/kg bw/day.
Body weight and body weight gain, including adjustment for the
contribution of the gravid uterus, was unaffected by treatment at 15, 50
or 150 mg/kg bw/day.
Food consumption was unaffected by treatment at 15, 50 or 150
Daily visual inspection of water bottles did not reveal any overt
Post Mortem Studies
No macroscopic abnormalities were detected for parental females at
15, 50 or 150 mg/kg bw/day.
Litter Data and Litter Placental and Fetal Weights
The number of implantations, subsequent embryofetal survival and
litter size, sex ratio and mean fetal, litter and placental weights on
Day 20 of gestation were unaffected by maternal treatment at 15, 50 or
150 mg/kg bw/day.
There was no effect of maternal treatment on morphological
development of the fetuses at 15, 50 or 150 mg/kg bw/day.
The No Observed Effect Level (NOEL) for the pregnant females and
the survival, growth and embryofetal development of the offspring was
considered to be 150 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.
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