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EC number: 203-733-6
CAS number: 110-05-4
The study was performed according to
the study plan presented in Appendix15and was designed to investigate
the effects of the test item on embryonic and foetal development
following repeated administration by gavage to the pregnant female (from
Day 3 to Day 19 of gestation) (and including period of
organogenesis). The results of the study are believed to be of value in
predicting the toxicity of the test item during pregnancy, and the
estimation of both a maternal and embryofoetal ‘No Observed Effect
This study was
designed to be compatible with the procedures indicated by the following
internationally accepted guidelines and recommendations:
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 laying down test methods
pursuant to Regulation (EC) No 1907/2006 of the European Parliament and
of the Council on the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH)
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 3 and 19 of gestation inclusive at dose levels 100, 300,
and 1000 mg/kg bw/day. A
further group of twenty-four time mated females was exposed to the
vehicle only (Corn Oil) to serve as a control.
signs, body weight change and food and water consumptions were monitored
during the study. Liver
and kidney weights were recorded for all females at termination.
All surviving 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, foetal
weight, sex and external and internal macroscopic appearance were
recorded. Half of each litter were preserved in 70% Industrial
Methylated Spirit (IMS) in distilled water and then following
examination for skeletal development transferred into 100% glycerol. The
remaining half were preserved in Bouin’s solution and transferred to 90%
IMS in distilled water and the viscera were examined.
There were no unscheduled deaths.
There were no toxicological
significant clinical signs observed at 100, 300 or 1000 mg/kg bw/day.
There were no effects of treatment on
body weight or body weight gain during gestation at 100, 300 or 1000
There were no effects of treatment on
food intake during gestation at 100, 300 or 1000 mg/kg bw/day.
No effect on water consumption during
gestation was detected at 100, 300 or 1000 mg/kg bw/day.
Post Mortem Studies
No macroscopic abnormalities were
detected for adult animals.
At 1000 mg/kg bw/day, liver weights
were considered to be increased in comparison to control.
Litter Data and Litter Placental and
There were no effects of maternal
treatment onin uterolitter data or on litter, placental or foetal
weights at 100, 300 or 1000 mg/kg bw/day.
Detailed examination of foetal
morphology did not indicate any effect of maternal treatment on
embryofoetal development at 100, 300 or 1000 mg/kg bw/day.
A dosage of 1000 mg/kg bw/day was
considered to represent a No Observed Adverse Effect Level (NOAEL) for
the pregnant female, with the No Observed Effect Level (NOEL) being
300 mg/kg bw/day. The NOEL for the survival, growth and morphological
development of the conceptus was considered to be 1000 mg/kg bw/day.
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