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EC number: 940-783-4
CAS number: -
The purpose of this Combined Repeated Dose
Toxicity Study with the Reproduction/Developmental Toxicity Screening
Test in the Rat study was to obtain information on the toxicity of the
test item PREPOLYMER D following repeated daily administration by oral
gavage to Wistar rats. The study also included a
reproductive/developmental toxicity-screening test, intended to provide
initial information on possible effects on male and female reproductive
performance such as gonadal function, mating behaviour, conception,
pregnancy, parturition and also on the development of the F1 offspring
conception to Day 4 post-partum.
Dose levels were set following a preliminary
study, where significant lethality was observed at 200 mg/kg/day hence
100 mg/kg/day was considered to be the MTD. Male and female Wistar rats
were treated for 2 weeks pre-mating, then during the mating/postmating
period, males for 28 days and females throughout gestation period and up
to and including postpartum/lactation Day PPD4, according to the
following Experimental Design:
Parameters measured during the study
included signs of morbidity and mortality twice daily, daily or detailed
weekly observation of clinical signs and neurological assessment, weekly
body weight and food consumption, and clinical pathology evaluation,
including haematology, coagulation, clinical
chemistry and urinalysis. In addition, the
reproductive performance and indices, pregnancy, parturition and
postpartum/lactation period were monitored in the adult animals, and
viability, clinical signs and development were evaluated in their F1
offspring until PND4. Pups were examined at euthanasia. At
termination of the adults, necropsy with
macroscopic examination was performed; weights of selected organs were
recorded and representative tissues/organs were sampled and preserved in
appropriate fixatives. For the adult animals, detailed histological
examination was performed on the selected list of retained organs in the
Control and High dose groups.
In summary, daily administration of
PREPOLYMER D by oral gavage to Wistar rats did not result in test item
related mortality or clinical adverse effects at daily, weekly or
neurological assessment or changes in the body weight, food consumption,
haematology, coagulation, clinical chemistry, or urinalysis parameters
at dose levels of 10, 30, or 100 mg/kg bw/day during the treatment
period under the conditions of this study. Dose levels were set
a preliminary study, where significant
lethality was observed at 200 mg/kg/day hence 100 mg/ kg/day was
considered to be the MTD.
No test item related, or adverse effects
were noted at evaluation of the reproductive parameters during mating
and gestation, delivery and post-partum/lactation period until PPD5,
under the conditions of this study.
There were no adverse effects ascribed to
test item administration on the F1 offspring viability, clinical signs,
development or at observations following euthanasia.
There were no adverse test item-related
changes observed in organ weights, at necropsy or at histopathology for
the adult animals of either sex. Liver weights were slightly higher at
100 mg/ kg/day in both sexes but was attributed to an adaptive change.
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