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EC number: 274-572-7
CAS number: 70331-94-1
The purpose of the
Reproduction/Developmental Toxicity Screening Test in the Rats was to
obtain initial information on possible effects on male and female
reproductive performance such as gonadal function, mating behaviour,
conception, pregnancy, parturition and development of the F1 offspring
from conception to Day 13 post-partum.
Male and female Wistar rats
were treated for 2 weeks pre-mating and then during the
mating/post-mating periods. This was 28 days in total for males. Females
were treated throughout gestation and up to and including
post-partum/lactation Day PPD13. The Experimental Design was as follows:
Dose Level(mg/kg bw/day)
females with proper oestrus cycles were selected for treatment and used
Parameters measured during
the study included signs of morbidity and mortality twice daily, daily
or detailed weekly observation of clinical signs, at least weekly body
weight and food consumption. In addition, the reproductive performance,
pregnancy, parturition and post-partum/lactation period were monitored
in the adult animals, and viability, clinical signs and development were
evaluated in their F1 offspring until PND13. At termination, necropsy
with macroscopic examination was performed. Weights of selected organs
were recorded and representative tissues/organs were sampled and
preserved in appropriate fixatives from the adult animals. Blood samples
for thyroid hormone measurement were also collected for parental males
and females at termination (Day 28 and PPD14), and for PND4 and PND13
For the adult animals, a
detailed histological examination was performed on the selected list of
retained organs in the Control and High dose groups as well as on the
reproductive organs of High dose animals with possible impaired
In summary, daily
administration of NAUGARD® XL-1 by oral gavage to Wistar rats at 100,
300 and 1000 mg/kg bw/day did not result in mortality or adverse changes
in clinical signs.
No test item effect was seen
in the body weight, body weight gain and food consumption values in any
There were no biologically
relevant differences between the Control and test item treated groups
with regard to reproductive ability, mating fertility or gestation.
No effect of the test item
was detected on the oestrus cycle of the parental female animals.
No test item related changes
were noted in the F1 offspring viability, clinical signs, body weight or
sexual development in any dose groups.
No test item related effect
was observed on the organ weights of any test item treated groups in the
study (parental and F1 generation).
Test item administration was
not associated with gross test item-related changes or microscopic
findings in any animals (parental or F1 offspring).
There were no test
item-related microscopic findings in the reproductive organs examined in
the High dose parental animals.
No test item related effect
was observed in the thyroid hormone analysis or thyroid weights in any
test item treated parental male or female animals or F1 generation pups.
In conclusion, under the
conditions of this study, the No Observed Adverse Effect Level (NOAEL)
for NAUGARD® XL-1 was considered to be:
NOAEL for general systemic
NOAEL for reproductive
NOAEL for developmental
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