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EC number: 500-281-4
CAS number: 98362-33-5
Reproduction data of the dams
mean per dam
Pre-implantation loss [%]
per group ##1
Post-implantation loss [%]
per group ##2
Statistical analyses were performed for the mean values per dam using an ANOVA/DUNNETT test.
The statistical comparison of the pre-implantation loss per group was done by comparing the values of implantation sites/corpora lutea of the test group with the ratio of implantation sites/corpora lutea of the control group using the Chi2test.
The statistical comparison of the post-implantation loss per group was done by comparing the values of live fetuses/implantation sites of the test group with the ratio of fetuses/implantation sites of the control group using the Chi2test.
The results of the test item-formulation analyses for the investigated
parameters are listed in the table below:
Sampling / dealing
Range of accuracy
(% of nominal concentration)
before administration to the last animal on test day 6
101.1% - 103.5%
immediately after test item-vehicle mixture preparation
100.8% - 103.8%
8h after test item-vehicle mixture preparation
101.7% - 103.4%
24h after test item-vehicle mixture preparation
100.7% - 102.6%
before administration to the first animal on test day 6
98.6% - 103.1%
during administration to the animals on test day 6
99.7% - 102.3%
before administration to the last animal on test day 21
99.0% - 103.5%
The aim of this dose-range-finding study was the examination of the
influence of test item administered orally during the critical period of
organogenesis and the fetal development (6th to 20th day of gestation)
on the pregnant rat and the fetus.
In this prenatal developmental toxicity study, the test item was
administered orally to female rats at dose levels of 100, 300 or 1000
mg/kg b.w./day from the 6th to 20th day of pregnancy.
Examination of the dams:
No premature death was noted in the control group and in the treatment groups (100, 300 or 1000 mg test item/kg b.w./day).
No observations that were considered to be adverse or of toxicological relevance were noted in the treatment groups.
Body weight and
body weight gain
No test item-related differences in body weight and body weight gain were noted between the control group and the treatment groups.
No test item-related differences in food consumption were noted between the control group and the treatment groups.
Drinking water consumption
No differences were noted.
No test item-related changes were noted during the macroscopic inspection of the dams at necropsy.
Uterus and carcass weights
No test item-related differences in uterus or carcass weight were noted between the control group and the treatment groups.
Increased relative and absolute organ weights were noted in the intermediate and high dose group (300 or1000 mg test item/kg b.w./day) for the liver and/or the kidneys. However, these observations were due to an increased work load of these organs and are not considered to be adverse.
No influence on the reproductive parameter (number of implantation sites, resorptions and fetuses) was noted.
Examination of the fetus
No dead fetuses were noted in any of the test groups.
Body weight of the fetuses
and the placentae
No test item-related differences were noted between the control group and the treatment groups.
No test item-related malformations were noted during the macroscopic examination at laparotomy(external inspection and inspection of the organs and tissues for gross lesions), the skeletal examination according toand thesoft tissueexamination according to.
No test item-related external variation was noted during macroscopic examination at laparotomy, the skeletal examination according to DAWSON and the soft tissue examination according to WILSON.
No test item related retardation was noted during the skeletal examination according toin the treatment groups (100, 300 or 1000 mg test item/kg b.w./day).
Analysis of test item
The measured actual concentrations of the test item in the test item vehicle mixtures were between 98.6% and 103.8% of the nominal concentrations, indicating correctly prepared and homogenized formulations which were stable at room temperature for at least 24h.
Under the present test conditions, the
no-observed-adverse-effect level (NOAEL) was above 1000 test item/kg
b.w./day for the dams.
None of the dams died prematurely.
No differences in body weight and food consumption were noted in
the treatment groups (100, 300 or 1000 mg test item/kg b.w./day).
Increases in relative and absolute organ
weights of the liver and kidneys that were not considered to be adverse
were noted for the intermediate and high dose group (300 or 1000 test
The no-observed-adverse-effect level (NOAEL)
for the fetal organism was above 1000 mgtest item/kg b.w./day.
The reproductive parameters (number of implantation sites, number
of resorptions and number of fetuses) were not influenced by the test
No dead fetuses, no malformations, no test item-related variations
or retardations were noted.
Under the conditions of the study,test
item did not show any teratogenic potential.
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