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EC number: 238-270-9
CAS number: 14324-55-1
ANALYTICAL VERIFICATION OF DOSES OR
- Linearity: The correlation
coefficient was 1.000 during the run which was performed during this
study and therefore the preset criterion (the correlation coefficient of
the calibration curves should be ≥ 0.996) was met.
- Homogeneity: The RSD between the
mean concentrations at three different locations was < 5% for all dose
levels and/or p was ≥ 0.01. Therefore the test substance was considered
to be homogeneously distributed in the gavage liquids.
- Content: The concentration of the
test substance was close to intended (90-110%) for all gavage liquids at
all dose levels.
1: Mean Body weights, Sex:
Profile = DecisionTree, * = p < 0.05, ** = p < 0.01, X = Group excluded
2: Mean Body weight
Day3 -> 6
Day6 -> 9
Day9 -> 12
Day12 -> 15
Day15 -> 29
Day3 -> 29
Profile = DecisionTree, * = p < 0.05, ** = p < 0.01,
= day; u=KRUSKAL-WALLIS-DUNN; k=KRUSKAL-WALLIS; a=ANOVA
3: Mean Uterine Weight, Sex:Female
Phase:Gestation, Day 29
Uterine Weight [g]
Empty Uterine Weight [g]
Profile = DecisionTree, * = p < 0.05, ** = p < 0.01
4: mean fetal
Fetus Weight (g)
Fetus Weight of Male Fetuses (g)
Fetus Weight of Female Fetuses (g)
Fetuses Examined (N)
Litters evaluated (N)
Total M - Malformation
Litters Affected (N)
Litters Affected (%)
Fetuses Affected (N)
% per Litter (Mean)
Total V - Variation
Profile = DecisionTree + FisherExact, * = p < 0.05, ** = p < 0.01
GLP-compliant developmental toxicity study performed according to OECD
guideline 414, the test substance was evaluated for its prenatal
developmental toxicity in pregnant female New Zealand White rabbits
(Triskelion B.V., 2017). The test substance was administered daily by
oral gavage as an suspension in corn oil to groups of 22 mated females
in doses of 0 (control), 2, 10 and 20 mg/kg bw on gestation days (GD) 6
through 28. A dose volume of 2 mL/kg body weight was applied in all
groups and corn oil was used as vehicle. In-life parameters included
signs of morbidity and mortality, body weight, food consumption. On
gestation day 29 the dams were sacrificed and examined macroscopically.
Foetuses, placentas and reproductive organs were weighed. The foetuses
were macroscopically examined and processed for visceral and skeletal
examinations. The content and homogeneity of the test substance in the
vehicle were confirmed by analysis.
With regard to
maternal toxicity, no test substance related deaths or clinical signs
were observed. Five unscheduled deaths were related to technical
difficulties in gavage administration and not considered related to the
test substance. No treatment related effects on body weight and food
consumption were observed. No effects were observed on the mean number
of corpora lutea, implantation sites and the mean number of live
reproductive performance, Out of 22 mated females per group, 19, 19, 21
and 18 (for the control group, low, mid and high dose group,
respectively) animals survived and were pregnant at necropsy. Mean
pre-implantation loss and post-implantation loss was comparable in all
examination, no differences were observed in foetal sex and weight or in
placental weight. External, visceral and skeletal examination of the
foetuses showed a limited number of malformations and variations in
several organs and bones in all groups, including the control group.
Based on the incidence and distribution of the external, visceral and
skeletal malformations and variations observed, no treatment-related
effects were observed.
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