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EC number: 297-628-2
CAS number: 93685-80-4
A) Maternal data:
Pregnancy rates were comparable between the
negative control and the treated groups. No mortality occurred in the
negative control and the treated groups. Mean body weight gain during
the pre-dosing and the dosing intervals were comparable between negative
control and treated groups, during the post-dosing interval mean weight
gain was statistical significant higher in the treated groups.
No indication of a treatment effect.
Likewise, the data were generally comparable between the negative and
the positive control groups.
Mean number of corpora lutea, implantation
sites, live fetuses, resorption sites, and the incidence of dams with
one or more resorption sites were comparable between the negative
control and the treated groups.
Implantation efficiency values were slightly
higher in the treated groups than in the negative control, in some
instances differences were statistically significant, however, this was
not considered indicative of an adverse effect.
In contrast, in the positive control group
the mean number of live fetuses was significantly decreased and the mean
number of resorption sites significantly increased compared to the
negative control. Likewise, the incidence of dams with two or more
resorptions was also significantly higher than in the negative control
group. The mean number of corpora lutea, implantations, and the
implantation efficiency value were comparable between the positive and
negative control groups.
Gross postmortem examinations:
Few gross lesions were observed at necropsy
of treated females (not further specified), no treatment-related effect
B) Fetal data:
Mean fetal weights and mean crown-rump
distances of both sexes were comparable for negative control and treated
groups, while in the positive control group they were significantly
lower. Mean numbers of male and female fetuses were comparable between
negative control and treated groups. Likewise, sex ratio data was
comparable for these groups. In contrast, the mean numbers of male and
female fetuses in the positive control group were significantly lower
compared to the negative control, due to lower numbers of fetuses in
Variations in degree of ossification:
These variations may represent delays in the
ossification process or slight ossification irregularities. The
incidences of fetuses with ossification variations was comparable
between negative control and the 400 ppm-treated group. In the 1200
ppm-treated group the incidence of fetuses with at least one
ossification variation was significantly higher compared to the negative
control. The incidence of litters containing fetuses with ossification
variations was comparable between negative and treated groups. Likewise,
the types and incidences of ossification variations were generally
similar between the negative control and the treated groups.
In contrast, in the positive control group
the incidence of fetuses with at least one variation was significantly
higher, ossification was retarded.
No treatment-related external, gross
evisceration, soft tissue and skeletal malformations were observed in
the fetuses of the treated and the negative control group. One late
resorption from one female of the 400 ppm group showed extreme edema,
however, no other unusual observations were noted in the other late
resorptions of treated and negative control groups. In contrast, in the
positive control group, external malformations were noted in 14.4 % of
the fetuses, the most common symptom was craniorachischisis with
protruding tongue and clubbed forelimbs. The incidences of soft tissue
malformations were comparable between the negative control and the
treated groups, no treatment-related effect was indicated. In the
positive control group, these incidences were significantly higher than
in the negative control.
data is being read across from the source study that tested
Hydrocarbons, C7-C9, isoalkanes based on analogue read across.
Under the design of the study the test
substance, hydrocarbons, C7-C9, isoalkanes, produced no negative effects.
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