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EC number: 609-530-2
CAS number: 38172-91-7
There were noted external, soft tissue and skeletal malformations in
test groups 1, 2 and 3 (1, 4 and 12 mg/kg bw/d). However, the low-dose
mean affected fetuses per litter (mean 1.2%) were statistically
significantly different from concurrent control. All of these individual
malformations (mandibular micrognathia, microstomia, severely malformed
skull bones, misshapen tuberositas deltoidea) of test group 1 were
scattered observations in individual fetuses of different litters. Some
of them are present in the historical control data. Due to the absent
relation to dose, an association of these findings to the treatment is
not assumed. Three fetuses were multiple malformed in each test group.
Male low-dose fetus No. 47-10 (1 mg/kg bw/d) had a mandibular
micrognathia and microstomia, comprising severely malformed skull bones
during skeletal examination. For male mid-dose fetus No. 57-03 (4 mg/kg
bw/d) a gastroschisis and a right-sided aortic arch were recorded, while
high-dose female fetus No. 98-02 (12 mg/kg bw/d) had a hydronephrosis
and a hydroureter. No ontogenetic pattern is recognizable for these
individual malformations nor was there any cluster of any of these
individual malformations seen in the other offspring of these test
groups. Most of them can be found in the historical control data of the
rat strain. An association of these,findings to the treatment is not
assumed. Further malformations, i.e. meningocele (in test group 3) and
misshapen tuberositas deltoidea (in test group 2), were observed in
individual fetuses, were not related to dose and can mostly be found in
the historical control data. An association of these findings to the
treatment is also not assumed.
External variations did not occur in any of the fetuses of the study.
Some soft tissue variations and a range of skeletal variations were
noted in all test groups including the controls. In test groups 1-3, all
statistically significantly increased fetal skeletal variations were
within the historical control range. None of the incidences showed a
relation to dose. The skeletal variations are equally distributed about
the different test groups, if normal biological variation is taken into
account, and can be found in the historical control data at a comparable
No unclassified external and unclassified soft tissue observations were
recorded for any of the fetuses in this study. A spontaneous origin is
assumed for the unclassified skeletal cartilage observations which were
observed in several fetuses of test groups 0, 1, 2 and 3 (0, 1, 4 and 12
mg/kg bw/d). The distribution and type of these findings do not suggest
any relation to treatment. Finally, fetal examinations revealed that
there is no effect of the compound on the respective morphological
structures up to the highest dose tested (12 mg/kg bw/d).
In a prenatal developmental toxicity study, the test substance
2-propyn-1-ol was administered to pregnant Wistar rats daily by gavage
from implantation to one day prior to the expected day of parturition
(GD 6-19) to evaluate its potential maternal and prenatal developmental
toxicity. Generally, clinical observations including food consumption
and body weight/body weight gain revealed no toxicologically relevant
differences between the animals receiving 1, 4 and 12 mg/kg bw/d
2-propyn-1-ol and controls.
Regarding pathology, the target organ was the liver. Increased absolute
and relative liver weights in test groups 2 and 3 were regarded as
treatment-related but not adverse. They were above the historical
control data (absolute: 10.81 – 11.45 g; relative: 4.55 – 4.73). Since
the weight increase was only minimal, it was regarded as an adaptive
No differences of toxicological relevance between the control and the
treated groups (1, 4 or 12 mg/kg bw/d) were determined for any
reproductive parameters, such as conception rate, mean number of corpora
lutea, mean number of implantations, as well as pre- and
postimplantation loss. Similarly, no influence of the test substance on
fetal weight and sex distribution of the fetuses was noted at any dose.
Overall, there was no evidence for toxicologically relevant adverse
effects of the test substance on fetal morphology at any dose.
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