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EC number: 931-292-6
CAS number: 308062-28-4
of foetal observations at skeletal examination – F0 -F1
Group: mg/kg bw/day
Previously recorded laboratory control values
Number of foetuses examined: One foetus may have more than one observation
Size of anterior fontanelle - small
0.0 -v 10.8
82,0 + 97.3
1.5 + 11.0
Incomplete ossification of cranial bones
0.0 + 13.0
Indentation in cranial bones
0.0 + 20.8
Discrete unossified area(s) in inferior
Absence of hyoid bone
0.0 + 12.2
Incomplete ossification of hyoid bone
Vertebral column and rib-cage -%with:
Number of ribs - 13
86.8 + 98.2
0.6 + 11.8
1.1 + 11.8
Incomplete ossification of one or more
18.1 + 70.3
thoracic vertebral centra
Asymmetrical ossification of one thoracic
Eleventh centrum slightly misaligned
lumbar vertebral centra
Asymmetrical ossification of one lumbar
Incomplete ossification of 4th lumbar
Reduced 5th lumbar vertebra, no other
lumbar vertebrae, no sacral or caudal vertebrae; displacement of ischial bones towards mid-line
Incomplete ossification of sternebrae
Sternebrae bipartite and offset
Limbs - % with:
Number of metacarpals/metatarsals - 3/4
31.5 + 77.6
22.4 + 64.9
Incomplete ossification of metacarpals/
0.0 + 0.8
metatarsals Others -%with:
Generalised reduction in ossification,
associated with immaturity
F0 Females allowed to litter
Gestation length was similar in all groups; all females littered between
Days 22 and 23\ post coitum. No incidences of dystocia were observed and
there was no effect upon gestation index.
Bodyweight of females during the lactation period was similar in all
Litter size, viability and mortality indices: were unaffected by
treatment of the F0 females.
Bodyweight of offspring Day 1 post-partum and bodyweight gain throughout
the lactation period was essentially similar in all groups.
Sex ratio at Days 1 and 25 post-partum showed no changes that could be
related to treatment of the F0 females.
Physical development of offspring as assessed by pinna unfolding, hair
growth, tooth eruption and eye opening was similar in all groups.
Auditory and visual functions were unaffected by treatment of the F0
Physical activity of offspring, no treatment-related effects were
Learning ability of offspring, all groups showed similar swimming times.
Locomotor co-ordination and muscle development were similar in all
At necropsy of F0 females, no macroscopic abnormalities were observed
that could be related to treatment.
General condition and mortality, no signs were noted that could be
related to treatment of the F0 females and no deaths occurred.
Bodyweight gain of unselected offspring, and of selected males and
females during the maturation, mating and gestation periods until
termination at Day 20 post coitum, showed no effects that could be
attributed to treatment of the F0 females.
Mating performance and fertility of F-, animals was similar in all
Terminal studies on F1 females killed on Day 20 of gestation
Maternal observations: at necropsy, no macroscopic abnormalities were
noted that could be related to treatment of the F0 females.
Litter responses, there were no treatment-related inter-group
differences in the numbers of corpora lutea, implantations or viable
young or in the extent of pre- and post-implantation losses.
Mean foetal weight in treated groups was similar to, or slightly greater
than that of the controls (Group 4, 200 mg/kg/day to F0 females, p <
0.05); placental weight was also slightly increased in Group 4 (200
mg/kg/day to F0 females, p < 0.05) and this was associated with an
increased incidence of large placentae (more than 0.70 g). However, all
values were within the laboratory background control range.
Unselected F1 offspring at 8 weeks of age, terminal necropsy of F1
offspring not selected to form the F1 parental generation revealed a
small number of abnormalities in all groups, but these were of types and
incidences which have previously been found to occur spontaneously in
this strain of rat in these laboratories.
F1 males, terminal necropsy of Fi males after Day 20 of gestation
revealed no macroscopic changes that could be related to treatment of
the F0 females.
The influence of Surfactant A upon the organogenesis phase of pregnancy
was assessed in rats of the Charles River CD strain. For this purpose,
Surfactant A was administered by oral gavage to groups of female rats at
nominal dose levels of 50, 100 and 200 mg/kg from Day 7 to 17 of
gestation. A fourth group, serving as controls, received the vehicle,
distilled water, on the same days of gestation and at the same
volume-dosage. On Day 20, approximately two-thirds of the females from
each group were killed for examination of their uterine contents; the
remainder were allowed to give birth naturally and to rear their young
to weaning. Randomly selected offspring of the F1 generation were then
reared, untreated, to maturity at approximately ten weeks of age, when
they were mated within groups. The F1 females were killed and examined
on Day 20 of gestation, at which point the study was terminated. The
offspring from these F1 females were evaluated for viability, weight,
and external morphology.
A dosage of 200 mg/kg bw/day to pregnant rats during organogenesis was
associated with maternal toxicity manifest as impaired body weight
performance, reduced food consumption and increased water intake. A
slight retardation of foetal growth was also seen at the same dosage,
but was without adverse effect upon pre- and post-natal survival and
development, or upon the subsequent mating performance and fertility of
the F1 offspring. There was a slight effect on the
ossification of some skeletal elements secondary to the observed F0
maternal toxicity. However no adverse effects were
seen on any on the post-natal development parameters of the F1
generation throughout the study.
Dosages of 50 and 100 mg/kg/day (nominal) were tolerated without
discernible influence upon the dam or upon the course and outcome of the
The substance was not teratogenic and the few slight effects seen on
skeletal ossification were secondary to maternal toxicity at 200 mg/kg
bw/day. The developmental NOAEL in this study was 100 mg/kg/day
(nominal) or 30 mg/kg/day (actual, based on the 30% active test
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