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EC number: 695-097-5
CAS number: 15789-90-9
range finding study:
- Food consumption during the dosage period was comparable among the
- Although not dosage dependent, body weight increased during the dosage
period in the 1.25, 2.5, 5, and 10 mg/kg/day AIM-treated rats were
117.6%, 111.4%, 119.4%, and 111.4% of the vehicle control values.
- During the postdosage period, increase in gain of body weight
- All rats were pregnant and all caesarean sectioning and litter
observations were comparable among the five groups.
Definitive developmental toxicity study:
- No mortality occurred during the study.
- Clinical signs that included occasional incidences of
chromorhinorrhea, excess salivation, sparse hair coat, localized
alopecia, urine-stained abdominal fur, soft or liquid feces, or
decreased activity were observed in a few animals from each group of
rats. None of these clinical signs were attributed to AIM because the
number of affected rats was not dosage related and did not significantly
differ between control and treated groups.
- Food consumption and body weight gains were unaffected by dosages of
AIM as high as 30 mg/kg/day (Table 1). For the dosage period, absolute
food consumption at 3, 10, and 30 mg/kg/day was 101.0%, 102.1%, and
102.6% of the control value, respectively, whereas body weight gains
were 99.0%, 99.9%, and 101.2% of the control value over the same time
period. Body weight gains were also comparable during the post- dosage
period (GDs 18 to 21).
maternal body weight gains in g (mean ± SD)
- Pregnancy occurred in 24 (96%), 25 (100%), 24 (96%), and 21 (84%) of
the 25 rats in the 0, 3, 10, and 30 mg/kg/day dosage groups, an event
determined before exposure was initiated.
- Number of caesarean sectioning or litter parameters were not affected
by dosages of AIM at 30 mg/kg/day (Table 2).
- The litter averages for corpora lutea, implantations, litter sizes,
live fetuses, resorptions, fetal body weights, percentage of dead or
resorbed conceptuses, and percentage of live male fetuses were
comparable among the three dosage groups, did not significantly differ
from the vehicle control group values, and were within the ranges
observed historically at the Testing Facility.
- Fetal evaluations were based on 353, 363, 336, and 301 live
caesarean-delivered fetuses from the 0, 3, 10, and 30 mg/kg/day dosage
- Each of these fetuses was examined for gross external alterations and
soft tissue or skeletal alterations (see Table 3 for detailed analyses).
Fetal alterations were defined as either malformations (irreversible
changes that occur at low incidences with this species and strain) or
variations (common findings in this species and strain including
reversible delays or accelerations in development).
- The only fetal gross external alterations occurred in one control
fetus in which a depressed left eye bulge, a fleshy thoracic protrusion,
and the presence of an extra hind limb were observed. Skeletal
examination of this fetus revealed a small left eye socket; the presence
of three femurs, tibia, and fibulas on the right side of the body
(partially fused), and extra metatarsals, digits, and three sets of
phalanges (four, five, and five) on the right hindlimbs.
- No soft tissue malformations occurred in any of the groups. Soft
tissue variations were limited to folded retinas in seven fetuses from
two different litters at 10 mg/kg/day (variations considered to be
artifacts of processing), slight dilation of the renal pelvis in one
fetus from the control and one fetus from the 3 mg/kg/day dosage groups,
and an aberrant umbilical artery in one and two fetuses at 3 and 10
- Skeletal malformations were absent (except in the control fetus
already described), and skeletal variations were limited to infrequent
incidences of delayed ossification at various bone ossification centers
(non–dose dependent) and the presence of cervical ribs at the 7th
cervical vertebra in four fetuses in each of the control and 30
mg/kg/day dosage groups.
- All fetal gross external, soft tissue, or skeletal alterations
(malformations or variations) were considered unrelated to AIM because
(1) neither the fetal nor litter incidences were dosage dependent;
(2) the incidences did not significantly differ from the control group
(3) the incidences were within the ranges observed historically at the
* includes folded retinas in three and four fetuses in two separate
litters, findings considered to be artifacts of processing.
A developmental study was conducted on 100 (25/dose) presumed pregnant
female rats. alpha-Iso-methylionone was administered by gavage on days
7-17 of gestation at dose levels of 0, 3, 10 or 30 mg/kg/day in corn
oil. The animals were observed twice daily for mortality and morbidity.
Clinical observations of test material effects and observations for
abortion and premature delivery were conducted before and approximately
one hour following dosing and once daily thereafter. Bodyweights were
recorded prior to the start of the study and daily during dosage and
post dosage periods. Feed consumption was recorded on days 0, 7, 10, 12,
15, 18 and 21. On day 21, all rats were sacrificed, caesarean sectioned
and a gross necropsy was conducted on all animals. The number and
distribution of corpora lutea were recorded. The uterus of each rat was
removed and examined for pregnancy, number and distribution of
implantation, fetal mortality and early and late resorptions. All female
rats survived to scheduled sacrifice. All clinical and necropsy
observations were considered to be unrelated to the administration of
the test material. Maternal body weights, bodyweight gains and absolute
and relative feed consumption values were unaffected at dosages of test
material as high as 30 mg/kg/day. Pregnancy occurred in 21 of 25 rats in
each dosage group. Caesarean-sectioning and litter parameters were not
affected by dosages of the test material as high as 30 mg/kg/day. No
fetal alterations occurred that were considered associated with the test
material. It was concluded that the maternal and developmental
no-observable-adverse-effect levels (NOAEL) for alpha-iso-methylionone
were greater than 30 mg/kg/day.
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