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EC number: 212-112-9 | CAS number: 763-69-9
- Pregnancy rates were comparable between the control and treated groups.
- Mean body weights were comparable between the control and test Groups II, III and IV throughout the gestation period. In Group V (1000 pprn) , a slight (-3% to -4.6%) decrease in mean weights was seen during the treatment period; these differences from control were not statistically significant.
Mean weight change for the Day 0-6 pre-exposure interval of gestation was considered comparable between the control and treated groups.
During the treatment period, control and all treated groups experienced a mean weight loss for the Day 6 -9 interval with initiation of exposures. These changes were considered comparable between the control and treated Groups II, III and IV. In Group V (1000 ppm), the mean weight loss encountered for the Day 6-9 gestation period was statistically significantly higher than control. Considerable variability in mean weight change data was seen for the Day 9 -12, 12 -15 and 15 -18 intervals of the treatment period; however, these data did not differ statistically between the control and treated groups.
Over the entire Day 6 -18 treatment period, the control group experienced a slight mean weight gain and Groups II, III and IV experienced a slight mean weight loss; however, these data did not differ statistically from control and in the absence of a dose relationship were not considered indicative of a treatment- related response. The mean weight loss seen for the high-dose group (Group V) during the treatment period differed statistically from control (p <0.05) and this change was considered indicative of a treatment-related effect.
During the Day 18-30 post-treatment interval , a comparable mean weight gain was seen for the control and Group II. In Groups III, IV and V, mean weight gain for the Day 18-30 post-t reatment interval of gestation was higher than control and these differences were statistically significant.
Food Consumption: The only adverse effect of treatment on food consumption occurred early in the treatment period (Day 6 and 7) at exposure levels of 250, 500 and 1000 ppm.
Physical Examinations: No adverse effect of treatment at the 125 or 250 ppm exposure levels was evident from physical observation data. In Groups IV and V (500 and 1000 ppm), several animals were noted with excessive lacrimation on Day 6 following the first exposure. Several Group V animals continued to show excessive lacrimation at various intervals during the treatment period.
Excessive salivation was also noted in several Group V females on Day 6.
Clinical signs noted during exposure intervals were primarily restricted to reduced activity and closing of the eyes. The incidence of these observations seemed to be directly related to concentration. Labored breathing and salivation were noted with increased
frequency among the animals at the higher concentrations ( i .e., 500 and 1000 ppm).
This inhalation developmental toxicity study was conducted for Eastman Kodak Company to evaluate the maternal toxic , embryotoxic, fetotoxic and teratogenic potentia1 of ethyl 3-ethoxypropionate in the New Zeal and White rabbit. Animals were exposed to test material for 6 hours/day during the Day 6 -18 gestation period in stainless steel and glass 10 cubic meter chambers. Target exposure levels were 125, 250, 500 and 1000 ppm; included in the study was a chamber-housed, sham air control group. Each test group contained 18 mated females (natural mating was used and the day of mating was Day 0 of gestation).
During gestation, animals were weighed and food consumption was recorded at regular intervals. Additionally, females were observed twice daily for pharmacologic/toxicologic effects and mortality and given a detailed physical examination on Day 0, 6-18, 24 and 30 of gestation. Animals that aborted or delivered prematurely were sacrificed on the day such evidence was observed. Remaining females were sacrificed on Day 30 of gestation. Each female received a gross postmortem examination at which time selected tissues were taken, preserved and evaluated histopathologically. The following organs were weighed at necropsy; intact uterus with ovaries attached; 1iver; kidneys; spleen and thymus. Prior to sacrifice, a blood sample was collected from the ear vein and standard hematological and clinical chemistry parameters evaluated.
Corpora lutea were counted on each ovary and uterine implantation sites identified as either fetuses or resorption sites. All fetuses were removed from the uterus, weighed, evaluated for external malformations, individually identified and processed for visceral (microdisection procedure with internal sexing) and skeletal (Alizarin Red S staining) evaluations.
Mean analytical concentrations were generally in good agreement with targeted concentrations. The mean daily analytical concentrations ( ± standard deviations) for the groups targeted at the 125, 250, 500 and 1000 ppm exposure levels were 124 (± 4.7), 247 ( ± 8.0), 498 ( ±20.2) and 997 ( ± 32.4) ppm, respectively.
No mortality occurred in the control or treated groups. Pregnancy rates and the incidence of pregnancies lost to abortion or premature delivery were comparable between the control and treated groups.
No adverse effect of treatment was evident from maternal hematology or clinical chemistry data, organ weight data, gross postmortem evaluations or histopathological evaluations of selected tissues.
At the 125 ppm exposure level , no adverse effects of treatment were evident from maternal or fetal parameters. Evaluation of fetuses recovered from females treated at this exposure level revealed no increase in malformation rate.
At the 250 ppm exposure level , a statistically significant reduction in mean maternal food consumption was seen on Days 6 and 7 of gestation. No other maternal toxicity was seen at this dose level and no effect on fetal parameters (i.e., fetal weight, sex distribution) was evident. Evaluation o f fetuses recovered at this exposure level revealed no increase in malformation rate.
At the 500 ppm exposure level , mean food consumption was statistically significantly lower than control at Days 6 and 7 of gestation and several females were noted with excessive lacrimation on Day 6 of gestation. No other adverse effects of treatment (maternal, fetal ) were evident at this exposure level. During the fetal visceral evaluation, four fetuses (3.5%), three fetuses from one litter and one fetus from a second litter, had severely distended lateral ventricles of the brain. Since this malformation was not seen among fetuses at the highest dose level (1000 pprn) which had approximately 30% more fetuses available for evaluation, its occurrence in this group was not considered to be related to treatment. Fetal external evaluations did not indicate an adverse effect of treatment.
At the 1000 ppm exposure level, statistically significant changes in body weight gain were seen for the Days 6-9 and Days 6-18 gestation intervals. In both instances this group experienced a mean weight loss in respect to the control which also experienced a slight mean weight loss for the Days 6 -9 interval but a slight mean weight gain for the Day 6 -18 interval. Mean food consumption was lower than control a t Days 6 and 7 of gestation and females in this group were noted with an increased incidence of excessive lacrimation and excessive salivation (Day 6). No adverse effect of treatment at the 1000 ppm level was evident from u t e r i n e implantation data, fetal weight data or fetal sex distribution data. External and visceral examination of fetuses recovered at the 1000 ppm exposure level did not indicate an adverse effect of treatment.
The incidence of fetuses with major skeletal malformations at the 500 and 1000 ppm exposure levels (2.6% and 2.7%, respectively), was slightly higher than control (0.7%). In each of these groups, one fetus with major skeletal malformations also had severe dissimilar external malformations which appeared to be of spontaneous origin and not treatment- related. If these fetuses were excluded, the incidence of fetuses with major skeletal malformations for the 500 and 1000 ppm levels was 1.8% and 2.0%, respectively, both of which were just slightly higher than the control incidence (0.7%). A broad spectrum o f skeletal
malformations was seen during the evaluation of the 134 control fetuses (15 1itters) and 559 treated group fetuses (62 1itters); however, 1ittle consistency was seen in the type or severity of the malformations to indicate an adverse effect of treatment.
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