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EC number: 248-363-6 | CAS number: 27247-96-7
Three groups of ten male and ten female Sprague-Dawley rats received the test item, 2-EHN (CAS No. 27247-96-7), daily, by oral (gavage) administration, before mating and through mating and, for the females, through gestation until day 5 post-partum, at dose-levels of 20, 100 or 500 mg/kg/day. Another group of ten males and ten females received the vehicle, 0.5% tween 80 in purified water, alone, under the same experimental conditions and acted as a control group. The dosing volume was 10 mL/kg.
Clinical signs and mortality were checked daily. Body weight and food consumption were recorded weekly until mating and then at designated intervals. The dams were allowed to litter and rear their progeny until day 6 post-partum. The total litter sizes and numbers of pups of each sex were recorded after birth, pup clinical signs were recorded daily and pup body weights were recorded on days 1 and 5 post-partum.
The males were sacrificed after completion of the mating period. The body weight, testes and epididymides weights were recorded and a macroscopic post-mortem examination of the principal thoracic and abdominal organs was performed. A microscopic examination was performed, for the control and high-dose group, on the testes and epididymides with special emphasis on the stages of spermatogenesis and histopathology of interstitial testicular structure.
The dams were sacrificed day 6 post-partum (or from day 25 post-coitum for females which did not deliver) and a macroscopic examination of the principal thoracic and abdominal organs was performed. In the females which were apparently non-pregnant, the presence of implantation scars on the uterus was checked using ammonium sulphide staining technique. A microscopic
examination was performed on the ovaries of the control and high-dose group females.
The pups were sacrificed on day 6 post-partum and were carefully examined for gross external abnormalities and a macroscopic post-mortem examination was performed.
There were no animals prematurely sacrificed for reasons of poor clinical condition during the study.
All animals given 500 mg/kg/day had ptyalism throughout the study which, when measured, lasted 4-5 hours after dosing and may be related to the taste of the test item formulations. Hypoactivity, half-closed eyes and loud breathing were also observed sporadically in a few males and females. One female also had emaciated appearance, round back and piloerection for some days during the study. The majority of the females given 100 mg/kg/day had ptyalism during the premating and gestation periods and a few males had ptyalism during the premating period, which may be related to the taste of the test item formulations. One female at 100 mg/kg/day had hypoactivity and half-closed eyes on day 12 of dosing. There were no clinical signs at 20 mg/kg/day.
Male and female groups at all dose-levels gained less weight than the controls during the premating period in a dose-related manner achieving statistical significance at 500 mg/kg/day. Females given 500 mg/kg/day continued to gain less weight during gestation, however all groups had approximately comparable weight gains to the controls during lactation. Females given 500 mg/kg/day consumed less food than the controls throughout the study. This was not also observed in the males and there were no effects of treatment at the other dose-levels.
All pairs mated and the mean number of days taken to mate was comparable with the controls for all groups.
There were no effects on the numbers of corpora lutea or implantations. The mean numbers of pups born per litter were comparable with the controls at all dose-levels.
At 500 mg/kg/day, there was one female with one dead fetus and nine implantation scars in the uterine horns and one female which delivered a litter of small pups, all of which were dead by day 3 post-partum. As pup survival was higher in the control group, a relationship to treatment cannot be excluded.
Mean pup body weight at 500 mg/kg/day on day 1 post-partum was non-statistically significantly lower than that of the controls. Pup weight gain from day 1 to day 5 post-partum was non-statistically significantly lower than the controls’ at 100 and 500 mg/kg/day in a
dose-related manner, and mean pup body weights were non-statistically significantly lower than the controls’ on day 5 post-partum at both dose-levels.
There were no treatment-related pup clinical signs or necropsy findings.
There were no treatment-related findings observed at macroscopic or microscopic examination of F0 animals and no effects on organ weights.
The test item, 2-EHN (CAS No. 27247-96-7), was administered daily by oral gavage to male and female Sprague-Dawley rats, from before mating, during mating, gestation and until day 5 post-partum, at dose-levels of 20, 100 or 500 mg/kg/day.
Systemic toxicity was observed at all dose-levels, as evidenced by reduced body weight gain during, at least, the premating period (at least 13% less weight gained than the controls during the first 2 weeks of treatment) (statistically significant at 500 mg/kg/day). As body weight gains which are reduced by more than 10% are considered biologically significant, all groups had biologically significantly reduced body weight gains. Clinical signs of hypoactivity and half-closed eyes were also observed at 100 and 500 mg/kg/day and food consumption was lower than controls’ for females given 500 mg/kg/day.
There were no effects of treatment on pairing but a relationship between development of the fetuses and pups and treatment cannot be excluded because there was one female with only implantation scars and a dead fetus in the uterine horns and another female which delivered a litter of small pups which consequently died on day 3 post-partum.
Mean pup body weight at 500 mg/kg/day was less than that of the controls on day 1 post-partum and pup body weight gain was reduced at 100 and 500 mg/kg/day.
Based on the experimental conditions of this study, the No Observed Adverse Effect Level (NOAEL) for parental toxicity was considered to be 20 mg/kg/day, and the NOAEL for toxic effect on reproductive performance and on progeny was 100 mg/kg/day.
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