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EC number: 256-360-6 | CAS number: 48145-04-6
Median precoital time and mean precoital time (ca. 3 days) were similar in animals treated with the test item at 300 and 800 mg/kg with respect to the control group. However, female no. 48 from the control group did not mate with the first male (no. 8) after a pairing period of 14 days and was mated a second time with male no. 6. This female presented an anoestrus cycle during 12 days. Although no differences in median precoital time at 100 mg/kg were recorded with respect to the other groups, mean precoital time was longer (ca. 5.2 days). Female no. 56 did not mate with the first male (no. 16) after a pairing period of 14 days and was mated a second time with male no. 11. This female presented an anoestrus cycle during 11 days. Females no. 52 (first mating) and 53 took nine and thirteen days, respectively, to mate and presented a regular cycle of 4-5 days. Female no. 57 took 14 days in its second mating and presented an anoestrus cycle of 12 days.
No treatment-related differences were recorded in the percentage of mating, the gestation index, fertility index or conception rate in females treated at the three administered doses with respect to the control group. Females no. 49 from the control group, no. 60 at 100 mg/kg and no. 76 at 800 mg/kg, which mated with males 9, 20 and 36, respectively, were not pregnant despite the presence of sperm in the vaginal smear and vaginal plug in the first two females. Mating length of those couples was 1-2 days. To check the fertility of the males whose first pairing did not result in mating, males no. 8 from the control group and no. 16 from the 100-mg/kg group were mated a second time with one female from a reserve group and mating led to pregnancy for male no. 16.
* Fisher´s exact test, singnificant at 5% level
No treatment-related differences with the control group were recorded in the mean of implantation sites per litter or corpora lutea. Higher mean postimplantation losses were recorded in all test item groups with respect to the control. Consequently, lower mean of live pups were recorded at first litter check. Female no. 73 at 800 mg/kg presented 100% implantation site loss. This animal had blood on vagina on day 22 of pregnancy. No differences in sex ratio were recorded.
The length of pregnancy was similar in all groups with a mean of 22 days. Pregnancy lasted 23 days for females no. 45 and 79 from the control- and 800-mg/kg groups, respectively. Female no. 42 from the control group and female no. 79 at 800 mg/kg had agalactorrhea and did not nurse their pups; consequently, the pups died or were devoured between days 0 and 2 of lactation. Dead pups did not have milk in the stomach. Female no. 79 showed enlarged mammary glands, whereas female no. 42 did not. One of the above females, no. 42 from control, also showed maternal neglect and did not properly clean the pups after giving birth. In addition, some pups in the litter females no. 53 at 100 mg/kg and no. 75 and 80 at 800 mg/kg showed no milk in stomach on day 1 postpartum and consequently they died.
At 800 mg/kg, thickened gastric mucosa was observed in 9/10 male and 9/10 females. Two of these males also presented reddish foci in gastric mucosa. Likewise, reddish mesenteric and mandibular lymph nodes were observed in one male and three females. One female had reddish foci in thymus and two had small thymus. At 300 mg/kg, reddish/ dark foci in gastric mucosa were recorded in three males and in one female. Moreover two females had thick stomach. Likewise, reddish foci in the thymus of one male and reddish mandibular lymph nodes in one female were observed. One female had small thymus. At 100 mg/kg, reddish focus in gastric mucosa was observed in two males. Likewise, reddish mandibular lymph nodes were observed in two males and reddish thymus in one male. Three females had thymus reduced in size, one of them with pale kidneys. At control group, one male had reddish mandibular lymph node and another one had reddish foci on thymus. Three females had small thymus. Yellowish gastric mucosa was recorded in few animals from all groups.
Acanthosis in stomach in animals from all groups, with greater incidence and severity in groups 3 and 4, with hyperkeratosis, increased incidence and/or severity of inflammatory infiltrate in submucosa and presence of forestomach ulcerations in animals from groups 3 and 4 were recorded. Minimal centrilobular hepatocellular hypertrophy with increased incidence of hematopoietic foci was observed in group-4 animals. All other findings recorded were within the range of normal background lesions which may be recorded in animals of this strain and age.
The toxicity and adverse effects of 2-phenoxyethyl acrylate on reproduction (including offspring development) were investigated in accordance with the requirements of OECD 422 test guideline. 2-phenoxyethyl acrylate was administered orally by gavage to three groups, each consisting of ten male and ten female RccHan®:WIST rats, for up to eight weeks (including two weeks prior to mating through mating, pregnancy and early lactation for females), at dose levels of 0 mg/kg body weight/day (control group); 100 mg/kg body weight/day; 300 mg/kg body weight/day and 800 mg/kg body weight/day.
In terms of mating and fertility, no treatment-related differences in mean or median precoital time were observed, nor in the percentage of mating, gestation index, fertility index or conception rate.
Further, an increase in postimplantation losses was observed in all test item groups, mainly at 800 mg/kg. No differences in corpora lutea, implantation sites, preimplantion losses nor sex ratio was observed with respect the control group.
In terms of breeding data, the length of pregnancy (days) was similar within groups. One female from control group and one at 800 mg/kg had agalactorrhea.
Treatment with 2-phenoxyethyl acrylate caused no indication of toxicity in the testes including testes weight. For the sperm stage evaluation, the sperm stages were complete in all animals. There was no indicator for induced maturation arrest, increased resorption, necrosis or any lesion in interstitial cells.
Based on these findings, NOAEL of 100 mg/kg bw/d was found for maternal toxicity in relation to local gastric irritation and ulceration, while a NOAEL of 300 mg/kg bw/d for toxicity to reproduction was found based on an increase in post-implantation loss at 800 mg/kg bw/d.
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