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EC number: 939-605-8
CAS number: 68152-93-2
In a key combined repeat dose reproductive/developmental toxicity study, the test material (Fatty acids, C14-18 and C16-18-unsatd., maleated) was administered daily via oral gavage at doses of 0, 100, 300, and 1000 mg/kg bw/day to Wistar rats (12/sex/dose) in a propylene glycol vehicle. Male rats were treated for a period of 35 days (14 days pre-mating, 14 days mating/post-mating period followed by an additional week) while female rats were treated for approximately 47 days (14 days pre-mating, for up to 7 days mating period, through gestation til PPD 4). A satellite group of nulliparous and nonpregnant female rats (5/sex/dose) was also employed in the study and treated with the test material for a period of 35 days.
All animals were observed twice daily for signs of clinical toxicity with special attention directed towards the observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Body weight determinations were made for adult main and satellite animals on Day 0, at least once weekly thereafter, and at termination. Parent females were weighed on gestation Days GD 0, 7, 14 and 20 and on post partal Days PPD0 (within 24 hours after parturition), and PPD5 (before termination). Food consumption was determined once weekly (at least) and hematology, urinalysis, and clinical chemistry parameters also evaluated (prior to necroscopy) on Day 35. Neurobehavioral examinations were undertaken in the study during the last exposure week (Day 32). Parameters such as testes, epididymides (total and cauda), prostate, seminal vesicles with coagulating gland were examined in male parental generations, all males (12/dose). For the F1-offspring, the number and sex of pups, stillbirths, live births; postnatal mortality; presence of gross anomalies, weight gain (PPD0-PPD4), physical or behavioural abnormalities were observed for in the study. Necroscopy was conducted at termination on Day 35, i.e. one day after the last treatment following overnight period food deprivation, or PND5. Organ weights of uterus (with and without cervix), vagina, testes, epididymides (total and cauda), prostate, seminal vesicles with coagulating glands, brain, and pituitary were also determined.
Statistical evaluation of data was carried out in this study using SPSS PC+4.0 (SPSS Hungary Kft, Budapest). Additionally, mating and fertility Indices, as well as mortality and sex ratio indices were calculated.
No signs of mortality or clinical toxicity were observed through the study period. Body weight and food consumption remained unaffected post-treatment with the test material. There was no effect of treatment on the oestrus cycle or reproductive parameters. There was no effect of treatment noted during gestation, parturition or the post-partal period. Test material related microscopic findings were found at 1000 mg/kg bw/day (High dose) in stomach, in the form of hyper/paraceratosis of the nonglandular gastric mucosa. This minimal to mild multifocal change occurred in 4 of 5 males and 2 of 5 females. There was no evidence of test item-related histological findings in the reproductive organs. Histopathological evaluation of the male gonads as well as testicular interstitial cell structure, the spermatogenic cells representing different phases of the development and differentiation of the spermatozoons were revealed normal histological pictures. The follicular, luteal and interstitial compartments of the ovary as well as epithelial capsule and stroma were similar histological structure in both Control and High Dose females.
There was/were no mortality or any adverse effects considered related to treatment or toxicologically significant in the F1 generation. No abnormal behaviour of the pups was noted. No external abnormalities ascribed to treatment were detected at the clinical or external macroscopic examinations of the pups. In single pups at 100, 300 and 1000 mg/kg haemorrhage was observed on PND0. The sex ratios were observed to be similar in the Control and treated groups. Body weight or body weight gain remained unaffected by treatment with fatty acids, C14-18 and C16-18-unsatd., maleated.
Daily oral gavage administration of fatty acids, C14-18 and C16-18-unsatd., maleated at dose levels of 100, 300 and 1000 mg/kg day was not associated with signs of developmental toxicity and the NOAEL was considered to be 1000 mg/kg /day.
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