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EC number: 306-246-8 | CAS number: 96690-51-6
Absolute organ weights
When compared to the control group 0 (set to 100%), the following mean absolute weights were significantly increased or decreased (statistically significant changes printed in bold):
*p ≤ 0.05
All other mean absolute weight parameters did not show significant differences when compared to the control group 0.
Relative organ weights
When compared to the control group 0 (set to 100%), the mean relative weights of the following organs were significantly decreased (statistically significant changes printed in bold):
*p ≤ 0.05; **p ≤ 0.01
All other mean relative weight parameters did not show significant differences when compared to the control group 0.
The repeated dose toxicity of “Fatty acids, C16-C18 and C18-unsatd., ME esters, epoxidized” was examined in a OECD TG 407 study under GLP conditions. The test substance was administered orally by gavage to groups of 5 male and 5 female Wistar rats at dose levels of 0 mg/kg bw/day, 100 mg/kg bw/day, 300 mg/kg bw/day and 1000 mg/kg bw/day over a period of 4 weeks.
Food consumption and body weight were determined weekly. The animals were checked daily for any abnormal clinically signs before the administration as well as within 2 hours and within 5 hours after the administration. Detailed clinical examinations in an open field were conducted prior to the start of the administration period and weekly thereafter. Beside this, a functional observational battery (FOB) as well as measurement of motor activity (MA) were carried out at the end of the administration period. Biochemical and hematological examinations as well as urinalyses were performed at the end of the administration period. After the administration period all rats were sacrificed and assessed by gross pathology, followed by histopathological examinations.
Clinical examinations did not reveal treatment-related, adverse effects up to a concentration of 1000 mg/kg bw/day. In addition, no test substance-related effects on estrous cycle length and the number of cycles were obtained. Concerning clinical pathology no treatment-related, adverse effects were observed up to a dose of the test substance of 1000 mg/kg bw/day. Furthermore, no test substance-related effects on sperm parameters were obtained. Regarding pathology, no treatment-related organ weight changes, gross lesions or histopathological findings were observed in the treated male and female animals including the reproductive organs. Based on these results, the administration of "Fatty acids, C16-C18 and C18-unsatd., ME esters, epoxidized" the no observed adverse effect level (NOAEL) was set at 1000 mg/kg bw/day in male and in female Wistar rats and the substance does not need to be classified for STOT-RE in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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