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EC number: 232-478-3 | CAS number: 8050-25-7
In a key combined repeated dose, reproductive/developmental toxicity study, the test material (Rosin, Ethylene Glycol Ester, CAS # 68512-65-2) was administered by continuous dietary admixture to Wistar Han™:RccHan™:WIST strain rats (12/sex/concentration) for up to eight weeks (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dietary concentrations of 3000, 7500 and 18000 ppm (equivalent to a mean achieved dosage of 176.3, 457.7 and 1094.1 mg/kg bw/day respectively for males and 215.1, 555.2 and 1272.7 mg/kg bw/day respectively for females during the pre-pairing phase). The dietary concentration given to the high dosage females during gestation and lactation was decreased to 15000 ppm to lessen the expected increase in achieved intake during these phases. A control group of twelve males and twelve females were treated with basal laboratory diet.
Clinical signs, body weight gain food consumption and haematology parameters appeared unaffected by exposure to the test material. Higher levels of alanine aminotransferase, alkaline phosphatase and urea were observed for males at 18000 ppm compared to control but individual values were nearly all within the historical control range. These increases are probably associated with adaptive liver changes and were considered not to represent an adverse effect of treatment.
Microscopic evaluation of the tissues on the study revealed minimal centrilobular hepatocellular hypertrophy of the liver for males at 18000 ppm and females at 18000/15000 ppm, which was probably the underlying cause for increased liver weight for both sexes at these dietary levels compared to control. The centrilobular hepatocellular hypertrophy was considered to be an adaptive change, probably resulting from enzyme induction resulting from high-dose administration of a xenobiotic, and did not represent an adverse effect of treatment. Increased liver weights were also observed for males receiving 3000 or 7500 ppm and probably reflects a similar, but less significant, adaptive response to exposure.
Higher absolute and body weight relative kidney weights compared to control were observed in treated males at all dietary levels but differences showed no dosage relationship and were within the historical range. In the absence of any microscopic kidney changes, these increased weights were considered to be incidental and of no toxicological significance.
Based on the results for this study, the No Observed Adverse Effect Level (NOAEL) for systemic toxicity was determined to be 18000/15000 ppm. There was no obvious effect of treatment on the reproductive parameters within the study. Therefore, the No Observed Effect Level (NOEL) for reproduction was determined to be 18000/15000 ppm.
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