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EC number: 232-476-2
CAS number: 8050-15-5
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.
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.
evaluation of the tissues on the study revealed minimal centrilobular
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.
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.
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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