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EC number: 614-523-2
CAS number: 68475-37-6
data is being read across from the source study that tested Resin acids
and Rosin acids, esters with ethylene glycol based on category read
across that is explained in the category justification document attached
in Section 13 of the dossier.
a key repeated dose oral toxicity study, the test material (Rosin,
esters with ethylene glycol; CAS# 68512-65-2) was administered by
continuous dietary admixture to three groups, each composed of ten male
and ten female Wistar Han™:RccHan™:WIST strain rats, for ninety
consecutive days, at dietary concentrations of 3000, 7500 and 18000 ppm
(equivalent to a mean achieved dosage of 205.7, 506.6 and 1202.5 mg/kg
bw/day for males and 243.2, 594.4 and 1377.8 mg/kg bw/day for females).
A control group of ten males and ten females were fed basal laboratory
signs, functional observations, bodyweight change, dietary intake and
water consumption were monitored during the study. Hematology and blood
chemistry were evaluated for all animals at the end of the study.
Ophthalmoscopic examination was also performed on control group and high
dose animals before the start of treatment and during Week 12 of the
study. All animals were subjected to gross necropsy examination and a
comprehensive histopathological evaluation of tissues from high dose and
control animals was performed.
continuous oral (dietary) administration of the test material in the
diet for ninety consecutive days was well tolerated and was not
associated with any obvious signs of systemic toxicity for animals of
either sex. There were no effects of dietary exposure indicated by body
weight performance, food and water
consumption, food conversion efficiency, functional observations or
ophthalmic examinations. Haematological investigations did not reveal
any adverse effect of treatment; however, blood chemical evaluations did
reveal a number of statistically significant intergroup differences.
Males fed diet containing 18000 ppm showed lower albumin and total
protein and higher cholesterol and bilirubin levels. The effect on
albumin was also evident in males fed diet containing 7500 ppm. Higher
bilirubin levels were also evident in females fed diet containing 18000
ppm. In animals of either sex fed diet containing 18000 ppm and males
fed diet containing 7500 ppm, liver weights both absolute and relative
to terminal body weight were higher than controls. These intergroup
differences in blood chemistry and organ weights may be a consequence of
enhanced hepatic metabolism and turnover as a by-product of xenobiotic
metabolism. However, due to the lack of pathological changes in the
liver, these intergroup differences may represent altered metabolic
function but these occurred in the absence of adverse gross or
microscopic hepatic effects after ninety consecutive days of dietary
on the results of this ninety-day study, the No Observed Adverse Effect
Level (NOAEL) for systemic toxicity was considered to be 18000 ppm
(equivalent to 1202.5 mg/kg bw/day for males and 1377.8 mg/kg bw/day for
females). The No Observed Effect Level (NOEL) was considered to be 3000
ppm based on non adverse absolute and relative liver weight changes in
males at 7500 ppm and both sexes at 15000 ppm.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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