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EC number: 700-204-6
CAS number: 1174627-68-9
systemic toxicity and potential adverse effects of Rhodiasolv Polarclean
following subchronic exposure via oral administration (gavage) was
investigated in rats in a GLP- compliant study in accordance with OECD
Three groups of ten male and ten female
Wistar rats received the test item, Rhodiasolv Polarclean (batch No.
CY-12018030), at dose-levels of 100, 300 or 1000 mg/kg/day. In addition,
one group of ten males and ten females received the vehicle alone
(drinking water treated by reverse osmosis) and acted as a control
group. The test item or the vehicle was administered during a 13-week
period by gavage under a constant dosage-volume of 5 mL/kg/day. The
actual test item concentration in each administered dose formulation was
determined in weeks 1, 4, 8 and 12 using a validated HPLC/UV analytical
method. The animals were checked daily for mortality and clinical signs.
Detailed clinical examinations were performed once before the beginning
of the treatment period and then once a week. A Functional Observation
Battery (FOB) was performed for all animals once in week 12. Body weight
and food consumption were recorded once a week during the study.
Ophthalmological examinations were performed on all animals before the
beginning of the treatment period and in control and high-dose groups on
completion of the treatment period. Hematology and blood biochemistry
were performed on all animals at the end of the treatment period. On
completion of the treatment period, the animals were sacrificed and a
full macroscopic post-mortem examination was performed. Designated
organs were weighed and selected tissue specimens were preserved. A
microscopic examination was performed on selected tissues from all
animals from groups 1 and 4 and on all macroscopic lesions.
The test item concentrations in the
administered dose formulations analyzed in weeks 1, 4, 8 and 12 remained
within an acceptable range of variations when compared to the nominal
There were no unscheduled deaths.
Ptyalism was observed in animals given the
test item at 300 or 1000 mg/kg/day. While test item treatment-related,
this finding is commonly observed and was considered of minor
No test item treatment-related effects were
noted duyring FOB. There were no relevant differences in rearing and
horizontal movements in test item-treated groups in both males and
females when compared with control group.
There were no effects on mean body weight,
mean body weight gain and mean food consumption.
There were no findings at the ophthalmology
examination at the end of the treatment period.
There were no test item-related effects on
mean hematology or blood biochemistry parameters.
There were slight increases in absolute and
relative kidney weights in high-dose females.
However, in the absence of correlating
microscopic findings, these increases were considered to be of no
There were no test item treatment-related
There were no test item treatment-related
For anatomic pathology, the NOAEL (No
Observable Adverse Effect Level) in this study was considered to be 1000
mg/kg/day in male and female rats.
Under the experimental conditions of this
study, the No Observable Adverse Effect Level (NOAEL) was considered to
be 1000 mg/kg/day in the absence of test item treatment-related
toxicologically significant findings at this dose-level.
Based on the results of this study, the test
substance Rhodiasolv Polarclean is not classified for repeated dose
to the classification criteria of the Regulation (EC) 1272/2008 (CLP)
and of the Directive 67/548/EEC.
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