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EC number: 256-062-6
CAS number: 43048-08-4
The objective of this study was to
evaluate the potential toxicity of the test item, following a single
dermal application to rats.
This study was conducted in compliance
with OECD Guideline No. 402 and the principles of Good Laboratory
The test item was applied in its
original form to the skin of five female then five male Sprague-Dawley
rats at the dose-level of 2000 mg/kg. The application site was covered
by a semi-occlusive dressing for 24 hours.
Each animal was observed at least once
a day for mortality and clinical signs for 15 days. From Day 2, any
local reactions at the treatment site were also noted. Body weight was
recorded on Day 1 and then on Days 8 and 15.
On completion of the observation
period, the animals were sacrificed and then submitted for a macroscopic post-mortem
examination.Macroscopic lesions were preserved in buffered formal in
then destroyed at the finalization of the study report as no microscopic
examination was performed.
deaths occurred during the study.
No clinical signs
indicative of systemic toxicity were observed in any animals.
A very slight to moderate-to-severe
erythema was noted in all males and a very slight to well-defined
erythema was recorded in all females from Day 2 until Day 6. This was
associated with very slight to moderate dryness from Day 4 or 5 until
Day 13 in all animals. Scabs were observed in 2/5 males from Day 7 to
When compared to CiToxLAB
France historical control data, a higher body weight gain
was observed in 1/5 males (+57 g vs. +39 ± 11.5 g in control
data base) between Days 1 and 8 whereas a lower body weight gain was
noted in 2/5 males (+35 g and +33 g, respectively, vs. +50 ± 12.0
g in control data base) between Day 8 and Day 15.
A lower body weight gain was observed
in 2/5 females (+13 g and +14 g, respectively, vs. +25 ± 10.0 g
in control data base) between Days 1 and 8. This was followed by a body
weight loss of 2 g in one of them over the second part of the
Nevertheless and in
absence of marked body weight effect, body
weight of animals was considered unaffected by the test item treatment
in both sexes when compared to CiToxLAB France historical control data.
At the end of the observation period,
there were no macroscopic findings at necropsy attributable to the
test item administration.
Under the experimental conditions of
this study, the dermal LD50 of the test item, was higher than
2000 mg/kg in rats.
Therefore, the test item should not be
classified as acutely toxic by dermal route according to the criteria of
the CLP Regulation.
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