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EC number: 701-362-9
CAS number: -
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 performed according to
the international guidelines (OECD No. 402 and Council Regulation No.
440/2008 of 30 May 2008, Part B.3) and in compliance with the principles
of Good Laboratory Practice.
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 formalin
then destroyed at the finalization of the study report as no microscopic
examination was performed.
No unscheduled deaths and no clinical
signs indicative of systemic toxicity were observed in any animals.
No cutaneous reactions were observed
in any animals.
When compared to CiToxLAB
France historical control data, a lower body weight gain
was noted in 4/5 males and in 3/5 females between day 1 and day 8.
There were no macroscopic changes
related to the test item treatment.
The dermal LD50 of the test item was
higher than 2000 mg/kg in rats.
Therefore, the test item is not
classified as toxic or harmful by dermal route according to the criteria
of CLP Regulation.
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