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EC number: 248-256-4
CAS number: 27138-01-8
see Executive summary
The objective of this study was to
evaluate the potential toxicity of the test item following a single
dermal application to rats, following the OECD 402 guideline. This study
was conducted in compliance with the principles of Good Laboratory
The test item was applied in its
original form (pre-moistened) 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. No tissues were preserved.
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 historical
control data, a lower body weight gain was noted in all females between
day 1 and day 8. Their body weight gain returned to normal thereafter. Body
weight of males was unaffected by the test item treatment. There
were no macroscopic findings in any animals.
The dermal LD50of the test
item was higher than 2000 mg/kg in rats. Therefore, the
test item is not classified as toxic by dermal route according to the
criteria of CLP Regulation.
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