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EC number: 289-200-9
CAS number: 86178-38-3
The objective of this study was to
evaluate the potential acute toxicity of the test item following a
single oral administration (gavage) to rats.
This study was conducted in compliance
with the OECD Guideline No. 423 and the principles of Good Laboratory
The test item was administered once by
the oral route (gavage) to three groups of three fasted female
Sprague-Dawley rats with a dosage-volume of 10 mL/kg. The test item was
prepared in corn oil.
No relevant toxicity data were
available for estimation of a lethal selected dose-level. The starting
dose-level selected was 300 mg/kg for ethical reasons. After the first
assay, the next higher dose-level of 2000 mg/kg was tested. Then, as no
toxicity was observed at this dose-level, the results were confirmed in
three additional females.
Each animal was observed at least once
a day for mortality and clinical signs for 15 days. 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 occurred during
At 300 mg/kg, no clinical signs were
observed in any animals.
At 2000 mg/kg, hypoactivity,
staggering gait and half-closed eyes were observed on Day 1
approximately 6 hours after treatment in 3/6 females, while another 1/6
females had ptyalism on Day 1, 30 minutes after treatment and slight
alopecia on both forelimbs from Day 14. No clinical signs were noted in
the remaining 2/6 females treated at the same dose-level.
No relevant differences from
historical control data were noted in the body weight change and body
weight of test item-treated animals over the study period.
There were no macroscopic findings at
Under the experimental conditions of this
study, the oral LD0 of the test item was higher than 2000 mg/kg in rats.
Therefore, the test item should not be
classified regarding its toxic potential by oral route according to the
criteria of CLP Regulation.
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