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Table 1 Individual Clinical Observations and Mortality Data
Dose Level mg/kg
Animal Number and Sex
Effects Noted After Dosing(Hours)
Effects Noted During Period After Dosing(Days)
0= No signs of systemic toxicity
Table 2 Individual Bodyweights and Bodyweight Changes
Bodyweight (g) at Day
Bodyweight Gain (g) During Week
Table 3 Individual Necropsy Findings
Animal Numberand Sex
Time of Death
Killed Day 14
No abnormalities detected
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat. The method was designed to be compatible with the following:
OECD Guidelines for Testing of Chemicals No 420 “Acute Oral Toxicity - Fixed Dose Method” (adopted17 December 2001)
Method B1bisAcute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008
Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
There were no deaths.
There were no signs of systemic toxicity.
All animals showed expected gains in bodyweight.
No abnormalities were noted at necropsy.
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System - Unclassified.
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