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EC number: -
CAS number: -
An acute oral toxicity study determined a LD50 as >2000mg/kg bodyweight. There is no evidence of a relevant intrinsic acute oral toxicity requiring classification or substance specific Risk Management Measures.
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)
signs of systemic toxicity
2 Individual Bodyweights and Bodyweight Changes
Bodyweight (g) at Day
Bodyweight Gain (g) During Week
Table 3 Individual
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
Method B1bis Acute 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 asuspension 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
All animals showed expected gains in
No abnormalities were noted at
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).
This summary is based upon a single acute oral toxicity study on Diurea
8. The results from this study showed no evidence of acute toxicity up
to the highest dose tested (2000 mg/kg in arachis oil BP).
There is no evidence of a relevant intrinsic acute oral toxicity
requiring classification or substance specific Risk Management Measures.
The oral LD50 value is greater than 2000 mg/kg bw, therefore, existing
data supports justification for non-classification.
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