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EC number: 944-817-9
CAS number: 244626-73-1
In an acute oral toxicity study performed
according to the OECD test guideline No. 423 and in compliance with GLP,
a group of three fasted female Sprague-Dawley rats received a single
oral gavage dose of the test material, formulated in corn oil, at a dose
level of 2000 mg/kg bodyweight. As results at this dose level indicated
the acute lethal oral dose of the test substance to be greater than 2000
mg/kg bodyweight, in compliance with the study guidelines, a further
group of three fasted females was similarly dosed at 2000 mg/kg
bodyweight to complete the study.
Clinical signs of reaction to treatment
comprised loose faeces seen in five females, urine staining in the
perigenital region in three females and post salivation staining,
hunched posture, fast breathing, piloerection and distended abdomen
observed in individual females dosed at 2000 mg/kg. These signs were
seen from approximately one hour after dosing. Recovery of animals, as
judged by external appearance and behaviour, was complete by Day 3.
All animals were considered to have achieved
satisfactory bodyweight gains throughout the study.
Macroscopic examination at study termination
on Day 15 revealed enlarged, swollen or thickened kidneys, pallor of the
kidneys and clear fluid in the kidneys in one female. These findings are
considered unlikely to be test substance related. No abnormalities were
revealed in any of the other five animals at the macroscopic examination
at this time.
The acute oral median lethal dose (LD50) of
the test material in the female Sprague-Dawley CD strain rat can be
estimated from the flow chart from OECD Guideline 423 (Appendix 2d) as
being greater than 5000 mg/kg bodyweight.
Under the test conditions, the test material
is not classified according to the annex VI of the Regulation EC No.
This study is considered as acceptable and
satisfies the requirement for acute oral toxicity endpoint.
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