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EC number: 940-783-4
CAS number: -
The single-dose oral toxicity of the test substance
was performed according to the acute toxic class method (OECD 423 and
Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris) in
The test substance was administered in PEG
400 at concentrations of 200, 30 and 5 mg/mL with a dosing volume of 10
A single oral treatment was carried out by
gavage for each animal after an overnight food withdrawal. Food was made
available again 3 hours after the treatment.
Dose at 2000 mg/kg bw (Group 1):
Initially, three females assigned to (Group
1) were treated at a dose level of 2000 mg/kg bw. The test item caused
mortality in this group (3/3). Therefore, a second group (Group 2) was
treated at a dose level of 300 mg/kg bw.
Dose at 300 mg/kg bw (Group 2):
The second group of three females (Group 2)
was treated at a dose level of 300 mg/kg bw. The test item caused
mortality in this group (2/3). Therefore, a third group (Group 3) was
treated at a dose level of 50 mg/kg bw.
Dose at 50 mg/kg bw (Group 3 and Group 4):
The third group of three females (Group 3)
was treated at a dose level of 50 mg/kg bw. The test item did not cause
mortality in this group; therefore a confirmatory group of three females
(Group 4) was treated at the same dose level. The test item did not
cause mortality in the confirmatory group, so no further testing was
required according to OECD 423 and Commission Regulation (EC) NO
440/2008 of 30 May 2008, B.1.Tris.
Clinical observations were performed on the
surviving animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and
daily for 14 days thereafter. Body weight was measured on Days -1, 0 and
7 and before necropsy. All animals were subjected to a necropsy and a
The test substance caused mortality at the
dose level of 2000 mg/kg bw (3/3) and at the dose level of 300 mg/kg bw
Treatment at the dose level of 2000 mg/kg bw
caused decreased activity (3/3), hunched back (1/3), prone position
(3/3), and death (3/3).
Treatment at dose level 300 mg/kg bw caused
decreased activity (3/3), excessive digging (2/3), hunched back (3/3),
prone position (1/3), piloerection (3/3), and death (2/3).
Treatment at dose level 50 mg/kg bw caused
faeces liquid (3/6).
Body weight and body weight gain
Body weight gains of treated animals during
the study showed no indication of a treatment-related effect on the
surviving animals at the dose level of 300 and 50 mg/kg bw.
Diffuse red discoloration of the glandular
stomach observed in 3/3 found dead animals dosed at 2000 mg/kg bw was
considered to be associated with administration of the test item.
Other changes such as dark/red discoloration
of the non-collapsed/collapsed lungs, foamy white material in the
trachea or red liquid at the perinasal fur were regarded as agonal or
post mortem dosed at 2000 and 300 mg/kg bw.
No macroscopic observations were seen in
animals dosed at 50 mg/kg bw and terminated on Day 14.
Also, no gross changes were noted in one
surviving rat dosed at 300 mg/kg bw and necropsied on Day 14.
The test substance was found to be between
50 and 300 mg/kg bw in female RccHan:WIST rats.
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