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EC number: 201-283-5
CAS number: 80-48-8
DOSE LEVEL: 300 mg/kg bw, Treatment on Day 0
DOSE LEVEL: 2000 mg/kg bw, Treatment on Day 0
= present -
= hour ‘
= Found dead
of observation = number of occurrence of observation/total number of
1 = slight/small/few, 2 = moderate/medium, 3 = marked/large/many
Body weight (g)
Day/Body Weight (g) Death
Body Weight Gain (g)
- = No data
# = Found
Necropsy Date/ Necropsy Day
23 May 2017
No external observations recorded
No internal observations recorded
14 May 2017
Discoloration, red, diffuse, all lobes
30 May 2017
06 June 2017
Dark discoloration, red, diffuse, all lobes
The single-dose oral
toxicity of PTSM 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 Crl:WI rats.
Two groups of three female
Crl:WI rats were treated with the test item at a dose level of 300 mg/kg
bw (Group 1 and Group 2) and one group of three female Crl:WI rats at a
dose level of 2000 mg/kg bw (Group 3).
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.
The test item was administered formulated in PEG 400 at a concentration
of 30 or 200 mg/mL at a dose volume of 10 mL/kg bw.
Initially, three females
(Group 1) were treated at a dose level of 300 mg/kg bw. As only one
animal was found dead, a confirmatory group (Group 2) was treated at the
same dose level. As no animal died in the confirmatory group, the next
dose level was 2000 mg/kg bw. As all animals were found dead in the
group treated at a dose level of 2000 mg/kg bw (Group 3), 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 at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily
for 14 days thereafter, where possible. Body weight was measured on Days
-1, 0 and 7 and 14 (before necropsy), where possible. All animals were
subjected to a necropsy and a macroscopic examination.
PTSM caused mortality in 1
of 6 animals at a dose level of 300 mg/kg bw and in 3 of 3 animals at a
dose level of 2000 mg/kg bw.
In the groups treated at a
dose level of 300 mg/kg bw, hunched back (6/6), slight to moderate
decreased activity (4/6), piloerection (3/6), slight to moderate
incoordination (2/6) and wasted condition (2/6) were recorded.
In the group treated at a
dose level of 2000 mg/kg bw, slight to moderate decreased activity
(3/3), hunched back (3/3), slight incoordination (3/3), piloerection
(3/3) and prone position (2/3) were seen before death.
Body Weight and Body Weight
Treatment related body
weight loss was observed in one of the surviving animals following
treatment, but the animal recovered the lost weight during the second
week of the observation period. The body weight changes of the animals
died during the study could not be evaluated. The body weight of the
other treated animals during the study showed no indication of a test
Red or dark red diffuse
discoloration of all lobes of the lungs was found in the rats that died
during the observation period.
No macroscopic findings were
noted in the surviving animals at necropsy dosed at 300 mg/kg bw and
terminated on Day 14.
Under the conditions of this
study, the acute oral LD50 value of the test item PTSM was found to be
between 300 and 2000 mg/kg bw in female Crl:WI rats.
According the GHS criteria,
PTSM can be ranked as "Category 4" for acute oral exposure.
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