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EC number: 256-032-2
CAS number: 42978-66-5
An acute reliable intraperitoneal toxicity study (Klimisch 2) in rats
with the test substance was conducted. The purpose of the study was to
evaluate the acute toxicity of the test material when administered by
intraperitoneal injection to rats, to detemine the intraperitoneal LD50
of the material, and to determine whether neurologic effects could be
produced with acute administration. Experiments were performed with five
Sprague-Dawley rats of each sex which were treated with 275, 325, 375
and 450 mg/kg bw of the test item. Appropriate amounts of the test
substance were weighed and placed in corn oil to achieve the total
desired weighed. The dose selction was based on the observed mortality
in a preliminary testing for 7 days with one male and female rat and
with doses up to 500 mg/kg bw. This screen revealed no mortality for
doses up to 300 mg/kg bw, but 50% or 100% mortality for doses of 400 and
500 mg/kg bw, respectively.
In the LD50-determination study no animals died at 275 and 325 mg/kg bw,
4/5 male and 3/5 female animals died at 375 mg/kg bw (days 2-8), 3/5
male and 5/5 female animals died at
450 mg/kg bw (23 hr to day 2). Fetal staining and soft stool were
exhibited by single animals in the control group. Most animals treated
with the test substance exhibited decreased activity and respiration
rates, nasal discharge, and apparent abdominal discomfort (writhing) on
the day of dosing. Unusual signs seen during the post-dose period
included urinary and/or fecal staining, soft stool, and an unthrifty
coat. Animals at the 375 mg/kg group also exhibited piloerection,
hynothermia, and decreased food consumption. Animals which died
generally exhibited antemortem weight losses or failure to gain weight.
Weight gains in animals which survived were comparable to those in
controls. Moreover, a large number of postmortem abnormalities, most
notably in the abdominal viscera were observed in animals which died and
in those which were killed after 14 days. Most of these appeared to
represent irritation and/or infectious sequlae resulting from
intraperitoneal injection of the vehicle and/or test material. According
to neurological signs a flaccid limb and/or body tone, ataxia and
impaired righting responses were seen in some animals in the 275, 325,
and 375 mg/kg exposure groups. Although these frequently appeared as
antemortem signs in animals which died before 24 hours, these
observations were also seen in some animals which subsequently survived.
Signs noted only as antemortem findings included tremors, pelvic
elevation, and an abnormal startle reflex.
Based on the mortality of this study the median lethal dose of the test
item after oral administration was found to be 370 mg/kg body weight in
rats after intraperitoneal injection.
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