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EC number: 940-783-4
CAS number: -
This study was designed to assess the
toxicity of formal [bis (2-chloroethoxy) methane) when administered
orally, via gastric intubation, to rats for at least two weeks to select
dose levels for a 90-day study. The test substance, administered as a
100 mg/ml solution in corn oil, was initially administered to 60
Sprague-Dawley CD rats (5/sex/group) at dose levels of 20, 40, 50, 60,
80 and 100 mg/kg bw/day. Control animals (5/sex) received the vehicle at
the same dose volume as administered to group VII animals (1.0 ml/kg
bw/day). Because no signs of toxicity were seen after the first week,
the two lower doses were raised from 20 and 40 mg/kg bw/day to 150 and
200 mg/kg bw/day, respectively, for the second week of the study.
Physical observations and body weight and
food consumption measurements were performed for all animals pretest and
weekly thereafter. hematology and clinical chemistry parameters were
evaluated for all survivors just prior to sacrifice. Opthalmology
examinations were performed for all animals pretest. After at least two
weeks of treatment, all survivors were sacrificed, selected organs were weighed
and organ/bodyweight ratios were calculated. Complete gross-mortem
examinations were conducted on all animals.
Two additional (satellite) studies were
performed to 1) clarify the effect of fasting on mortality at the 100
mg/kg dose level and 2) provide information on mortality, clinical signs
and clinical laboratory values in animals receiving doses of 120 and 160
mg/kg bw/day (5/sex/dose) for up to seven days.
In the first satelite group all females in
group I (fasted) died and all males in group I were moribund. All
animals in group II (unfasted) survived.
Oral administration produced partial
mortality (one in five females) at doses as low as 60 and 80 mg/kg
bw/day and complete mortality (ten of ten animals) at doses of 160 and
200 mg/kg bw/day. Intermediate doses produced no mortality at the 100
mg/kg bw/day level and mortality in 7 of 10 and 8 of 10 animals at the
120 and 150 mg/kg bw/day doses. Animals receiving doses of 20 and 40
mg/kg bw/day survived for the week these doses were administered. Time
to death was generally dose related. Animals in the 60 and 80 mg/kg
bw/day groups died after 16 doses, while animals which died at doses of
120 mg/kg bw/day and higher died after receiving one to nine doses.
Abnormal signs, body weight depressions and
hematological abnormalities weer seen as antemortem findings in animals
which died. Unusual signs in some of these animals included lethargy,
dyspnea, tremors, irregular gait, yellow or brown staining of the
ano-genital area, salivation, moist rales, hypothermia and general poor
condition as well as antemortem weight losses or decreased weight gains,
relative to control values, and marked decreases in food consumption.
Hematological alterations consited of
elevated hemoglobin, hematocrit and total erythrocyte values, relative
to control values, for the two males each in the 120 and 160 mg/kg
bw/day groups which were bled in a moribund condition and one of the two
males surviving after one week of dosing at 150 mg/kg bw/day. This may
be a direct effect of the test substance administration or may represent
hemoconcentration secondary to dehydration in these animals. Similar
differences were not apparent in females. No clear effects on platelets
or total and differential leukocyte counts were seen in animals of
Clinical chemistry studies in animals
which were bled in a moribund condition at the120 and 160mg/kg bw/day
dose levels revealed a variety of abnormalities. Altered values seen in
several animals included elevated serum transaminase (SGOT and SGPT),
alkaline phosphatase, BUN and glucose levels and decreased serum sodium
levels. Similar differences were not evident in females. Evaluations
performed on animals surviving after one week of FORMAL administration
at the150 mg/kg bw/day dose level revealed elevated serum glutamic
oxoalecetic (SGOT) values. SimiIar elevations in akaline phosphatase
values were also seen in 3 of the 5 males which received 100 mg/kg
bw/day for two weeks. A non dose-related trend toward elevated blood
urea nitrogen values was evident in females which were treated with
daily doses of 50, 60, 80 or 100 mg/kg bw/day of FORMAL for at least two
weeks. Alterations in organ weight values were limited to elevations in
liver weights and liver/body weight ratios for females which received 80
or 100 mg/kg bw/day of test substance for at least two weeks. Gross
postmortem examinations revealed no abnormalities attributable to test
Based on the apparent effects on blood
urea nitrogen levels in females receiving doses as low as 50 mg/kg
bw/day and on the elevated alkaline phosphatase level in males receiving
100 mg/kg bw/day, the NOEL for FORMAL in rats under conditions of this
study was40 mg/kg bw/day for females and 80 mg/kg bw/day for males.
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