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EC number: 201-158-5
CAS number: 78-92-2
Four groups, each containing 25 Fischer 344 rats per sex and 10 CD®-1
mice per sex, were exposed for six hours per day, five days per week,
for thirteen weeks to isopropanol vapor (CAS No. 67-63-0). Target
concentrations of isopropanol were 0 (control), 500, 1500, and 5000 ppm.
An additional group of 10 Fischer 344 rats per sex and 10 CD®-1 mice per
sex were exposed to a target concentration of 100 pprn with the same
exposure regimen. Monitors for toxic effect included clinical
observations, functional observational battery and motor activity (rats
only), ophthalmic examination, body and organ weights, food and water
consumption, hematologic and serum clinical chemistry evaluations, and
macroscopic and microscopic evaluations. Detailed microscopic
evaluations were performed on the nervous system of selected rats
following perfusion fixation of tissues.
Mean isopropanol analytical concentrations of 100, 506, 1508 and 5008
ppm were measured. No exposure-related mortalities occurred during the
study, although two mice died due to incidental causes. Clinical signs
observed in some of the rats and mice during exposures at 5000 ppm
included ataxia, narcosis, lack of a startle reflex, and hypoactivity.
During exposures to 1500 ppm, narcosis, ataxia, and hypoactivity were
observed in some mice, while only hypoactivity was observed in rats. The
clinical signs noted during exposures were either seldom observed or
completely absent following exposures. Clinical signs that were observed
following exposures in rats of the 5000 ppm group included swollen
periocular tissue (females only), perinasal encrustation (males only),
ataxia (one male), and paresis (one female). Perinasal encrustation
(males only) was also observed in rats of the 500 and 1500 ppm groups.
Hypoactivity (one male) and ataxia (three females) were observed
following exposures in mice of the 5000 ppm group. Neurobehavioral
evaluations indicated no changes in the functional observational
battery; however, increased motor activity for female rats in the 5000
ppm group was noted at Weeks 9 and 13.
Decreases in absolute body weight and body weight gain were observed in
rats of the 5000 ppm group at the end of the first week of exposure.
Absolute body weight and body weight gain were also slightly decreased
in the 1500 ppm group of female rats. The decreases in body weight and
body weight gain observed during the first week of exposure were,
however, transient. Increased body weight and/or body weight gain were
observed in male and female rats of the 1500 and 5000 ppm groups during
the remaining weeks of the study. No exposure-related effects on body
weight were noted in male mice; however, increased body weight and body
weight gain were observed in female mice of the 5000 ppm group starting
at approximately Week 3. Increases or decreases in food and water
consumption generally corresponded to changes in body weight and body
Upon hematologic evaluation at Week 6, decreases in total erythrocytes,
hemoglobin, hematocrit, and platelet counts were observed in both sexes
of rats of the 5000 ppm group. In addition, increases in mean
corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH) were
observed in males of the 5000 ppm group. Increased MCV and/or MCH were
also noted in both sexes of rats of the 5000 ppm group at Week 14. These
changes indicated a slight anemia was present at Week 6 but not at Week
14. Another hematologic effect observed in male rats included increased
platelet counts in the 1500 and 5000 ppm groups at Week 14. There were
no exposure-related changes in serum clinical chemistry parameters for
male and female rats. Various changes in hematologic and serum clinical
chemistry parameters observed in female mice of the 5000 ppm group
indicated a possible slight dehydration effect; there were no
exposure-related changes in hematology or serum clinical chemistry for
The only organ weight effect noted was an increased relative liver
weight in both sexes of rats and female mice of the 5000 ppm group. At
necropsy, there were no gross lesions determined to be exposure related.
Histologic examination revealed hyaline droplets within the kidneys of
all male rats including controls. However, the size and frequency of the
hyaline droplets were increased for the exposure groups, albeit not in a
concentration-related manner. There were no microscopic lesions in
female rats or in mice of either sex that could be attributed to the
isopropanol exposures. Neuropathologic examination revealed no
exposure-related lesions in the central or peripheral nervous system of
Repeated exposure to
IPA for 98 days produced toxic effects only at the highest concentration
(5000 ppm) and a kidney change of unknown biological signifiance.
Clinical signs of toxicity on the central nervous system (including
ataxia, narcosis, lack of a startle reflex, and/or hypoactivity) are
acute effects and not relevant for limit value determination for
repeated dose systemic effects. Decreases in absolute body weight and
body weight gain, and changes in hematology parameters in animals
exposed to 1500 and 5000 ppm of isopropanol, increased relative liver
weight in male and female rats exposed to 5000 ppm, as well as increased
motor activity for female rats in the 5000 ppm group have been observed.
Clinical signs of
toxicity on the central nervous system (including ataxia, narcosis, lack
of a startle reflex, and/or hypoactivity) during exposures to 1500 ppm
in some mice are acute effects and not relevant for limit value
determination for repeated dose systemic effects. In mice exposed to
1500 and 5000 ppm of isopropanol, increased body weight and body weight
gain and in female mice of the 5000 ppm group are observed. Various
changes in hematologic and serum clinical chemistry parameters are
observed in female mice of the 5000 ppm group, and increased relative
liver weight in female mice of the 5000 ppm group.
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