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EC number: 200-661-7
CAS number: 67-63-0
The inhalation toxicity of IPA has been assessed in a 104-week
oncogenicity study in rats (Burleigh-Flayer and Benson, 1994). This
GLP study was conducted according to OECD test guideline 451.
IPA was administered by whole-body inhalation to groups of male
and female Fischer 344 rats (75 rats/sex) for6 hours/day 5
days/weekfor at least 104 weeks at nominal concentrations of 0
(control), 500, 2500, or 5000 ppm (measure concentrations of0,
504, 2509, or 5031 ppm, respectively). Ten
rats/sex/group were assigned to interim sacrifice at Week 73. Animals
were monitored for clinical observations, body and organ weights,
ophthalmology examinations, hematology, urinalysis and urine chemistry
examinations, gross pathology and microscopic examinations.
Exposure of rats to IPA vapour for 104 weeks produced clinical signs of
toxicity (including hypoactivity, lack of startle reflex, and/or
narcosis), changes in body weight, and urinalysis and urine chemistry
indicative of kidney changes (decrease in osmolality and increase in
total volume and/or protein) in the 2500 and 5000 ppm groups. At
terminal sacrifice, increased absolute and relative kidney weights were
noted in males at 2500 ppm and females at 5000 ppm. Macroscopic
changes such as granular kidney were noted in males and females of 2500
and 5000 ppm groups. A number of non-neoplastic histopathological
changes were observed, with the most significant being in the kidney. The
only neoplastic change observed was in male rats and was an increase in
interstitial cell adenomas of the testis considered to represent marked
hyperplasia and not autonomous growth. The increased
incidence was considered related to the unusually low frequency of
testicular tumors in the control group. No increases
in the incidence of neoplastic lesions were noted for female rats. In
summary, the report allows the conclusion that there no adverse exposure
related effects. Therefore, from the present report, a NOAEL of 5000 ppm
IPA can be derived.
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