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EC number: 937-158-3
CAS number: -
is being read across from the source study that tested Hydrocarbons,
C11-C14, n-alkanes, isoalkanes, cyclics, < 2% aromatics based on
analogue read across.
BRIGHTSOL was administered by inhalation to
albino rats for 6 hours/day, 5 days/week for 13 weeks at nominal vapor
concentrations of 1500 mg/m3 and 3000 mg/m3, and
6000 mg/m3 to assess inhalation toxicity. No
mortality or treatment-related effects in any of the hematology and
serum chemistry values were observed. Liver and kidney weights were
increased in male rats at all exposure levels, and liver weights were
increased in female rats at 6000 mg/m3. In addition, the
male rats exposed to BRIGHTSOL at all concentrations contained multiple,
hyaline, intracytoplasmic, inclusion-droplets in the epithelium of the
proximal convoluted tubules and showed an increased incidence of focal
cortical, tubular basophilia. The kidney effects
observed in male rats are indicative of alpha-2u-globulin nephropathy.
Alpha-2u-globulin nephropathy, also known as hyaline droplet
nephropathy, results from the formation of complexes with a naturally
occurring protein (alpha-2u-globulin) in the kidneys of male rats.
These complexes can accumulate in the proximal renal tubules and may
produce species-specific histopathological changes. These kidney
effects are specific to male rats and are not considered to be of
biological relevance to humans. Histopathological examination did not
reveal any abnormalities that were considered treatment related. As
there were no pathologic changes, changes in liver weight to body weight
ratios mentioned above were judged to have been compensatory rather than
toxic effects. Based on these results, the No Observed Adverse Effect Concentration
(NOAEC) was greater than or equal to 6000 mg/m3.
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