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EC number: 946-212-5
CAS number: -
In this study, the calcium sulfonate read
across substance (CAS 61789-86-4, product as manufactured diluted to 65%
in mineral oil) was administered to assess the toxic effects by
inhalation of the test item as an aerosol to 30 rats (5/sex/group) for 6
hours per day, 5 days per week for 4 weeks at target concentrations of
50, 150 and 250 milligrams aerosol per cubic meter of air
(mg/m3). Control animals (5/sex) received air only, while in chamber.
Exposure levels were monitored gravimetrically four times per chamber
per day. Particle size distribution measurements were made once each
week using a Delron DCI-6 Cascade Impactor.
Physical observations for abnormal signs
were made during exposure for all animals. Detailed physical
examinations were conducted weekly on all animals. Body weight
measurements were recorded weekly and once during the pre test period,
on test day 1; body weight measurements were also obtained just prior to
sacrifice on test day 29. Just prior to sacrifice, blood samples were
obtained for haematology and clinical chemistry then all animals were
sacrificed, selected organs were weighed and organ/body weight ratios
were calculated. A complete gross post-mortem examination was conducted
on all animals followed by microscopic examination of selected tissues.
The cumulative mean analytical exposure
concentrations as determined gravimetrically were 49.5, 156 and 260
mg/m3, with an average nominal concentration of 272, 1060 and 1360 mg/m3
for the low, mid and high dose groups, respectively. Particle size
distribution determinations indicated the test aerosol atmosphere was
respirable to the rat.
All animals survived the duration of the
study. Physical observations during the exposures included red nasal
discharge, matted coat and decreased activity at the two higher levels.
No significant respiratory signs were noted during the weekly
observations. However, increased incidence of dried red nasal discharge
and matted coat was seen among the treated animals. Body weight
measurements indicated a trend towards lower weight gain, especially in
the high level males. Nevertheless, this difference was not
statistically significant. Haematology and clinical chemistry parameters
were generally not indicative of any test-material effect. Terminal
organ weight and organ body weight ratios were clearly indicative of a
respiratory effect with significant dose related increases in lung
weights and ratios at the mid and high levels. Other organ weights and
ratios were unremarkable.
Gross post mortem evaluations were
unremarkable. However, a higher incidence was seen microscopically in,
the mid and high level lungs of accumulation of intraalveolar
macrophages and hyperplasia/hypertrophy of bronchiole epithelium. Other
microscopic findings were not considered test-article related.
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