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EC number: 250-797-6
CAS number: 31775-16-3
Analysed test item concentrations were:
54 +/- 6 mg/m3
157 +/- 9 mg/m3
410 +/- 12 mg/m3
Subacute toxicity of the test item was investigated in an 21 days
aerosol inhalation study in rats, which were exposed to 0, 54, 157, 410
mg/m3 test item (6 h/d, 5 d/w).
The bodyweights of the male and
female rats of the highest treatment group were slightly decreased
during the exposure period when compared with those of the control and
other treated groups. In the treated rats from all concentration level
groups yellowish or yellow discoloration of the lungs was seen at
autopsy. Slight but significant increase of both absolute and relative
weights of the lungs was noted in rats from the top concentration group.
Histopathology revealed in the lungs of these rats pneumoconiosis
showing numerous brown-yellow, birefringent particles about 2 - 4 um in
diameter in the lumen of numerous alveoli, in small bronchi, in numerous
histiocytes in the interstitium and in peribronchial lymphatic tissue,
associated with focal accumulation of foamy pneumocytes in the alveoli
and focal lymphohistiocytic infiltration.
After a recovery period of 21 days,
to which a further group of rats exposed to the 410 mg/m3concentration
of the tested compound was subjected, practically no regression of the
pulmonal changes was observed.
In treated rats from the 157 mg/m3and
54 mg/m3concentration groups focal accumulation of minute
brown-yellow, birefringent particles was observed in the cytoplasm of
histiocytic elements in the interstitium, in occasional alveoli, in the
lumen of a few small bronchi and very occasionally also in the
peribronchial lymphatic tissue, however without obvious accumulation of
foamy cells in the alveoli and without inflammatory infiltration.
Other minor microscopical findings
obtained in some treated and control animals were only incidental in
nature and not related to the inhalation of the test item.
It can be inferred from the
observations made during the above study that the "no observable effect
level" for rats is below 54 mg/m3air.
effects observed at the mid and low test concentration were only due to
the deposition of the test material but did not cause adverse effects
like inflammation etc. Therefore, the mid test concentration of 157
mg/m3 can be regarded as "no observable adverse effect level".
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