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EC number: 226-789-3
CAS number: 5468-75-7
Analysed test item concentrations were:
52 +/- 4 mg/m3
151 +/- 9 mg/m3
401 +/- 15 mg/m3
Subacute toxicity of the test item was investigated in an 21 days
aerosol inhalation study in rats, which were exposed to 0, 52, 151, 401
mg/m3 test item (6 h/d, 5 d/w).
slight but significant (p < 0.01) decrease in the bodyweight of the
male rats an the highest concentration at termination of the exposure
period was observed when compared with those of the controls and the
other treated animals.
slight change was found to occur in the differential leucocyte count
of male and female rats at the highest exposure level, where
a higher percentage of polymorphonuclear neutrophils and a
lower percentage of lymphocytes was observed. This change persisted
upon cessation of treatment.
lungs of all rats from the highest concentration group were slightly
enlarged and yellowish in colour. The yellowish discoloration
of the lungs was also noted in rats from the group which was sacrificed
after an additional recovery period of
days. The lung weights, the lung to bodyweight and lung to brain
weight ratios of these animals were significantly increased. The
weight increase persisted in rats of this group after anadditional
recovery period of 21 days.
histopathological examination the lungs of all rats from the
highest concentration group showed focal accumulation of slightly
basophilic material and of numerous foamy cells in the alveoli. In
frozen sections large amount of minute yellow-brownforeign
particles (1 - 3 um) in the lumen of the alveoli, in the cytoplasm
of some foamy cells, in the lumen of occasional small bronchi
and in the macrophages in the interstitium were observed. There was also
slight focal lymphohistiocytic infiltration in the interstitium.
Focal pneumoconiosis showing brown-yellow foreign particles
(dissolved by the procedure
for tissue embedding) was also observed in the treated rats from the top
after the withdrawal period of 3 weeks. Small accumulation of
brown-yellow particles was occasionally found in the intrapulmonal
lymphoid tissue of these animals.
the rats treated with the intermediate concentration level the lungs
showed at autopsy slight yellowish discoloration. Histopathology
revealed brown-yellow, fat soluble particles in the alveoli
and in the interstitium of the lungs. In 8 out of 20 rats from
this group focal accumulation of foamy cells in several alveoli
was observed as well.
yellowish discoloration of the lungs was not observed in rats from
the lowest concentration group. Neither accumulation of foamy cells
in the alveoli, nor interstitial inflammatory infiltration was
seen upon histopathology in these animals. Minute brownyellow
fat soluble foreign particles were however found in frozen sections
in the interstitium of the lungs and in occasional alveoli.
other gross or microscopical changes which could be related to
the inhalation of the test item were found in the treated animals.
can be inferred from the observations made during the above
study that the "no observable effect level" for rats is
below 52 mg/m3of
air. The effects observed at the lowest test concentration were only due
to the deposition of the test material but did not cause adverse effects
like inflammation etc. Therefore, the lowest test concentration can be
regarded as "no observable adverse effect level".
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