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EC number: 213-590-1
CAS number: 991-84-4
The test article was administered in the diet to rats at levels of 0,
5000, 10,000 and 20,000 p.p.m. (equivalent to an average daily intake of
0, 311, 594.5 and 1297.3 mg/kg body weight), for not less than 91 days.
No deaths occurred and no clinical symptoms were recorded. Body weight
gains and food consumption were within normal limits and, in treated
groups, comparable to controls.
No important differences were seen between groups in respect of
haematology, clinical chemistry and urine analysis parameters.
Ophthalmic examination did not reveal any eye changes caused by
treatment. Neither at autopsy nor on histopathological examination were
any changes referable to the administration of the test item seen. Organ
weights (both absolute and relative) were comparable in all groups. In
the recovery group, no deaths and no clinical symptoms were recorded.
Laboratory parameters were all within normal limits. Body weight gains
anc food consumption were within normal limits. The apparent fall in
body weights of male animals in group 1 (control) during the recovery
period was due to the fact that the five animals had a lower average
starting weight than the remainder of that group. No treatment induced
changes were seen at autopsy. In view of the negative findings in group
4 (20,000 p.p.m.) of
the main study, no histopathological examination was carried out in
group 5 (20,000 p.p.m.). Based on these findings, a NOAEL was set
at 1297.3 mg/kg body weight in rats, which was the highest concentration
tested in this study.
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