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EC number: 291-454-0
CAS number: 90411-76-0
100, 300 and 1000 mg/kg bw/day Nigrosin WLF dissolved in tap water, was
administered orally by gavage to 5 male and 5 female Wistar rats per
dose group for a period of 4 weeks according to OECD TG 407 and GLP.
Survival, body weight development as well as food and water intake in
treated groups were not affected by treatment, Neither hematology nor
clinical chemistry gave evidence for treatment related effects up to
1000 mg/kg bw/day. Test item related macroscopic and microscopic changes
at terminal sacrifice were slight gray or black discolorations in a
dose-related manner in all treated groups. All these discolorations were
considered to be due to the staining property of the test item. In the
view of the very limited degree of changes and as any indication of
structural change or functional impairment of the organs concerned was
lacking, they were considered to be non-adverse.
Therefore, under the conditions described, the NOAEL for administration
of Nigrosin WLF to male and female rats was 1000 mg/kg bw/day.
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