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EC number: 402-420-3 | CAS number: -
Reactive Red 239 was administered overa period of 29 days, SPF-Wistar rats at dose levels of 0, 40, 200 and 1000 mg/kg body weight per day orally by gavage (total 28 applications, 7 days a week).In all experimental groups, the behavior and general health were checked twice daily, on weekends and holidays once daily. Body weight gain and food consumption were determined twice a week; water consumption weekly. Haematological, clinical chemistry and urinalysis tests were performed at the end of the study.
At necropsy, the animals were examined macroscopically for organ changes; the major organs were weighed and relative organ weights were calculated. The most important organs of these animals were collected and histological specimens were prepared and examined for microscopic changes. Body weights, hematology and clinical chemistry parameters, albumin and globulin values, urinalysis (pH, density) and the absolute and relative organ weights were statistically tested for differences compared to the control groups.
The 28-day administration of 1000 mg/kg bw Reactive Red 239 resulted in no compound-related impairment of general health status or body weight gain. Feed and water consumption were also unaffected by the test substance.
The hematological investigations showed no evidence of compound-related toxicity. The evaluation of the clinical-chemical parameters resulted in lower creatinine values in females of the 1000 mg/kg bw-group. All other changes were within the normal range of the used rat strain and are therefore not related to the administration of the test substance administration. In the animals of the 200 and 1000 mg/kg bw-groups, the urine was brown-yellow to red discolored. Otherwise, the urinalysis was normal.
In male animals at 1000 mg/kg bw, the adrenal weights were increased. In females at the 200 and 1000 mg/kg bw, increases in relative liver weights and at 1000 mg/kg bw increases in relative kidney weights were observed.
The macroscopic examinations revealed reddish discoloration of various tissues and organs. The affected organs were the kidneys of the 40 mg/kg bw-group females, 200 mg/kg bw-group males, and 1000 mg/kg bw-group rats, as well as the connective and stomach tissue at 1000 mg/kg bw. In addition, in males the testes and colon were stained red.
Microscopically, dose-dependent increase in deposits of the substance in the proximal tubulesof the kidneys were found in the top two dose groups (200 and 1000 mg/kg bw), which is interpreted to be a sign of reabsorption of the dye resulting in intra-cellular lysosomal storage. No other substance-related changes were observed.
In summary, in this 29-day subacute toxicity test (28 applications in 29 days)the administreation of Reactive Red 239 resulted in a dose-dependent incorporation of the substance in the proximal tubule of the kidneys without causing changes in renal morphology in animals of the 200 and 1000 mg/kg bw groups.Since the clinical chemistry parameters revealed also no evidence of impaired renal function in the 1000 mg/kg bw-group,a toxic effect is unlikely in this dose group.
Consequently, the 'no observed effect level' (NOEL) in this study is 200 mg/kg bw/day. Howerer, clear signs of toxic effects were also not seen in the 1000 mg/kg bw group, which was defined as the 'no observed adverse effect level' (NOAEL).
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