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EC number: 402-170-5
CAS number: 106359-91-5
C.I. REACTIVE YELLOW 174; GIALLO REATTIVO 174; JAUNE REACTIF 174; REAKTIV GELB 174
The subacute 28-day study with FAT 40224/C was carried out in Wistar rats according to OECD guideline 407 and EU method B.7 as per GLP compliance. The test substance administered daily by gavage to SPF-bred Wistar rats. The study was comprised of four groups, each containing 5 male and 5 female rats. The dose levels were administered are 0, 50, 200 and 1000 mg/kg body weight. No deaths which could be related to test article application occurred during the course of the study. Animal No. 38 (female, group 4) died spontaneously during anesthesia for terminal blood collection. No clinical signs which could be related to test article application were observed during the study period. No statistically significant differences in food consumption and body weight gain were observed between the animals of the test article-treated and control groups. No treatment-related findings were noted. The assessment of hematological, biochemical and urinalysis data indicated no changes of toxicological significance between treated rats and controls, at the end of the treatment. No statistically significant differences in organ weights and organ to body weight ratios were observed between the animals of the control and test article treated groups. All pathology findings recorded were of a spontaneous nature common to rats of this age and strain. There was no evidence of abnormal histopathological findings resulting from treatment with FAT 40224 / C. Based on the results obtained in this study, the "no-toxic effect- level" of FAT 40224/C is greater than 1000 mg/kg body weight for male and females rats when administered orally by gavage.
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