9.2 Repeated dose toxicity OECD Guideline #407 (17) 9.2.1 Five day dose ranging study in rats (18) Aqueous solutions of Monoazo Red TZ 3369 were administered daily by gavage to groups of three male and three female Han Wistar rats at doses of 0, 200 mg/kg/day or 1000 mg/kg/day. Animals were observed for five days. During the males in the higher dose group had slightly reduced food consumption and a decreased gain in body weight. High dose females and rats of both sexes receiving 200mg/kg did not show these signs. No other clinical symptoms were reported during the study and no deaths occurred. At autopsy, males and females receiving 1000mg/kg day had discoloured mucosa in the upper part of the gastrointestinal tract in two out of three animals of either sex. Males receiving 1000 mg/kg/day also showed discolouration of the testes. These signs were considered to be related to the dye properties of the test compound, not to its toxicological properties. Isolated dark red foci were reported in the fundus of two high dose males. This was considered not significant in the terms of selection of dose for the 28 day oral toxicity study. Doses selected for the 28 day study were 0, 50, 200, and 1000mg/kg. 9.2.2. 28 Day oral toxicity study in rats (19) Groups of five male and five female HanIbm Wistar (SPF) rats received daily oral doses of 0, 50, 200, and 1000mg/kg/day for 28 days. An additional five males and five females were added to the group receiving 0 and 1000mg/kg/day and were observed for two weeks after dosage had been discontinued. In this report, they are designated as the recovery groups. Animals were observed daily, food consumption and body weights were recorded weekly. Haematology, serum chemistry, and urinalysis was carried out at the termination of the study either after the 28 day exposure or at the end of the two week recovery period. At necropsy, gross examination was performed and tissues taken for histopathology as follows:
9.2 Repeated dose toxicity OECD Guideline #407 (17) 9.2.1 Five day dose ranging study in rats (18) Aqueous solutions of Monoazo Red TZ 3369 were administered daily by gavage to groups of three male and three female Han Wistar rats at doses of 0, 200 mg/kg/day or 1000 mg/kg/day. Animals were observed for five days. During the males in the higher dose group had slightly reduced food consumption and a decreased gain in body weight. High dose females and rats of both sexes receiving 200mg/kg did not show these signs. No other clinical symptoms were reported during the study and no deaths occurred. At autopsy, males and females receiving 1000mg/kg day had discoloured mucosa in the upper part of the gastrointestinal tract in two out of three animals of either sex. Males receiving 1000 mg/kg/day also showed discolouration of the testes. These signs were considered to be related to the dye properties of the test compound, not to its toxicological properties. Isolated dark red foci were reported in the fundus of two high dose males. This was considered not significant in the terms of selection of dose for the 28 day oral toxicity study. Doses selected for the 28 day study were 0, 50, 200, and 1000mg/kg. 9.2.2. 28 Day oral toxicity study in rats (19) Groups of five male and five female HanIbm Wistar (SPF) rats received daily oral doses of 0, 50, 200, and 1000mg/kg/day for 28 days. An additional five males and five females were added to the group receiving 0 and 1000mg/kg/day and were observed for two weeks after dosage had been discontinued. In this report, they are designated as the recovery groups. Animals were observed daily, food consumption and body weights were recorded weekly. Haematology, serum chemistry, and urinalysis was carried out at the termination of the study either after the 28 day exposure or at the end of the two week recovery period. At necropsy, gross examination was performed and tissues taken for histopathology as follows: