groups; the incidence and severity of the skin histological lesions were slightly reduced after 2 weeks recovery; diffuse hepatocellular hypertrophy was seen in both male and female rats administered 2000 mg/kg/day, but the liver lesions were not observed in the recovery group Test Method: based on OECD Guidelines for Testing Chemicals No: 410 (16); it was noted that individual animal data were not provided for any of the study parameters Result: the study showed that the target organ of toxicity in rats following repeated dermal exposure was the liver; because hepatocellular hypertrophy was not observed in the 500 mg/kg/day females, the increase in absolute liver weight was not considered to be treatment related 9.3 Genotoxicity 9.3.1 Salmonella typhimurium Reverse Mutation (17) Strains: Salmonella strains TA 98, TA 100, TA 1535, TA 1537 and TA 102 Concentration range: 95, 285, 950, 2850 or 9500 µg/plate Procedure: strains were cultured with MCP 1440 in the absence or presence of rat liver S9; DMSO was used as a solvent control, and 2nitrofluorene, and mitomycin C were used as positive controls Test Method: -incorporation method in accordance with OECD Guidelines for Testing Chemicals No: 471 (18) Result: there were no significant increases in the number of revertant colonies in the treated plates compared to controls; the positive controls produced marked increases in the number of revertant colonies in all the test strains; under the test condition, MCP 1440 was not mutagenic in the Salmonella typhimurium reverse mutation assay
groups; the incidence and severity of the skin histological lesions were slightly reduced after 2 weeks recovery; diffuse hepatocellular hypertrophy was seen in both male and female rats administered 2000 mg/kg/day, but the liver lesions were not observed in the recovery group Test Method: based on OECD Guidelines for Testing Chemicals No: 410 (16); it was noted that individual animal data were not provided for any of the study parameters Result: the study showed that the target organ of toxicity in rats following repeated dermal exposure was the liver; because hepatocellular hypertrophy was not observed in the 500 mg/kg/day females, the increase in absolute liver weight was not considered to be treatment related 9.3 Genotoxicity 9.3.1 Salmonella typhimurium Reverse Mutation (17) Strains: Salmonella strains TA 98, TA 100, TA 1535, TA 1537 and TA 102 Concentration range: 95, 285, 950, 2850 or 9500 µg/plate Procedure: strains were cultured with MCP 1440 in the absence or presence of rat liver S9; DMSO was used as a solvent control, and 2nitrofluorene, and mitomycin C were used as positive controls Test Method: -incorporation method in accordance with OECD Guidelines for Testing Chemicals No: 471 (18) Result: there were no significant increases in the number of revertant colonies in the treated plates compared to controls; the positive controls produced marked increases in the number of revertant colonies in all the test strains; under the test condition, MCP 1440 was not mutagenic in the Salmonella typhimurium reverse mutation assay
NA298FR.docx