Challenge Erythema was absent in both induced and uninduced – animals. The body weight changes were normal in all animals. During observation period, diarrhoea and soiling of the anogenital area were noted. was no evidence of reactions indicative of skin sensitisation to the notified chemical under the conditions of the test. MB Research Laboratories (2002b). 7.7. Repeat dose toxicity Not determined. 7.8. (a) Genotoxicity bacteria – Zonatac Alternate #1 Lite (ASL 5264) PH 301T AC-015-84 30/10/84 – Method analogous to OECD TG 471 Bacterial Reverse Mutation Test. Plate incorporation method. Species/Strain S. typhimurium: TA1538, TA1535, TA1537, TA98, TA100. Metabolic Activation System S-9 fraction from Aroclor 1254-treated rat liver. Concentration in a) With metabolic activation: 100 10,000µg/plate. – Main Test b) Without metabolic activation: 100 10,000µg/plate. – Vehicle Tetrahydrofuran (THF) Remarks Method No strains were tested. Preliminary test carried out Escherichia coli – without metabolic activation. . Metabolic Test Substance Concentration (µg/plate) Resulting in: Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect PreliminaryTest* Main Test Present Test 1 N/A 100 g/plate Negative ≥ Absent Test 1 >10,000g/plate >10,000g/plate 100 g/plate Negative ≥ *TA1538, TA100 used in preliminary test Remarks Results There were no observed increases in mutation frequencies in strains – TA1535, TA1537, TA1538, TA98 and TA100 of Salmonella with and without metabolic activation preparation at doses typhimurium of 100, 333, 1000, 3333 and 10,000 Results of positive and μg/plate. negative controls were within historical control data. The notified chemical was not mutagenic to bacteria under the conditions of the test. Pharmakon (1984a) 7.8. (b) Genotoxicity bacteria – Zonatac Alternate #1 (ASL 5263)
Challenge – Erythema was absent in both induced and uninduced animals. The body weight changes were normal in all animals. During observation period, diarrhoea and soiling of the anogenital area were noted. was no evidence of reactions indicative of skin sensitisation to the notified chemical under the conditions of the test. MB Research Laboratories (2002b). 7.7. Repeat dose toxicity Not determined. 7.8. (a) Genotoxicity – bacteria Zonatac Alternate #1 Lite (ASL 5264) PH 301T – AC-015-84 30/10/84 Method analogous to OECD TG 471 Bacterial Reverse Mutation Test. Plate incorporation method. Species/Strain S. typhimurium: TA1538, TA1535, TA1537, TA98, TA100. Metabolic Activation System S-9 fraction from Aroclor 1254-treated rat liver. Concentration in Main Test a) With metabolic activation: 100 – 10,000µg/plate. b) Without metabolic activation: 100 – 10,000µg/plate. Vehicle Tetrahydrofuran (THF) Remarks – Method No Escherichia coli strains were tested. Preliminary test carried out without metabolic activation. . Metabolic Activation Test Substance Concentration (µg/plate) Resulting in: Cytotoxicity in PreliminaryTest* Cytotoxicity in Main Test Precipitation Genotoxic Effect Present Test 1 N/A ≥ 100 g/plate Negative Absent Test 1 >10,000g/plate >10,000g/plate ≥ 100 g/plate Negative *TA1538, TA100 used in preliminary test Remarks – Results There were no observed increases in mutation frequencies in strains TA1535, TA1537, TA1538, TA98 and TA100 of Salmonella typhimurium with and without metabolic activation preparation at doses of 100, 333, 1000, 3333 and 10,000 μg/plate. Results of positive and negative controls were within historical control data. The notified chemical was not mutagenic to bacteria under the conditions of the test. Pharmakon (1984a) 7.8. (b) Genotoxicity – bacteria Zonatac Alternate #1 (ASL 5263)