level of alkaline phosphatase in males at 400 mg.kg-1.d-1; statistically significant changes in liver weight and haematological parameters were observed at 1 000 mg.kg-1.d-1 9.3 Genotoxicity 9.3.1 Salmonella typhimurium and Escherichia coli Reverse Mutation Assay (Nishiuchi, 1991) Strains: S. typhimurium TA1535, TA1537, TA98 and TA100; Escherichia coli WP2uvrA Concentration 0 - 5000 µg per plate; assays were carried out in the presence or absence of rat liver S9 fraction Test method: similar to OECD TG 471 (Organisation for Economic Co-operation and Development, Result: the notified chemical was not mutagenic in either of the assays in the bacterial strains tested either with or without metabolic activation provided by rat S9 fraction 9.3.2 Salmonella typhimurium and Escherichia coli Reverse Mutation Assay (Thompson, 1993) Strains: S. typhimurium TA1535, TA1537, TA98 and TA100; Escherichia coli WP2uvrA Concentration range: 0 - 5000 µg per plate; assays were carried out in the presence or absence of rat liver S9 fraction Test method: similar to OECD TG 471 (Organisation for Economic Co-operation and Development, Result: the notified chemical was not mutagenic in either of the assays in the bacterial strains tested either with or without metabolic activation provided by rat liver S9 fraction 9.3.3 Chromosomal Aberration Assay in Chinese Hamster Lung Cells (Wright, 1993)
concentration 24 hours* 48 hours* 24 48 25% 0/20** 0/20 0/10 0/10 50% 0/20 0/20 0/10 0/10 * time after patch removal ** number of animals exhibiting positive response Test method: Buehler delayed contact hypersensitivity study based on OECD TG 406 (Organisation for Economic Co-operation and Development, Result: M32F was not a skin sensitiser when tested in guinea pigs Salmonella typhimurium Reverse Mutation Assay on M32F-Y (Thompson, 1996a) Strains: S. typhimurium TA1535, TA1537, TA1538, TA98 and TA100 Concentration range: 0 – 5 000 µg per plate; assays were carried out in the presence or absence of rat liver S9 fraction Test method: similar to OECD TG 471 (Organisation for Economic Co-operation and Development, Result: M32F-Y was not mutagenic in either of the assays in the bacterial strains tested either with or without metabolic activation provided by rat liver S9 fraction Salmonella typhimurium Reverse Mutation Assay on M32F-Y (Thompson, 1996b) Strains: S. typhimurium TA1535, TA1537, TA1538, TA98 and TA100 Concentration range: 0 – 5 000 µg per plate; assays were carried out in the presence or absence of rat liver S9 fraction Test method: similar to OECD TG 471 (Organisation for Economic Co-operation and Development, Result: M32F-M was not mutagenic in either of the assays in the bacterial strains tested either with or without
Vessels normal Vessels definitely injected normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids Swelling with lids to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent Discharge with moistening of lids and hairs and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe