no increase in the number of revertant colonies Comments: occurred with any of the 4 strains of bacteria at the concentrations tested either in the presence or absence of metabolic activation; the ability of the test system to detect known mutagens was demonstrated with positive controls. all strains showed toxicity at 5 000 both in g/plate the presence and absence of S-9 and slight toxicity at 500 in the presence of S-9. g/plate under the study conditions, the notified chemical Result: did not induce mutations in the bacteria strains tested. Metaphase Chromosome Analysis of Human Lymphocytes Cultured in vitro (Akhurst, 1996) cultured human lymphocytes Species/strain: first test: Concentration 156.3-625 (without S-9, 21 hour harvest), g/mL 312.5-1 250 (with S-9, 21 hour harvest); g/mL second test: 156.3-625 (without S-9, 21 hour harvest), g/mL 625-1 500 (with S-9, 21 hour harvest), g/mL 625 (without S-9, 45 hour harvest), g/mL 1 500 (with S-9, 45 hour harvest). g/mL OECD TG 473 (Organisation for Economic Co- Test method: operation and Development, 1995-1996) the notified chemical caused no statistically Comments: significant increases in the proportion of metaphase figures containing chromosomal aberrations at any dose level when compared with the solvent control in both the absence and presence of S-9. All positive controls caused large statistically significant increases in the proportion of aberrant cells. the notified chemical showed no evidence of Result: clastogenic activity in this cytogenetic test in vitro system.
Comments: no increase in the number of revertant colonies occurred with any of the 4 strains of bacteria at the concentrations tested either in the presence or absence of metabolic activation; the ability of the test system to detect known mutagens was demonstrated with positive controls. all strains showed toxicity at 5 000 g/plate both in the presence and absence of S-9 and slight toxicity at 500 g/plate in the presence of S-9. Result: under the study conditions, the notified chemical did not induce mutations in the bacteria strains tested. Metaphase Chromosome Analysis of Human Lymphocytes Cultured in vitro (Akhurst, 1996) Species/strain: cultured human lymphocytes Concentration first test: 156.3-625 g/mL (without S-9, 21 hour harvest), 312.5-1 250 g/mL (with S-9, 21 hour harvest); second test: 156.3-625 g/mL (without S-9, 21 hour harvest), 625-1 500 g/mL (with S-9, 21 hour harvest), 625 g/mL (without S-9, 45 hour harvest), 1 500 g/mL (with S-9, 45 hour harvest). Test method: OECD TG 473 (Organisation for Economic Co- operation and Development, 1995-1996) Comments: the notified chemical caused no statistically significant increases in the proportion of metaphase figures containing chromosomal aberrations at any dose level when compared with the solvent control in both the absence and presence of S-9. All positive controls caused large statistically significant increases in the proportion of aberrant cells. Result: the notified chemical showed no evidence of clastogenic activity in this in vitro cytogenetic test system.
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