The notified chemical was non mutagenic under the Result: conditions of the test as no increases in the numbers of revertant colonies above background were observed. 9.3.2 Chromosomal Aberration Assay in human lymphocytes in vitro (Safepharm Laboratories Ltd, 2000k) Human lymphocytes. Cells: Induced rat microsomal fraction. Metabolic activation system: Dosing schedule: Experiment Test concentration (g/mL) Controls Activation Number -S9 1 Treatment time = 4 hours; Positive: EMS expression time = 16 hours. Test concentration = 0*, 39.06, 78.13, 156.25, 312.5, 625*, 1250*, Negative: Vehicle = 2500* and 5000 microgram/mL. minimal essential medium 2 Treatment time = 20 hours. Test concentration = 0, 78.13, 156.25, 312.5, 625*, 1250*, and 2500* microgram/mL. +S9 1 Treatment time = 4 hours; Positive: CP (S9 = 1%) expression time = 16 hours. Test concentration = 0*, 39.06, 78.13, 156.25, 312.5*, 625*, 1250*, Negative: Vehicle = minimal essential 2500 and 5000 microgram/mL. medium 2 Treatment time = 4 hours; (S9 = 2%) expression time = 16 hours. Test concentration = 0*, 78.13, 156.25, 312.5, 625*, 1250*, and 2500* microgram/mL. EMS = ethylmethanesulphonate; CP = cyclophosphamide * - cultures selected for metaphase analysis OECD TG 473 Test method: Positive controls demonstrated the sensitivity of the test and Comment: negative controls were within historical limits. Precipitation was observed at all dose levels and there was no reduction in mitotic index at any dose. No
Result: The notified chemical was non mutagenic under the conditions of the test as no increases in the numbers of revertant colonies above background were observed. 9.3.2 Chromosomal Aberration Assay in human lymphocytes in vitro (Safepharm Laboratories Ltd, 2000k) Cells: Human lymphocytes. Metabolic activation system: Induced rat microsomal fraction. Dosing schedule: Activation Experiment Number Test concentration (g/mL) Controls -S9 1 Treatment time = 4 hours; expression time = 16 hours. Positive: EMS Negative: Vehicle = minimal essential medium Test concentration = 0*, 39.06, 78.13, 156.25, 312.5, 625*, 1250*, 2500* and 5000 microgram/mL. 2 Treatment time = 20 hours. Test concentration = 0, 78.13, 156.25, 312.5, 625*, 1250*, and 2500* microgram/mL. +S9 1 (S9 = 1%) Treatment time = 4 hours; expression time = 16 hours. Positive: CP Negative: Vehicle = minimal essential medium Test concentration = 0*, 39.06, 78.13, 156.25, 312.5*, 625*, 1250*, 2500 and 5000 microgram/mL. 2 (S9 = 2%) Treatment time = 4 hours; expression time = 16 hours. Test concentration = 0*, 78.13, 156.25, 312.5, 625*, 1250*, and 2500* microgram/mL. EMS = ethylmethanesulphonate; CP = cyclophosphamide * - cultures selected for metaphase analysis Test method: OECD TG 473 Comment: Positive controls demonstrated the sensitivity of the test and negative controls were within historical limits. Precipitation was observed at all dose levels and there was no reduction in mitotic index at any dose. No
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