-S9 First test Treatment/recovery time Positive: mitomycin C =3/18 hours (0.8 g/mL) 6.25, 12.5, 25, 50, 100*, Negative: DMSO 200*, 400* and 800 g/mL Second test Treatment time=21 hours 50, 100, 150, 200*, 300*, Positive: mitomycin C 400*, 500* and 600 g/mL (0.4 g/mL) Negative: DMSO +S9 First test Treatment/recovery time Positive: =3/18 hours cyclophosphamide 6.25, 12.5, 25, 50, 100*, (20 g/mL) 200*, 400* and 800* g/mL Negative: DMSO Second test Treatment/recovery time =3/18 50, 100, 200*, 400*, 500, 600, 700 and 800* g/mL DMSO dimethylsulphoxide – * cultures selected for metaphase analysis OECD TG 473 Test method: The notified chemical showed toxic at 400 and 800 g/mL Comment: without S9 and 800 g/mL with S9 in the first test, and showed toxic at 600 g/mL without S9 in the second test. Precipitates were observed at the 235.5 g/mL in culture medium when DMSO was used as the solvent. The notified chemical did not show indication of inducing chromosomal aberrations in the absence or presence of metabolic activation in this cytogenetic test system. in vitro Both positive control compounds caused large, statistically significant increases in the proportion of aberrant cells. The notified chemical was non clastogenic under the Result: conditions of the test. 9.3.3 Mammalian Cell Gene Mutation Test in the Mouse (Adams, 1998) in vitro Mouse lymphoma L5178Y cells Cells: Liver fraction (S9 mix) from rats pretreated with Aroclor Metabolic activation 1254. system:
-S9 First test Treatment/recovery time =3/18 hours 6.25, 12.5, 25, 50, 100*, 200*, 400* and 800 g/mL Positive: mitomycin C (0.8 g/mL) Negative: DMSO Positive: mitomycin C (0.4 g/mL) Negative: DMSO Second test Treatment time=21 hours 50, 100, 150, 200*, 300*, 400*, 500* and 600 g/mL +S9 First test Treatment/recovery time =3/18 hours 6.25, 12.5, 25, 50, 100*, 200*, 400* and 800* g/mL Positive: cyclophosphamide (20 g/mL) Negative: DMSO Second test Treatment/recovery time =3/18 50, 100, 200*, 400*, 500, 600, 700 and 800* g/mL DMSO – dimethylsulphoxide * cultures selected for metaphase analysis Test method: OECD TG 473 Comment: The notified chemical showed toxic at 400 and 800 g/mL without S9 and 800 g/mL with S9 in the first test, and showed toxic at 600 g/mL without S9 in the second test. Precipitates were observed at the 235.5 g/mL in culture medium when DMSO was used as the solvent. The notified chemical did not show indication of inducing chromosomal aberrations in the absence or presence of metabolic activation in this in vitro cytogenetic test system. Both positive control compounds caused large, statistically significant increases in the proportion of aberrant cells. Result: The notified chemical was non clastogenic under the conditions of the test. 9.3.3 Mammalian Cell Gene Mutation Test in vitro in the Mouse (Adams, 1998) Cells: Mouse lymphoma L5178Y cells Metabolic activation system: Liver fraction (S9 mix) from rats pretreated with Aroclor 1254.
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