Test 2 Not seen 1 000 Not seen >5 000 1 000 Present Test 1 Not seen 1 000 Not seen Test 2 Not seen 1 000 Not seen Remarks - Results No significant increases in revertant colony numbers of any tested strains were observed following treatment with the notified chemical either in the presence or absence of metabolic activation in both incorporation test and pre-incubation test. The positive controls induced a distinct increase of induced revertant colonies. The notified chemical was not mutagenic to bacteria under the conditions of the test. Bioservice Scientific Laboratories GmbH (1999g). 7.9. Genotoxicity in vitro – Komplexseife TH17 OECD TG 473 In vitro Mammalian Chromosomal Aberration Test. Cell Type/Cell Line Chinese hamster V79 Metabolic Activation S-9 mix System Vehicle DMSO Remarks - Method GLP & QA. Metabolic Test Substance Concentration (μg/mL) Exposure Harvest Activation Period Time Absent Test 1 0, 5*, 50* and 100* 4 h 20 h Test 2 0, 5*, 50* and 100* 20 h 20 h Present Test 1 0, 5*, 50* and 100* 4 h 20 h *Cultures selected for metaphase analysis. Metabolic Test Substance Concentration (µg/mL) Resulting in: Activation Cytotoxicity in Cytotoxicity in Precipitation Genotoxic Effect PreliminaryTest Main Test Absent Test 1 Not seen 5 Not seen Test 2 Not seen 5 Not seen Present Test 1 Not seen 5 Not seen Remarks - Results The notified chemical did not increase the frequency of aberration in Chinese V79 cells in the presence and absence of metabolic activation. The positive controls induced a significant increase of cells with structural chromosome aberrations above test laboratory’s historic control level.
Test 2 Not seen 1 000 Not seen Present >5 000 1 000 Test 1 Not seen 1 000 Not seen Test 2 Not seen 1 000 Not seen Remarks - Results No significant increases in revertant colony numbers of any tested strains were observed following treatment with the notified chemical either in the presence or absence of metabolic activation in both incorporation test and pre-incubation test. The positive controls induced a distinct increase of induced revertant colonies. The notified chemical was not mutagenic to bacteria under the conditions of the test. Bioservice Scientific Laboratories GmbH (1999g). 7.9. Genotoxicity – in vitro Komplexseife TH17 OECD TG 473 In vitro Mammalian Chromosomal Aberration Test. Cell Type/Cell Line Chinese hamster V79 Metabolic Activation System S-9 mix Vehicle DMSO Remarks - Method GLP & QA. Metabolic Activation Test Substance Concentration (μg/mL) Exposure Period Harvest Time Absent Test 1 0, 5*, 50* and 100* 4 h 20 h Test 2 0, 5*, 50* and 100* 20 h 20 h Present Test 1 0, 5*, 50* and 100* 4 h 20 h *Cultures selected for metaphase analysis. Metabolic Activation Test Substance Concentration (µg/mL) Resulting in: Cytotoxicity in PreliminaryTest Cytotoxicity in Main Test Precipitation Genotoxic Effect Absent Test 1 Not seen 5 Not seen Test 2 Not seen 5 Not seen Present Test 1 Not seen 5 Not seen Remarks - Results The notified chemical did not increase the frequency of aberration in Chinese V79 cells in the presence and absence of metabolic activation. The positive controls induced a significant increase of cells with structural chromosome aberrations above test laboratory’s historic control level.
STD1021FR.docx