no mutagenic activity of the notified chemical Result: was observed in bacteria at doses up to 5 000 g/plate in the presence or absence of metabolic activation provided by rat liver S9 fraction; positive controls demonstrated the sensitivity of the assay and negative controls were within normal limits; no cytotoxicity was evident at the top dose Chromosomal Aberration Assay in Chinese Hamster V79 Cells (Czich, 1997) Chinese Hamster V79 Cell line: concentrations ( g/mL) without S9 mix: 18 hours 10 300 (plus 1 000 in – one replicate) 28 hours 50 300 (plus 1 000 in – one replicate) with S9 mix: 18 hours 10 1 000 – 28 hours 50 1 000 – S9 mix was prepared from Wistar rats treated with Treatment details: phenobarbital and -naphthoflavone; treatment with S9 was for 4 hours, followed by 18 or 28 hours in the test article, with colcemid added 2.5 hours prior to harvest OECD guideline TG 473 (Organisation for Test method: Economic Co-operation and Development, 1995- 1996) no increase in chromosomal aberrations was Result: induced by the notified chemical; negative controls were within historical limits and positive controls demonstrated the sensitivity of the
Result: no mutagenic activity of the notified chemical was observed in bacteria at doses up to 5 000 g/plate in the presence or absence of metabolic activation provided by rat liver S9 fraction; positive controls demonstrated the sensitivity of the assay and negative controls were within normal limits; no cytotoxicity was evident at the top dose Chromosomal Aberration Assay in Chinese Hamster V79 Cells (Czich, 1997) Cell line: Chinese Hamster V79 concentrations ( g/mL) without S9 mix: 18 hours 10 – 300 (plus 1 000 in one replicate) 28 hours 50 – 300 (plus 1 000 in one replicate) with S9 mix: 18 hours 10 – 1 000 28 hours 50 – 1 000 Treatment details: S9 mix was prepared from Wistar rats treated with phenobarbital and -naphthoflavone; treatment with S9 was for 4 hours, followed by 18 or 28 hours in the test article, with colcemid added 2.5 hours prior to harvest Test method: OECD guideline TG 473 (Organisation for Economic Co-operation and Development, 1995- 1996) Result: no increase in chromosomal aberrations was induced by the notified chemical; negative controls were within historical limits and positive controls demonstrated the sensitivity of the
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