Dosing schedule: Metabolic Experiment/ Test concentration (g/mL) Controls Activation Study Number -S9 I harvest time = 18 Positive: EMS treatment time = 4 0, 25.6, 64.0*, 160.0*, 400.0p*, 1000.0p and 2860p II harvest time = 18 hours Negative: ethanol treatment time = 18 0, 6.3*, 12.5*, 25.0*, 50.0p, 100.0p and 200.0p II harvest time = 18 treatment time = 28 0, 25.0, 50.0, 100.0 and 200.0p* +S9 I harvest time = 18 Positive: CP treatment time = 4 hours 0, 25.6, 64.0, 160.0*, 400.0p*, 1 Negative: ethanol 000.0p* and 2860.0p* II harvest time = 28 hours treatment time = 4 hours 0, 25.6, 64.0, 160.0, 400.0p*, 1 000.0p* and 2860.0p* EMS - ethyl methanesulphonate * doses selected for metaphase analysis CP - cyclophosphamide p turbidity of the test item at the of treatment, oily film on the surface of culture medium after 4 hours – OECD TG 476 Test method: in both experiments neither significant/biologically relevant Comment: increases in chromosomal aberrations nor an increase in the frequencies of polyploid metaphases were observed the notified chemical was non clastogenic under test Result: conditions 9.4 Human Patch Test (Kremer and Holz, 1999) Three different chemicals were tested. Only findings relevant to the notified chemical are included in this report. Humans Species/strain: 20 volunteers of both sexes Number and sex: a single dose of the notified chemical (100%, 70 L) was Doses and method of applied under a occlusive dressing for 24 hours on the backs administration: of the test subjects
Dosing schedule: Metabolic Activation Experiment/ Study Number Test concentration (g/mL) Controls -S9 I harvest time = 18 treatment time = 4 0, 25.6, 64.0*, 160.0*, 400.0p*, 1000.0p and 2860p Positive: EMS Negative: ethanol II harvest time = 18 hours treatment time = 18 0, 6.3*, 12.5*, 25.0*, 50.0p, 100.0p and 200.0p II harvest time = 18 treatment time = 28 0, 25.0, 50.0, 100.0 and 200.0p* +S9 I harvest time = 18 treatment time = 4 hours 0, 25.6, 64.0, 160.0*, 400.0p*, 1 000.0p* and 2860.0p* Positive: CP Negative: ethanol II harvest time = 28 hours treatment time = 4 hours 0, 25.6, 64.0, 160.0, 400.0p*, 1 000.0p* and 2860.0p* EMS - ethyl methanesulphonate * doses selected for metaphase analysis CP - cyclophosphamide p – turbidity of the test item at the of treatment, oily film on the surface of culture medium after 4 hours Test method: OECD TG 476 Comment: in both experiments neither significant/biologically relevant increases in chromosomal aberrations nor an increase in the frequencies of polyploid metaphases were observed Result: the notified chemical was non clastogenic under test conditions 9.4 Human Patch Test (Kremer and Holz, 1999) Three different chemicals were tested. Only findings relevant to the notified chemical are included in this report. Species/strain: Humans Number and sex: 20 volunteers of both sexes Doses and method of administration: a single dose of the notified chemical (100%, 70 L) was applied under a occlusive dressing for 24 hours on the backs of the test subjects
NA861FR.docx