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
positive controls: Texapon N28 1% AS sodium dodecyl sulphate 0.5% AS negative control: demineralised Test method: according to COLIPA standard; evaluated according to Frosch scale (Frosch, 1979) Comment: skin reactions of erythema, oedema, scaling and fissures were used to determine skin tolerance to the test substance; no reactions were observed on exposure to the notified chemical all positive and negative controls responded appropriately Result: notified chemical was well tolerated by the human skin under test condition 9.5 Overall Assessment of Toxicological Data The notified chemical was of very low oral toxicity (LD50 > 5 000 mg/kg) and low dermal toxicity (LD50 > 5 000 mg/kg) in rats. In rabbits, it was a slight skin and eye irritant. The notified chemical was not a skin sensitiser in a non-adjuvant type test in guinea pigs. A 13 week repeat dose dietary study in rats established a NOEL of > 1 000 mg/kg/day the highest dose tested. The notified chemical was not mutagenic in a reverse mutation assay in bacteria. It was non clastogenic in the in vitro chromosomal aberration assay in Chinese Hamster V79 cells. The notified chemical was well tolerated in a patch test. The notified chemical is not classified as a hazardous substance according to NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC, 1999). 10. ASSESSMENT OF ENVIRONMENTAL EFFECTS The notifier provided the following ecotoxicity data, which were performed in accordance with OECD Test Guidelines. Test Species Results (Nominal, WAF) Acute Toxicity [OECD 203] Brachydanio rerio (zebra fish) LC50(96 h) > 100 mg/L NOEC = 100 mg/L Acute Immobilisation [OECD 202/1 ] Daphnia magna EC50(48 h) > 100 mg/L NOEC = 100 mg/L