positive controls: Texapon N28 1% AS sodium dodecyl sulphate 0.5% AS negative control: demineralised according to COLIPA standard; evaluated according to Test method: Frosch scale (Frosch, 1979) skin reactions of erythema, oedema, scaling and fissures Comment: 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 notified chemical was well tolerated by the human skin Result: 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 chromosomal aberration assay in Chinese in vitro 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 (NOHSC, 1999). Approved Criteria for Classifying Hazardous Substances 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 LC50(96 h) > 100 mg/L Brachydanio rerio [OECD 203] (zebra fish) NOEC = 100 mg/L Acute Immobilisation EC50(48 h) > 100 mg/L Daphnia magna [OECD 202/1 ] NOEC = 100 mg/L
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
NA861FR.docx