metabolic activation; no significant increases in revertant colonies for any of the bacterial strains at any dose with or without metabolic activation; according to OECD guidelines (Organisation for Test method: Economic Cooperation and Development, 1983b), (Organisation for Economic Cooperation and Development, 1983a) the notified chemical was considered not to be Result: mutagenic in the bacterial strains tested with and without metabolic activation Micronucleus Assay in the Bone Marrow Cells of the Mouse not conducted. Overall Assessment of Toxicological Data The studies were conducted on a reaction mixture known as M-1999, containing the notified chemical. The notifier made claims for variation of the Schedule data requirements (acute inhalation studies, skin sensitisation, repeat dose toxicity and germ cell in vivo induction and chromosome damage) on the basis that the notified chemical is never in vitro isolated from the reaction mixture and therefore the pure substance is not available for testing. This claim for variation was accepted. M-1999 exhibited low acute oral toxicity in rats: the LD50 for males was 590 mg/kg and for females 540 mg/kg. In an acute dermal toxicity test, M-1999 was moderately toxic to rabbits with an LD50 in the range of 200 to 2 000 mg/kg. M-1999 is an eye irritant, with corneal and conjunctival effects present in rabbits at 21 days. Necrotic skin was visible after a 4-hour treatment in the skin corrosivity test and severe oedema and/or well-defined erythema-pallor persisted for seven days in the skin irritation study. M-1999 was not mutagenic in and strains with or Salmonella typhimurium Escherichia coli without metabolic activation. M-1999 is toxic via the oral and dermal route, irritating to the eye, and corrosive to skin. M- 1999 is not mutagenic to bacteria. Therefore, on the basis of the toxicological data provided, M-1999 would be classified as a hazardous substance (Toxic) in accordance with the NOHSC (ref). The appropriate risk phrases are R24 Toxic in contact with skin, Approved Criteria – R22 Harmful if swallowed, R34 Causes burns, and R36 Irritating to eyes. – – –
metabolic activation; no significant increases in revertant colonies for any of the bacterial strains at any dose with or without metabolic activation; Test method: according to OECD guidelines (Organisation for Economic Cooperation and Development, 1983b), (Organisation for Economic Cooperation and Development, 1983a) Result: the notified chemical was considered not to be mutagenic in the bacterial strains tested with and without metabolic activation Micronucleus Assay in the Bone Marrow Cells of the Mouse not conducted. Overall Assessment of Toxicological Data The studies were conducted on a reaction mixture known as M-1999, containing the notified chemical. The notifier made claims for variation of the Schedule data requirements (acute inhalation studies, skin sensitisation, repeat dose toxicity and in vivo germ cell induction and in vitro chromosome damage) on the basis that the notified chemical is never isolated from the reaction mixture and therefore the pure substance is not available for testing. This claim for variation was accepted. M-1999 exhibited low acute oral toxicity in rats: the LD50 for males was 590 mg/kg and for females 540 mg/kg. In an acute dermal toxicity test, M-1999 was moderately toxic to rabbits with an LD50 in the range of 200 to 2 000 mg/kg. M-1999 is an eye irritant, with corneal and conjunctival effects present in rabbits at 21 days. Necrotic skin was visible after a 4-hour treatment in the skin corrosivity test and severe oedema and/or well-defined erythema-pallor persisted for seven days in the skin irritation study. M-1999 was not mutagenic in Salmonella typhimurium and Escherichia coli strains with or without metabolic activation. M-1999 is toxic via the oral and dermal route, irritating to the eye, and corrosive to skin. M- 1999 is not mutagenic to bacteria. Therefore, on the basis of the toxicological data provided, M-1999 would be classified as a hazardous substance (Toxic) in accordance with the NOHSC Approved Criteria (ref). The appropriate risk phrases are R24 – Toxic in contact with skin, R22 – Harmful if swallowed, R34 – Causes burns, and R36 – Irritating to eyes.
NA575FR.docx