NA/439 FULL PUBLIC REPORT FAT 40’530/A 1. APPLICANT Ciba-Geigy Australia Ltd of 235 Settlement Road THOMASTOWN Victoria 3074 has submitted a standard notification statement with their application for an assessment certificate for FAT 40’530/A. 2. IDENTITY OF THE CHEMICAL Fat 40’530/A is not considered to be hazardous based on the nature of the chemical and the data provided. Therefore the chemical name, chemical abstract service number, molecular and structural formulae, spectral data, exact purity, use and volume have been exempted from publication in the Full Public Report and the Summary Report. Other Names: FAT 40’530/A Reactive Navy DER 7850 (50.2% of the notified chemical together with known coloured, unknown coloured, known uncoloured and unknown uncoloured by- products) Trade Name: Cibacron Navy LS-G (notified chemical, by- products, stabilising agents, inhibitors and other additives) Method of Detection and Determination: the notified chemical is identified by nuclear magnetic resonance (NMR) and infrared (IR) spectroscopy and quantitatively determined by ultraviolet (UV/Vis) spectral analysis 3. PHYSICAL AND CHEMICAL PROPERTIES Appearance at 20°C and 101.3 kPa: violet to blue black powder Odour: no odour Melting does not melt but decomposes at > 230°C Density: 1 790 kg/m3 at 23oC Vapour Pressure: 3.6 x 10-37 kPa at 25°C
(v/v); distilled water; adjuvant/saline 1:1 (v:v) mixture with distilled water(w/w) 1:1. Induction at day 8: test topical: 50% notified chemical in distilled water; control group distilled water only Challenge at day 22: test and control group 1, 50% notified chemical in distilled water and distilled water only. Re-challenge at day 29: test and control group 2, 15 and 25% notified chemical in distilled water The Challenge Outcome: Challenge Concentration 24 hrs 48hrs test control test control 0% 0/20 0/10 0/20 0/10 25% 14/20 *4/10 13/20 4/10 * 50% concentration of FAT’530/A showed an irritancy potential of 40% on the control group 1. A second challenge was performed with two lower concentrations, 15% and 25% on the same test group but using a new control group (control group 2) Re-challenge Concentration 24 hrs 48hrs test control test control 0% 3/20 0/10 0/20 0/10 25% 7/20 0/10 6/20 0/10 Test Method: Directive 92/69/EEC (5) test B6 (27) Result: skin sensitiser in the guinea 9.1.6.2 Test 2 (13) Species/strain: Himalayan spotted guinea pig Number of animals: 20 in test group, female guinea pigs/10 in control groups (Ibm: GOHI) Induction at day 1: test group: injections of adjuvant/saline mixture 1:1 (v/v); 5% notified chemical in distilled water; 5% notified chemical in the
presence of metabolic activation, in the duplicate experiment the limit was nearly exceeded under same conditions; weakly mutagenic with metabolic activation 9.3.2 In Vitro cytogenetic assay in Chinese hamster V79 cells (16) Dose levels: Experiment 1 18h: 3, 10, 30 g/ml 28h: 100g/ml (without metabolic activation) 18h: 30, 50, 100 g/ml (with metabolic activation) Experiment 2 18h: 100, 300, 500g/ml 28h: 500g/ml (without metabolic activation 18h: 50, 100, 300 g/ml 28h: 500 g/ml Experiment 3 18h: 100, 500, 500g/ml 28h: 500g/ml (without metabolic activation 18h: 100, 300, 500 g/ml 28h: 400 g/ml Metabolic activation: rat liver S9 Test Method: 84/449/EEC Test B10 (27) Toxicologically significant observations: in experiment 3, in the absence of metabolic activation, toxicity was observed with 1000 g/ml (28 h interval; 27.8%) and 800 g/ml (28 h interval; 53.3%); in experiment 3 in the presence of metabolic activation toxicity was observed with 500 g/ml (18 h interval; 16.1%) at other dose levels there were no significant reduction in mitotic index to infer toxicity Result: the notified chemical showed clastogenic effects in Chinese hamster V79 cells in vitro with metabolic activation 9.4 Overall Assessment of Toxicological Data