NA/608 FULL PUBLIC REPORT LR-147 APPLICANT Panasonic Australia Pty Limited of Austlink Corporate Park 1 Garigal Road BELROSE NSW 2085 and Kyocera Electronics Australia Pty Limited of Unit 8, 43-45 Herbert Street ARTARMON NSW 2064 have submitted a standard notification statement in support of their application for an assessment certificate for LR-147. IDENTITY OF THE CHEMICAL LR-147 is not a hazardous substance on the toxicological data provided. Therefore the chemical name, CAS number, molecular and structural formulae, molecular weight, spectral data and details of exact import volume have been exempted from publication in the Full Public Report and the Summary Report. Trade Name: LR-147 Method of Detection and Determination: ultraviolet/visible (UV/Vis) spectrophotometry, infrared (IR) spectroscopy and nuclear magnetic resonance (NMR) spectroscopy PHYSICAL AND CHEMICAL PROPERTIES Appearance at 20°C and 101.3 kPa: white powder Melting Point: decomposes prior to melting at 340°C Specific Gravity: 1.3735 at 23C Vapour Pressure: < 1.3 x 10-9 kPa at 25°C (estimate) Water Solubility: 4 380 mg.L-1 at 20°C and pH 4
Morphological findings: no abnormalities were noted for animals that survived the dosing; the animal that died on the day of dosing had haemorrhagic lungs, dark liver, dark kidneys and haemorrhage of the gastric mucosa Test method: similar to OECD TG 401 (Organisation for Economic Co-operation and Development, 1995- 1996) LD50: > 2 000 mg.kg-1 Result: the notified chemical is of low acute oral toxicity in rats Dermal Toxicity (Tuffnell, 1992b) Species/strain: rat/Sprague-Dawley Number/sex of animals: 5/sex Observation period: 14 days Method of administration: dose of 2 000 mg.kg-1 of the notified chemical was applied to an area of shaved skin for 24 hours under an occlusive dressing Clinical observations: no signs of systemic toxicity were observed; desquamation was noted at the treatment sites of four females three to six days after dosing and persisted in two females seven days after dosing Mortality: nil Morphological findings: nil Test method: similar to OECD TG 402 (Organisation for Economic Co-operation and Development, 1995- 1996) LD50: > 2 000 mg.kg-1 Result: the notified chemical is of low toxicity when applied dermally to rats
Inhalation Toxicity No was provided by the notifier. Skin Irritation (Tuffnell, 1992c) Species/strain: rabbit/New Zealand Number/sex of animals: 3 males Observation period: 72 hours Method of administration: 0.5 g of the test material, moistened with 0.5 mL distilled was applied under a gauze patch for a period of 4 hours Test method: similar to OECD TG 404 (Organisation for Economic Co-operation and Development, 1995- 1996) Draize scores (Draize, 1959) (see Attachment 1 for Draize scales): one animal developed erythema and oedema (Draize score of 1) by the 24 hour reading; oedema had cleared by 48 and erythema had disappeared by day 7 Result: the notified chemical is a slight irritant to the skin of rabbits Eye Irritation (Tuffnell, 1992d) Species/strain: rabbit/New Zealand Number/sex of animals: 3 males Observation period: 72 hours for two of the animals, 7 days for the third animal. Method of administration: 0.1 mL of the test solution was placed into the conjunctival sac of the right eye; the left eye was used as a control; animals 2 and 3 were administered one drop of local anaesthetic into each eye 1-2 minutes before dosing
control: 0 mg.kg-1.day-1 low dose: 150 mg.kg-1.day-1 mid dose: 400 mg.kg-1.day-1 high dose: 1 000 mg.kg-1.day-1 an additional satellite group of 10 animals (5/sex) included in the control and high dose groups were maintained for a further 14-day recovery period prior to sacrifice Clinical observations: mid and low dose animals showed no of toxicity during the study; high dose animals of both sexes showed isolated incidents of increased salivation after day 5, together with fur wetting and red/brown staining of the external body surface; one high does female developed hunched posture, pilo- erection, decreased respiratory rate, lethargy and ptosis by day 27; following dosing, deterioration continued and the animal was killed in extremis Clinical mid and low dose animals showed no treatment- related changes in blood chemistry or haematological parameters; high dose animals of both sexes and mid- dose males showed increases in plasma alkaline phosphatase; male animals in this group showed increases in aspartate aminotransferase and bilirubin while both cholesterol and triglycerides were slightly elevated in females; plasma alanine aminotransferase was also slightly raised in all animals in the high dose group; treatment-related changes had regressed completely after 14 days without treatment; all high- dose animals showed a reduction in haemoglobin concentration and haematocrit; reductions in mean corpuscular haemoglobin and mean corpuscular volume suggest that the anaemia was microcytic and hypochromic in nature; cessation of treatment resulted in complete recovery by day 14 Terminal studies, including histopathology: high dose animals of both sexes had a statistically significant increase in both absolute and relative liver weight compared with controls; several animals had a pale liver at the end of the treatment period; treatment-related hepatic changes were observed including hepatocyte enlargement and increased hepatocytoplasmic density but no evidence of hepatocellular degeneration; the brain and kidney