File No: NA/925 May 2001 NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME FULL PUBLIC REPORT Lexmark Red Dye 93A This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) and Regulations. This legislation is an Act of the Commonwealth of Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered by the National Occupational Health and Safety Commission which also conducts the occupational health & safety assessment. The assessment of environmental hazard is conducted by the Department of the Environment and the assessment of public health is conducted by the Department of Health and Aged Care. For the purposes of subsection 78(1) of the Act, copies of this full public report may be inspected by the public at the Library, National Occupational Health and Safety Commission, 92-94 Parramatta Road, Camperdown NSW 2050, between the following hours: Monday - Wednesday 8.30 am - 5.00 pm Thursday 8.30 am - 8.00 pm Friday 8.30 am - 5.00 pm Copies of this full public report may also be requested, free of charge, by contacting the Administration Coordinator on the fax number below. For enquiries please contact the Administration Coordinator at: Street Address: 92 -94 Parramatta Rd CAMPERDOWN NSW 2050, AUSTRALIA Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA Telephone: (61) (02) 9577 9514 FAX (61) (02) 9577 9465 Director Chemicals Notification and Assessment TABLE OF CONTENTS
skin sensitisation guinea pig Non sensitiser (Glaza MS, 1993b) 9.1.1 Oral Toxicity (Glaza MS, 1993a) Species/strain: Rats/Crl:CD BR Number/sex of animals: 5/sex Observation period: 14 days Method of administration: A single oral dose of 5000 mg/kg (0.5 g/mL in distilled water) was given by gavage Test method: OECD TG 401 (limit test) Mortality: None Clinical observations: Red-stained urine, soft stool and haircoat Morphological findings: All animals had diffusely red tail and/or hair coat around the perianal region. Microscopic investigation was not conducted in the Comment: All animals appeared normal by day 14 LD50: > 5000 mg/kg Result: the notified chemical was of very low acute oral toxicity in rats 9.1.2 Dermal Toxicity (Allen DJ, 1996) Species/strain: Rats/Sprague-Dawley Number/sex of animals: 5/sex Observation period: 14 days Method of administration: A single dermal dose of 2000 mg/kg (moistened with distilled was applied under a semi-occlusive dressing for 24 hours Test method: OECD TG 402 (limit test) Mortality: None Clinical observations: None
Morphological findings: No treatment related changes were observed at necropsy. Microscopic investigation was not conducted in the study. Comment: Purple coloured staining of the treatment site was in all animals which prevented accurate evaluation of erythema during the study. LD50: > 2000 mg/kg Result: the notified chemical was of low dermal toxicity in rats Inhalation Toxicity No report on inhalation toxicity was provided. 9.1.4 Skin Irritation (Glaza MS, 1992) Species/strain: Rabbits/New Zealand White Number/sex of animals: 3/sex Observation period: 7 days Method of administration: A single dermal dose of 0.5 g notified chemical (moistened with 0.9% saline) was applied under a semi-occlusive dressing for 4 hours Test method: OECD TG 404 Draize scores: Time Animal # treatment (days) 1 2 3 4 5 6 Erythema 1 2a,b,c 2b,c 1c 1c 1c 1c 2 2b,c 2b,c 1c 1c 1c 1c 3 2b,c 2b,c 1c 1c 1c 1c 4 1 1 0 1 1 0 7 0d 0d 0 0 0 0 Oedema 1 0 1 1 0 0 1
6 0* 0 0* 0 0* 0 0 0 0 0 Iris All animals scored zero Conjunctiva r c d r c d r c d r c d r c d 1 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 2 2 1 0 1 0 0 1 0 0 0 0 0 0 0 0 3 1 1 0 1 1 0 1 1 0 1 0 0 0 0 0 4 1 0 0 1 0 0 1 0 0 1 0 0 0 0 0 5 1 1 0 1 0 0 0 0 0 0 0 0 0 0 0 6 1 1 0 1 1 0 1 0 0 0 0 0 0 0 0 1 see Attachment 1 for Draize scales * no apparent opacity; cornea stained light-red to dark purple which resolved by day 4 o = opacity a = area r = redness c = chemosis d = discharge Comment: No staining was evident in all animals when fluorescein dye was applied to the eyes at 24 and 72 hours, and day 7. All treated eyes returned to normal by day 7 Result: the notified chemical was slightly irritating to the eyes of rabbits 9.1.6 Skin Sensitisation (Glaza MS, 1993b) Species/strain: Guinea pigs/Crl: (HA)BR Number of animals: Control 10 Test group: 20 Induction procedure: test group: day 1 day 7 day 8 Intradermal Induction: pairs of intradermal injections (0.1mL) across the shoulder region of the animals: Freund’s complete adjuvant (FCA) 1:1 in sterile water 5% w/v notified chemical in sterile water 5% w/v notified chemical in a 1:1 mixture of FCA and sterile water Local Irritation: Animals pre-treated with 10% w/w sodium lauryl sulphate in petrolatum at the induction site Topical Induction: A 48-hour occluded application of 25% w/w notified chemical in petrolatum to the test area.
The test material did not induce significant increases in the numbers of polyploid cells in both experiments at any dose level, in the presence or absence of S9. Result: the notified chemical was non clastogenic the conditions of the test 9.3.4 Micronucleus Assay in the Bone Marrow Cells of the Mouse No report of in vivo micronucleus assay was provided. 9.4 Overall Assessment of Toxicological Data The notified chemical was of very low acute oral (LD50 >5000 mg/kg) and low acute dermal toxicity (LD50 >2000 mg/kg) in rats. No report on inhalation toxicity was provided. It was a slight eye irritant and slight to moderate skin irritant to rabbits. Evidence of skin sensitisation potential was not observed in guinea pigs in an adjuvant study. In a repeat dose oral toxicity study in rats, a NOAEL was established as >1000 mg/kg/day based on no adverse effects at the highest dose tested. The notified chemical was not mutagenic in the bacterial stains tested. In an in vitro chromosome aberration study using human lymphocytes, a non-dose response slight increase in aberrant cells were observed in the absence of metabolic activation (S9). No report of an in vivo micronucleus assay was provided. Based on the toxicological data provided, the notified chemical, Lexmark Red Dye 93A is not classified as a hazardous substance according to the NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC, 1999). 10. ASSESSMENT OF ENVIRONMENTAL EFFECTS The following ecotoxicity studies have been supplied by the notifier and are summarised in the following table. The tests were performed in compliance with OECD/EEC Test Methods and according to OECD Principles of Good Laboratory Practices. Test Species Results (Nominal concentrations) Acute Toxicity – Semi-Static (OECD TG 203) Rainbow Trout Oncorhynchus mykiss 96 h LC50 > 100 mg/L NOEC > 100 mg/L Acute Toxicity – Immobilisation (OECD TG 204) Water Flea Daphnia 48 h EC50 > 100 mg/L NOEC > 100 mg/L