zilongwang/ReadingBank huggingface dataset:
16. National Occupational Health and Safety Commission 1994, Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(1994)], Australian Government Publishing Service, Canberra. 17. Standards Australia 1978, Australian Standard 2161-1978, Industrial Safety Gloves and Mittens (excluding electrical and medical gloves), Standards Association of Australia Publ., Sydney. 18. National Occupational Health and Safety Commission 1994, National Code of Practice for the Preparation of Material Safety Data Sheets [NOHSC:2011(1994)], Australian Government Publishing Service, Canberra. Attachment 1 The Draize for evaluation of skin reactions is as follows: Erythema Formation Rating Oedema Formation Rating No erythema 0 No oedema 0 Very slight erythema (barely perceptible) 1 Very slight oedema (barely perceptible) 1 Well-defined erythema 2 Slight oedema (edges of area by definite raising 2 Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4 The Draize scale for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible 1 slight 25% to 50% 2 Easily visible translucent details of iris slightly obscure 2 mild 50% to 75% 3 Opalescent areas, no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with 0 none 1 slight 2 mod. No swelling Any swelling above normal Obvious swelling with partial eversion of lids 0 none 1 slight 2 mild 3 mod. No discharge Any amount different from normal Discharge with moistening of lids and adjacent 0 none 1 slight 2 mod.
The Draize Scale for evaluation of skin reactions is as follows: Erythema Formation Rating Oedema Formation Rating No erythema No oedema 0 Very slight erythema (barely perceptible) 1 Very slight oedema (barely perceptible) 1 Well-defined erythema 2 Slight oedema (edges of area by definite raising 2 Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4 The Draize for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible 1 slight 25% to 50% 2 Easily visible translucent areas, details of iris slightly obscure 2 mild 50% to 75% 3 Opalescent areas, no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none
CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe
Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red 1 slight 2 mod. 3 severe Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 2 mild 3 mod. 4 severe Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 2 mod. 3 severe IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe
Vessels definitely injected normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse red 1 slight 2 mod. 3 severe Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 2 mild 3 mod. 4 severe Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 2 mod. 3 severe IRIS Values Rating Normal 0 none above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe
No erythema 0 No oedema 0 Very slight erythema (barely perceptible) 1 Very slight oedema (barely perceptible) 1 Well-defined erythema 2 Slight oedema (edges of area by definite raising 2 Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4 The Draize scale for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible 1 slight 25% to 50% 2 Easily visible translucent areas, details of iris slightly obscure 2 mild 50% to 75% 3 Opalescent areas, no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent Discharge with moistening of lids and hairs and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe
USE, VOLUME AND FORMULATION The notified polymer will not be manufactured in Australia. It will be imported into Australia in 200 L steel drums as a component of Croda Supershield CSB 4032 (contains 41% notified polymer). This will be reformulated into paint products for professional use only; these products will contain 15.7% of the notified polymer. These paints will be used for high build applications such as rolling stock and agricultural machinery. Import volumes for the notified polymer are as follows: Year 1 2 - 4 5 Import Volume (tonnes) 25 25 - 200 200 OCCUPATIONAL EXPOSURE The notified polymer is not manufactured in Australia but imported as a component of the formulation Croda Supershield CSB 4032. The likelihood of occupational exposure prior to reformulation at paint manufacturing facilities is low; exposure is only likely to occur due to accidental spillage. Occupational exposure to the notified polymer can potentially occur during reformulation and during application of the paint products containing 15.7% of the notified polymer. The processes involved in paint formulation include: lab development, which will involve personnel for periods of 8 hours/day for 10 days/year. paint makeup, which will involve personnel for periods of 3 hours/day; frequency dependent on market acceptance of the polymer formulation. quality control (QC) testing, which will involve personnel for periods of 6 hours/day; frequency dependent on market acceptance of the polymer formulation. filling, which will involve personnel for periods of 6 hours/day; frequency dependent on market acceptance of the polymer formulation. All the above processes will occur under exhaust ventilation with the capture of volatiles using scrubbers. Staff will be provided with personal protective equipment including goggles and solvent resistant gloves. Paint products containing the notified polymer will be applied using the airless spray technique. This will occur in spray booths with fume extraction and downdraft ventilation which will reduce worker exposure. The main exposure pathways during reformulation of the notified polymer will be dermal and possibly ocular. Inhalational exposure to both the notified polymer and solvent fumes will be minimised by the use of exhaust ventilation and scrubbers for volatiles. In addition the notified polymer is not considered volatile. During spray application dermal, ocular and inhalational exposure is possible during both
NA/442 FULL PUBLIC REPORT Copy Charge PSY APPLICANT Hoechst Australia of 606 St. Road, MELBOURNE, VIC 3004 and Brother Industries Pty. Ltd. of 7 Khartoum Road, North Ryde, NSW 2113 have submitted a limited notification statement in support of their application for an assessment certificate for Copy Charge PSY. IDENTITY OF THE CHEMICAL Copy Charge PSY is not considered to be hazardous on the nature of the chemical and the data provided. Therefore the chemical name, CAS number, molecular and structural formulae, molecular weight, spectral data, details of toner composition and details of exact import volume have been exempted from publication in the Full Public Report and the Summary Report. IDENTITY OF THE CHEMICAL Trade Name: Copy Charge PSY Copy Charge PSY VP 2038 Molecular Weight: < 1 000 Method of Detection and Determination: Infrared (IR) ultraviolet (UV), nuclear magnetic resonance (NMR) PHYSICAL AND CHEMICAL PROPERTIES Appearance at 20°C and 101.3 kPa: white powder Melting 250°C Density: 20 D =1 150 kg/m3 4
Very slight erythema (barely perceptible) 1 Very slight oedema (barely perceptible) 1 Well-defined erythema 2 Slight oedema (edges of area by definite raising 2 Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4 The Draize scale for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible 1 slight 25% to 50% 2 Easily visible translucent areas, details of iris slightly obscure 2 mild 50% to 75% 3 Opalescent areas, no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe
Comments on Physico-Chemical Properties Tests were performed according to EEC/OECD test guidelines at facilities complying with OECD Principles of Good Laboratory Practice. The notifiers state that the imidazolone rings may undergo hydrolysis under highly acidic conditions but the substance is expected to be stable in the environmental pH range. No information was provided on the adsorption/desorption properties of the chemical. Given the chemical's high water solubility and low partition coefficient it is anticipated that it will not strongly adsorb to soils. The notified chemical contains no dissociable hydrogens or basic functionalities. PURITY OF THE CHEMICAL Degree of Purity: 85% Toxic or Hazardous Impurities: Chemical name: formaldehyde CAS No.: 50-00-0 Weight percentage: ~ 0.05% Toxic properties: confirmed carcinogen with experimental carcinogenic, tumorigenic and teratogenic data; poison by ingestion; experimental poison by ingestion, skin contact, intravenous, intraperitoneal and subcutaneous routes; human systemic effects by inhalation: lacrimation, olfactory changes and pulmonary changes; human mutation data reported; human skin and eye irritant; frequent or prolonged exposure can cause hypersensitivity leading to contact dermatitis; an air concentration of 20 ppm is quickly irritating to eyes (1) Non-hazardous Impurities (> 1% by weight): unidentified impurities consisting of 5-15% of the notified chemical consist of dimers, trimers and oligomers Additives/Adjuvants: none
Well-defined erythema 2 Slight oedema (edges of area by definite raising 2 Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4 The Draize scale for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible 1 slight 25% to 50% 2 Easily visible translucent areas, details of iris slightly obscure 2 mild 50% to 75% 3 Opalescent areas, no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe
Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4 The Draize scale for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible 1 slight 25% to 50% 2 Easily visible translucent areas, details of iris slightly obscure 2 mild 50% to 75% 3 Opalescent areas, no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe
concentration 0.5. 1.0 and 2.0% active ingredient in distilled water Challenge procedure: day 36 patch applied for 24 hours; concentration 1% active ingredient in distilled water Challenge outcome: no positive results at challenge, no positive or negative controls in Test method: according to Stotts, 1980 (16) Result: not a sensitiser under these test conditions 9.2 Repeated Dose Toxicity (17) this study was conducted on an analogue of the notified chemical, Stepantex VS 90 Species/strain: rat/Sprague-Dawley CD Number/sex of animals: 10M/10F per dose Method of administration: orally in distilled water Dose/Study duration:: doses: 0, 100, 300, 1 000 mg.kg-1.day-1 for 96 days , 131 days for main study Clinical observations: 3 mortalities during study, all males, 2 deaths attributed to ether anaesthesia, third was in high dose group; this high dose animal also showed daily weight loss Clinical chemistry/Haematology an intermediate haematological examination showed an increased thromobocytes in 300 mg.kg-1 males, a final examination showed a decrease in mean cell volume in high dose females; an intermediate biochemical examination showed high dose males to have an increase in alanine transaminase (ALT) and calcium content, high dose females also had an increased ALT content; in the final examination the high dose animals again had elevated ALT, males in addition had a slight increase in potassium and females an increase in creatin and chloride and a slight increase in alkaline phosphatase (AP)
PURITY OF THE CHEMICAL Degree of Purity: > 99% or Hazardous Impurities: Chemical name: dibutylstannane Synonyms: di-n-butyltin dibutyltin dibutyloxostannane CAS No.: 1002-53-5 Weight percentage: 0.2% properties: organotin compounds have an exposure standard of time-weighted average (TWA) of 0.1 mg/m3 listed in Worksafe Australia’s Exposure Standards for Atmospheric Contaminants in the Occupational Environment (1); the basis of this is their toxicity, they are used as biological control agents The other hazardous impurity according to Worksafe Australia’s List of Designated Hazardous Substances (2); is an irritant and respiratory sensitiser; the concentration is below the threshold listed in (2). Non-hazardous Impurities (> 1% by weight): < 0.5% None of the non-hazardous impurities are listed on Worksafe Australia’s List of Designated Hazardous Substances (2), Toxline (3) or in Sax and Lewis (4) as having hazardous properties. Maximum Content of Residual Monomers: 0.7% (see harmful and non-hazardous impurities) Additives/Adjuvants: none
Swelling with lids half-closed to completely closed and considerable area around eye IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe
Standards Australia (1990), Australian Standard 3765.1-1990, Clothing for Protection against Hazardous Chemicals Part 1 Protection against General or Specific Chemicals, Standards Association of Australia Publications, Sydney. Standards Australia/Standards New Zealand (1992), Australian/New Zealand Standard 1337-1992, Eye Protectors for Industrial Applications. Standards Association of Australia/Standards Association of New Zealand Publications, Sydney/Wellington. Standards Australia/Standards New Zealand (1994), Australian/New Zealand Standard 2210-1994, Occupational Protective Footwear, Standards Association of Australia/Standards Association of New Zealand Publications, Sydney/Wellington. Trimmer G.W. (1995) 28-Day Repeated Dose Dermal Toxicity Study in the Rat. Project No. 106210, Exxon Biomedical Sciences, Inc., East Millstone, New Jersey, USA. Wolf R., Movshowitz M. and Brenner S. (1996) Supplemental in the evaluation of occupational hand dermatitis in soldiers. International J of Dermatology vol. 35(3), pp. 173-176.
Given the likely low hazard of the notified chemical and low level of exposure the health risk to workers or the general public arising from transport, storage, use or disposal of the notified chemical is expected to be minimal. 13. RECOMMENDATIONS To minimise occupational exposure to the notified chemical the following guidelines and precautions should be observed: Spillage of the notified chemical should be avoided, spillages should be cleaned up promptly with absorbents which should then be put into containers for disposal; When work is to proceed in confined spaces, Australian Standard 2865 (20) should be consulted; Good personal hygiene should be practised to minimise the potential for ingestion; A copy of the Material Safety Data Sheet (MSDS) should be easily accessible to employees. 14. MATERIAL SAFETY DATA SHEET The MSDS for the notified chemical was provided in accordance with the National Code of Practice for the Preparation of Material Safety Data Sheets (21). This MSDS was provided by the applicant as part of the notification statement. It is reproduced here as a matter of public record. The accuracy of this information remains the responsibility of the applicant. 15. REQUIREMENTS FOR SECONDARY NOTIFICATION the Act, secondary notification of the notified chemical shall be required if any of the circumstances stipulated under subsection 64(2) of the Act arise. In addition, Secondary notification will be required if the method of use changes in such a way as to greatly increase the environmental exposure of the notified chemical, particularly to natural waters, or if additional information becomes available on adverse environmental effects of the chemical. Ecotoxicity results for algae would be required should more significant exposure of the aquatic compartment be expected (e.g. from mine sites without a similar ability to retain water as the proposed site). 16. REFERENCES 1. Mackay, D. & Wolkoff, A.W. 1973, 'Rate of evaporation of low-solubility contaminants from water bodies to atmosphere', Environ. Sci. Technol., vol. 7, no. 7, pp. 611-614.
CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible 1 slight 25% to 50% 2 Easily visible translucent details of iris slightly obscure 2 mild 50% to 75% 3 Opalescent no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe
Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red 1 slight 2 mod. 3 severe Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 1 slight 2 mild 3 mod. 4 severe Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe
The notified chemical was not mutagenic in bacteria and did not cause chromosome damage in mouse bone marrow cells in vivo. Based on the toxicological studies provided by the notifier, Monoazo Red SR 6947 would be classified as hazardous according to the Approved Criteria for Classifying Hazardous Substances (19), based on skin sensitising effects. 10. ASSESSMENT OF ENVIRONMENTAL EFFECTS The following ecotoxicity studies have been supplied by the notifier. The tests were performed in compliance with OECD/EEC Test Methods (1, 2) and according to OECD Principles of Good Laboratory Practice. Test Species Results (Nominal) Acute Toxicity (Static Test) (OECD TG 203 (1)) Zebra Fish (Brachydanio rerio) 96 hour LC50 > 1 000 mg/L Acute Toxicity - Immobilisation Test (Static Test) (OECD TG 202 (1)) Water Flea (Daphnia magna) 48 hour NOEC = 125 mg/L 48 hour EC50 = 420.5 mg/L Growth Inhibition - Growth () & Biomass (b) (Static Test) (OECD TG 201 (1)) Algae (Scenedesmus subspicatus) 72 hour = 27.6 mg/L 72 hour EC50 = 1 193 mg/L Respiration Inhibition (OECD 209 (1)) Activated Sludge - Aerobic Waste Water Bacteria 3 h IC50 > 100 mg/L Tests determined that the test media concentrations were all sufficiently stable. Although not reported, test media were most probably slightly to strongly coloured by the test substance at even low concentrations. The ecotoxicity data for the substance shows that the dye is practically nontoxic to the zebra fish and water flea. At all test concentrations (down to 100 mg/L), a slight change in the swimming behaviour of the test fish was observed. the test solution is intensely coloured deleterious effects can be caused by the interception of light (shading effect) necessary for algal growth. However, a modified growth inhibition test (to differentiate between a real toxic effect of the notified chemical or an effect caused by shading) was not performed. It should be that for environmental purposes, growth inhibition, whether due to chemical or physical factors, is still of relevance. Algistatic effects may still lead to an undesirable environmental impact if exposure is continuous. Thus, the notified chemical can be considered as slightly toxic to algae.
Comment: for Test 2 and Test 3, the observation times did not extend beyond 72 and 48 hours, respectively, even though dermal responses were still present at these times, therefore, the reversibility of the dermal effects cannot be evaluated Result: Test 1: at 5%, the notified chemical was a slight irritant to rabbit skin; Test 2: at 76%, the notified chemical was slight to moderate irritant to rabbit skin; Test 3: at 90%, the notified chemical was a moderate to severe irritant to rabbit skin; Eye Irritation 1, 2 and 3 were conducted by (Thompson GW 1981), (Harris DL 1975), and (Thompson GW 1981), respectively. Test Substance Test 1: Varisoft 3690, 5 % solids Test 2: Varisoft 3690, 76 % solids Test 3: Varisoft 3690, 90 % solids Species/strain: rabbit/New Zealand Number/sex of animals: 3/sex/test Observation period: 7 days Method of administration: 0.1 mL of the test substance placed on the everted lid of one eye; the contralateral eye served as the control Observation after application: Test 1: 24, 48, 72 and 96 hours and 7 days Test 2: 24, 48 and 72 hours Test 3: 24, 48, 72 and 96 hours and 7 days Draize scoresa of non-irrigated eyes: Test 1: VARISOFT 3690, 5% solids Time after Instillation Animal 1 day 2 days 3 days 4 days 7 days Cornea o a o a o a o a o a 1 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 3 0 0 0 0 0 0 0 0 0 0
5 0 0 0 0 6 0 0 0 0 Iris 1 0 0 0 0 No readings given 2 0 0 0 0 3 0 0 0 0 4 0 0 0 0 5 0 0 0 0 6 0 0 0 0 Conjunctiva r c d r c d r c d 1 3 3 3 3 3 3 Scores not given, but reported as corrosive, irreversible damage to the eye 2 2 2 2 2 2 2 3 3 2 2 3 2 2 4 3 2 2 3 2 2 5 3 2 2 3 2 2 6 3 3 2 3 3 2 1 see Attachment 1 for Draize scales o opacity, a area, r redness, c chemosis, d discharge Draize scoresa of non-irrigated eyes (continued): Test 3: VARISOFT 3690, 90% solids Time after Instillation Animal 1 day 2 days 3 days 4 days 7 days Cornea o a o a o a o a o a 1 1.5 E 100 4 2 E 100 4 3 E 75 1.5 4 E 75 2 2.5 E 50 2 2 4 E 100 1 4 E 100 1 4 E 100 1 4 E 100 1 3 E 100 4 3 4 E 100 1 4 E 100 1 3 E 60 2 3 E 100 L 3 3 E 10 2 4 1.5 E 100 3 2 E 60 2 2.5 E 40 2 2 E 30 1.5 2 E 10 1
CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids Swelling with lids to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe
Partition Co-efficient: log Kow = 7.2 at 23°C (n-octanol/water) Hydrolysis as a function of pH: Half-life at 25°C ~ 11 days at pH 4 ~ 131 days at pH 7 ~ 10 days at pH 9 Adsorption/Desorption: Not determined Dissociation Constant: Not determined Flash Point: Not applicable to solids Flammability Limits: Negative at 27°C Pyrolysis products: methane, ammonia, oxides of carbon, oxides of nitrogen and HCl gas. Autoignition Temperature: >400°C Explosive Properties: Non-explosive Reactivity/Stability: Not an oxidising agent. Incompatible with strong oxidising agents. Comments on Physical and Chemical Properties: The partition coefficient was estimated according to a High Pressure Liquid Chromatography (HPLC) procedure outlined in OECD Test Guideline 117. From this value, Kodak calculated the water solubility using the equation: log(1/S) = 1.339 log Kow - 0.978; S is in moles/L (1). The adsorption-desorption test was not conducted as the notifier was unable to measure the test substance in aqueous solution with sufficient sensitivity. However, the notifier indicated that the notified substance was observed to adhere to surfaces in vessels in which the limit of solubility was exceeded, and that it would be likely to adsorb on to solid materials. The high partition coefficient is indicative of strong adsorption (1).
CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to haemorrhage, gross destruction 2 severe
Attachment 1 The Draize Scale for evaluation of skin reactions is as follows: Erythema Formation Rating Oedema Formation Rating No erythema 0 No oedema 0 Very slight erythema (barely perceptible) 1 Very slight oedema (barely perceptible) 1 Well-defined erythema 2 Slight oedema of area by definite raising 2 Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4 The Draize scale for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible 1 slight 25% to 50% 2 Easily visible translucent areas, details of iris slightly obscure 2 mild 50% to 75% 3 Opalescent areas, no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe
Attachment 1 The Draize Scale for evaluation of skin reactions is as follows: Erythema Formation Rating Oedema Formation Rating No erythema 0 No oedema 0 Very slight erythema (barely perceptible) 1 Very slight oedema (barely perceptible) 1 Well-defined erythema 2 Slight oedema of area by definite raising 2 Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4 The Draize for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible 1 slight 25% to 50% 2 Easily visible translucent areas, details of iris slightly obscure 2 mild 50% to 75% 3 Opalescent areas, no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none
CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent Discharge with moistening of lids and and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe
Erythema Formation Rating Oedema Formation Rating No erythema 0 No oedema 0 Very slight erythema (barely perceptible) 1 Very slight oedema (barely perceptible) 1 Well-defined erythema 2 Slight oedema (edges of area by definite raising 2 Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4 The Draize scale for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible 1 slight 25% to 50% 2 Easily visible translucent details of iris slightly obscure 2 mild 50% to 75% 3 Opalescent no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to haemorrhage, gross destruction 2 severe
Fate Release of the notified polymer during application of the formulated product is expected to be small due to the efficient nature of industrial roller coating processes. Any paint residues and spilled paint are likely to cure and be disposed of into landfill. If sent to landfill leaching will be very slow since the polymer will be incorporated in a crosslinked matrix. Instead it will be subject to the slow abiotic and biotic degradation processes operative in landfills. If incinerated in a furnace the notified material will be destroyed with production of water vapour and oxides of carbon. Almost all the notified material will eventually be released as a consequence of disposal of the used food cans. These are likely to be placed into landfill or recycled for metal recovery. The notified material which is lost during reformulation and application will be disposed of into landfill or incinerated. If sent to landfill, since the material is likely to be incorporated within a crosslinked matrix with other waste polymers, leaching is likely to be very slow and the polymer will be subject to the slow abiotic and biotic degradation processes operative in landfills. If incinerated in a furnace the notified material will be destroyed with production of water vapour and oxides of carbon. After the food cans have been used they will be either disposed of into landfill or perhaps recycled for metal recovery. If placed into landfill the coating incorporating the notified polymer is likely to be slowly degraded and destroyed as described above, while if sent for recycling the polymers will be destroyed via incineration. 8. EVALUATION OF TOXICOLOGICAL DATA No toxicology data were provided, which is acceptable for polymers of NAMW greater than 1 000 according to the Act. 9. ASSESSMENT OF ENVIRONMENTAL EFFECTS No ecotoxicology data were provided, which is acceptable for polymers of NAMW greater than 1000 according to the Act. Data on the monomer constituents, together with the high molecular weight and water insolubility of the polymer, provides substantial assurance of the likely low toxicological hazard presented by the notified chemical 10. ASSESSMENT OF ENVIRONMENTAL HAZARD The environmental hazard from the notified polymer is considered to be low. Only small quantities of the notified polymer are likely to be released during reformulation activity, and in the manufacture of the specialised can coating containing the material. The essentially hydrophobic nature of the polymer is such
Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4 The Draize scale for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible 1 slight 25% to 50% 2 Easily visible translucent areas, details of iris slightly obscure 2 mild 50% to 75% 3 Opalescent areas, no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS Values Rating Normal 0 none Folds above normal, congestion, swelling, circumcorneal injection, iris reacts to light 1 slight No reaction to light, haemorrhage, gross destruction 2 severe
16. REFERENCES Attachment 1 The Draize Scale for evaluation of skin reactions is as follows: Erythema Formation Rating Oedema Formation Rating No erythema 0 No oedema 0 Very slight erythema (barely perceptible) 1 Very slight oedema (barely perceptible) 1 Well-defined erythema 2 Slight oedema (edges of area by definite raising 2 Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4 The Draize scale for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible 1 slight 25% to 50% 2 Easily visible translucent areas, details of iris slightly obscure 2 mild 50% to 75% 3 Opalescent areas, no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling above normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 0 none 1 slight 2 mod. 3 severe IRIS
Clinical observations: none at 100 mg/kg; clinical observations were noted at the other doses as follows: Dose (mg/kg): 2 000 825 464 215 Symptom 3-6D* “ “ “ “ 4H- 6D 4H- 6D 4H- 5D 1-9D 1-9D 2-9D 2-9D 4H- 7D 1-7D 8-16D 7D 1-9D 1-6D 1-6D 4H- 5D 4H- 5D 1H- 1D 1H- 1D 4H- 1D 4H- 4D 1H- Dyspnea Apathy Staggering Spastic Gait Faeces – Blue- Violet Urine – Blue- Violet Piloerection Diarrhea Exsiccosis Poor General State 3-6D 1-6D 6D 3-6D 1H- 1D H = hour, D = day Females Dose (mg/kg): 2 000 825 464 215 Symptom Dyspnea Apathy Abnormal Posn Staggering Paresis Spastic Gait Faeces – Blue- Violet Urine – Blue- Violet Piloerection Diarrhea Exsiccosis Impaired General State Poor General State 3-7D* 3-7D 3D 3-7D 3D 3-7D 4H- 7D 4H- 7D 4H- 5D 3D 3-7D 1-16D 1-15D 2-15D 2-15D 1H- 7D 4H- 7D 8-21D 1-5H 7D 16D 1-15D 1-16D 1-8D 2-8D 2-8D 1H- 7D 4H- 7D 8-16D 1H- 5H 7D 16D 1-8D 4H- 1D 4H- 1D 4H- 4D 1H- 5D 4H- 1D * H = hour, D = day
Australian Standard 2161-1978, "Industrial Safety Gloves and Mittens (excluding Electrical and Medical Gloves)", Standards Association of Australia Publ., Sydney, 1978. National Occupational Health and Safety Commission, Guidance Note for the Completion of a Material Safety Data 2nd. edition, AGPS, Canberra, 1990.
24. Standards Australia/Standards New Zealand 1994, Australian/New Zealand Standard 1716-1994, Respiratory Protective Devices, Standards Association of Australia/Standards Association of New Zealand, Sydney/Wellington. 25. National Occupational Health and Safety Commission 1994, National Code of Practice for the Preparation of Material Safety Data Sheets [NOHSC:2011(1994)], Australian Government Publishing Service, Canberra. Attachment 1 The Draize Scale for evaluation of skin reactions is as follows: Erythema Formation Rating Oedema Formation Rating No erythema 0 No oedema 0 Very slight erythema (barely perceptible) 1 Very slight oedema (barely perceptible) 1 Well-defined erythema 2 Slight oedema (edges of area by definite raising 2 Moderate to severe erythema 3 Moderate oedema (raised approx. 1 mm) 3 Severe erythema (beet redness) 4 Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4 The Draize scale for evaluation of eye reactions is as follows: CORNEA Opacity Rating Area of Cornea involved Rating No opacity 0 none 25% or less (not zero) 1 Diffuse area, details of iris clearly visible 1 slight 25% to 50% 2 Easily visible translucent areas, details of iris slightly obscure 2 mild 50% to 75% 3 Opalescent areas, no details of iris visible, size of pupil barely discernible 3 moderate Greater than 75% 4 Opaque, iris invisible 4 severe CONJUNCTIVAE Redness Rating Chemosis Rating Discharge Rating Vessels normal Vessels definitely injected above normal More diffuse, deeper crimson red with individual vessels not easily discernible Diffuse beefy red 0 none 1 slight 2 mod. 3 severe No swelling Any swelling normal Obvious swelling with partial eversion of lids Swelling with lids half-closed Swelling with lids half-closed to completely closed 0 none 1 slight 2 mild 3 mod. 4 severe No discharge Any amount different from normal Discharge with moistening of lids and adjacent hairs Discharge with moistening of lids and hairs and considerable area around eye 0 none 1 slight 2 mod. 3 severe
Oral Toxicity (Hildebrand & Kirsch, 1989) Species/strain: rat/Wistar Number/sex of animals: 5/sex Observation period: 14 days Method of administration: gavage Clinical observations: none Mortality: none Morphological findings: none Test method: unspecified LD50: > 2 000 mg/kg Result: the notified chemical was of very low acute oral toxicity in rats Acute Inhalation Toxicity (Gelbke, 1989) Species/strain: rat/Wistar Number/sex of animals: 5/sex Observation period: 14 days Method of administration: 4-hour exposure, nose-only; particle size: 95% < 29.5 m; 77% < 8.5m Clinical observations: days one and two: staggering unsteady gait, red eye discharge, accelerated respiration Mortality: none Morphological findings: none Test method: according to OECD guideline TG 403 (Organisation for Economic Co-operation and Development, 1995-1996) LC50: > 5.2 mg/L