File No PLC/950 October 2010 NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME (NICNAS) FULL PUBLIC REPORT Melflux 5581 F This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (Cwlth) (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 Department of Health and Ageing, and conducts the risk assessment for public health and occupational health and safety. The assessment of environmental risk is conducted by the Department of the Environment, Water, Heritage and the Arts. For the purposes of subsection 78(1) of the Act, this Full Public Report may be inspected at our NICNAS office by appointment only at 334-336 Illawarra Road, Marrickville NSW 2204. This Full Public Report is also available for viewing and downloading from the NICNAS website or available on request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS Administration Coordinator at: Street Address: Postal Address: TEL: FAX Website: Director NICNAS 334 - 336 Illawarra Road MARRICKVILLE NSW 2204, AUSTRALIA. GPO Box 58, SYDNEY NSW 2001, AUSTRALIA. + 61 2 8577 8800 + 61 2 8577 8888. www.nicnas.gov.au TABLE OF CONTENTS FULL PUBLIC REPORT ....................................................................................................................................... 3 1. APPLICANT AND NOTIFICATION DETAILS .................................................................................... 3 2. IDENTITY OF CHEMICAL ................................................................................................................... 3 3. PLC CRITERIA JUSTIFICATION ......................................................................................................... 3 4. PHYSICAL AND CHEMICAL PROPERTIES ....................................................................................... 4 5. INTRODUCTION AND USE INFORMATION ..................................................................................... 4 6. HUMAN HEALTH IMPLICATIONS ..................................................................................................... 4 7. ENVIRONMENTAL IMPLICATIONS .................................................................................................. 5 8. CONCLUSIONS AND RECOMMENDATIONS ................................................................................... 6 October 2010 NICNAS FULL PUBLIC REPORT Melflux 5581 F 1. APPLICANT AND NOTIFICATION DETAILS APPLICANT(S) International Sales & Marketing Pty Ltd (ABN 36 467 259 314) 262 Highett Road Highett VIC 3190 NOTIFICATION CATEGORY Polymer of Low Concern EXEMPT INFORMATION (SECTION 75 OF THE ACT) Data items and details claimed exempt from publication: Chemical Name, CAS Number, Molecular and Structural Formulae, Molecular Weight, Polymer Constituents, Residual Monomers/Impurities, Use Details and Import Volume. VARIATION OF DATA REQUIREMENTS (SECTION 24 OF THE ACT) No variation to the schedule of data requirements is claimed. PREVIOUS NOTIFICATION IN AUSTRALIA BY APPLICANT(S) None NOTIFICATION IN OTHER COUNTRIES US (2004) Canada (2007) 2. IDENTITY OF CHEMICAL MARKETING NAME(S) Melflux 5581 F (contains > 85% notified polymer) MOLECULAR WEIGHT (MW) Number Average Molecular Weight (Mn) > 10,000 Da REACTIVE FUNCTIONAL GROUPS The notified polymer contains only low concern functional groups. 3. PLC CRITERIA JUSTIFICATION Criterion Molecular Weight Requirements Functional Group Equivalent Weight (FGEW) Requirements Low Charge Density Approved Elements Only Stable Under Normal Conditions of Use Not Water Absorbing Not a Hazard Substance or Dangerous Good Criterion met Yes Yes Yes Yes Yes Yes Yes The notified polymer meets the PLC criteria. FULL PUBLIC REPORT: PLC/950 Page 3 of 7 October 2010 4. PHYSICAL AND CHEMICAL PROPERTIES Appearance at 20°C and 101.3 kPa Melting Point/Glass Transition Temp Density Water Solubility Dissociation Constant Particle Size Reactivity Degradation Products 5. NICNAS Yellow to brown powder Softens at approximately 40°C 1030-1060 kg/m3 (20% aqueous solution) 400-600 kg/m3 (powder bulk-density) > 500 g/L at 20°C. The notified polymer is water miscible/soluble at high loading levels of the solid polymer. It is produced as an approximately 45% aqueous solution with a density of approximately 1.1 g/cm3 giving a calculated solubility of approximately 495 g/L. The notified polymer is a salt of a weak acid and will be ionised in the environmental pH range (4–9). Inhalable fraction (< 100 m): < 38% Respirable fraction (< 10 m): < 8.5% Stable under normal environmental conditions. A test was conducted of the hydrolytic stability of an analogue polymer using a procedure based on OECD TG 111. This test showed that the polymer was stable at pH 1.2 (40°C) for 24 hours and at pH 4–9 (40°C) for 14 days. None under normal conditions of use. INTRODUCTION AND USE INFORMATION MAXIMUM INTRODUCTION VOLUME OF NOTIFIED CHEMICAL (100%) OVER NEXT 5 YEARS Year 1 2 3 4 Tonnes 1-3 1-3 1-3 3-5 5 3-5 Use The notified polymer will be used for flow improvement in cementitious construction materials. Reformulation The notified polymer at concentrations of > 85% will be delivered to the reformulation plants in 15 kg bags. The bags will be cut open, and the contents transferred to an additive silo from where the notified polymer will be dosed into the powder mixer. Empty bags containing less than 100 g of the notified polymer will be disposed of to landfill. The notified polymer will be blended in the powder mixer with the other components that will be present in the cementitious construction materials. Reformulation is estimated to take place regularly throughout the year. The mortar containing the notified polymer is then packed in 20 kg sacks for sale. Dust extraction systems will be used during the reformulation of the notified polymer. Concrete Manufacture At the concrete production plant the sacks of mortar containing the notified polymer will be transferred to the mortar mixer where they will be blended with water and occasionally other components to produce the final concrete mixture. Concrete manufacture is expected to take place all year round. Mortar placing and application The finished concrete mixture will be poured into place or applied manually by construction workers. Mode of Introduction and Disposal The notified polymer will not be manufactured within Australia. The notified polymer will be imported as the product Melflux 5581 F (contains > 85% notified polymer) in 15 kg paper bags. 6. HUMAN HEALTH IMPLICATIONS Hazard Characterisation No toxicological data were submitted. The notified polymer meets the PLC criteria and can therefore be considered to be of low hazard. The particle size of the notified polymer indicates that a portion will be respirable (< 10 m). The notified FULL PUBLIC REPORT: PLC/950 Page 4 of 7 October 2010 NICNAS polymer is water soluble and therefore if inhaled at low levels is likely to be cleared from the upper respiratory tract readily through mucociliary action. Small proportions of the notified polymer may reach the lower respiratory tract, but it should still be readily cleared from the lungs unless high levels are inhaled. When high concentrations of the notified polymer are inhaled, it is likely to be cleared from the lungs, but this may be slower and temporary respiratory impairment is possible. The expected use of dust masks and local exhaust ventilation when handling the powdered notified polymer by reformulation workers should reduce inhalation exposure levels and hence lower the risk of temporary lung overloading. Occupational Health and Safety Risk Assessment Reformulation Dermal, ocular and inhalation exposure to the notified polymer may potentially occur during its reformulation. The greatest potential for exposure is during the opening of the imported bags of notified polymer (> 85%) and transfer to the additive silo. During repackaging and storage of the blended mortar, exposure is expected to be low due to the low concentration of the notified polymer (< 1%). At the reformulation sites exposure to the notified polymer will be reduced through the use of local exhaust ventilation, and the use of PPE by workers, including goggles, gloves and dust masks. The greatest risk to workers during reformulation is from inhalation exposure during opening and transfer of the notified polymer from the bags that it is imported in, however the risk is expected to be low due to the controls used (dust masks and local exhaust ventillation) and assumed low hazard of the notified polymer. Given that the NOHSC exposure standard for Portland cement (a component of mortar) is 10 mg/m3 TWA, concentrations of airborne particulates are likely to be kept below this level. Concrete manufacture Dermal, ocular and inhalation exposure to the notified polymer may potentially occur during mortar manufacture and may be from either the dry mortar or the prepared concrete. Exposure to the notified polymer may occur during the transfer of the dry mortar to the mortar mixing equipment, or during cleaning of equipment. Exposure to significant amount of the notified polymer is unlikely during these processes, due to the low concentration of the notified polymer (< 1%) and the PPE that is expected to be worn by workers including goggles, dust masks and gloves. The risk to workers from the notified polymer during concrete manufacture is considered to be low due to its assumed low hazard and the low concentration of the notified polymer in the mortar. Mortar placing and application Construction workers may have inhalation, dermal and ocular exposure to the dry mortar and prepared concrete containing the notified polymer, however exposure to the notified polymer would likely be limited due to its low concentration (< 1%). The risk to workers during mortar placing and application is considered to be low due to the assumed low hazard of the notified polymer and low concentration of the notified polymer in the mortar. Construction workers would also experience extensive exposure to the solidified concrete containing the notified polymer. However, in this state the notified polymer will be bound within the hardened matrix of the concrete, and will be unavailable for exposure. Public Health Risk Assessment The notified polymer is intended only for use in industry and as such public exposure to the notified polymer is not expected. The public may come into contact with hardened concrete containing the notified polymer, however, in this state the notified polymer will be bound within the hardened matrix of the concrete, and will be unavailable for exposure. 7. ENVIRONMENTAL IMPLICATIONS Hazard Characterisation No ecotoxicological data were submitted. Anionic polymers are known to be moderately toxic to algae. The mode of toxic action is over-chelation of nutrient elements needed by algae for growth. The highest toxicity is when the acid is on alternating carbons of the polymer backbone. Whether this applies to the notified polymer is unclear. However, the toxicity to algae is likely to be further reduced due to the presence of calcium ions, which will bind to the functional groups. Environmental Risk Assessment FULL PUBLIC REPORT: PLC/950 Page 5 of 7 October 2010 NICNAS The imported notified polymer will be reformulated in Australia and blended into cementitious construction materials. Solid wastes (up to 2% of the annual import volume of notified polymer) resulting from spills, container residues, and dust emissions during reformulation and use are expected to be collected and recycled or disposed of to landfill. Water washings from the cleaning of concrete mixing and delivery equipment (containing up to 1% of the annual import quantity of notified polymer) will be reused in subsequent batches of concrete, or disposed of to soil or the sewer. Dried unused and old cementitious materials from demolition operations will be disposed of to landfill. In set mortar or concrete, the notified polymer will be trapped within the solid matrix and is expected to be immobile and bio-unavailable. The unbound notified polymer is water soluble, however, the high molecular weight of the notified polymer will reduce its mobility in soils. Bioaccumulation is not likely based on the high molecular weight of the notified polymer and its limited potential for exposure to the aquatic environment when used as proposed. Whilst the notified polymer is hydrolytically stable, it is expected to degrade very slowly to form water, oxides of carbon and inorganic salts. The notified polymer is not expected to present a risk to the environment when it is stored, transported, used, recycled and disposed of in the proposed manner. 8. CONCLUSIONS AND RECOMMENDATIONS Human health risk assessment Under the conditions of the occupational settings described, the notified polymer is not considered to pose an unacceptable risk to the health of workers. When used in the proposed manner, the notified polymer is not considered to pose an unacceptable risk to public health. Environmental risk assessment Based on the reported use pattern, the notified polymer is not expected to pose a risk to the environment. Recommendations CONTROL MEASURES Occupational Health and Safety Employers should implement the following engineering controls to minimise occupational exposure to the notified polymer when introduced in the powdered form at > 85%: Local exhaust ventilation Employers should implement the following safe work practices to minimise occupational exposure during handling of the notified polymer: Avoid inhalation of dusts The level of atmospheric dust should be maintained as low as possible. The Australian recommended exposure standard for dust is 10 mg/m3 [NOHSC 3008:\(1995\)]. A copy of the MSDS should be easily accessible to employees. If products and mixtures containing the notified polymer are classified as hazardous to health in accordance with the Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(2004)], workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation must be in operation. Disposal The notified polymer should be disposed to landfill. Emergency procedures FULL PUBLIC REPORT: PLC/950 Page 6 of 7 October 2010 NICNAS Spills and/or accidental release of the notified polymer should be handled by physical containment, collection and subsequent safe disposal. Regulatory Obligations Secondary Notification This risk assessment is based on the information available at the time of notification. The Director may call for the reassessment of the polymer under secondary notification provisions based on changes in certain circumstances. Under Section 64 of the Industrial Chemicals (Notification and Assessment) Act (1989) the notifier, as well as any other importer or manufacturer of the notified polymer, have post-assessment regulatory obligations to notify NICNAS when any of these circumstances change. These obligations apply even when the notified polymer is listed on the Australian Inventory of Chemical Substances (AICS). Therefore, the Director of NICNAS must be notified in writing within 28 days by the notifier, other importer or manufacturer: (1) Under Section 64(1) of the Act; if the notified polymer is introduced in a chemical form that does not meet the PLC criteria. or (2) Under Section 64(2) of the Act; if the function or use of the notified polymer has changed from a component of cementitious construction materials for industrial use, or is likely to change significantly; the amount of notified polymer being introduced has increased, or is likely to increase, significantly; the notified polymer has begun to be manufactured in Australia; additional information has become available to the person as to an adverse effect of the chemical on occupational health and safety, public health, or the environment. The Director will then decide whether a reassessment (i.e. a secondary notification and assessment) is required. Material Safety Data Sheet The MSDS of products containing the notified polymer provided by the notifier were reviewed by NICNAS. The accuracy of the information on the MSDS remains the responsibility of the applicant. FULL PUBLIC REPORT: PLC/950 Page 7 of 7