3. PLC CRITERIA JUSTIFICATION Criterion Criterion met Molecular Weight Requirements Yes Functional Group Equivalent Weight (FGEW) Requirements Yes Low Charge Density Yes Approved Elements Only Yes Stable Under Conditions of Use Yes Not Water Absorbing Yes Not a Hazard Substance or Dangerous Good Yes The notified polymer has potential for biodegradation. However, the potential release of the notified polymer to the aquatic environment is not significant according to the proposed use in the industries as a component of a lubricant for heavy duty gearboxes. PHYSICAL AND CHEMICAL PROPERTIES Appearance at 20 °C and 101.3 kPa Yellow, viscous liquid with specific odour -35°C (product) Density 926 kg/m3 at 15°C (product) Water Solubility 8.4 mg/L at 20 °C Reactivity Stable under normal conditions of use Degradation Products No significant release to the environment under normal condition of use INTRODUCTION AND USE INFORMATION Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years Year 1 2 3 4 5 Tonnes < 10 < 20 < 20 < 30 < 30 Use The notified polymer will not be manufactured in Australia. It will be imported at a concentration of< 80% as a component of an industrial heavy duty gear lubricant in 180 kg closed head steel drums and distributed to customers by road. The imported lubricant containing the notified polymer will not be reformulated or repackaged in Australia; however, this may occur in the future. It will be used in specialised industrial applications including mining equipment and wind turbines. The lubricant will not be sold to general public. HUMAN HEALTH RISK ASSESSMENT The notified polymer meets the PLC criteria and is therefore assumed to be of low hazard. This is supported by tests submitted on the following toxicological endpoints. Endpoint Result Effects Test Guideline Observed? 1. Rat, acute oral LD50> 2,000 mg/kg bw Yes OECD TG 423 2. Genotoxicity - bacterial non mutagenic No OECD TG 471 reverse mutation Acute Oral Toxicity Hunched postures and piloerections were observed on all test animals within 6 hrs of the administration of the test substance at 2,000 mg/kg bw and all the test animals recovered to normal within 6 to 24 hrs.
3. PLC CRITERIA JUSTIFICATION Criterion Criterion met Molecular Weight Requirements Yes Functional Group Equivalent Weight (FGEW) Requirements Yes Low Charge Density Yes Approved Elements Only Yes Stable Under Conditions of Use Yes Not Water Absorbing Yes Not a Hazard Substance or Dangerous Good Yes The notified polymer has potential for biodegradation. However, the potential release of the notified polymer to the aquatic environment is not significant according to the proposed use in the industries as a component of a lubricant for heavy duty gearboxes. PHYSICAL AND CHEMICAL PROPERTIES Appearance at 20 °C and 101.3 kPa Yellow, viscous liquid with specific odour -35°C (product) Density 926 kg/m3 at 15°C (product) Water Solubility 8.4 mg/L at 20 °C Reactivity Stable under normal conditions of use Degradation Products No significant release to the environment under normal condition of use INTRODUCTION AND USE INFORMATION Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years Year 1 2 3 4 5 Tonnes < 10 < 20 < 20 < 30 < 30 Use The notified polymer will not be manufactured in Australia. It will be imported at a concentration of< 80% as a component of an industrial heavy duty gear lubricant in 180 kg closed head steel drums and distributed to customers by road. The imported lubricant containing the notified polymer will not be reformulated or repackaged in Australia; however, this may occur in the future. It will be used in specialised industrial applications including mining equipment and wind turbines. The lubricant will not be sold to general public. HUMAN HEALTH RISK ASSESSMENT The notified polymer meets the PLC criteria and is therefore assumed to be of low hazard. This is supported by tests submitted on the following toxicological endpoints. Endpoint Result Effects Observed? Test Guideline 1. Rat, acute oral LD50> 2,000 mg/kg bw Yes OECD TG 423 2. Genotoxicity - bacterial reverse mutation non mutagenic No OECD TG 471 Acute Oral Toxicity Hunched postures and piloerections were observed on all test animals within 6 hrs of the administration of the test substance at 2,000 mg/kg bw and all the test animals recovered to normal within 6 to 24 hrs.
PLC1151-FR.docx