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Polymer in E7581 Overview and Recommendations

07 July 2005

Overview

Background
Polymer in E7581 was assessed as NA/752 under the NICNAS New Chemicals program in 1999 in the limited notification category. As a result of new data on skin and eye irritation and reproduction/developmental effects becoming available, Polymer in E7581 has now been reassessed under the secondary notification provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) relevant to existing chemicals, as more than five years has elapsed since the original assessment.


Polymer in E7581 is an amber viscous liquid, stable under normal conditions. For commercial purposes, it is prepared in solvent, and never isolated. It is combustible as formulated, with oxides of carbon, hydrogen and nitrogen being produced. Its water solubility is < 10.0 mg/L and flash point 410C, as it exists in solvent. Its boiling point has not been determined.

Uses

Polymer in E7581 is not manufactured in Australia, but is imported as a component in fuel additive packages. The major use of Polymer in E7581 is as a detergent additive in gasoline. The use pattern in Australia has not changed since its introduction as a new chemical. Approximately 200-250 tonnes of the chemical is imported annually.

Exposure

The assessment of Polymer in E7581 as a new chemical in 1999 indicated that exposure from drips and spills is possible when the additive package is added to the fuel, using automated processes and dedicated delivery lines and equipment. However, the exposure is expected to be confined to skin contamination which may occur during the connection and disconnection of transfer lines and equipment. The polymer is a minor component in petrol.


The polymer and additive package is not directly marketed to the public, but preblended into the petrol sold at service stations, hence, direct contact with the polymer by members of the public is unlikely.

Health Effects

No toxicology data were provided for the chemical substance during assessment as a new chemical. Data on acute toxicity, repeated dose toxicity, and genotoxicity were provided on a polymeric substance similar in composition and molecular weight distribution to Polymer in E7581. A reassessment of this data has not been conducted. In this report, new eye and skin irritation studies and a reproduction/developmental study conducted on the Polymer in E7581 (without solvent) are assessed.

The assessment conducted in 1999 on a substance analogous to Polymer in E7581 indicated very low acute oral toxicity in rats (LD50 >5000 mg/kg bw). It is not a skin sensitiser. In a 28-day repeated-dose gavage study in rats, the NOAEL was identified as 1250 mg/kg bw/day based on the absence of systemic toxicity or pathological effects at this level. An in vitro and in vivo genotoxicity test were performed with Polymer in E7581. The chemical was negative in the Salmonella/Mammalian Microsome Plate Incorporation Mutagenicity Assay and in the in vivo mouse micronucleus test. Overall the chemical is not considered genotoxic.

Assessment of current data indicate that Polymer in E7581 is a skin irritant, not an eye irritant, and is not a substance toxic to reproduction.

Polymer in E7581 is classified as a hazardous chemical under the NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004). Polymer in E7581 is classified as a hazardous substance under the Globally Harmonised System of Classification and Labelling of Chemicals (GHS), and would require appropriate labelling when this system is adopted in Australia. Polymer in E7581 is not listed in the Australian Code for the Transport of Dangerous Goods by Road and Rail (FORS, 1998). The classification of the fuel additive package in which the polymer will be contained is a Class 3 Flammable Liquid, Packaging Group III.

The use of dedicated and automatic transfer lines and enclosed, automated injection into fuel would reduce the risk of exposure to the additive package. The risk to service station workers and mechanics is expected to be low, as exposure for these workers is negligible because of the very low concentration (< 0.1%) of polymer in the fuel.

Based on the use pattern, Polymer in E7581 will not pose a significant risk to public health.

Environmental Effects

Based on the use pattern resulting in the majority of the chemical being bound in a polymer matrix, environmental exposure is expected to be minimal. Potential release to the environment would only be through accidental spills. The empty drums and their residues are sent to a certified drum recycler where they are rinsed and the rinsate disposed in accordance with government regulations. Polymer released to soil through either a spill or leak from a storage tank is expected to bind strongly to soil due to its low water solubility. Polymer released to an aquatic environment would tend to partition out of water and into sediment.

Ecotoxicological data for Polymer in E7581 were obtained from information provided with the earlier submission (NA/752). The polymer is unlikely to be mobile given the very low water solubility and high binding affinity to soil. The polymer’s large molecular size and very low water solubility should prevent bioaccumulation. However, the product contains components which may be persistent in the environment. Based on the above, environmental exposure and risk are expected to be low.

Recommendations

This section provides the recommendations arising from the assessment of Polymer in E7581. Recommendations are directed principally at regulatory bodies and importers and formulators of Polymer in E7581. Implicit in these recommendations is that best practice is implemented to minimise occupational and public exposure and environmental impact.

Recommendations for regulatory bodies

NOHSC

Polymer in E7581 is classified as hazardous in accordance with the NOHSC Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004), with the following risk phrase:

  • R38 – Irritating to Skin;

The following safety phrase is also recommended for Polymer in E7581:

  • S24 – Avoid contact with skin

Products containing Polymer in E7581 at concentrations ≥ 20 % are determined to be hazardous.

It is recommended that NOHSC adopt this classification and include it in the List of Designated Hazardous Substances (NOHSC, 2005) as soon as possible.

Recommendations for Importers and State and Territory Authorities

Hazard communication – Material Safety Data Sheet

Under the National Model Regulations for the Control of Workplace Hazardous Substances (NOHSC, 1994) and the Commonwealth, State and Territory regulations introduced in accordance with these national model regulations, employees shall have ready access to Material Safety Data Sheets (MSDS) for hazardous substances at their workplace.

In accordance with the National Code of Practice for the Preparation of Material Safety Data Sheets (NOHSC 2005) it is recommended that importers of Polymer in E7581 review their MSDS for compliance and pay particular attention to the following points:

  • Risk phrases and hazard information should be updated to reflect the hazard classification;

  • Safety phrases should be included as recommended in the hazard classification.

Hazard communication – Labels

In accordance with the National Code of Practice for the Labelling of Workplace Substances (NOHSC 1994a) it is recommended that importers of Polymer in E7581 review their labels for compliance and pay particular attention to the following points:

  • Risk phrases and hazard information should be updated to reflect the hazard classification;

  • Safety phrases should be included as recommended in the hazard classification.

Recommendation for importers and users

Occupational controls

The risk of adverse efects from occupational use of Polymer in E7581 is low. This assessment supports the control measures recommended in the original new chemical assessment report NA/752. The control measures for Polymer in E7581 are as follows:

  • local exhaust ventilation at the refinery/terminal facility when the petrol additive is blended with petrol;
  • avoidance of spillage and splashing of the chemical. Spillages should be cleaned up promptly and put into containers for disposal;
  • if engineering controls and safe work practices are insufficient to reduce exposure, employers should ensure that personal protective equipment (PPE) such as gloves, safety glasses and overalls are used by workers to minimise occupational exposure. The personal protective equipment used should be in accordance with Australian, Australian/New Zealand or other approved standards.

Disposal

Accidental leaks and spillages should be cleaned up promptly with absorbents and put into containers for disposal. The empty drums and their residues should be disposed in accordance with government regulations.
 

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