National Industrial Chemicals Notification and Assessment Scheme s26
June 2014
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
PUBLIC REPORT
Polymer in Toner PearlsThis 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 Department of Health, 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.
For the purposes of subsection 78(1) of the Act, this Public Report may be inspected at our NICNAS office by appointment only at Level 7, 260 Elizabeth Street, Surry Hills NSW 2010.
This 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: Level 7, 260 Elizabeth Street, SURRY HILLS NSW 2010, AUSTRALIA.
Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.
TEL: + 61 2 8577 8800
FAX + 61 2 8577 8888
Website: www.nicnas.gov.au
Director
NICNAS
TABLE OF CONTENTS
SUMMARY 3
CONCLUSIONS AND REGULATORY OBLIGATIONS 3
ASSESSMENT DETAILS 5
1. APPLICANT AND NOTIFICATION DETAILS 5
2. IDENTITY OF CHEMICAL 5
3. COMPOSITION 5
4. PHYSICAL AND CHEMICAL PROPERTIES 5
5. INTRODUCTION AND USE INFORMATION 6
6. HUMAN HEALTH IMPLICATIONS 7
6.1. Exposure Assessment 7
6.1.1. Occupational Exposure 7
6.1.2. Public Exposure 7
6.2. Human Health Effects Assessment 7
6.3. Human Health Risk Characterisation 8
6.3.1. Occupational Health and Safety 8
6.3.2. Public Health 8
7. ENVIRONMENTAL IMPLICATIONS 9
7.1. Environmental Exposure & Fate Assessment 9
7.1.1. Environmental Exposure 9
7.1.2. Environmental Fate 9
7.1.3. Predicted Environmental Concentration (PEC) 9
7.2. Environmental Effects Assessment 10
7.2.1. Predicted No-Effect Concentration 11
7.3. Environmental Risk Assessment 11
Appendix A: Physical and Chemical Properties 12
Appendix B: Toxicological Investigations 14
B.1. Acute toxicity – oral 14
B.2. Acute toxicity – dermal 14
B.3. Irritation – skin 15
B.4. Irritation – eye 15
B.5. Skin sensitisation – mouse local lymph node assay (LLNA) 16
B.6. Skin sensitisation – mouse local lymph node assay (LLNA) 16
B.7. Repeat dose toxicity 17
B.8. Genotoxicity – bacteria 18
B.9. Genotoxicity – in vivo 19
Appendix C: Environmental Fate and Ecotoxicological Investigations 21
C.1. Environmental Fate 21
C.1.1. Ready biodegradability 21
C.1.2. Bioaccumulation 21
C.2. Ecotoxicological Investigations 22
C.2.1. Acute toxicity to fish 22
C.2.2. Acute toxicity to aquatic invertebrates 23
BIBLIOGRAPHY 25
June 2014 NICNAS
SUMMARY
The following details will be published in the NICNAS Chemical Gazette:
ASSESSMENT REFERENCE / APPLICANT(S) / CHEMICAL OR TRADE NAME / HAZARDOUS chemical / INTRODUCTION VOLUME / USESTD/1447 / Canon Australia Pty Ltd / Polymer in Toner Pearls / No / ≤ 10,000 tonnes per annum / Component of printing ink
CONCLUSIONS AND REGULATORY OBLIGATIONS
Hazard classification
Based on the available information, the notified polymer is not recommended for classification according to the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS), as adopted for industrial chemicals in Australia, or the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004).
Human health risk assessment
Under the conditions of the occupational settings described, the notified polymer is not considered to pose an unreasonable risk to the health of workers.
When used in the proposed manner, the notified polymer is not considered to pose an unreasonable risk to public health.
Environmental risk assessment
On the basis of the assessed use pattern and the low toxicity up to the limit of water solubility, the notified polymer is not expected to pose an unacceptable risk to the aquatic environment.
Recommendations
Control Measures
Occupational Health and Safety
Guidance in selection of personal protective equipment can be obtained from Australian, Australian/New Zealand or other approved standards.
· A copy of the (M)SDS should be easily accessible to employees.
· If products and mixtures containing the notified polymer are classified as hazardous to health in accordance with the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS) as adopted for industrial chemicals in Australia, workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation should be in operation.
Disposal
· The notified polymer should be disposed of to landfill.
Emergency procedures
· Spills 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 chemical 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(2) of the Act; if
- the function or use of the polymer has changed from component of printing ink, or is likely to change significantly;
- the amount of polymer being introduced has increased, or is likely to increase, significantly;
- the polymer has begun to be manufactured in Australia;
- additional information has become available to the person as to an adverse effect of the polymer 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.
No additional secondary notification conditions are stipulated.
(Material) Safety Data Sheet
The (M)SDS of the products containing the notified polymer provided by the notifier were reviewed by NICNAS. The accuracy of the information on the (M)SDS remains the responsibility of the applicant.
ASSESSMENT DETAILS
1. APPLICANT AND NOTIFICATION DETAILS
Applicant(s)Canon Australia Pty Ltd (ABN: 66 005 002 951)
Building A, The Park Estate
5 Talavera Road
MACQUARIE PARK NSW 2113.
Notification Category
Standard: Synthetic polymer with Mn < 1,000 Da (more than 1 tonne per year).
Exempt Information (Section 75 of the Act)
Data items and details claimed exempt from publication: chemical name, other names, CAS number, molecular and structural formulae, molecular weight, analytical data, degree of purity, polymer constituents, residual monomers, impurities, use details, and import volume.
Variation of Data Requirements (Section 24 of the Act)
Variation to the schedule of data requirements is claimed as follows: skin irritation, eye irritation, skin sensitisation, acute daphnia toxicity and acute algae toxicity.
Previous Notification in Australia by Applicant(s)
No
Notification in Other Countries
USA (2008)
South Korea (2011)
China (2012)
EU
2. IDENTITY OF CHEMICAL
Marketing Name(s)Low melting polyester amide resin
Oce Toner Pearls (contains notified polymer at ≤ 50% concentration)
Molecular Weight
NAMW < 500 Da
Analytical Data
Reference IR and HPLC spectra were provided.
3. COMPOSITION
Degree of Purity / 50-60%4. PHYSICAL AND CHEMICAL PROPERTIES
Appearance at 20 ºC and 101.3 kPa: Yellowish solid/off-white waxy powderProperty / Value / Data Source/Justification
Melting Point / 11–15 °C / Measured
Boiling Point / > 225 °C at 101.3 kPa / Measured. Decomposes without boiling.
Density / 1,177 kg/m3 at 20 °C / Measured
Vapour Pressure / < 8.4 × 10-10 kPa at 20 °C / Measured
Water Solubility / ≤ 0.2× 10-3g/L / Estimated (EPIWEB 4.1; US EPA, 2011)
Hydrolysis as a Function of pH / Not determined / The notified polymer contains hydrolysable functional groups. However, significant hydrolysis is not expected under environmental conditions based on its low solubility in water.
Partition Coefficient
(n-octanol/water) / log Pow ³ 3.8 at 25 °C / Measured
Adsorption/Desorption / log Koc ³ 3.81 at 35 °C / Measured
Dissociation Constant / Not determined / No readily dissociable functionalities
Flammability / Not highly flammable / Measured
Flammability in Contact with Water / Not predicted to be flammable in contact with water / Estimated
Autoignition Temperature / 425 °C / Measured
Explosive Properties / Not predicted to be explosive / Estimated
Oxidising Properties / Not predicted to be oxidising / Estimated
Discussion of Properties
For full details of tests on physical and chemical properties, refer to Appendix A.
Reactivity
The notified polymer is expected to be stable under normal conditions of use.
Physical hazard classification
Based on the submitted physico-chemical data depicted in the above table, the notified polymer is not recommended for hazard classification according to the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS), as adopted for industrial chemicals in Australia.
5. INTRODUCTION AND USE INFORMATION
Mode of Introduction of Notified Chemical (100%) Over Next 5 YearsThe notified polymer will not be manufactured or reformulated in Australia. The notified polymer will be imported as a component of a finished product, in closed ink cartridges at ≤ 50% concentration.
Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years
Year / 1 / 2 / 3 / 4 / 5
Tonnes / 5,000 / 5,000 / 5,000 / 5,000 / 10,000
Port of Entry
Sydney (by sea and air)
Transportation and Packaging
Finished products containing the notified polymer at ≤ 50% concentration will be imported as solid spheres (with a diameter of about 12 mm) contained in polystyrene cartridges in sealed styrene-butadiene packaging. Each cartridge will contain either 500 g or 900 g of finished ink. These cartridges will be packed in boxes. These will be packed in pallets and distributed within Australia by road.
Use
The notified polymer will be used as part of an ink for printing at ≤ 50% concentration. The finished products are only expected to be used in large format printers.
Operation description
There will be no manufacture, reformulation or repackaging of the notified polymer in Australia.
End-use
The cartridges containing the finished inks will be taken out of the blister package and placed into the printers. During this process, engineering controls will ensure that no ink will fall out of the cartridges. During the printing process, the ink will pass a spindle and fall into the imaging device in a closed system. Inside the printer the ink will be printed onto the paper.
Most of the ink (> 98%) will be consumed during printing, with the remainder (< 2%) ending as waste in a waste box. From time to time, contamination on the printer heads will be rinsed away with ink, which will be automatically collected in a waste box (capacity 300 g). The waste material is solid and no direct contact to the user is expected. The waste box will be disposed of to landfill.
6. HUMAN HEALTH IMPLICATIONS
6.1. Exposure Assessment
6.1.1. Occupational Exposure
Category of WorkersCategory of Worker / Exposure Duration (hours/day) / Exposure Frequency (days/year)
Importation/waterside / 8 / 10–50
Transport and storage workers / 8 / 10–50
Office worker / Occasional / 200
Service technician / 1 / 52
Exposure Details
Transport and storage
Transport and storage workers may be exposed to the notified polymer as a component of the finished ink products at ≤ 50% concentration, only in the event of an accidental rupture of containers.
End-use
Given the low vapour pressure (8.4 × 10-10 kPa at 20 °C) of the notified polymer and the particle size (12 mm) of the finished products, inhalation exposure to the notified polymer is not expected. As the finished products are contained within a sealed cartridge and the printing process is enclosed, the potential for dermal exposure will be limited during printing. However, service technicians and office workers may be dermally exposed to the notified polymer at ≤ 50% concentration on an infrequent basis when changing cartridges, removing waste boxes or during printer maintenance. Service technicians may wear gloves, though office workers are unlikely to do so.
Dermal exposure from contact with printed paper is not expected as the notified polymer will be bound to the paper matrix when printed.
6.1.2. Public Exposure
Finished ink products are expected to be used by industrial and office workers only in large format printers. Hence, public exposure is not expected during printing processes. The public may come into contact with the finished product containing the notified polymer at ≤ 50% concentration. However, the notified polymer is not expected to be bioavailable as the polymer will be bound to the paper matrix when printed.
6.2. Human Health Effects Assessment
The results from toxicological investigations conducted on the notified polymer (purity 50-60%) and finished products containing the notified polymer are summarised in the following table. The impurities contained in the notified polymer have similar functionality and are therefore expected to have similar toxicological properties to the notified polymer. Thus the results obtained from toxicological studies conducted on the notified polymer with purity of 50-60% are expected to represent the toxicological profile of the notified polymer. For full details of the studies, refer to Appendix B.Endpoint / Result and Assessment Conclusion
Rat, acute oral toxicity / LD50 > 2,000 mg/kg bw; low toxicity
Rat, acute dermal toxicity / LD50 > 2,000 mg/kg bw; low toxicity
Rabbit, skin irritation / non-irritating*
Rabbit, eye irritation / slightly irritating*
Mouse, skin sensitisation – Local lymph node assay / no evidence of sensitisation*
Mouse, skin sensitisation – Local lymph node assay / no evidence of sensitisation#
Rat, repeat dose oral toxicity – 28 days. / NOAEL 1,000 mg/kg bw/day
Mutagenicity – bacterial reverse mutation / non mutagenic
Genotoxicity – in vivo mouse micronucleus test / non genotoxic
*Tests performed on finished product 1 containing the notified polymer at ≤ 50% concentration
#Test performed on finished product 2 containing the notified polymer at ≤ 50% concentration
Toxicokinetics.Whilst absorption of the notified polymer may occur (MW < 500 Da), the extent of absorption through the skin or gastrointestinal tract is expected to be limited, based on its low water solubility ( 0.1 mg/mL at 20 °C) and relatively high log Pow (≥ 3.8 at 25 °C).