File No: STD/1516
August 2014
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
PUBLIC REPORT
NT-45
This 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 8
7.1. Environmental Exposure & Fate Assessment 8
7.1.1. Environmental Exposure 8
7.1.2. Environmental Fate 9
7.1.3. Predicted Environmental Concentration (PEC) 9
7.2. Environmental Effects Assessment 9
7.2.1. Predicted No-Effect Concentration 10
7.3. Environmental Risk Assessment 10
Appendix A: Physical and Chemical Properties 11
Appendix B: Toxicological Investigations 13
B.1. Acute toxicity – oral 13
B.2. Acute toxicity – dermal 13
B.3. Irritation – skin 14
B.4. Irritation – eye 14
B.5. Skin sensitisation – mouse local lymph node assay (LLNA) 15
B.6. Repeat dose toxicity 16
B.7. Genotoxicity – bacteria 17
B.8. Genotoxicity – in vitro 18
Appendix C: Environmental Fate and Ecotoxicological Investigations 20
Chronic toxicity to fish 21
Inhibition of microbial activity 22
BIBLIOGRAPHY 23
August 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/1516 / Canon Australia Pty Ltd
Hewlett Packard Australia Pty Ltd / NT-45 / No / ≤ 300 tonnes per annum / Component of toner
CONCLUSIONS AND REGULATORY OBLIGATIONS
Hazard classification
Based on the available information, the notified chemical 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 chemical is not considered to pose an unreasonable risk to the health of workers.
When used in the proposed manner, the notified chemical is not considered to pose an unreasonable risk to public health.
Environmental risk assessment
The notified chemical is not expected to pose an unreasonable risk to the aquatic environment based on the low ecotoxicity and assessed use pattern.
Recommendations
Control Measures
Occupational Health and Safety
· A person conducting a business or undertaking at a workplace should implement the following safe work practices to minimise occupational exposure when handling the notified chemical during end use:
- Avoid contact with eyes
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 chemical 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
· Disposal should be in accordance with Australian, state, territory and local government laws. Landfilling is a disposal option frequently used for industrial chemicals.
Emergency procedures
· Spills or accidental release of the notified chemical should be handled by physical containment, collection and subsequent 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 chemical, have post-assessment regulatory obligations to notify NICNAS when any of these circumstances change. These obligations apply even when the notified chemical 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 chemical has changed from component of toner, or is likely to change significantly;
- the amount of chemical being introduced has increased, or is likely to increase, significantly;
- the chemical 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.
No additional secondary notification conditions are stipulated.
Safety Data Sheet
The SDS of the notified chemical and product containing the notified chemical provided by the notifier were reviewed by NICNAS. The accuracy of the information on the SDS remains the responsibility of the applicant.
ASSESSMENT DETAILS
This notification has been conducted under the cooperative arrangement with USA. The health and environmental hazard assessment components of the USA report were provided to NICNAS and, where appropriate, used in this assessment report. The other elements of the risk assessment and recommendations on safe use of the notified chemical were carried out by NICNAS.
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
Hewlett Packard Australia Pty Ltd (ABN: 74 004 394 763)
353 Burwood Hwy
FOREST HILL VIC 3131
Notification Category
Standard: Chemical other than polymer (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, impurities, additives/adjuvants, 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: flash point and acute inhalation toxicity
Previous Notification in Australia by Applicant(s)
None
Notification in Other Countries
USA (2013)
2. IDENTITY OF CHEMICAL
Marketing Name(s)
NT-45
Molecular Weight
500-1000 Da
Analytical Data
Reference IR spectra were provided.
3. COMPOSITION
Degree of Purity
> 95%
4. PHYSICAL AND CHEMICAL PROPERTIES
Appearance at 20 ºC and 101.3 kPa: white solidProperty / Value / Data Source/Justification
Melting Point/Freezing Point / 67.6-74.0 °C / Measured
Boiling Point / > 400 °C at 100.8 kPa / Measured
Density / 1000 kg/m3 at 22 °C / Measured
Vapour Pressure / < 1.3 × 10-3 kPa at 25 °C / Measured
Water Solubility / < 3.22 x 10-4 g/L 20 °C / Measured, OECD 105, column elution method
Hydrolysis as a Function of pH / Not determined / The notified chemical contains functional groups that are expected to hydrolyse slowly in the environmental pH range
(4-9).
Partition Coefficient
(n-octanol/water) / log Pow > 6.5 / Measured, OECD 117, HPLC method
Adsorption/Desorption / log Koc > 5.63 / Measured, OECD 121, HPLC method
Dissociation Constant / Not determined / No dissociable functionality
Particle Size / Inhalable fraction (< 100 mm): 0.134% / Measured
Flash Point / Not determined / Solid
Flammability / Not highly flammable / Measured
Autoignition Temperature / No self-ignition below the melting temperature / Measured
Explosive Properties / Predicted negative / Estimated based on chemical structure
Oxidising Properties / Predicted negative / Estimated based on chemical structure
Discussion of Properties
For full details of tests on physical and chemical properties, refer to Appendix A.
Reactivity
The notified chemical 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 chemical 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 Years
The notified chemical will not be manufactured or reformulated in Australia. The notified chemical will be imported as a component of a finished product, in closed toner cartridges at < 20% concentration.
Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years
Year / 1 / 2 / 3 / 4 / 5Tonnes / < 100 / < 300 / < 300 / < 300 / < 300
Port of Entry
To be decided
Identity of Recipients
Canon Australia Pty Ltd
Transportation and Packaging
The finished product (containing the notified chemical at < 20%) will be contained in sealed plastic cartridges (0.2-4 L). These cartridges will be packed in boxes, stacked on pallets and distributed within Australia by road or rail.
Use
The notified chemical will be used as component of toner for electro-photocopying machine or electro-photographic printer at < 20% concentration.
Operation description
There will be no manufacture, reformulation or repackaging of the notified chemical in Australia.
End-users (including service technicians, office workers and the general public) will remove the cartridge from the packaging and place the cartridge into the photocopier or printer. The cartridge will be disposed of when empty.
6. HUMAN HEALTH IMPLICATIONS
6.1. Exposure Assessment
6.1.1. Occupational Exposure
Category of Workers
Category of Worker / Exposure Duration (hours/day) / Exposure Frequency (days/year)Import/waterside / < 8 / 10-50
Storage and transport / < 8 / 10-50
Office workers / 10 seconds / 2
Service technicians / 1 / 200
Exposure Details
Waterside, storage and transport workers may come into contact with the notified chemical, as a component of toner (< 20%), only in the unlikely event of an accident.
Service technicians may be exposed to the toner containing < 20% notified chemical during repair and cleaning of photocopiers and printers. Due to the low volatility of the notified chemical and the large particle size, inhalation exposure is not likely and dermal exposure is expected to be the main potential route of exposure. Exposure to the notified chemical may occur while changing cartridges if the toner is inadvertently handled.
Office workers may be exposed to the toner when replacing the cartridge in machines but the extent of exposure is predicted to be very low. Instructions on how to replace the cartridges safely are included with the cartridge. Occasional dermal exposure during use of the printer may occur if the printed pages were handled inadvertently before the toner had dried, or if toner-stained parts of the printer were touched. Once the toner dries, the notified chemical will be bonded to the paper as part of the print, and therefore not expected to be bioavailable.
6.1.2. Public Exposure
Dermal exposure of the public to toner containing the notified chemical (at < 20%) is expected to be similar, though less frequent, than that described above for office workers.
6.2. Human Health Effects Assessment
The results from toxicological investigations conducted on the notified chemical are summarised in the following table. For full details of the studies, refer to Appendix B.Endpoint / Result and Assessment Conclusion
Rat, acute oral toxicity / LD50 > 2000 mg/kg bw; low toxicity
Rat, acute dermal toxicity / LD50 > 2000 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
Rat, repeat dose oral toxicity – 28 days / NOAEL = 1,000 mg/kg bw/day (male)
NOAEL = 300-1,000 mg/kg bw/day (female)
Mutagenicity – bacterial reverse mutation / non mutagenic
Genotoxicity – in vitro mammalian chromosome aberration / non genotoxic
Toxicokinetics, metabolism and distribution
No toxicokinetic data on the notified chemical were submitted. Absorption across biological membranes is expected to be limited by the relatively high molecular weight (> 500 Da) and high log Kow.
Acute toxicity
In studies conducted in rats the notified chemical was found to have low acute oral and dermal toxicity.
As the dust generation properties of the notified chemical were shown to be low, it was considered impossible to generate a suitable test atmosphere from the notified chemical in its original form or as a liquid formulation, for use in an inhalation study.
Irritation
Based on studies conducted in rabbits the notified chemical was non-irritating to the skin and slightly irritating to eyes.
Sensitisation
The notified chemical at concentrations up to 10% (the highest attainable dose) in a mouse Local Lymph Node Assay showed no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation.
Repeated dose toxicity
A 28 day repeat dose study by oral gavage was conducted in rats with the notified chemical at dose levels of 30, 300 and 1000 mg/kg bw/day. The No Observed adverse Effect Level (NOAEL) was established as 1000 mg /kg bw/day for males, based on no changes observed at the highest dose tested. As the liver weight changes observed in the female at 1,000 mg/kg were of borderline significance, the NOAEL based on this was likely to be between 300 and 1,000 mg/kg bw/day.