September 2010
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
INK BH11 MThis 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 Level 7, 260 Elizabeth Street, Surry Hills NSW 2010.
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: 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
Full Public Report 4
1. APPLICANT AND NOTIFICATION DETAILS 4
2. IDENTITY OF CHEMICAL 4
3. COMPOSITION 4
4. PHYSICAL AND CHEMICAL PROPERTIES 4
5. INTRODUCTION AND USE INFORMATION 5
6. HUMAN HEALTH IMPLICATIONS 6
6.1 Exposure assessment 6
6.1.1 Occupational exposure 6
6.1.2. Public exposure 6
6.2. Human health effects assessment 6
6.3. Human health risk characterisation 7
6.3.1. Occupational health and safety 7
6.3.2. Public health 7
7. ENVIRONMENTAL IMPLICATIONS 8
7.1. Environmental Exposure & Fate Assessment 8
7.1.1 Environmental Exposure 8
7.1.2 Environmental fate 8
7.1.3 Predicted Environmental Concentration (PEC) 9
7.2. Environmental effects assessment 9
7.2.1 Predicted No-Effect Concentration 9
7.3. Environmental risk assessment 10
8. CONCLUSIONS AND REGULATORY OBLIGATIONS 10
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. Repeat dose toxicity 16
B.7. Genotoxicity – bacteria 19
B.8. Genotoxicity – in vitro 20
Appendix C: Environmental Fate and Ecotoxicological Investigations 21
C.1. Environmental Fate 21
C.1.1. Ready biodegradability 21
C.2. Ecotoxicological Investigations 21
C.2.1. Acute toxicity to fish 21
C.2.2. Acute toxicity to aquatic invertebrates 22
C.2.3. Algal growth inhibition test 23
C.2.4. Inhibition of microbial activity 23
Bibliography 25
September 2010 NICNAS
Full Public Report
INK BH11 M1. APPLICANT AND NOTIFICATION DETAILS
Applicant(s)Brother International (Aust) Pty Ltd (17 001 393 835)
Suite 1, Level 3, Building A
11 Talavera Road
MACQUARIE PARK NSW 2113
Notification Category
Limited-small volume: Chemical other than polymer (1 tonne or less 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, import volume and identity of recipients.
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
Japan (2009)
2. IDENTITY OF CHEMICAL
Marketing Name(s)INK BH11 M
Molecular Weight
500 Da
Analytical Data
Reference NMR, IR, HPLC, UV spectra and Karl Fischer titration data were provided.
3. COMPOSITION
Degree of Purity / > 90%4. PHYSICAL AND CHEMICAL PROPERTIES
Appearance at 20ºC and 101.3 kPa: Dark red powderProperty / Value / Data Source/Justification
Melting Point / Decomposed from ~245oC / Measured
Boiling Point / Not determined / Decomposes on melting
Density / 1480 kg/m3 at 20oC / Measured
Vapour Pressure / < 6.3 x 10-7 kPa at 25oC / Measured
Water Solubility / 140 g/L at 20.0 ± 0.5oC / Measured
Hydrolysis as a Function of pH / t½ >1 year at 25°C, pH 4–9 / Measured
Partition Coefficient
(n-octanol/water) / log Pow < -4.35 at 20oC, pH ~7 / Measured
Surface Tension / 72.5 mN/m at 21oC / Measured
Adsorption/Desorption / log Koc < 1.25 at 30°C / Measured
Dissociation Constant / Not determined / The notified chemical is a salt and is expected to be ionised under environmental conditions
Particle Size / Inhalable fraction (<100 mm): 42.6%
Respirable fraction (<10 mm): 0.26%
Fraction (<5 mm): 0.11% / Measured
Flash Point / Not determined / Not applicable as low volatility solid.
Flammability / Not highly flammable / Measured
Autoignition Temperature / 352oC / Measured
Explosive Properties / Not expected to be explosive / The structural formula contains no explosophores.
Discussion of Properties
For full details of tests on physical and chemical properties, refer to Appendix A.
Reactivity
The notified chemical is predicted to be stable under normal conditions of use.
Dangerous Goods classification
Based on the submitted physical-chemical data in the above table the notified chemical is not classified according to the Australian Dangerous Goods Code (NTC, 2007). However the data above do not address all Dangerous Goods endpoints. Therefore consideration of all endpoints should be undertaken before a final decision on the Dangerous Goods classification is made by the introducer of the chemical.
5. INTRODUCTION AND USE INFORMATION
Mode of Introduction of Notified Chemical (100%) Over Next 5 YearsThe notified chemical will be imported only as a component of ink, which has already been incorporated into cartridges (< 5% concentration).
Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years
Year / 1 / 2 / 3 / 4 / 5
Tonnes / < 1 / < 1 / < 1 / < 1 / < 1
Port of Entry
Sydney
Transportation and Packaging
The notified chemical will be imported as a component of ink-jet printer ink contained in 12 mL plastic cartridges. The cartridges will be packed in plastic bags which in turn will be packaged in cardboard boxes. Boxes of these cartridges will be transported by road to storage, retail and end-use sites.
Use
The notified chemical will be used as a dye component of imported inkjet printer inks (< 5%).
The inks will be used by office workers and the public for routine but varied colour printing operations in home and small office scenarios. Sealed ink cartridges containing the notified chemical will be used as necessary to replace spent cartridges in inkjet printers.
Operation description
No reformulation or repackaging of the notified chemical will occur in Australia. The products containing the notified chemical will be delivered to the end-user in the same form in which they are imported. The cartridges will be installed or replaced into the inkjet printer by office workers, service technicians or consumers.
6. HUMAN HEALTH IMPLICATIONS
6.1 Exposure assessment
6.1.1 Occupational exposure
Exposure to the notified chemical during the importation, transport and storage of the printer cartridges is not expected, except in the unlikely event of an accident where the cartridge and its packaging may be breached.Both office workers and service technicians may be exposed to the notified chemical in inks (< 5% concentration) while changing printer cartridges, and service technicians may additionally be exposed during printer maintenance. Dermal exposure to small quantities of the notified chemical may occur if the print heads are touched while replacing the cartridges. In addition, dermal and possibly ocular exposure could occur when handling faulty or ruptured cartridges. Exposure during handling and cleaning or printer components is likely to be limited to the fingertips. Therefore, the exposure of these workers is expected to be minimal and infrequent.
Dermal exposure of workers may also occur when handling printed media before the ink is adequately dried, especially when printing on non-absorbent materials. Dermal exposure of office workers to the notified chemical from dried inks on printed paper is expected to be minimal, as the dye will be largely bound to the paper within the matrix of the dried ink.
The extent of dermal exposure of workers to wet ink on paper or other non-absorbent substrate has been estimated by the notifier. One kilogram of pure dye would be expected to produce several million sheets of A4 coloured text or graphics. Under worst-case conditions, each piece of A4 paper could be assumed to incorporate a maximum of 1 mg of notified chemical. Based on a 50% transfer on contact when handling printed paper or other substrate (assuming partially dry ink), and the relative contact area of fingertips and paper size:
Area of contact with finger ends (four fingers on one hand) = 8 cm2
A4 sized paper = ~600 cm2
% Removal = (8/600) ´ 0.5 ´ 100 = < 1%
\ Exposure to fingertips per event = < 1% of 1 mg = < 0.01 mg per event.
For extensive contact with wet ink on paper or other substrate (i.e. >10 events per day) the daily systemic exposure (assuming no washing between events) for a 70 kg person using 100% dermal absorption, would be:
Daily exposure = (< 0.01 (mg/event)×10) ÷ 70 = ~0.0014 mg/kg bw/day.
6.1.2. Public exposure
The exposure of the public to the notified chemical in inkjet printer inks is expected to be identical, or of a lesser extent, than that experienced by office workers using the same ink.6.2. Human health effects assessment
The results from toxicological investigations conducted on the notified chemical are summarised in the table below. Details of these studies can be found in 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 150 mg/kg bw/day
Mutagenicity – bacterial reverse mutation / non mutagenic
Genotoxicity – in vitro chromosomal aberration / non genotoxic
Toxicokinetics
There are no toxicokinetic data on the notified chemical. The notified chemical has a molecular weight > 500 Da and a water solubility of 140 g/L at 20oC and partition coefficient (log Pow) of -4.35 at 20oC. The moderately high molecular weight and hydrophilicity of the notified chemical suggest that dermal absorption is unlikely, however there may be potential for absorption across the GI tract. This is supported by the observation of red coloured urine in animals in the repeated dose 28-day oral toxicity study in rats.
Acute toxicity
The notified chemical is of low acute dermal and oral toxicity (LD50 >2000 mg/kg bw) based on studies conducted in rats.
No acute inhalation toxicity study was conducted using the notified chemical.
Irritation and Sensitisation
Based on studies conducted in rabbits the notified chemical is not irritating to skin but slightly irritating to eyes.
Conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24-hour observation period. All treated eyes appeared normal at the 48-hour observation.
In a LLNA study, the notified chemical showed no evidence of a skin sensitisation potential.
Repeated Dose Toxicity
The 28-day oral toxicity study for the notified chemical showed no mortality at up to 1000 mg/kg bw/day. The observation of red coloured urine provided evidence that absorption of the notified chemical had occurred. Based on non-adverse histological findings observed at 150 and 1000 mg/kg bw/day, the NOAEL was established as 150 mg/kg bw/day.
Mutagenicity
The notified chemical was not mutagenic in a bacterial reverse mutation assay and not clastogenic to Chinese hamster lung cells in vitro.
Summary
The notified chemical is of low acute oral and dermal toxicity. It is not irritating to skin but may be slightly irritating to eyes. It is not a skin sensitiser and not mutagenic. Given the notified chemical can cross the GI tract, there may be some potential for systemic toxicity via the oral route.
Health hazard classification
Based on the provided data the notified chemical is not classified as hazardous according to the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004).
6.3. Human health risk characterisation
6.3.1. Occupational health and safety
Dermal and ocular exposure of workers to the notified chemical should occur infrequently and be of small amounts, given the containment of the notified chemical within ink cartridges. The notified chemical, present in inks at concentrations < 5%, is not likely to be toxic at the highest levels of probable exposure (worst-case exposure estimate of ~0.0014 mg/kg bw/day, compared with NOAEL of150mg/kgbw/day).Given that exposure of workers to the notified chemical is expected to be low, the OHS risk is not considered to be unacceptable.
6.3.2. Public health
The exposure and hazard of the notified chemical to the members of the public during the use of inkjet printers are expected to be identical or similar to that experienced by office workers. Therefore, the risk of the notified chemical to the health of the public is assessed to be low. The unlikely but potential public exposure through accidents during importation, transportation or storage is considered as negligible.7. ENVIRONMENTAL IMPLICATIONS
7.1. Environmental Exposure & Fate Assessment
7.1.1 Environmental Exposure
Release of Chemical at SiteThe notified chemical is an ink dyestuff and will be imported into Australia as a component of ink in ready to use sealed printing cartridges for home or office inkjet printers. No manufacturing, reformulation or repackaging of the notified chemical will take place in Australia. Environmental release of the notified chemical is unlikely to occur during importation, storage and transportation as containers are designed to minimise release. In the event of an accidental spill the ink containing the notified chemical will be absorbed with inert material and disposed of to landfill.
Release of Chemical from Use
The notified chemical will be contained in ink cartridges and it is expected that < 1% of the annual import volume of the notified chemical may be spilt. If leakage or spillage does occur, the ink will be physically contained with absorbent material and disposed of to landfill. The ink cartridges will be contained within the printer until the contents are consumed. The empty cartridges, estimated to contain < 1% of the annual import volume of notified chemical, will be removed and disposed of to landfill or sent for recycling.