May 2008
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
FULL PUBLIC REPORT
EnviroGem AD 01This 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 334-336 Illawarra Road, Marrickville NSW 2204.
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: 334 - 336 Illawarra Road MARRICKVILLE NSW 2204, 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 3
1. APPLICANT AND NOTIFICATION DETAILS 3
2. IDENTITY OF CHEMICAL 3
3. COMPOSITION 3
4. PHYSICAL AND CHEMICAL PROPERTIES 4
5. INTRODUCTION AND USE INFORMATION 4
6. HUMAN HEALTH IMPLICATIONS 5
6.1 Exposure assessment 5
6.1.1 Occupational exposure 5
6.1.2. Public exposure 7
6.2. Human health effects assessment 7
6.3. Human health risk characterisation 9
6.3.1. Occupational health and safety 9
6.3.2. Public health 9
7. ENVIRONMENTAL IMPLICATIONS 10
7.1. Environmental Exposure & Fate Assessment 10
7.1.1 Environmental Exposure 10
7.1.2 Environmental fate 11
7.1.3 Predicted Environmental Concentration (PEC) 11
7.2. Environmental effects assessment 11
7.2.1 Predicted No-Effect Concentration 11
7.3. Environmental risk assessment 12
8. CONCLUSIONS AND REGULATORY OBLIGATIONS 12
Hazard classification 12
Human health risk assessment 12
Environmental risk assessment 12
Recommendations 12
Regulatory Obligations 13
Appendix A: Physical and Chemical Properties 15
Appendix B: Toxicological Investigations 17
B.1. Irritation – skin 17
B.2. Irritation – eye 17
B.3. Skin sensitisation – mouse local lymph node assay (LLNA) 18
B.4. Repeat dose toxicity 18
Appendix C: Environmental Fate and Ecotoxicological Investigations 21
C.1. Environmental Fate 21
C.1.1. Ready biodegradability 21
C.1.2. Inherent biodegradability 21
C.1.3. Bioaccumulation 22
C.2. Ecotoxicological Investigations 22
C.2.1. Acute toxicity to fish 22
C.2.2. Acute toxicity to aquatic invertebrates 23
C.2.3. Algal growth inhibition test 23
C.2.4a. Inhibition of microbial activity 24
C.2.4b. Inhibition of microbial activity 25
Bibliography 26
May 2008 NICNAS
Full Public Report
EnviroGem AD 011. APPLICANT AND NOTIFICATION DETAILS
Applicant(s)IMCD Australia Limited (ABN 44 000 005 578)
Level 1, 372 Wellington Road
Mulgrave VIC 3170
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, Spectral data, Methods of detection and determination, Purity, Impurities, Additives/adjuvants, Use details, Identity of manufacturers, Analogue chemical (identity and other information).
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
United Kingdom (date unknown).
2. IDENTITY OF CHEMICAL
Marketing Name(s)EnviroGem AD 01
Molecular Weight
<500 Da
Analytical Data
Reference NMR, IR, GC, UV spectra were provided.
3. COMPOSITION
Degree of Purity / >95%4. PHYSICAL AND CHEMICAL PROPERTIES
Appearance at 20ºC and 101.3 kPa: Colourless to pale yellow, viscous liquid.Property / Value / Data Source/Justification
Melting Point/Freezing Point / -37oC / Measured
Boiling Point / 278ºC / Measured
Density / 900 kg/m3 at 20.1ºC / Measured
Vapour Pressure / 1.94×10-5 kPa at 20ºC
2.88×10-5 kPa at 25ºC / Measured
Water Solubility / 1.57±0.11 g/L at 19.8ºC / Measured
Hydrolysis as a Function of pH / t½ >1 year at pH 4,7 and 9 / Measured (data for an acceptable analogue chemical)
Partition Coefficient
(n-octanol/water) / logPow = 3.8 (CLOGP)
logPow = 4.32 (KOWWIN) / Estimated
Surface tension / 33.4 mN/m at 20ºC / Measured
Adsorption/Desorption / logKoc = 3.88 at 25ºC / Estimated by HPLC simulation
Dissociation Constant / Not determined / Contains no water-dissociable groups
Particle Size / Not determined / Liquid chemical
Flash Point / >110ºC at 101.3 kPa / Measured
Flammability / Not expected to be highly flammable / Estimated based on vapour pressure, autoignition temperature and experience in use
Autoignition Temperature / 385±5ºC / Measured
Explosive Properties / Not explosive / Measured
Discussion of Properties
The notified chemical is of limited water solubility, estimated to be reasonably lipid soluble, and is surface active in water. It is non-volatile and is not expected to present a physical hazard (based on the available data).
For full details of tests on physical and chemical properties, please refer to Appendix A.
Reactivity
The notified chemical is stable under normal conditions of use and does not react with water.
5. INTRODUCTION AND USE INFORMATION
Mode of Introduction of Notified Chemical (100%) Over Next 5 YearsThe notified chemical will be imported into Australia by sea.
Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years
Year / 1 / 2 / 3 / 4 / 5
Tonnes / 1-3 / 1-3 / 3-10 / 3-10 / 3-10
Port of Entry
All major sea ports throughout Australia.
Identity of Manufacturer/Recipients
IMCD Australia Limited
Transportation and Packaging
The notified chemical will be imported as a neat liquid in 200 L and 250 L steel drums or 22.7 L steel pails.
Use
The notified chemical will be used as a surfactant in paints, inks, and adhesives for industrial applications (~95%) and in domestic products (~5%, mainly in decorative paints). The primary industrial use is in coatings. Industrial coatings may contain <2% notified chemical, while decorative paints will contain <1% notified chemical.
Operation description
Transport and storage
The notified chemical will be imported as a raw material in liquid form. The notified chemical will be transported from the docks to the notifier’s manufacturing facility where it will be stored on site until required. The notified chemical will be usually transferred into ‘day’ tanks at reformulation sites, from where it will subsequently be delivered into mixing vessels through automated processes.
Formulation of coatings, inks and adhesives
The notified chemical will be pumped into the mixing vessel and mixed with resin, pigments, solvents, fillers and other additives until all components are adequately blended. Small samples of the blended formulation are likely to be taken for quality control purposes and tested by in-house laboratories to ensure that they meet set specifications. The finished coating product (<2% notified chemical) will then be filled into cans, pails, drums or totes via pipes and transfer lines.
In formulations for Do-It-Yourself (DIY) domestic applications, the imported notified chemical will be used by resin manufacturers (i.e., emulsions or binder manufacturers) to formulate a binder (containing 2% maximum of the notified chemical). These binders will be sent to paint manufacturers who will combine it with other ingredients (fillers, extenders, pigments, etc.) to form the final paint formulations (containing 1% maximum of the notified chemical).
Industrial application of coatings, inks and adhesives
Industrial use will vary depending on the formulated coating product. Typically, the notified chemical will be applied to substrates by experienced personnel under controlled conditions. For industrial paint/lacquer coating applications, the coatings will be predominantly applied by spray (~99%), either through the use of robotics or by worker-operated spray guns, within spray booths. The remainder may be applied using a roller or brush. Any overspray will be allowed to dry and collected for disposal.
When used in printing inks, the ink formulation (containing the notified chemical) will be transferred to the printing equipment and stored in an enclosed vessel; transfer of the material will occur via automated lines that are connected to the storage drums.
The application of industrial adhesives is expected to be via brushes or rollers (or equivalent).
DIY application of coatings
A small proportion of the notified chemical (<5% of annual importation volumes) may be available for use by the general public as decorative paints. The DIY public users will manually decant a small amount of the paint into paint trays for roller application, and are expected to only use rollers and/or brushes for paint application. Brushes and rollers may be cleaned with water, with potential residues likely washed into drains.
6. HUMAN HEALTH IMPLICATIONS
6.1 Exposure assessment
6.1.1 Occupational exposure
Number and Category of WorkersCategory of Worker / Number / Exposure Duration (hours/day) / Exposure Frequency (days/year)
Waterside workers / 10 / 4 / 50
Storage and transport personnel / 30 / 5 / 150
Coatings formulation personnel
-Charging of mixing vessel / 2 / <1 / 100
-Blending / 2 / 2 / 100
-Equipment cleaning / 2 / 2 / 100
-Product packaging / 2 / 2 / 100
Quality Assurance personnel / 5 / 3 / 100
Application
-Transfer to equipment / 1 / 0.5 / 60
-Application to substrate / 1 / 6 / 60
-Cleanup of equipment / 1 / 0.5 / 60
Exposure Details
Transport and storage
Transport workers are not expected to come into contact with the notified chemical, as it will be sealed within import containers. Exposure is only possible in the case of accidental spillage.
Workers involved with transferring the notified chemical to ‘day tanks’ may experience dermal and ocular exposure to the notified chemical during connection and disconnection of lines.
Formulation of coatings, inks and adhesives
Dermal and ocular exposure to the neat notified chemical is possible during connection and disconnection of lines. Similar exposures to lower concentrations in blended or partially blended products containing the notified chemical (<2%) are possible during connection and disconnection of lines, sampling for quality assurance, cleaning of equipment, or filling of product containers.
Workers involved in the manufacturing process are expected to wear personal protective equipment (PPE) including long sleeved clothing, eye protection, safety shoes, coveralls and impermeable gloves.
Inhalation exposure to the notified chemical is not expected, due to its low vapour pressure and the high viscosity of the notified chemical and formulated products (mixed in closed vessels). Nonetheless, the notifier reports that mixing processes are expected to be carried out under local exhaust ventilation.
Industrial application of coatings, inks and adhesives
Dermal, ocular and inhalation exposure to the notified chemical (<2%) is possible during application of coatings by brush, roller and spray.
Workers involved with the application of the notified chemical (i.e. mixing and transferring the formulated coating to the application equipment, applying the coating to the substrate, and cleaning the application equipment) are expected to wear PPE including long sleeved clothing, eye protection, impermeable gloves, coveralls and safety shoes.
Spray application is expected to be carried out in a downdraft spray booth (or similar) under most circumstances. Professional spray painters are expected to wear PPE including protective clothing and boots, chemical resistant gloves and goggles. Where engineering controls are not able to be used (e.g. in outdoor or in large applications) or are not effective to remove airborne droplets, suitable respirators (including the use of air-fed hoods) are expected to be utilised. Inhalation exposure is therefore expected to be low during spray application.
Once applied to the substrate, the notified chemical is expected to be trapped within the dried polymeric layer of the coating, and therefore should not be readily available to cause exposure to workers.
Exposure estimation
The primary route of systemic absorption is via dermal exposure. In the absence of better information, 100% dermal and inhalation absorption is assumed. From the proposed operation description, the expected dermal exposures to the notified chemical can be loosely categorised into two groups: (1) Incidental exposures during reformulation and (2) exposures during application and use.
1. Incidental exposures during reformulation:
The highest probable exposure of this kind is during the coupling and uncoupling of transfer lines for the neat liquid notified chemical (>95%, assumed 100% for exposure estimation purposes). For worst-case estimates, this is assumed to occur daily (although in practice it may be less frequent). The dermal exposure during such processes has been described as a probable half-hand exposure (420 cm2) and an exposure level of 0.1mg/cm2/day to an adult male worker (70 kg body weight (bw)) (EC, 2003). The combination of these gives a worst-case dermal exposure of:
(0.1 mg/cm2/day × 420 cm2 × 100% absorption)/70 kg bw = 0.6 mg/kg bw/day
The dermal exposures that are expected during sampling or other formulation steps (where the notified chemical is diluted) are likely to be lower than this estimate.
2. Exposures during application and use:
The worst-case exposure to the notified chemical will occur during the spraying of coatings and adhesives (<2% concentration, assumed 2% for exposure estimation purposes). For worst-case estimates, this is assumed to occur daily (although in practice it may be less frequent). Measured data for dermal exposure during the spraying of large amounts of low-volatility paints has been described by the RISKOFDERM project, which has described reasonable worst-case exposure of 12000 mg/scenario, and typical-case exposures of 3400mg/scenario (Marquart et al, 2006). Assuming one scenario/day for an adult male worker (70 kg bw) wearing gloves and protective clothing (90% protection), the combination of these gives an expected dermal exposure range of:
((3400× 0.02 × 0.1)/70 kg bw) to ((12000× 0.02 × 0.1)/70 kg bw) = 0.10-0.34 mg/kg bw/day
This exposure estimate is expected to be additionally conservative, as it does not account for interactions of the notified chemical within coating products that might limit the extent of its bioavailability. Also, spray application is expected to be carried out in a downdraft spray booth (or similar) under most circumstances, which will lead to lower dermal exposures from paint overspray. Dermal exposures during cleaning of spray guns and equipment cannot be calculated, but are likely to be small due to the use of automated cleaning apparatus and dilution with water/solvent.
6.1.2. Public exposure
Dermal and ocular exposure to the notified chemical (<1%) is possible during DIY application of coatings by brush and roller, and during the cleaning of equipment. Due to the low volatility of the notified chemical, the public are not expected to experience significant inhalation exposure to the notified chemical. Accidental oral exposure is possible, but not expected.Exposure estimation
Dermal exposure of the public to the notified chemical is expected during the application of coatings products (<1% concentration, assumed 1% for exposure estimation purposes). For worst-case estimates, this is assumed to occur daily (although in practice it will likely be less than a few days per year). Measured data for dermal exposure during the brush and roller application of relatively viscous, low volatility liquid products on surfaces (average durations of use, 59 and 74 minutes) has been described by the RISKOFDERM project, which has described reasonable worst-case exposures of 6500mg/scenario, and typical-case exposures of 1000mg/scenario (Marquart et al, 2006). Members of the public are not expected to wear PPE during application of decorative paints (apart from perhaps a long-sleeved shirt or similar). The combination of these factors, for adult males and females (65 kg bw (EC, 2003)), gives an expected dermal exposure range of:
((1000× 0.01)/65 kg bw) to ((6500× 0.01)/65 kg bw) = 0.15-1.0 mg/kg bw/day
This exposure estimate is expected to be additionally conservative, as it does not account for interactions of the notified chemical within coating products that might limit the extent of its bioavailability. Once applied to the substrate, the notified chemical is expected to be trapped within the dried polymeric layer of the coating, and therefore should not be readily available to cause exposure.
6.2. Human health effects assessment
The results from toxicological investigations conducted on the notified chemical are summarised in the table below. In addition, toxicological data for the acceptable analogue are considered for the acute dermal and acute inhalation toxicity end-points and for comparison with that obtained for the notified chemical.Endpoint / Result and Assessment Conclusion
Rat, acute oral / Low toxicity, LD50 >2,000 mg/kg bw
Rabbit, skin irritation* / Moderately irritating
Rabbit, eye irritation* / Irritating
Mouse, skin sensitisation – LLNA* / No evidence of sensitisation up to 50% (v/v)
Rat, repeat dose oral toxicity - 28 days* / NOAEL 150 mg/kg bw/day
Bacterial reverse mutation (Ames) test / Non-mutagenic
In vitro chromosome aberration assay / Non-clastogenic
Cytotoxicity – in vitro / Cytotoxic to cultured cells
* Details of these studies can be found in Appendix B.