File No: LTD/1740
September 2014
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
PUBLIC REPORT
Chemical in Irgazin Rubine L 4030
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 9
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) 10
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 13
B.1. Repeat dose toxicity 13
B.2. Genotoxicity – bacteria 15
B.3. Genotoxicity – in vitro 15
B.4. Genotoxicity – in vitro 16
B.5. Genotoxicity – in vivo 17
B.6. Genotoxicity – in vivo 18
BIBLIOGRAPHY 20
September 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 / USELTD/1740 / BASF Australia Ltd / Chemical in Irgazin Rubine L 4030 / No / ≤ 1 tonne per annum / Component of automotive refinish paints
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
On the basis of the assessed use pattern, the notified chemical is not considered to pose an unreasonable risk to the environment.
Recommendations
Control Measures
Occupational Health and Safety
· A person conducting a business or undertaking at a workplace should implement the following engineering controls to minimise occupational exposure to the notified chemical:
- Local exhaust ventilation during spray application
· A person conducting a business or undertaking at a workplace should implement the following safe work practices to minimise occupational exposure during handling of the notified chemical:
- Avoid inhalation of spray particles
· A person conducting a business or undertaking at a workplace should ensure that the following personal protective equipment is used by workers to minimise occupational exposure to the notified chemical:
- Coveralls, safety glasses, impervious gloves
Guidance in selection of personal protective equipment can be obtained from Australian, Australian/New Zealand or other approved standards.
· Spray applications should be carried out in accordance with the Safe Work Australia Code of Practice for Spray Painting and Powder Coating (SWA, 2012) or relevant State or Territory Code of Practice.
Disposal
· Where reuse or recycling are not available or practical, dispose of the chemical in an environmentally sound manner in accordance with relevant Commonwealth, state, territory and local government legislation.
Emergency procedures
· Spills or accidental release of the notified chemical should be handled by containment, physical 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 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 automotive refinish paints, 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.
(Material) Safety Data Sheet
The (M)SDS of the notified chemical (and products containing the notified chemical) 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)
BASF Australia Ltd (ABN: 62 008 437 867)
Level 12, 28 Freshwater place
SOUTHBANK VIC 3006
Notification Category
Limited-small volume: Chemical other than polymer (1 tonne or less per year) – Similar to a chemical that has been previously assessed by NICNAS.
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, use details and import volume.
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
USA
2. IDENTITY OF CHEMICAL
Marketing Name(s)
QAVR Additive N-7635 Dry
Irgazin Rubine L 4030 (product containing approx. 4% of notified chemical)
Molecular Weight
UVCB, molecular weight generally < 500 Da.
Analytical Data
Reference IR, HPLC, NMR, MS and UV spectra were provided.
3. COMPOSITION
Degree of Purity
Chemical is a multi-component reaction mixture.
Additives/Adjuvants
None
4. PHYSICAL AND CHEMICAL PROPERTIES
Appearance at 20 ºC and 101.3 kPa: Dark red powderProperty / Value / Data Source/Justification
Melting Point / > 300 °C / Measured
Boiling Point / Not determined / Expected to be very high, based on melting point
Density / 1370 kg/m3 at 22°C / Measured
Vapour Pressure / Not determined / Expected to be very low, based on melting point
Water Solubility / 1.0 × 10-4 g/L at 20 °C / Measured (OECD TG 105)
Hydrolysis as a Function of pH / Not determined / Due to the low water solubility no significant hydrolysis is expected in the environment
Partition Coefficient
(n-octanol/water) / log Pow = 5.76 at 25 °C / Calculated (fragment method, OECD TG 117)
Adsorption/Desorption / Not determined / The notified chemical is expected to have potential to adsorb to sediment sludge from water based on the low water solubility
Dissociation Constant / pKa = 3, 0.3 / Estimated based on the structural information
Surface Tension+ / 62.2-64.4 mN/m at 20 °C / Measured
Particle Size / Inhalable fraction (< 100 mm): approx. 95%
Respirable fraction (< 10 mm): 24-33%
MMAD * = 20.4 μm / Measured
Flash Point / Not determined / Not applicable for solid material
Autoignition Temperature / 260 °C / Measured
Explosive Properties / Not considered to have explosive properties / Measured
Oxidising Properties / Not considered to have oxidising properties / Measured
* MMAD = Mass Median Aerodynamic Diameter
+ New study (refer to Appendix A for details)
Discussion of Properties
The following tests carried out for explosive properties were negative: thermal sensitivity, mechanical sensitivity (shock) and mechanical sensitivity (friction).
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 be imported as a component of automotive refinish paints.
Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years
Year / 1 / 2 / 3 / 4 / 5Tonnes / <1 / <1 / <1 / <1 / <1
Port of Entry
Melbourne and Sydney
Identity of Manufacturer/Recipients
Notifier
Transportation and Packaging
The notified chemical will be imported as a component of automotive refinish paints in 1L and 3.5L tin cans packed in fibreboard cartons and shrink wrapped in wooden pallets. The pallets of cartons will be transported by road for storage at contracted warehouses.
Use
The notified chemical will be used as a component of automotive refinish paints at a concentration of ≤ 0.5%.
Operation description
There will be no reformulation or repackaging of products containing the notified chemical in Australia.
End-use
The imported automotive paints containing the notified chemical at up to 0.5% concentration will be used at automotive refinish sites. Paint products will be prepared by stirring, transferring and dilution and will be applied to automobiles, predominantly by spray painting conducted in a dedicated spray booth with downdraft ventilation. However touch-up applications may also be performed using paint brushes under ventilation.
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)Transport and storage / 1-2 / 10-20
Warehouse / 1-2 / 10-20
End-use / 1-2 / 50-100
Exposure Details
Transport and storage workers may come in contact with the notified chemical as a component of automotive paints at up to 0.5% concentration only in the event of accidental rupture of containers.
Dermal and ocular exposure to the notified chemical (≤ 0.5%) may occur during weighing, mixing and transfer of the automotive paint, and application of touch-up paint by brush. The notifier states that exposure to the notified chemical would be limited by the use of standard procedures and personal protective equipment (PPE).
Dermal, ocular and inhalation exposure to the notified chemical (≤ 0.5%) may occur during spray application of the finished paints to automobile parts and when cleaning spray gun equipment. The notifier states that these processes will be carried out in a dedicated spray booth with downdraft ventilation, with the use of PPE including an air-fed respirator, which would substantially reduce exposure.
Workers may also contact the dried paint surfaces, however in this form the notified chemical is expected to be incorporated in the paint matrix, and to not be bioavailable.
6.1.2. Public Exposure
Products containing the notified chemical will not be sold to the general public. Automotive refinish paints will only be used by professional automotive repairers. The public may come into contact with auto body parts and automobiles after the paints have been applied and dried however the notified chemical (≤ 0.5% concentration) will be incorporated within the paint matrix and is not expected to be bioavailable.
6.2. Human Health Effects Assessment
The results from toxicological investigations conducted on the notified chemical and a chemical that is structurally similar to the notified chemical are summarised in the table below. The results of new toxicological investigations conducted on the notified chemical are asterisked, with full details in Appendix A.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
Guinea pig, skin sensitisation – adjuvant test / no evidence of sensitisation
*Rat, repeat dose oral toxicity – 28 days. / NOAEL = 1000 mg/kg bw/day
*Mutagenicity – bacterial reverse mutation / non mutagenic
*Genotoxicity – in vitro chromosome aberrations in Chinese hamster V79 cells / non genotoxic
*Genotoxicity – in vitro chromosome aberrations in cultured human peripheral blood lymphocytes / non genotoxic
*Genotoxicity – in vivo mouse bone marrow micronuclei test / non genotoxic
*Genotoxicity – in vivo unscheduled DNA synthesis / non genotoxic
Toxicokinetics, metabolism and distribution.
No information is available on the toxicokinetics of the notified chemical. The notified chemical has a low molecular weight (< 500 Da) but of low water solubility (1.0 × 10-4 g/L) therefore dermal absorption is limited. The respirable fraction is significant (24-33%) and most of the particles can be inhaled (~95%) allowing for accumulation in the respiratory tract and transport to the gastrointestinal tract, however the notified chemical is not introduced in powder form.
Acute toxicity.
The notified chemical was of low acute oral (LD50 > 2000 mg/kg bw) and dermal (LD50 > 2000 mg/kg bw) toxicity in the rat with no deaths or body weight effects noted in either study. Effects reported in the oral study included dyspnea (for up to 5 hours after administration), hunched posture (for up to one day) and piloerection (for up to 2 days after dosing). Effects reported in the dermal study included slight piloerection and slight erythema (which could be attributed to dark red colour of the test substance) in all animals on day 1.