July 2013
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
PUBLIC REPORT
Bruggolite FF6This 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 Sustainability, Environment, Water, Population and Communities.
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 4
1. APPLICANT AND NOTIFICATION DETAILS 4
2. IDENTITY OF CHEMICAL 5
3. COMPOSITION 5
4. PHYSICAL AND CHEMICAL PROPERTIES 5
5. INTRODUCTION AND USE INFORMATION 6
6. HUMAN HEALTH IMPLICATIONS 6
6.1. Exposure Assessment 6
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 9
6.3.1. Occupational Health and Safety 9
6.3.2. Public Health 9
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) 10
7.2. Environmental Effects Assessment 10
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 – oral 13
B.3. Acute toxicity – dermal 13
B.4. Irritation – skin 14
B.5. Irritation – eye 14
B.6. Skin sensitisation 15
B.7. Repeat dose toxicity 15
B.8. Repeat dose toxicity 16
B.9. Genotoxicity – bacteria 17
B.10. Genotoxicity – in vitro 18
B.11. Genotoxicity – in vivo 19
B.12. Developmental toxicity 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
July 2013 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/1463 / Nuplex Industries (Aust) Pty Ltd / Bruggolite FF6 / No / ≤ 20 tonnes per annum / Agent for polymer manufacture
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 isolation and engineering controls to minimise occupational exposure to the notified chemical as introduced:
- Enclosed, automated processes, where possible.
· 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 as introduced:
- Avoid eye contact
- Avoid inhaling dust
· 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 as introduced:
- Goggles
- Respiratory protection where dust may occur
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
· The notified chemical should be disposed of to landfill.
Storage
· The handling and storage of the notified chemical should be in accordance with the Safe Work Australia Code of Practice for Managing Risks of Hazardous Chemicals in the Workplace (SWA, 2012) or relevant State or Territory Code of Practice.
Emergency procedures
· Spills or accidental release of the notified chemical 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 chemical, have post-assessment regulatory obligations to notify NICNAS when any of these circumstances change. These obligations apply even when the notified chemical/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 chemical has changed from an agent for polymer manufacture, 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.
(Material) Safety Data Sheet
The (M)SDS of the notified chemical provided by the notifier was 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)Nuplex Industries (Aust) Pty Limited (ABN: 25 000 045 572)
49-61 Stephen Road
BOTANY NSW 2019
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, CAS number, molecular and structural formulae, molecular weight, analytical data, degree of purity, impurities, use details, import volume and identity of recipients.
Variation of Data Requirements (Section 24 of the Act)
Variation to the schedule of data requirements is claimed as follows: boiling point, hydrolysis as a function of pH, adsorption/desorption, flash point, oxidising properties and acute inhalation toxicity.
Previous Notification in Australia by Applicant(s)
None
Notification in Other Countries
ECHA (2010) and New Zealand (2010)
2. IDENTITY OF CHEMICAL
Marketing Name(s)Bruggolite FF6Other Name(s)
Bruggolite FF6 M
Brüggolit FF6 M
Bruggolite FF7
Brüggolit FF7
Molecular Weight
500 Da
Analytical Data
Reference NMR, IR and UV spectra were provided.
3. COMPOSITION
Degree of Purity / 60-80%4. PHYSICAL AND CHEMICAL PROPERTIES
Appearance at 20 ºC and 101.3 kPa: White powderProperty / Value / Data Source/Justification
Melting Point / Decomposes without melting at > 200 °C / Measured
Boiling Point / Not determined / Decomposes before boiling based on melting point determination
Density / 1840 kg/m3 at 20 °C / Measured
Vapour Pressure / < 1x10-10 kPa at 25 °C / Calculated
Water Solubility / ≥ 125.76 g/L at 20 °C / Measured
Hydrolysis as a Function of pH / Not determined / Expected to react with other ingredients in water to initiate polymerisation
Partition Coefficient
(n-octanol/water) / log Pow < -2.4 at 20 °C / Measured
Adsorption/Desorption / Not determined / Not expected to absorb to soil/sediment strongly based on the reported high water solubility
Dissociation Constant / pKa = 7.00 at 20°C / Measured
Particle Size / Inhalable fraction (< 100 mm): 99%
Respirable fraction (< 10 mm): 28%
MMAD* = 17.52 mm / Measured
Flash Point / Not determined / The notified chemical is a solid.
Flammability / Not highly flammable / Measured
Autoignition Temperature / > 400 °C / Measured
Explosive Properties / Not explosive / Measured
Oxidising Properties / Not determined / Contains no functional groups that imply oxidative properties
* MMAD = Mass Median Aerodynamic Diameter
Discussion of PropertiesFor 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 YearsThe notified chemical will be imported as a powder at up to 80% concentration.
Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years
Year / 1 / 2 / 3 / 4 / 5
Tonnes / ≤ 20 / ≤ 20 / ≤ 20 / ≤ 20 / ≤ 20
Port of Entry
Sydney
Identity of Manufacturer/Recipients
The notified chemical will be manufactured overseas and imported by the notifier.
Transportation and Packaging
The notified chemical (at ≤ 80% concentration) will be imported by sea in 25 kg PE bags and distributed by road.
Use
The notified chemical will be used in the manufacture of polymers.
Operation description
The notified chemical will be imported into Australia at up to 80% concentration for use in the manufacture of polymers. The notified chemical is consumed during this process and will not be present in the end product polymers.
End-use/ Polymer manufacture
The notified chemical in powder form will be added to a reactor vessel and dissolved in water in the sealed vessel. The resulting solution will be added to the polymerisation process using dedicated lines and a fully automated process. The notified chemical will be consumed during the reaction process.
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)
Transportation / 8 / 200
Storage / 8 / 200
Synthesis of polymers / 8 / 200
Exposure Details
Transport and storage
Transport and storage workers may come into contact with the notified chemical (at ≤ 80% concentration) only in the event of accidental rupture of containers.
End use/ Polymer manufacture
Dermal and ocular exposure of workers to the notified chemical (at ≤ 80% concentration) may occur during formulation when charging the mixing tanks and while performing maintenance and cleaning of equipment. Inhalation of the powdered notified chemical is also possible when adding the notified chemical to the mixing tank. Exposure is expected to be minimised through the use of mechanical ventilation and enclosed systems and through the use of personal protective equipment (PPE) such as coveralls, safety glasses and impervious gloves.
6.1.2. Public Exposure
The notified chemical will only be used by industry in the production of polymers and will not be available to the public. In addition, the notified chemical will be consumed in the manufacture process and will not be available for exposure in finished products.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; 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
Rat, repeat dose oral toxicity – 90 days. / NOAEL = 250 mg/kg bw/day
Mutagenicity – bacterial reverse mutation / non mutagenic
Genotoxicity – in vitro Mammalian chromosome aberration / genotoxic
Genotoxicity – in vivo Mammalian erythrocyte micronucleus / non genotoxic
Rat, developmental toxicity / NOAEL = 1000 mg/kg bw/day
Toxicokinetics.
The notified chemical is highly hydrophilic (log Pow < -2.4 at 20° C), hence dermal absorption is not expected. Given the low molecular weight of the notified chemical (< 500 Da) absorption across the respiratory or GI tract may occur. This is supported by evidence of systemic toxicity at high doses in an acute oral toxicity study and in a 90-day repeated dose oral toxicity study.
Acute toxicity.
There are two studies on the acute oral toxicity of the notified chemical. The data indicate that the notified chemical is of low acute oral toxicity. One study reported hunched posture and apathy in animals treated at 2000 mg/kg bw. The second study reported no signs of toxicity at 2000 mg/kg bw but observed lethargy, decreased reaction to stimuli, coma and death in groups treated with 4000 mg/kg bw notified chemical.