File No: STD/1551
May 2015
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
PUBLIC REPORT
2-Butene, 1,1,1,4,4,4-hexafluoro-, (2Z)-
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 6
1. APPLICANT AND NOTIFICATION DETAILS 6
2. IDENTITY OF CHEMICAL 6
3. COMPOSITION 7
4. PHYSICAL AND CHEMICAL PROPERTIES 7
5. INTRODUCTION AND USE INFORMATION 7
6. HUMAN HEALTH IMPLICATIONS 9
6.1. Exposure Assessment 9
6.1.2. Public Exposure 9
6.2. Human Health Effects Assessment 10
6.3. Human Health Risk Characterisation 12
6.3.1. Occupational Health and Safety 12
6.3.2. Public Health 13
7. ENVIRONMENTAL IMPLICATIONS 13
7.1. Environmental Exposure & Fate Assessment 13
7.1.1. Environmental Exposure 13
7.1.2. Environmental Fate 14
7.1.3. Predicted Environmental Concentration (PEC) 14
7.2. Environmental Effects Assessment 14
7.2.1. Predicted No-Effect Concentration 15
7.3. Environmental Risk Assessment 15
Appendix A: Physical and Chemical Properties 16
Appendix B: Toxicological Investigations 18
B.1. Toxicokinetic 18
B.2. Acute toxicity – inhalation 19
B.3. Acute toxicity – inhalation 19
B.4. Irritation – skin 20
B.5. Repeat dose toxicity 20
B.6. Repeat dose toxicity 22
B.7. Repeat dose toxicity 23
B.8. Repeat dose toxicity 24
B.9. Cardiac sensitisation to adrenaline 25
B.10. Genotoxicity – bacteria 29
B.11. Genotoxicity – in vitro 29
B.12. Genotoxicity – in vivo 31
B.13. Developmental toxicity 31
B.14. Developmental toxicity 32
B.15. Toxicity to reproduction – two generation study 34
Appendix C: Environmental Fate and Ecotoxicological Investigations 36
C.1. Environmental Fate 36
C.1.1. Ready biodegradability 36
C.1.2. Inherent biodegradability 36
C.2. Ecotoxicological Investigations 37
C.2.1. Acute toxicity to fish 37
C.2.2. Acute toxicity to fish 38
C.2.3. Chronic toxicity to fish 38
C.2.4. Acute toxicity to aquatic invertebrates 39
C.2.5. Chronic toxicity to aquatic invertebrates 39
C.2.6. Algal growth inhibition test 40
C.2.7. Inhibition of microbial activity 41
BIBLIOGRAPHY 42
May 2015 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/1551 / The Chemours Company (Australia) Pty Ltd / 2-Butene, 1,1,1,4,4,4-hexafluoro-, (2Z)- / No / 350 tonnes per annum / Foam expansion agent, fire extinguishant, refrigerant, cleaning solvent and heat transfer fluid
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).
The environmental hazard classification according to the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS) is presented below. Environmental classification under the GHS is not mandated in Australia and carries no legal status but is presented for information purposes.
Hazard classification / Hazard statementAcute Category 3 / 402 – Harmful to aquatic life
Human health risk assessment
Provided that the recommended controls are being adhered to, 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 its low hazard to the environment and 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 for non-enclosed processes, when 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:
- Avoid using the notified chemical in small rooms with limited ventilation
- Avoid breathing vapours or mists
- Avoid skin and eye contact with the notified chemical in liquid form
- Maintain and monitor equipment for leaks and take immediate corrective action where leaks are detected
- Follow all applicable industry standards and regulations for use of the notified chemical
· 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:
- Suitable respiratory equipment in case of insufficient ventilation, such as a positive-pressure supplied-air respirator
- Impervious clothing
- Face-shield and eye protection
- Protective/cold insulating gloves
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.
· This assessment will be referred to Safe Work Australia for consideration of the Workplace Environmental Exposure Level (WEEL) Guide of 500 ppm: 8 h time weighted average (TWA) for the notified chemical (OARS, 2014) in the Australian context.
Public Health
· The following measures should be taken by manufacturers, distributors or unit owners to minimise public exposure to the notified chemical:
- Equipment should be maintained and monitored for leaks, with immediate corrective action taken where leaks are detected.
Disposal
· The notified chemical should be disposed of via an appropriate product stewardship scheme where practicable.
Storage
· The following precautions should be taken regarding storage of the notified chemical:
- Keep containers tightly closed in a cool, well-ventilated place and away from direct sunlight.
Emergency procedures
· Spills or accidental release of the notified chemical should be allowed to evaporate; ventilate enclosed areas until safe for re-entry.
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(1) of the Act; if
- The notified chemical is proposed to exceed 20% concentration in polyurethane foams (including spray polyurethane foams) for use in residential or commercial buildings.
(2) Under Section 64(2) of the Act; if
- the function or use of the chemical has changed from foam expansion agent, fire extinguishant, refrigerant, cleaning solvent and heat transfer fluid, 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 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)
The Chemours Company (Australia) Pty Ltd (ABN: 90 169 142 750)
7 Eden Park Drive
MACQUARIE PARK NSW 2113
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: other names, analytical data, degree of purity, impurities, other physical and chemical properties, and import volume.
Variation of Data Requirements (Section 24 of the Act)
Variation to the schedule of data requirements is claimed as follows: dissociation constant, autoignition temperature, acute oral toxicity, acute dermal toxicity, eye irritation and skin sensitisation.
Previous Notification in Australia by Applicant(s)
None
Notification in Other Countries
USA
EU
Switzerland
2. IDENTITY OF CHEMICAL
Marketing Name(s)
Formacel® 1100
CAS Number
692-49-9
Chemical Name
2-Butene, 1,1,1,4,4,4-hexafluoro-, (2Z)-
Other Names
FEA-1100
Formacel FEA-1100
HFO 1336mzz(Z)
cis-1,1,1,4,4,4-Hexafluoro-2-butene
Molecular Formula
C4H2F6
Structural Formula
Molecular Weight
164.05 Da
Analytical Data
Reference GC-FID, NMR, FTIR, MS, UV-Vis spectra were provided.
3. COMPOSITION
Degree of Purity
> 99%
4. PHYSICAL AND CHEMICAL PROPERTIES
Appearance at 20 ºC and 101.3 kPa: Colourless, transparent liquidProperty / Value / Data Source/Justification
Freezing Point / - 90.5 °C / Published (Henne et. al., 1947)
Boiling Point / 33 - 33.5 °C at 101.3 kPa
33.2 °C at 101.3 kPa / Measured
Published (Henne et. al., 1947)
Density / 1,377 kg/m3 at 20 °C / Measured
Vapour Pressure / 60.4 kPa at 20 °C / Measured
Water Solubility / 0.7633 g/L at 25 °C / Measured
Hydrolysis as a Function of pH / t0.525 °C > 1 year at pH 4, 7, and 9 / Measured
Partition Coefficient
(n-octanol/water) / log Pow = 2.3 at 30 °C / Measured
Adsorption/Desorption / log Koc = 2.48 (soil)
log Koc = 2.51 (sewage sludge) / Measured
Dissociation Constant / Not determined / Contains no dissociable functionalities
Flash Point / Does not flash / Measured
Flammability / Not flammable / Measured
Autoignition Temperature / Not determined / Not expected to undergo autoignition
Explosive Properties / Not determined / Contains no functional groups that imply explosive properties
Oxidising Properties / Not determined / Contains no functional groups that imply explosive properties
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. Hazardous decomposition products may include carbon monoxide and hydrogen fluoride.
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 into Australia neat (> 99% purity) as a liquid.
Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years
Year / 1 / 2 / 3 / 4 / 5Tonnes / < 50 / < 100 / < 200 / < 300 / < 350
Port of Entry
Sydney and Melbourne
Identity of Recipients
The Chemours Company (Australia) Pty Ltd
Transportation and Packaging
The notified chemical will be imported in 200 L drums and then transported from the port to distributors’ warehouses for storage until delivery to end users.
Use
The notified chemical is proposed for the following uses:
· foam expansion agent at 5-20% concentration;
· fire extinguishant at 50-100% concentration;
· refrigerant for centrifugal chiller at 40-100% concentration;
· cleaning solvent at 4-100% concentration; and
· heat transfer fluid at 40-100% concentration.
Operation description
The notified chemical will not be manufactured in Australia, but may be reformulated after importation.
Reformulation
The notified chemical will be pumped from drums into a mixing tank where it will be blended with other materials to form formulated products containing the notified chemical at required concentrations.
End use as a foam expansion agent
The notified chemical will be used as a foam expansion agent in the manufacture of polyurethane foams, including spray polyurethane foams.
At foam manufacturing sites, the notified chemical at 100% concentration or formulated products containing the notified chemical at 10-40% concentration will be pumped from the receiving drums directly into a closed blending vessel, where it may be mixed with other materials to produce the blended product. The blended product containing the notified chemical will then be transferred to the foaming machine where it will be blended with isocyanate to make the polyurethane foam. The viscous foam will then be discharged at low pressure through a pouring tube into a mould, where it will be left to partially cure and solidify, and then put out onto a pallet to complete the curing process. The foam will then be cut to size. The foam will be used for insulation in commercial and residential structures such as roofs, walls, foundations, storage tanks, insulated panels, refrigerated truck bodies, etc. The concentration of the notified chemical in finished foam products will be 5-20% concentration which will be trapped within the closed cells of the foam.