File No: STD/1485

October 2013

NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME

(NICNAS)

PUBLIC REPORT

Polymer in ClearShield UV 390B

This 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 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 8

6.2. Human Health Effects Assessment 8

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 10

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 14

B.1. Acute toxicity – oral 14

B.2. Irritation – skin 14

B.3. Irritation – eye 14

B.4. Skin sensitisation – mouse local lymph node assay (LLNA) 15

B.5. Repeat dose toxicity 16

B.6. Genotoxicity – bacteria 16

B.7. Genotoxicity – in vitro 17

B.8. Genotoxicity – in vitro 18

Appendix C: Environmental Fate and Ecotoxicological Investigations 20

C.1. Environmental Fate 20

C.1.1. Ready biodegradability 20

C.2. Ecotoxicological Investigations 20

C.2.1. Acute toxicity to fish 20

C.2.2. Acute toxicity to aquatic invertebrates 21

C.2.3. Algal growth inhibition test 22

BIBLIOGRAPHY 23

October 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 / USE
STD/1485 / Milliken Design Inc. / Polymer in ClearShield UV 390B / Yes / ≤ 100 tonnes per annum / UV absorber in polyethylene terephthalate (PET) containers

CONCLUSIONS AND REGULATORY OBLIGATIONS

Hazard classification

Based on the available information, the notified polymer 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 statement
Acute Category 2 / H401, Toxic to aquatic life
Chronic Category 2 / H411, Toxic to aquatic life with long lasting effects

Human health risk assessment

Under the conditions of the occupational settings described, the notified polymer is not considered to pose an unreasonable risk to the health of workers.

When used in the proposed manner, the notified polymer is not considered to pose an unreasonable risk to public health.

Environmental risk assessment

Based on the assessed use pattern, the notified polymer is not expected to pose an unreasonable risk to the environment.

Recommendations

Control Measures

Occupational Health and SafetyMilliken

·  A person conducting a business or undertaking at a workplace should implement the following engineering controls to minimise occupational exposure to the notified polymer during reformulation processes:

-  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 polymer during reformulation processes:

-  Avoid skin contact

·  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 polymer during reformulation processes:

-  Gloves

-  Safety glasses

-  Coveralls.

  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 polymer 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 polymer should be disposed of to landfill.

Emergency procedures

·  Spills or accidental release of the notified polymer 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 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 polymer has changed from UV absorber in polyethylene terephthalate (PET) containers or is likely to change significantly;

-  the amount of polymer being introduced has increased, or is likely to increase, significantly;

-  the polymer has begun to be manufactured in Australia;

-  additional information has become available to the person as to an adverse effect of the polymer 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 polymer 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

This notification has been conducted under the cooperative arrangement with Canada. The health and environmental hazard assessment components of the Canadian report were provided to NICNAS and, where appropriate, used in this assessment report. The other elements of the risk assessment and recommendations on safe use of the notified chemical were carried out by NICNAS.

1.  APPLICANT AND NOTIFICATION DETAILS

Applicant(s)

Milliken Design Inc. (ABN: 581 420 967 59)

7/860 Doncaster Road

DONCASTER EAST VIC 3109

Notification Category

Standard (Reduced fee notification): Synthetic polymer with Mn < 1000 Da (more than 1 tonne per year)- Comparable agency modular assessment.

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, polymer constituents, residual monomers, impurities, additives/adjuvants, use details, import volume, site of reformulation and identity of manufacturer/recipients.

Variation of Data Requirements (Section 24 of the Act)

Variation to the schedule of data requirements is claimed as follows: Particle size, flammability, autoignition temperature, explosive properties, oxidising properties, acute dermal toxicity, acute inhalation toxicity, and genotoxic damage in vivo.

Previous Notification in Australia by Applicant(s)

None

Notification in Other Countries

USA (2003), Canada (2010), Korea (2006), New Zealand (2010) and China (2009)

2.  IDENTITY OF CHEMICAL

Marketing Name(s)

ClearShield UV 390B (Product containing the notified polymer at > 80% concentration)

Other Name(s)

Uncut ClearShield UV 390B (name on (M)SDS - neat notified polymer)

Molecular Weight

< 1000 Da

Analytical Data

Reference IR, GPC, and UV spectra were provided.

3.  COMPOSITION

Degree of Purity

90%

4.  PHYSICAL AND CHEMICAL PROPERTIES

Appearance at 20 ºC and 101.3 kPa: viscous amber liquid
Property / Value / Data Source/Justification
Freezing Point / 2.0 °C (gel point) / Measured
Boiling Point / Decomposes before boiling from 364.3°C at 101.3 kPa / Measured
Density / 1.144 kg/m3 at 25 °C / Measured
Vapour Pressure / < 2.19x10-5 kPa at 25 °C / Estimated using Modified Watson Correlation method
Water Solubility / 2 g/L at 22 °C / Measured
Hydrolysis as a Function of pH / t1/2 = 12.6 at 50°C, pH = 4.0;
t1/2 = 42.0 at 25 °C, pH = 7.0;
t1/2 = 12.8 at 25 °C, pH = 9.0. / Measured
Partition Coefficient
(n-octanol/water) / log Pow = 2.03 at 20 - 25°C / Measured
Adsorption/Desorption / Log Koc = 2.04 – 2.08 / Estimated using method developed by Güsten and Sabljic (Güsten, 1995)
Dissociation Constant / Not determined / Not expected to be ionised at environmental pH range of 4-9
Flash Point / > 110 °C at unknown kPa (closed cup) / Measured
Flammability / Not determined / Not expected to be highly flammable based on flash point
Autoignition Temperature / Not determined / Not expected to autoignite based on flash point
Explosive Properties / Not determined / Does not contain any functional groups that imply explosive properties
Oxidising Properties / Not determined / Does not contain any functional groups that imply oxidising properties
Discussion of Properties

For full details of tests on physical and chemical properties, refer to Appendix A.

Reactivity

The notified polymer is expected to be stable under normal conditions of use. The notified polymer is susceptible to hydrolysis in water, however, once incorporated into the polymer matrix it is no longer expected to be susceptible to hydrolysis.

Physical hazard classification

Based on the submitted physico-chemical data depicted in the above table, the notified polymer 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 polymer will not be manufactured in Australia. The notified polymer will be imported as a component of the product ClearShield UV 390B at > 80% concentration.

Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years
Year / 1 / 2 / 3 / 4 / 5
Tonnes / 10-50 / 10-50 / 50-100 / 50-100 / 50-100
Port of Entry

Sydney and Melbourne

Identity of Recipients

The product containing the notified polymer will be supplied to companies involved in the manufacture of PET containers.

Transportation and Packaging

ClearShield UV 390B, containing the notified polymer at > 80% concentration will be imported in either polyethylene lined 208.2 L plastic drums or in 1,041 L Shutz totes. The drums will be shipped to Australia by sea or air and the totes will be shipped by sea. Within Australia the products will be transported by road or rail.

Use

ClearShield UV 390B, containing the notified polymer (at > 80% concentration) will be imported as a liquid concentrate for use as a UV absorber in PET containers. The final products (containers) will contain < 0.5% of the notified polymer and will be used to manufacture plastic articles, food and beverage containers, and containers for products for health beauty aid and household products.

Operation description

The notified polymer will be imported as part of a liquid concentrate at 80% concentration for reformulation into PET pellets and finally plastic containers. The plastic pellets produced during reformulation will contain < 0.5% of the notified polymer and will be used to manufacture plastic articles, food and beverage containers, and containers for products for health beauty aid and household products.

Reformulation

The product containing the notified polymer (at > 80% concentration) will be transported to plastics compounding facilities where it will be incorporated into PET pellets containing < 0.5% notified polymer. The compounding process will occur using largely automated processes and closed systems, although some manual transfer steps may be involved. Once in dried pellet form, the notified polymer is trapped in the inert matrix and no longer bioavailable.

The pellets may then be used at various sites to manufacture plastic articles such as food and beverage containers, and containers for products for health beauty, and household products. Final product containers will contain the notified polymer at < 0.5% concentration.

End use

The finished PET containers containing the notified polymer at < 0.5% concentration will be transported from the manufacturers sites to customers for sale to the general public.

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)
Process operators at PET manufacturing sites / 0.5 / 250

Exposure Details

Transport and storage

Transport and storage workers may only come into contact with the notified polymer at > 80% concentration in the event of accidental rupture of containers.

Reformulation of products

Dermal and ocular exposure of workers to the notified polymer (at > 80% concentration) may occur at compounding sites during formulation of PET pellets, particularly when charging the mixing tanks and while performing maintenance and cleaning of equipment and drum reconditioning. Inhalation exposure is not expected due to the low vapour pressure of the notified polymer. Dermal and ocular exposure is expected to be minimised through the use of enclosed systems and through the use of personal protective equipment (PPE) such as coveralls, safety glasses and impervious gloves.