Diamide Epoxy Curing Agent

Existing Chemical Secondary Notification Assessment Report LTD/1646S

NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME

GPO Box 58, Sydney NSW 2001 AUSTRALIA www.nicnas.gov.au

ISBN 978-0-9758470-1-5

© Commonwealth of Australia 2015This work is copyright. You may download, display, print and reproduce this material in unaltered form only (retaining this notice) for your personal, non-commercial use or use within your organisation. Apart from any use as permitted under the Copyright Act 1968, all other rights are reserved. Requests and inquiries concerning reproduction and rights should be addressed to Commonwealth Copyright Administration, Attorney General’s Department, National Circuit, Barton ACT 2600 or posted at www.ag.gov.au/cca .

PrefaceThis assessment was carried out under the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). This scheme was established by the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act), to aid in the protection of the Australian people and the environment by assessing the risks of industrial chemicals, providing information and making recommendations to promote their safe use. NICNAS assessments are carried out by staff employed by the Australian Government Department of Health in conjunction with the Australian Government 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 assessment 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

DirectorNICNAS

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ContentsPREFACE II

CONTENTS III

OVERVIEW V

RECOMMENDATIONS VII

SECONDARY NOTIFICATION IX

ABBREVIATIONS AND ACRONYMS X

1. INTRODUCTION 1

1.1 Background 1

1.2 Declaration 1

1.3 Objectives 1

1.4 Peer review 2

1.5 Applicant 2

1.6 Exempt information 2

2. CHEMICAL IDENTITY, PHYSICAL AND CHEMICAL PROPERTIES 3

2.1 Chemical identity 3

2.2 Composition 3

2.3 Physical and chemical properties 3

3. IMPORTATION AND USE 5

4. EXPOSURE 7

4.1 Public exposure 7

4.2 Occupational exposure 7

4.2.1 Operational description 7

4.2.2 Estimates of occupational exposure 7

4.3 Environmental exposure & fate assessment 7

4.3.1 Environmental exposure 7

4.3.2 Environmental Fate 8

4.3.3 Predicted environmental concentration (PEC) 9

5. HAZARD ASSESSMENT 10

5.1 Physicochemical and human health hazard assessment 10

5.1.1 Physicochemical effects assessment 10

5.1.2 Human health effects assessment 10

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5.1.3 Hazard classification 10

5.2 Environmental hazard assessment 11

5.2.1 Environmental effects assessment (ND) 11

5.2.2 Predicted No-Effect Concentration 15

5.2.3 Hazard classification (ND) 15

6. RISK CHARACTERISATION 16

6.1 Public health risk estimation 16

6.2 Occupational health risk estimation 16

6.3 Environmental risk estimation (ND) 16

APPENDIX 17

REFERENCES 22

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Overview Background

The notified chemical, Diamide Epoxy Curing Agent, was originally assessed in 2014 as a new chemical in the limited notification category (LTD/1646). In 2014, the notified chemical was listed on the public section of the Australian Inventory of Chemical Substances (AICS). Following issuing of the certificate but prior to AICS listing, the Director was notified of ecotoxicological data not considered in the new chemical assessment, and determined that these data warranted secondary notification of Diamide Epoxy Curing Agent in order to reassess the environmental risks of the notified chemical.

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, degree of purity, impurities, import volume, and exact percentage of chemical in products.

Importation and uses

The notified chemical is imported into Australia as an ingredient of two-part epoxy adhesives for bonding applications in the automotive, aerospace and industrial markets. Pack sizes range from 50 to 950 mL and contain Diamide Epoxy Curing Agent at a concentration of 40-90%. In the new chemical assessment, import volume was notified as less than 1 tonne per annum.

New information on importation and use of the notified chemical was provided during secondary notification, with an increase in sales and the expected introduction of a new product range. Import volume is expected to increase from the original volume reported in the new chemical assessment of ≤ 1 tonne to ≤ 10 tonnes per annum. The new product range will contain the notified chemical at a lower concentration of ≤ 20% in pack sizes of 18 or 208 L pails. The use of adhesives containing Diamide Epoxy Curing Agent in the automotive, aerospace and industrial markets remains unchanged.

Health effects

No new toxicity data were submitted for the secondary notification of Diamide Epoxy Curing Agent. Health effects of the notified chemical were not reassessed in this secondary notification assessment and remain unchanged from the original new chemical assessment. The health hazards of this chemical according to the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS; United Nations, 2009) are Category 2 Skin Corrosion/Irritation and Category 1 Skin Sensitisation.

Occupational exposure and health risks

A new product range is likely to be introduced containing the notified chemical in larger volumes of 18 or 208 L, compared to ≤ 0.95 L pack sizes for adhesive products already used in Australia. Worker exposure will not significantly differ from the original new chemicals assessment because of a reduction in the concentration of the notified chemical in the new products and the use of meter mix dispensing equipment in the application of adhesives from 18 and 208 L pails. Consequently, effects on the health of workers were not reassessed in this secondary notification assessment.

Public exposure and health risks

In both the original new chemical assessment and the current secondary notification assessment, adhesives containing the notified chemical are used exclusively in industrial settings. The public will only come into contact with cured adhesives, where the notified chemical is part of the polymeric matrix and not available for exposure. Therefore, risk to the public was also not reassessed in the current secondary notification assessment.

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Environmental effects

New studies on aquatic species, namely fish, daphnia and algal toxicity studies, were provided for the secondary notification assessment. Under the GHS (United Nations, 2009), the notified chemical is considered to be very toxic to fish, aquatic invertebrates and algae and is formally classified as ‘Acute Category 1: Very toxic to aquatic life’.

Based on its reported use pattern, ecotoxicologically significant quantities are not expected to be released to the aquatic environment. Therefore, the predicted environmental concentration (PEC) and Predicted No-Effect Concentration (PNEC) have not been calculated for the notified chemical.

Biodegradability of Diamide Epoxy Curing Agent could not be assessed at the time of its notification as a new chemical. For the secondary notification, a test report was provided on ready biodegradation. The biodegradation of the test substance at the completion of test was < 0%, signifying the chemical is not readily biodegradable. Therefore, on the basis of the acute toxicity and this lack of ready biodegradability, the notified chemical is classified ‘Chronic Category 1: Very toxic to aquatic life with long lasting effects’ under the GHS classification for the chronic hazard.

Environmental exposure and risks

The risk quotient (Q = PEC/PNEC) for the notified chemical has not been calculated as significant quantities are not expected to be released to the aquatic environment. The majority of the notified chemical will be disposed of to landfill in articles to which it has been applied. In its cured state, the notified chemical is bound into an inert matrix and is unlikely to leach. Based on the assessed use pattern, the notified chemical is not considered to pose an unreasonable risk to the environment.

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RecommendationsThis section provides the recommendations arising from the secondary notification assessment of the notified chemical, and incorporates the applicable recommendations from the new chemical assessment report (NICNAS, 2014). The hazard classifications presented below are according to the GHS (United Nations, 2009). Recommendations based on the assessment of new data are marked ND.

Recommendations are directed principally to regulatory bodies, importers and reformulators of the notified chemical. Implicit in these recommendations is the use of industrial best practice to minimise occupational exposure.

Recommendations to national bodies

The notified chemical is classified according to the GHS (United Nations, 2009), as:

Skin Corrosion/Irritation (Category 2): H315 – Causes skin irritation Skin Sensitisation (Category 1): H317 – May cause an allergic skin reaction Acute Aquatic Toxicity (Category 1): H400 – Very toxic to aquatic life (ND) Chronic Aquatic Toxicity (Category 1): H410 – Very toxic to aquatic life with long lasting

effects (ND)

Recommendations to importers and state and territory governments

Hazard communication

Labels

Importers of the notified chemical should update their labels to reflect the new hazards identified by this assessment. In addition, importers should review their labels for compliance with the Labelling of workplace hazardous chemicals - Code of practice (Safe Work Australia, 2011a).

Safety Data Sheets

Under the Model Work Health and Safety Regulations (Safe Work Australia, 2014) and the Commonwealth, state and territory regulations introduced in accordance with these model regulations, employees shall have ready access to the SDS for hazardous substances at their workplace. The SDS, previously called material safety data sheets (MSDS), provide information to those who use the hazardous substance.

Importers of the notified chemical should:

update their SDS to reflect the new hazards identified by this assessment review their SDS for compliance with the Preparation of safety data sheets for hazardous

chemicals - Code of practice (Safe Work Australia, 2011b) ensure that employees have easy access to a copy of the SDS.

Control measures

Occupational controls

A person conducting a business or undertaking (PCBU) at a workplace should implement the following safe work practices to minimise occupational exposure during handling of the notified chemical in the finished product:

Avoid skin and eye 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 chemical in the finished product:Diamide Epoxy Curing Agent vii

Impervious gloves Safety goggles Protective coveralls.

Guidance in selection of personal protective equipment can be obtained from Australian, Australian/New Zealand or other approved standards.

A copy of the 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 GHS (United Nations, 2009) as adopted for industrial chemicals in Australia, workplace practices and control procedures should be consistent with provisions of State and Territory hazardous substances legislation.

Environment

On the basis of the assessed use pattern, the notified chemical is not considered to pose an unreasonable risk to the environment.

Disposal

Where reuse or recycling are not appropriate, disposal of the notified chemical should occur in an environmentally sound manner in accordance with relevant Commonwealth, state, territory and local government legislation (ND).

Emergency procedures

Spills or accidental release of the notified chemical should be handled by physical containment, collection and subsequent safe disposal (ND).

Health surveillance

As the notified chemical is a skin sensitiser, employers should carry out health surveillance for any worker identified in the workplace risk assessment as having a significant risk of sensitisation.

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Secondary notificationThis 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 Act) the notifier, as well as any other importer or manufacturer of the notified chemical, has post-assessment regulatory obligations to notify NICNAS when any of these circumstances change.

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 importation volume exceeds five tonnes per annum notified chemical;

or

(2) Under Section 64(2) of the Act; if

the function or use of the chemical has changed from component of adhesives or is likely to change 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.

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Abbreviations and acronymsAct, the Commonwealth Industrial Chemicals (Notification and Assessment) Act 1989

AICS Australian Inventory of Chemical Substances

CAS Chemical Abstracts Service

CAS RN Chemical Abstracts Service Registry Number

d day

Director, the Director of National Industrial Chemicals Notification and Assessment Scheme (NICNAS)

EC European Commission

EL50 effective loading rate resulting in 50% effect

ErL50 effective growth loading 50

EU CLP European Union Classification, Labelling and Packaging Regulation

EyL50 effective yield loading 50

GHS Globally Harmonised System of Classification and Labelling of Chemicals

GLP good laboratory practice

h hour

hazard inherent property of an agent or situation having the potential to cause adverse effects when an organism, system or (sub)population is exposed to that agent; intrinsic property of a substance to cause harm

HSIS Hazardous Substances Information System

i.e. that is

KOC organic carbon normalised adsorption coefficient

kg kilogram

kPa kilopascal

L litre

LL50 lethal loading 50

LTD Limited notification category for new chemicals (NICNAS)

m3 cubic metre

mg milligram

mL millilitre

MW molecular weight

ND new data/recommendation/information

NICNAS National Industrial Chemicals Notification and Assessment Scheme

NOELR no observable effect loading rate

NOHSC National Occupational Health and Safety Commission

OECD Organisation for Economic Cooperation and Development

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PEC predicted environmental concentration

PNEC predicted no-effect concentration

risk probability or likelihood of harm and the likely extent of the harm; the probability of an adverse effect in an organism, system or (sub)population caused under specified circumstances by exposure to an agent

PPE personal protective equipment

Q Q=PEC/PNEC

SDS safety data sheet

TG test guideline

ThOD theoretical oxygen demand

US EPA United States Environmental Protection Agency

USA United States of America

UVCB (chemical of) Unknown or Variable Composition, complex reaction products or Biological material

WAF water accommodated fraction

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1. Introduction1.1 BackgroundThe notified chemical, Diamide Epoxy Curing Agent, is a UVCB substance. It was originally assessed as a new chemical in the limited notification category (LTD/1646) under the marketing name Diamide Epoxy Curing Agent. The final report was completed and certificate issued in July 2014. The notified chemical was listed on the public section of the AICS in September 2014 following receipt of an early listing application in August 2014. In July 2014, the notifier advised the Director of the availability of ecotoxicological data from:

an algae growth inhibition test a ready biodegradability test a daphnia acute immobilisation test a fish acute toxicity test

The notifier also advised of its intention to increase the import volume of the chemical and to introduce a new product range. The new ecotoxicological data warranted secondary notification of Diamide Epoxy Curing Agent from an environmental perspective.

This secondary notification assessment focuses on the risk to the environment from Diamide Epoxy Curing Agent. No ecotoxicological data were submitted for the original new chemical assessment. The ecotoxicogical studies provided during secondary notification were used to reassess the environmental hazard and risk posed by the notified chemical. This report incorporates these studies and considers the implications on environmental risk posed by the notified chemical. The increased import volume and introduction of a new product range do not represent a significant change in the conditions of use. As a result, the risk posed by this chemical in the workplace and to the general public was not reassessed in this secondary notification assessment. The human health effects and associated risk have been reproduced from the original new chemical report without significant modification. Details of the studies provided for the new chemical assessment of Diamide Epoxy Curing Agent are reproduced in the Appendix of this report. New data, information and recommendations in this assessment are indicated by the abbreviation ND.

1.2 DeclarationA notice was published in the Chemical Gazette of July 2015, requiring secondary notification of Diamide Epoxy Curing Agent, in accordance with Section 65(2) of the Act. The declaration required the provision of any information relevant to assessment of the notified chemical that was not covered in the new chemical assessment, and included the following:

1) Identity, Properties and Uses a) Name(s) under which the chemical is marketed by the introducerb) The uses of the chemical, specifying uses not covered in the original assessment of the

chemicalc) Proposed annual import quantity of the chemical for the next 5 yearsd) The concentration and purity (including details of any hazardous impurities) of the chemical

in imported productse) If reformulation will occur in Australia, the concentration of the chemical in finished products

2) Environmental Effects a) Full ecotoxicological studies on the chemical, particularly in regard to biodegradability and

aquatic toxicity. Studies previously provided to NICNAS need not be includedb) Any additional information on ecotoxicological effects of the chemical

1.3 Objectives

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The objectives of this assessment are to review the new data made available since the publication of the new chemical assessment report and, where appropriate, to revise the original assessment to:

characterise the environmental hazards characterise the related risk recommend controls as required.

1.4 Peer reviewDuring all stages of preparation, this report has been subject to internal peer review by NICNAS.

1.5 ApplicantFollowing the secondary notification declaration of Diamide Epoxy Curing Agent, one company applied for assessment of this chemical.

In accordance with the Act, NICNAS provided the applicant with a draft copy of the report for comment during the corrections/variations phase of the assessment. The applicant details are as follows:

3M Australia Pty LtdBuilding A, 1 Rivett RoadNorth Ryde NSW 2113

1.6 Exempt informationThe applicant has claimed the following data items as exempt from publication under Section 75 of the Act: chemical name, other names, CAS number, molecular and structural formulae, molecular weight, spectral data, degree of purity, impurities, import volume, and exact percentage of chemical in products.

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2. Chemical identity, physical and chemical properties2.1 Chemical identityMarketing name: Diamide Epoxy Curing Agent

Molecular weight: > 500 Da

Analytical data: Reference NMR spectra were provided

2.2 CompositionDegree of purity: > 85%

2.3 Physical and chemical properties Summary of the notified chemical’s physical and chemical properties

Property Value Data Source/JustificationAppearance at 20 ºC and 101.3 kPa

Dark brown-green, clear to cloudy liquid

Pour point -12.5 ± 3 °C MeasuredBoiling Point > 250 °C at 101.3 kPa MeasuredDensity 979.7 kg/m3 at 23 °C MeasuredVapour Pressure 1.72 × 10-28 kPa at 25 °C Estimated. EPI Suite v4.0

(Modified Grain method)Water Solubility 3.6 × 10-4 g/L

Forms emulsionMeasured. The notified chemical is dispersible based on an emulsion formation at concentration greater than 100 mg/L.

Hydrolysis as a Function of pH

Not Determined The notified chemical contains functional groups that are expected to hydrolyse slowly in the environmental pH range (4-9) at ambient temperature.

Partition Coefficient(n-octanol/water)

Not Determined Expected to partition to phase boundaries based on its surfactant properties.

Adsorption/Desorption log Koc = 7.8 at 25 C Estimated (KOCWIN v2.00, US EPA 2011). Expected to partition to surfaces from water in the environment based on its surface activity.

Dissociation Constant Not determined The notified chemical contains dissociable functionalities. However, it is not expected to be significantly ionised in the environmental pH range of 4‒9.

Flash Point > 93 °C at 101.3 kPa Closed cup

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Flammability Not expected to be flammable

Based on measured flash point

Autoignition Temperature Not determined Not expected to autoignite under normal conditions

Explosive Properties Not expected to be explosive Contains no functional groups that would imply explosive properties

Oxidising Properties Not expected to be oxidising Contains no functional groups that would imply oxidising properties

Discussion of properties:For full details of tests on physical and chemical properties, refer to Appendix A1.

Reactivity:The notified chemical is expected to be stable under normal conditions of use.

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3. Importation and useNew data on use of the notified chemical for the secondary notification assessment are marked ND.

Importation

Mode of introduction of notified chemical (100%) over next 5 years:The notified chemical will be imported as a component of highly viscous adhesive products at ≤ 90% concentration.

Maximum introduction volume of notified chemical (100%) over next 5 years (ND):Year 1 2 3 4 5

Tonnes ≤10 ≤10 ≤10 ≤10 ≤10

Port of entry:Sydney

Identity of recipients:3M Australia Pty Ltd

Transportation and packaging:The finished adhesive products containing the notified chemical will be imported by sea in 50 mL or 200 mL Duo-Syringe cartridges designed for use in 3M applicators. When used as a void-filling compound the finished product containing the notified chemical will be packed in 950 mL foil sachets or 500 mL stainless steel cans. The notifier intends to introduce a new range of adhesives for application to large surface areas in Duo-Syringe cartridges, and also in 18 L and 208 L pails (ND). The products will be distributed within Australia by road.

Use

The notified chemical will be used as a curing agent in two-part epoxy amide adhesives for bonding applications in automotive, aerospace and industrial markets. The notified chemical will be present in the Part A component at a concentration of 40-90%. After mixing with Part B, the concentration of the notified chemical in the adhesive ranges from 12 to 45%. The adhesive can be used to bond various types of substrates such as plastics, metals, rubber, or glass. The notified chemical is included in the Part A component of the new range of adhesives at < 20%, and when mixed with an equal volume of Part B results in a final concentration of < 10% (ND). Bonding applications for the new range of adhesives are the same as in the new chemical assessment report (ND).

Operation description

The products containing the notified chemical will be supplied in either purpose-built dual chamber cartridges, 500 mL stainless steel cans or 950 mL foil sachets. In addition to cartridges, the new range of adhesives may also be available in 18 L and 208 L pails (ND).

The cartridges will be used with either a manual or pressure-assisted applicator to depress the plunger and slowly extrude the adhesive onto the surface. The operator will cut the end of the cartridge and fit the cartridge into the applicator. The adhesive will be extruded through a mixing nozzle, which mixes Part A containing the notified chemical at ≤ 90% concentration and Part B in a fixed ratio. The adhesive has a curing time of 10 minutes (work life) and two hours for complete bonding. For the new range of adhesives, cure time is approximately 90 minutes (ND). The bond line can be heated using a heat gun to 60-80 °C to accelerate the curing. Any excess adhesive will be removed using a spatula or cloth.

When the product is supplied in cans or sachets, these containers will be opened and the contents manually squeezed out or removed with a spatula or trowel and placed in a separate container for mixing with Part B prior to application to the treated surface.

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Products in 18 L and 208 L pails will be applied to surfaces using meter mix dispensing equipment (ND).

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4. Exposure New information on the use of Diamide Epoxy Curing Agent provided for the secondary notification assessment has not altered public or occupational exposure. Therefore, the public and occupational exposure sections have been reproduced from the new chemical assessment report - LTD/1646, NICNAS, 2014 - without modification.

The notified chemical was not readily biodegradable in a ready biodegradability study (Maxxam, 2014a) submitted for the secondary notification (ND). This study did not impact upon environmental exposure and, therefore the environmental exposure section has been reproduced from the new chemical assessment report without significant modification.

4.1 Public exposureThe finished product will be used by industry professionals only. The public may come into contact with surfaces treated with the adhesives. However, once the adhesives are cured and dried, the notified chemical will become part of a polymeric matrix and will not be available for exposure.

4.2 Occupational exposure

4.2.1 Operational description Category of Workers

Category of Worker Exposure Duration (hours/day)

Exposure Frequency (days/year)

Transport and storage 2 12-24End-use 8 200

4.2.2 Estimates of occupational exposureTransport and storage

Transport and storage workers may come into contact with the notified chemical as a component of the adhesive finished products at up to 90% concentration only in the event of accidental rupture of containers.

End-use

Workers may be exposed to the notified chemical at concentrations up to 90% when manually mixing the two components of the adhesive, during application (particularly when not using a cartridge) and when removing excess adhesive. The most likely route of exposure during these operations will be dermal. Ocular and oral exposure routes are also possible. Inhalation exposure to the notified chemical is unlikely due to its relatively high molecular weight, low vapour pressure and high viscosity of the product in which it is contained. The potential for exposure should be reduced by the expected use of PPE by these workers.

Once the adhesive has cured and dried, the notified chemical will become part of a polymeric matrix and will not be available for exposure.

4.3 Environmental exposure & fate assessment

4.3.1 Environmental exposureRelease of chemical at site

The notified chemical will not be manufactured in Australia and, therefore, no release of the notified chemical to the environment is expected from this activity. The imported cartridges containing the notified chemical are designed to minimise the release of the notified chemical to the environment

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during importation, storage and transport. If release does occur as a result of an accident, it is expected to be contained, collected and disposed of to landfill.

Release of chemical from use

A small amount of the notified chemical may be released to the environment as a result of spills during the application of the adhesive products. Any spilt notified chemical is expected to be collected and be disposed of to landfill. Excess adhesive may be cleared with a cloth or spatula. Adhesive on cleaning clothes and spatulas (up to 2% of the total import volume) is expected to be disposed of to landfill.

Release of chemical from disposal

The majority of the notified chemical will be cured into an inert polymer matrix expected to be associated with articles after application. It is expected to share the fate of the articles to which it is applied and is disposed of to landfill or be subjected to metal recycling processes. Residual notified chemical in empty cartridges (2%) is expected to be disposed of to landfill along with empty cartridges in accordance with local regulations.

4.3.2 Environmental FateThe majority of the notified chemical is expected to be cured into an inert polymer matrix during use and, therefore, is not expected to be mobile, bioavailable or readily biodegradable in this form. Bioaccumulation of the uncured notified chemical is unlikely due to its potential surface activity and limited potential for aquatic exposure. The notified chemical is expected to degrade in landfill or by thermal decomposition during metal reclamation processes, to form water and oxides of carbon and nitrogen. No studies were available to address the ready biodegradability of the notified chemical for its notification as a new chemical. For the secondary notification, the applicant provided a new test report on ready biodegradation. Below is the summary for the test details followed by a conclusion.

Ready biodegradability (ND)

TEST SUBSTANCE Notified chemicalMETHOD OECD TG 301 F Ready Biodegradability: Manometric

Respirometry Test.Inoculum Activated sludgeExposure Period 28 daysAuxiliary Solvent None reportedAnalytical Monitoring Theoretical oxygen demand (ThOD)Remarks - Method Conducted in accordance with the test guidelines above, and in

compliance with GLP standards and principles.RESULTS

Test substance Sodium benzoateDay % Degradation Day % Degradation1428

N/A< 0

1428

6670

Remarks - Results All validity criteria for the test were met

The reference substance (sodium benzoate) was degraded >60% by the 14th day, indicating the suitability of the inoculum and test conditions. The test substance did not surpass 10% biodegradation and therefore did not enter the 10 day window. The biodegradation of the test substance at the completion of

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test was < 0%.

CONCLUSION The notified polymer is not readily biodegradableTEST FACILITY Maxxam (2014a)

4.3.3 Predicted environmental concentration (PEC)The predicted environmental concentration (PEC) has not been calculated for the notified chemical as, based on its reported use pattern, which remains the same as originally assessed, ecotoxicologically significant quantities are not expected to be released to the aquatic environment, even with the intended increase in introduction volume, to ≤ 10 tonnes per year.

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5. Hazard assessment5.1 Physicochemical and human health hazard assessmentThis section contains a summary of all the data relevant to the physicochemical and human health hazard assessment of the notified chemical. The robust summaries of the toxicological data available for the assessment of the notified chemical as a new chemical are reproduced from the new chemical assessment report - LTD/1646, (NICNAS, 2014) - without modification in the Appendix of this report.

No new studies relevant to the physiochemical or human health hazards of the notified chemical were submitted for the secondary notification assessments. Therefore, the physicochemical and human health hazard assessment sections have been reproduced from the new chemical assessment report without significant modification.

5.1.1 Physicochemical effects assessmentBased on the submitted physico-chemical data, the notified chemical is not recommended for hazard classification according to the GHS (United Nations, 2009), as adopted for industrial chemicals in Australia.

5.1.2 Human health effects assessmentThe results from toxicological investigations conducted on the notified chemical are summarised in the following table. For full details of the studies, refer to Appendix A2.

Endpoint Result and Assessment ConclusionRabbit, skin irritation severely irritatingGuinea pig, skin sensitisation – Maximisation test

evidence of sensitisation

Irritation and sensitisation.

Two studies were performed to assess skin corrosivity under semi-occluded conditions. In the first study, the skin of a single rabbit exhibited corrosive effects including subcutaneous haemorrhage and possible necrosis. No signs of irritation were observed at 21 days; however, scar tissue remained. In the second corrosivity study, which was performed after the first study, no evidence of corrosion was observed at any of the test sites for any of the exposure periods. Slight dermal irritation was observed as a result of 3-minute exposure; slight to moderate irritation was observed as a result of the 1-hour exposure; and moderate to severe irritation was observed as a result of the 4-hour exposure. The second study used three rabbits and was performed to OECD Test Guidelines. Based on the weight of evidence, the notified chemical is considered to be not corrosive to the skin of rabbits under semi-occluded conditions. The notified chemical is expected to be severely irritating to the skin and eyes.

In a Guinea Pig Maximisation Test, the notified chemical was found to be an extreme dermal sensitiser. In the sensitisation study, cases of mild to intense dermal reactions to the challenge application were observed in 19/20 test animals. Desquamation was observed at the challenge sites in 7/20 test animals. Nineteen out of 20 animals in the test group (95%) are considered to have been sensitised to the notified chemical.

5.1.3 Hazard classification Based on the available information, the notified chemical is recommended for hazard classification according to the GHS (United Nations, 2009), as adopted for industrial chemicals in Australia. The recommended hazard classification is presented in the following table.

Hazard classification Hazard statementDiamide Epoxy Curing Agent xxii

Skin Corrosion/Irritation (Category 2) H315 – Causes skin irritation

Skin Sensitisation (Category 1) H317 – May cause an allergic skin reaction

Based on the available information, the notified chemical is recommended for hazard classification according to the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004), with the following risk phrase(s):

R38: Irritating to skin R43: May cause sensitisation by skin contact

5.2 Environmental hazard assessmentThis section contains a summary of all the data relevant to the environmental hazard assessment of the notified chemical, with a focus on new data. The robust summaries of the ecotoxicological studies on the notified chemical submitted for the secondary notification assessment, and resulting environmental hazard classification are summarised in this section and designated as ND.

5.2.1 Environmental effects assessment (ND)New ecotoxicological investigations of the notified chemical on fresh water aquatic species were provided for the secondary notification assessment. The results are summarised in the table below.

Endpoint Result Assessment Conclusion

Fish Acute Toxicity

96h LL50 = 2.16 mg/L Toxic to fish

Daphnia Acute Toxicity

48h EL50 = 0.57 mg/L Very toxic to aquatic invertebrates

Algal Toxicity Growth

72h LL50 = 0.43 mg/L Very toxic to algae

Under the GHS (United Nations, 2009), the notified chemical is considered to be very toxic to fish, aquatic invertebrates and algae and is formally classified as ‘Acute Category 1: Very toxic to aquatic life’. On the basis of its acute toxicity and its lack of ready biodegradability, the notified chemical is classified ‘Chronic Category 1: Very toxic to aquatic life with long lasting effects’.

Acute toxicity to fish (ND)

TEST SUBSTANCE Notified chemical

METHOD OECD TG 203 Fish, Acute Toxicity Test - Static

Species Fathead minnow (Pimephales promelas)Exposure Period 96 hoursAuxiliary Solvent Not reportedWater Hardness 132-140 mg CaCO3/LAnalytical Monitoring Not reportedRemarks – Method After a range finding test, a definitive test was conducted

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in accordance with the guidelines above and in compliance with GLP standards and principles. No significant deviations to the test protocol were reported.

The test substance was prepared as a Water Accommodated Fraction (WAF) due to its low water solubility.

The test solution was prepared by direct addition (10 mg) of the notified chemical into 8 L of test water. This mixture was stirred for 48 hours and allowed to stand for 1 hour. The solution was removed by mid-depth siphoning to give the stock solution.

The 96 h LL50 were calculated using the computerised statistical package (CETIS Version1.7.0.3), a Comprehensive Environmental Toxicity Information System.

RESULTS

Concentration mg/L Number of Fish MortalityNominal 2

4 h

48 h

72 h

96 h

ControlWAF

Control0.6251.252.5510

7777777

0000077

0000377

0000477

0000577

LL50 2.16 mg/L at 96 hours.NOELR 1.25 mg/L at 96 hours.Remarks – Results The validity criteria for the test were met.

This test was conducted under static conditions to assess the effects of the test substance by observing the survival of fish over a 96 hour exposure period, under controlled conditions.

No confirmatory analysis measurements were conducted for this study; therefore, all test endpoints were calculated using nominal loading rates of the test substance.

CONCLUSION The notified chemical is toxic to fish

TEST FACILITY Maxxam (2014b)

Acute toxicity to aquatic invertebrates (ND)

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TEST SUBSTANCE Notified chemical

METHOD OECD TG 202 Daphnia sp. Acute Immobilisation Test - Static.

Species Daphnia magnaExposure Period 48 hoursAuxiliary Solvent NoneWater Hardness 92 mg CaCO3/LAnalytical Monitoring Not reportedRemarks - Method After a range finding test, a definitive test was conducted in

accordance with the guidelines above and in compliance with GLP standards and principles. No significant deviations to the test protocol were reported.

The test substance was prepared as a Water Accommodated Fraction (WAF) due to its low water solubility.

The test solution was prepared by direct addition (10 mg) of the notified chemical into 8 L of test water. This mixture was stirred for 48 hours and allowed to stand for 1 hour. The solution was removed by mid-depth siphoning to give the stock solution.

The 48 h EL50 was calculated using the computerised statistical package (CETIS Version1.7.0.3), a Comprehensive Environmental Toxicity Information System.

RESULTS

Concentration mg/L Number of D. magna Number Immobilised

Nominal 24 h 48 h 21 d

ControlWAF

Control0.10.20.40.81.6

100100100100100100100

0000025

0000055

EL50 0.57 mg/L at 48 hoursNOELR 0.4 mg/L at 48 hoursRemarks - Results The validity criteria for the test were met.

This test was conducted under static conditions to assess the effects of the test substance by observing the immobility of Daphnia over a 48 hour exposure period, under controlled conditions.

No confirmatory analysis measurements were conducted for

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this study; therefore, all test endpoints were calculated using nominal loading rates of the test substance.

CONCLUSION The notified chemical is very toxic to aquatic invertebratesTEST FACILITY Maxxam (2014c)

Algal growth inhibition test (ND)

TEST SUBSTANCE Notified chemicalMETHOD OECD TG 201 Alga, Growth Inhibition Test.Species Pseudokirchneriella subcapitataExposure Period 72 hoursConcentration Range Nominal: 0.07, 0.14, 0.28, 0.56 and 1.12 mg/L (WAF)Auxiliary Solvent NoneWater Hardness Not reportedAnalytical Monitoring Not reportedRemarks - Method After a range finding test, a definitive test was conducted in

accordance with the guidelines above and in compliance with GLP standards and principles. No significant deviations to the test protocol were reported.

The test substance was prepared as a Water Accommodated Fraction (WAF) due to its low water solubility.

The test solution was prepared by direct addition (10 mg) of the notified chemical into 8 L of test water. This mixture was stirred for 48 hours and allowed to stand for 1 hour. The solution was removed by mid-depth siphoning to give the stock solution.

The 72 h LL50 was calculated using the computerised statistical package (CETIS Version1.7.0.3), a Comprehensive Environmental Toxicity Information System.

RESULTS

Biomass GrowthEyL50 NOELR ErL50 NOELR

mg/L at 72 h mg/L mg/L at 72 h mg/L0.28 0.14 0.43 0.28

Remarks - Results The validity criteria for the test were met.

No confirmatory analysis measurements were conducted for this study; therefore, all test endpoints were calculated using nominal loading rates of the test substance.

CONCLUSION The notified chemical is very toxic to algae

TEST FACILITY Maxxam (2014d)

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5.2.2 Predicted No-Effect ConcentrationA Predicted No-Effect Concentration (PNEC) has not been calculated for the notified chemical as, based on its reported use pattern, ecotoxicologically significant quantities are not expected to be released to the aquatic environment.

5.2.3 Hazard classification (ND)The environmental hazard classification according to the GHS (United Nations, 2009) is presented below. Environmental classification under the GHS is not mandated in Australia and carries no legal status but is presented for information purposes.

Environmental hazard classificationHazard classification Hazard statement

Acute (Category 1) H400 - Very toxic to aquatic life

Chronic (Category 1) H410 - Very toxic to aquatic life with long lasting effects

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6. Risk characterisationThe health hazards and exposure of the notified chemical to the public and workers have not changed since the original new chemical assessment. Therefore, the public and occupational health risk assessment sections have been reproduced from the new chemical assessment report - LTD/1646, NICNAS, 2014 - without modification. The environmental risk posed by the notified chemical has been updated to account for the ecotoxicological studies provided during secondary notification.

6.1 Public health risk estimationThe public will not be exposed to the notified chemical except in the unlikely event of an accident or spill; hence, the risk to the public is not considered unreasonable.

6.2 Occupational health risk estimationThe notified chemical causes skin irritation and sensitisation. Dermal exposure to the notified chemical at up to 90% concentration may occur when manually mixing components and cleaning up excess material as well as during any potential spills. This risk of exposure is expected to be reduced given use of PPE such as impervious gloves and goggles. Once the adhesive has cured and dried, the notified chemical will become part of a polymeric matrix and will not be available for exposure.

Under the proposed usage conditions and provided that appropriate PPE is used to minimise exposure, the risk of exposure to the notified chemical to workers is not considered to be unreasonable.

6.3 Environmental risk estimation (ND)The risk quotient (Q = PEC/PNEC) for the notified chemical has not been calculated as significant quantities are not expected to be released to the aquatic environment. The majority of the notified chemical will eventually be disposed of to landfill associated with the articles to which it has been applied. In its cured state, the notified chemical will be bound into an inert matrix and is not likely to leach from the inert matrix. On the basis of the assessed use pattern, the notified chemical is not considered to pose an unreasonable risk to the environment.

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AppendixA1 Physical and chemical properties

Pour point -12.5 ± 3 °C

Method ASTM D97.Remarks In a preliminary freezing/melting point study, the substance was observed

to become more viscous without crystallisation as it is cooled; therefore, the pour point was determined.

Test Facility

3M Analytical (2012)

Boiling Point > 250 °C at 101.3 kPa

Method ASTM D1120-94 Standard Test Method for Boiling Point of Engine Coolants.

Remarks Test substance did not boil up to 250 °C.Test Facility

3M Analytical (2012)

Density 979.7 kg/m3 at 23°C

Method OECD TG 109 Density of Liquids and Solids.Remarks Pycnometer methodTest Facility

3M Analytical (2012)

Water Solubility 0.36 mg/L at 20 °C

Method OECD TG 105 Water Solubility (Flask Method)

Remarks The water solubility was evaluated by two different modified shake flask procedures.The first was conducted by placing accurately weighed notified chemical in a vial, submerging into 5 L of water and stirring overnight at 22.4ºC. The amount of the notified chemical lost from the vial was determined gravimetrically.

In the second procedure accurately weighed notified chemical was placed into 40 mL of water in a sealed centrifuge tube. The tube was mixed overnight on a rotisserie shaker at 22.4ºC. The non-solubilised fraction of the notified chemical was determined gravimetrically.

Results from first screening indicated the solubility of the notified chemical as tested was 0.36 mg/L. The report also concluded that as the notified chemical is a mixture of monomers, dimers and higher weight oligomers, the overall solubility will change slightly, depending on the exact distribution in that particular batch. The second study confirmed

Diamide Epoxy Curing Agent xxix

only that the solubility was < 100 mg/L. While the solubility may vary, the results also showed that the notified chemical is dispersible into a semi-stable emulsion in pure water at concentrations above 100 mg/L.

Test Facility

3M Environmental (2013)

Flash Point > 93 °C at 101.3 kPa

Method ASTM D-3278-96 e-1 Flash points of Liquids by Small Scale Closed-Cup Apparatus

Remarks The test substance was ramped between 70 °F to 200 °F at a rate of 5 °F/minute and tested every two degrees with no flash point detected.

Test Facility

3M Analytical (2012)

A2 Toxicological investigations

The robust summaries of the toxicological studies analysed for the assessment of the notified chemical as a new chemical are reproduced here without modification.

A2.1 Irritation – skin

TEST SUBSTANCE Notified chemical (purity not provided)

METHOD OECD TG 404 Acute Dermal Irritation/Corrosion.Species/Strain Rabbit/New Zealand WhiteNumber of Animals 1Vehicle Test substance administered as suppliedObservation Period 21 daysType of Dressing Semi-occlusive.Remarks - Method Observations were made at 30 minutes, 24, 48, 72 and 96 hours

and at 7, 14 and 21 days after patch removal. The animal was exposed to the test material for 4 hours

RESULTS

Lesion Mean Score*Animal No.

Maximum Value

Maximum Duration of Any

Effect

Maximum Value at End of Observation

Period1

Erythema/Eschar 4 4 > 14 days 0Oedema 3 3 > 14 days 0*Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.

Remarks - Results Severe erythema and moderate oedema were observed that persisted to Day 7 and cleared by Day 21. Subcutaneous haemorrhage (observed at 30 minutes post-exposure), possible necrotic area (observed between 24 hours and 7 days) and scar tissue (observed between Day 14 and Day 21) was also observed. All irritation, with the exception of the scar tissue, cleared in the

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animal by the Day 21 observation.

CONCLUSION The notified chemical is corrosive to the skin.

TEST FACILITY Hazleton (1995a)

A2.2 Irritation – skin

TEST SUBSTANCE Notified chemical (purity not provided)

METHOD UN/DOT Regulations similar to OECD TG 404 Acute Dermal Irritation/Corrosion.

Species/Strain Rabbit/New Zealand WhiteNumber of Animals 3Vehicle Test substance administered as suppliedObservation Period 7 daysType of Dressing Semi-occlusive.Remarks - Method Observations were made at 30 minutes, 24, 48, 72 and 96

hours and at Day 7 after patch removal. Animals were exposed to the test material for 3 minutes, 1 hour, and 4 hours.

RESULTS

3-minute exposure periodLesion Mean Score*

Animal No.Maximum

ValueMaximum

Duration of Any Effect

Maximum Value at End of Observation

Period1 2 3

Erythema/Eschar 1 1 1 1 > 7 days 1Oedema 0 0 1 1 < 7 days 0

1-hour exposure periodLesion Mean Score*

Animal No.Maximum

ValueMaximum

Duration of Any Effect

Maximum Value at End of Observation

Period1 2 3

Erythema/Eschar 1 2 1 2 > 7 days 1Oedema 0 2.3 1.3 3 > 7 days 1

4-hour exposure periodLesion Mean Score*

Animal No.Maximum

ValueMaximum

Duration of Any Effect

Maximum Value at End of Observation

Period1 2 3

Erythema/Eschar 2 3 3 3 > 7 days 2Oedema 1.7 2 2.7 3 > 7 days 2*Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.

Diamide Epoxy Curing Agent xxxi

Remarks - Results No evidence of corrosion was observed at any of the test sites for any animals. Slight dermal irritation was observed as a result of 3-minute exposures, slight to moderate irritation was observed after the 1-hour exposures and moderate to severe irritation was observed as a result of the 4-hour exposures. In the cases of the 3minute, 1-hour and 4-hour exposures, all the signs of irritation had not subsided at the end of the observation period.

CONCLUSION The notified chemical is severely irritating to the skin.

TEST FACILITY Hazelton (1995b)

A2.3 Skin sensitisation

TEST SUBSTANCE Notified chemical (purity not provided)

METHOD Similar to OECD TG 406 Skin Sensitisation – Maximization testEC Directive 96/54/EC B.6 Skin Sensitisation - Maximization test

Species/Strain Guinea pig/Crl:(HA)BRPRELIMINARY STUDY Maximum Non-irritating Concentration:

intradermal: none foundtopical: 50%

MAIN STUDYNumber of Animals Test Group: 20 Control Group: 10

INDUCTION PHASE Induction Concentration:intradermal: 1%topical: 100%

Signs of Irritation Mild to moderate erythema and oedema reactions with scab formation were observed during the induction phase in the control and test group.

CHALLENGE PHASE1st challenge topical: 50%

Remarks - Method The control animals were pre-treated with 10% sodium lauryl sulfate prior to topical induction. Mineral oil was used as the diluent to prepare the test concentrations.

RESULTS

Animal Challenge Concentration Number of Animals Showing Skin Reactions after:

1st challenge

24 h 48 h

Test Group 50% 18/20 19/20

Control Group 0% 0/10 0/10

Diamide Epoxy Curing Agent xxxii

Remarks - Results Nineteen of the 20 animals in the test group exhibited mild to intense dermal reactions challenged with the test substance at 50% concentration in mineral oil. Desquamation was also observed within the challenge sites of 7 animals in the test group. Eighteen of the 20 animals at the 24-hour point and 19/20 animals at the 48-hour point exhibited a response.

CONCLUSION The notified chemical is a skin sensitiser under the conditions of the test.

TEST FACILITY Covance (2000)

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References3M Analytical Laboratory (2012) Analytical results [notified chemical] (Study no M12-1412, September, 2012). Location unspecified (Unpublished report submitted by the notifier).

3M Environmental Laboratory (2013) Screening Evaluation of [notified chemical] Water Solubility (Study No. E13-0201, May, 2013). St. Paul, Minnesota, USA, 3M Environmental Laboratory (Unpublished report submitted by the notifier).

Covance (2000) Dermal Sensitization Study of T-7353 in Guinea Pigs- Maximisation Test (Study no. 91202076, March, 2000). Madison, Wisconsin, USA, Covance Laboratories Inc. (Unpublished report submitted by the notifier).

Hazelton (1995) Skin corrosivity Study of T-6142 in rabbits (DOT/UN Regulations) (Study no. HWI 41202295, March, 1995). Madison, Wisconsin, USA, Hazelton Wisconsin, Inc. (Unpublished report submitted by the notifier).

Hazelton (1995) Skin corrosivity Study of T-6142 in rabbits (DOT/UN Regulations) (Study no. HWI 41202295, March, 1995). Madison, Wisconsin, USA, Hazelton Wisconsin, Inc. (Unpublished report submitted by the notifier).

Maxxam (2014a) Ready Biodegradability of notified chemical Using the Manometric Respirometry Test (study No 2-11-1131, 28 February, 2014) Burnaby, Maxxam Analytics, Canada. (Unpublished report submitted by the notifier).

Maxxam (2014b) Acute Toxicity Test of the notified chemical Using Fathead Minnow, Pimephales promelas (study No 2-11-1131, 26 February, 2014) Burnaby, Maxxam Analytics, Canada. (Unpublished report submitted by the notifier).

Maxxam (2014c) Acute Immobilization Test of the notified chemical using Daphnia magna (study No 2-11-1131, 5 February, 2014) Burnaby, Maxxam Analytics, Canada. (Unpublished report submitted by the notifier).

Maxxam (2014c) 72·hour Growth Inhibition Test of the notified chemical Using Pseudokirchneriella subcapitata (study No 2-11-1131, 27 February, 2014) Burnaby, Maxxam Analytics, Canada. (Unpublished report submitted by the notifier).

NICNAS (2014) Full Public Report: Diamide Epoxy Curing Agent (File No. LTD/1646). National Industrial Chemicals Notification and Assessment Scheme. Available at: www.nicnas.gov.au/__data/assets/word_doc/0014/13082/LTD-1646-FR-Final.docx

NOHSC (2004) Approved Criteria for Classifying Hazardous Substances, 3rd edition [NOHSC:1008(2004)]. National Occupational Health and Safety Commission, Canberra, AusInfo.

United Nations (2009) Globally Harmonised System of Classification and Labelling of Chemicals (GHS), 3rd revised edition. United Nations Economic Commission for Europe (UN/ECE), <www.unece.org/trans/danger/publi/ghs/ghs_rev03/03files_e.html>.

US EPA (2011) Estimation Programs Interface (EPI) Suite™ for Microsoft® Windows, v 4.10. United States Environmental Protection Agency. Washington DC, USA.

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