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Diamide Epoxy Curing Agent

ISBN 978-0-9758470-1-5

© Commonwealth of Australia 2015
This 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

Preface

This 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: /

Director
NICNAS

Contents

Preface

Contents

Overview

Recommendations

Secondary notification

Abbreviations and acronyms

1.Introduction

1.1Background

1.2Declaration

1.3Objectives

1.4Peer review

1.5Applicant

1.6Exempt information

2.Chemical identity, physical and chemical properties

2.1Chemical identity

2.2Composition

2.3Physical and chemical properties

3.Importation and use

4.Exposure

4.1Public exposure

4.2Occupational exposure

4.2.1Operational description

4.2.2Estimates of occupational exposure

4.3Environmental exposure & fate assessment

4.3.1Environmental exposure

4.3.2 Environmental Fate

4.3.3Predicted environmental concentration (PEC)

5.Hazard assessment

5.1Physicochemical and human health hazard assessment

5.1.1Physicochemical effects assessment

5.1.2Human health effects assessment

5.1.3Hazard classification

5.2Environmental hazard assessment

5.2.1Environmental effects assessment (ND)

5.2.2Predicted No-Effect Concentration

5.2.3Hazard classification (ND)

6.Risk characterisation

6.1Public health risk estimation

6.2Occupational health risk estimation

6.3Environmental risk estimation (ND)

Appendix

References

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 Agentin 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 wasnotified 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 208L 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 thissecondary 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 healthrisks

A new product range is likely to be introduced containing the notified chemicalin 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.

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, thepredicted environmental concentration (PEC) andPredicted 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 readilybiodegradable. 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.

Recommendations

This 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 markedND.

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

Recommendations to national bodies

The notified chemical is classified according tothe 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 toa 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:

  • 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 workeridentified in the workplace risk assessment as having a significant risk of sensitisation.

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 Act)the notifier, as well as any other importer or manufacturer of the notified chemical, haspost-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.

Abbreviations and acronyms

Act, the / CommonwealthIndustrial 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 UnionClassification, 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
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

1

Diamide Epoxy Curing Agent

1.Introduction

1.1Background

The 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 AICSin 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 itsintention 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 datawere 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 anew product range do not represent a significant change inthe 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.

1.2Declaration

A notice was published in the Chemical Gazette of July 2015, requiring secondary notificationof Diamide Epoxy Curing Agent, in accordance with Section 65(2) of the Act. Thedeclaration required the provision of any information relevant to assessment of the notified chemicalthat 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 introducer

b)The uses of the chemical, specifying uses not covered in the original assessment of the chemical

c)Proposed annual import quantity of the chemical for the next 5 years

d)The concentration and purity (including details of any hazardous impurities) of the chemical in imported products

e)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 included

b)Any additional information on ecotoxicological effects of the chemical

1.3Objectives

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.

1.4Peer review

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

1.5Applicant

Following the secondary notification declaration of Diamide Epoxy Curing Agent, one companyapplied 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: