PREFACE III
OVERVIEW AND RECOMMENDATIONS V
TABLE OF CONTENTS XVII
ACRONYMS AND ABBREVIATIONS XXIV
GLOSSARY XXX
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INTRODUCTION 1
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Declaration 1
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Objectives 1
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Sources of information 1
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Peer review 2
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BACKGROUND 3
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Introduction 3
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Global production 3
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Australian perspective 4
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Assessments by other national or international bodies 4
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APPLICANTS 5
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CHEMICAL IDENTITY AND COMPOSITION 8
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Chemical name (IUPAC) 8
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Registry numbers 8
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Other names 8
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Molecular formula 8
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Structural formula 9
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Molecular weight 9
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Composition of commercial grade product 9
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PHYSICAL AND CHEMICAL PROPERTIES 10
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Physical state 10
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Physical and chemical properties 10
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Conversion factors 12
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METHODS OF DETECTION AND ANALYSIS 13
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Characterisation 13
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Atmospheric monitoring methods 13
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6.2.1
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In the workplace
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13
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6.2.2
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In the environment
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14
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6.2.3
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Indoor air
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15
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6.2.4
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Off-gas monitoring from wood products
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16
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6.3
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Biological
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monitoring
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17
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6.4
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Water
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17
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6.5
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Soil
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18
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MANUFACTURE, IMPORTATION AND USE 19
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7.1
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Manufacture
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19
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7.2
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Importation
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22
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7.3
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Use
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23
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7.3.1
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Formulation of formaldehyde products
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24
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7.3.2
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Repackaging
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29
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7.3.3
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End use of formaldehyde products
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29
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7.4
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Export
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42
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ENVIRONMENTAL RELEASE, FATE AND EFFECTS 43
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8.1
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Release
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43
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8.1.1
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Emissions to the atmosphere
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43
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8.1.2
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Emissions to water and soil
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45
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8.2
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Fate
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45
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8.2.1
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Atmosphere
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46
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8.2.2
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Water
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47
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8.2.3
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Soil and sediment
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48
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8.2.4
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Biota
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48
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8.3
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Effects on
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organisms in the environment
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48
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8.3.1
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Aquatic organisms
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48
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8.3.2
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Terrestrial organisms
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50
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8.3.3
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Micro-organisms
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51
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8.3.4
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Summary
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52
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KINETICS AND METABOLISM 54
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Absorption 54
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Distribution 54
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Metabolism 54
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Elimination and excretion 55
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EFFECTS ON LABORATORY MAMMALS AND OTHER TEST
SYSTEMS 56
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Acute toxicity 56
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Corrosivity/Irritation 56
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Skin and eye irritation 56
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Respiratory irritation 57
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Sensitisation 58
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Skin 58
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Respiratory 58
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Repeat dose toxicity 59
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Inhalation 59
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Oral 62
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Dermal 63
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Genotoxicity 63
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In vitro studies 63
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In vivo studies 64
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Carcinogenicity 66
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Inhalation 66
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Oral 67
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Dermal 68
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Reproductive toxicity 68
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Developmental toxicity 69
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11.
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HUMAN
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HEALTH EFFECTS
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71
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11.1
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Acute toxicity
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71
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11.2
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Irritation/Corrosivity
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71
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|
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11.2.1 Skin irritation
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71
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|
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11.2.2 Sensory irritation
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72
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11.3
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Sensitisation
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74
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|
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11.3.1 Skin
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74
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|
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11.3.2 Respiratory
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82
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11.4
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Non-neoplastic effects
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84
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|
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11.4.1 Respiratory-related effects
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84
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|
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11.4.2 Neurological effects
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86
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11.5
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Genotoxicity
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87
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11.6
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Carcinogenicity
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87
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|
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11.6.1 Nasal tract, pharynx and pulmonary tumours
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88
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|
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11.6.2 Non-respiratory tract cancers
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98
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11.7
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Reproductive toxicity
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110
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11.8
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Developmental toxicity
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111
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12.
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HAZARD
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CLASSIFICATION
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113
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12.1
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Acute toxicity
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113
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12.2
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Irritation
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114
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12.3
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Sensitisation
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114
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12.4
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Repeat dose toxicity
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115
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12.5
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Genotoxicity
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116
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12.6
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Carcinogenicity
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117
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12.7
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Reproductive effects
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119
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12.8
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Developmental toxicity
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120
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ENVIRONMENTAL EXPOSURE 121
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Ambient air concentrations 121
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13.1.1
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Point source emissions from industry
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121
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13.1.2
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Diffuse source emissions
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127
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13.1.3
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Natural background concentrations
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128
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13.1.4
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Combining PECs from all sources
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129
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13.1.5
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Measured data
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129
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13.1.6
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Summary
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131
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13.2
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Indoor air
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concentrations
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133
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13.2.1
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Residential buildings
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133
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13.2.2
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Non-residential buildings
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137
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13.2.3
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Estimation of indoor to outdoor ratio
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140
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Formaldehyde concentrations in water and soil 141
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Concentrations in water 141
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Concentrations in soil and sediment 143
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PUBLIC EXPOSURE 144
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Direct exposure 144
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Cosmetic and consumer products 144
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Smoking 144
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Indirect exposure 145
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14.2.1
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Indoor air
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145
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14.2.2
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Ambient air
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146
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14.2.3
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Drinking water, food, and soil
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146
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OCCUPATIONAL EXPOSURE 147
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Routes of exposure 147
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Methodology for assessing occupational exposure 147
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Formaldehyde manufacture 148
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Importation and transportation 149
Table 15.1: Air monitoring data during formaldehyde manufacture 150
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Formulation and repackaging 151
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Resin manufacture 151
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Formulation of formaldehyde products other than resins 152
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Repackaging 155
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End uses of formaldehyde products 157
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15.6.1
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Formaldehyde resins
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157
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15.6.2
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Forensic/hospital mortuaries and pathology laboratories
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162
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15.6.3
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Embalming
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163
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15.6.4
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Photographic film processing
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171
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15.6.5
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Leather tanning using formalin solutions
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171
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15.6.6
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Sanitising treatment
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172
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15.6.7
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Lubricant products
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172
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15.6.8
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Analytical laboratories
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172
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15.6.9
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Fumigation
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173
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15.6.10
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Monitoring data on other use of formaldehyde products
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173
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15.7
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Summary
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173
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CRITICAL HEALTH EFFECTS FOR RISK CHARACTERISATION 175
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Acute effects 175
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Repeated dose effects (other than carcinogenicity) 176
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Carcinogenicity 177
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Dose-response analysis 178
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Sensory irritation 178
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Skin sensitisation 179
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Cell proliferation 179
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Carcinogenicity 180
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RISK CHARACTERISATION 183
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Environmental risks 183
17.1.1
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Atmospheric compartment
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183
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17.1.2
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Aquatic compartment
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184
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17.1.3
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Terrestrial compartment
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185
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Public health risks 185
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17.2.1
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Public exposure
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185
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17.2.2
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Health impacts
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186
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17.2.3
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Uncertainties
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187
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17.2.4
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Summary
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188
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17.2
17.3 Occupational health risks 188
17.3.1 Physicochemical hazards 188
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17.3.2
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Occupational exposure and health impacts
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188
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17.3.3
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Uncertainties in occupational risk characterisation
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191
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17.3.4
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Areas of concern in occupational settings
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191
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17.4
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Data gaps
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191
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RISK MANAGEMENT 193
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Environmental risk management 193
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Current ambient air quality controls 193
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Other environmental controls 197
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Further actions identified 198
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Public health risk management 199
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Current indoor air quality management 199
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Formaldehyde emission controls from wood products 203
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Product labelling schemes 207
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Current risk management for consumer products 208
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Further actions identified 209
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Occupational health and safety risk management 211
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18.3.1
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Current regulatory controls
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211
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18.3.2
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Current industry controls
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215
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18.3.3
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Further actions identified
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221
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SECONDARY NOTIFICATION 222
REFERENCES APPENDICES
APPENDIX 1 - List of organisations and individuals consulted during this assessment
|
314
223
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APPENDIX 2 – Questionnaire for formulators/manufacturers of formaldehyde products
|
227
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APPENDIX 3 - Summary tables of human epidemiology data
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233
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APPENDIX 4 - GHS classification
|
238
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APPENDIX 5 - Conceptual framework for considering mode-of-action of chemical carcinogenesis of formaldehyde
|
239
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APPENDIX 6 - Modelling for atmospheric concentrations of formaldehyde
|
246
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APPENDIX 7 - Estimates of point source emissions from industry
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254
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APPENDIX 8 - EASE modelling for film processing
|
257
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APPENDIX 9 - Biologically motivated case-specific model for cancer
|
259
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APPENDIX 10 - Worst-case scenario cancer risk estimation
|
264
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APPENDIX 11 - Sample labels for Australian-made plywood products
|
267
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APPENDIX 12 - Australian-made wood panel products 268
APPENDIX 13 - MSDS assessment 273
APPENDIX 14 – Sample Material Safety Data Sheet for formaldehyde solution, 37% 279
APPENDIX 15 - Label assessment 287
APPENDIX 16 - Proposed occupational exposure standard 290
APPENDIX 17 – MDF Plant Formaldehyde Air Dispersion, Report No 79365,
by EML Air Ltd 297
APPENDIX 18 - Review of MDF Plant Formaldehyde Air Dispersion, EML Report 79365, prepared for NICNAS, by M.F. Hibberd & M. E. Cope 308
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