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Table of Contents


PREFACE III

OVERVIEW AND RECOMMENDATIONS V

TABLE OF CONTENTS XVII

ACRONYMS AND ABBREVIATIONS XXIV



GLOSSARY XXX


  1. INTRODUCTION 1

    1. Declaration 1

    2. Objectives 1

    3. Sources of information 1

    4. Peer review 2

  2. BACKGROUND 3

    1. Introduction 3

    2. Global production 3

    3. Australian perspective 4

    4. Assessments by other national or international bodies 4

  3. APPLICANTS 5

  4. CHEMICAL IDENTITY AND COMPOSITION 8

    1. Chemical name (IUPAC) 8

    2. Registry numbers 8

    3. Other names 8

    4. Molecular formula 8

    5. Structural formula 9

    6. Molecular weight 9

    7. Composition of commercial grade product 9

  5. PHYSICAL AND CHEMICAL PROPERTIES 10

    1. Physical state 10

    2. Physical and chemical properties 10

    3. Conversion factors 12

  6. METHODS OF DETECTION AND ANALYSIS 13

    1. Characterisation 13

    2. Atmospheric monitoring methods 13







6.2.1

In the workplace

13

6.2.2

In the environment

14

6.2.3

Indoor air

15

6.2.4

Off-gas monitoring from wood products

16

6.3

Biological

monitoring

17

6.4

Water




17

6.5

Soil




18



  1. MANUFACTURE, IMPORTATION AND USE 19

7.1

Manufacture

19

7.2

Importation

22

7.3

Use

23




7.3.1

Formulation of formaldehyde products

24




7.3.2

Repackaging

29




7.3.3

End use of formaldehyde products

29

7.4

Export




42




  1. ENVIRONMENTAL RELEASE, FATE AND EFFECTS 43

8.1

Release




43




8.1.1

Emissions to the atmosphere

43




8.1.2

Emissions to water and soil

45

8.2

Fate




45




8.2.1

Atmosphere

46




8.2.2

Water

47




8.2.3

Soil and sediment

48




8.2.4

Biota

48

8.3

Effects on

organisms in the environment

48




8.3.1

Aquatic organisms

48




8.3.2

Terrestrial organisms

50




8.3.3

Micro-organisms

51




8.3.4

Summary

52



  1. KINETICS AND METABOLISM 54

    1. Absorption 54

    2. Distribution 54

    3. Metabolism 54

    4. Elimination and excretion 55




  1. EFFECTS ON LABORATORY MAMMALS AND OTHER TEST

SYSTEMS 56

    1. Acute toxicity 56

    2. Corrosivity/Irritation 56

      1. Skin and eye irritation 56

      2. Respiratory irritation 57

    3. Sensitisation 58

      1. Skin 58

      2. Respiratory 58

    4. Repeat dose toxicity 59

      1. Inhalation 59

      2. Oral 62

      3. Dermal 63

    5. Genotoxicity 63

      1. In vitro studies 63

      2. In vivo studies 64

    6. Carcinogenicity 66

      1. Inhalation 66

      2. Oral 67

      3. Dermal 68

    7. Reproductive toxicity 68

    8. Developmental toxicity 69



11.

HUMAN

HEALTH EFFECTS

71




11.1

Acute toxicity

71




11.2

Irritation/Corrosivity

71







11.2.1 Skin irritation

71







11.2.2 Sensory irritation

72




11.3

Sensitisation

74







11.3.1 Skin

74







11.3.2 Respiratory

82




11.4

Non-neoplastic effects

84







11.4.1 Respiratory-related effects

84







11.4.2 Neurological effects

86




11.5

Genotoxicity

87




11.6

Carcinogenicity

87







11.6.1 Nasal tract, pharynx and pulmonary tumours

88







11.6.2 Non-respiratory tract cancers

98




11.7

Reproductive toxicity

110




11.8

Developmental toxicity

111



12.

HAZARD

CLASSIFICATION

113




12.1

Acute toxicity

113




12.2

Irritation

114




12.3

Sensitisation

114




12.4

Repeat dose toxicity

115




12.5

Genotoxicity

116




12.6

Carcinogenicity

117




12.7

Reproductive effects

119




12.8

Developmental toxicity

120




  1. ENVIRONMENTAL EXPOSURE 121

    1. Ambient air concentrations 121




13.1.1

Point source emissions from industry

121

13.1.2

Diffuse source emissions

127

13.1.3

Natural background concentrations

128

13.1.4

Combining PECs from all sources

129

13.1.5

Measured data

129

13.1.6

Summary

131

13.2

Indoor air

concentrations

133




13.2.1

Residential buildings

133




13.2.2

Non-residential buildings

137




13.2.3

Estimation of indoor to outdoor ratio

140

Formaldehyde concentrations in water and soil 141

      1. Concentrations in water 141

      2. Concentrations in soil and sediment 143

  1. PUBLIC EXPOSURE 144

    1. Direct exposure 144

      1. Cosmetic and consumer products 144

      2. Smoking 144

    2. Indirect exposure 145

14.2.1

Indoor air

145

14.2.2

Ambient air

146

14.2.3

Drinking water, food, and soil

146



  1. OCCUPATIONAL EXPOSURE 147

    1. Routes of exposure 147

    2. Methodology for assessing occupational exposure 147

    3. Formaldehyde manufacture 148

    4. Importation and transportation 149

Table 15.1: Air monitoring data during formaldehyde manufacture 150



    1. Formulation and repackaging 151

      1. Resin manufacture 151

      2. Formulation of formaldehyde products other than resins 152

      3. Repackaging 155

    2. End uses of formaldehyde products 157




15.6.1

Formaldehyde resins

157

15.6.2

Forensic/hospital mortuaries and pathology laboratories

162

15.6.3

Embalming

163

15.6.4

Photographic film processing

171

15.6.5

Leather tanning using formalin solutions

171

15.6.6

Sanitising treatment

172

15.6.7

Lubricant products

172

15.6.8

Analytical laboratories

172

15.6.9

Fumigation

173

15.6.10

Monitoring data on other use of formaldehyde products

173

15.7

Summary




173



  1. CRITICAL HEALTH EFFECTS FOR RISK CHARACTERISATION 175

    1. Acute effects 175

    2. Repeated dose effects (other than carcinogenicity) 176

    3. Carcinogenicity 177

    4. Dose-response analysis 178

      1. Sensory irritation 178

      2. Skin sensitisation 179

      3. Cell proliferation 179

      4. Carcinogenicity 180

  2. RISK CHARACTERISATION 183

    1. Environmental risks 183




17.1.1

Atmospheric compartment

183

17.1.2

Aquatic compartment

184

17.1.3

Terrestrial compartment

185

Public health risks 185

17.2.1

Public exposure

185

17.2.2

Health impacts

186

17.2.3

Uncertainties

187

17.2.4

Summary

188




17.2

17.3 Occupational health risks 188

17.3.1 Physicochemical hazards 188






17.3.2

Occupational exposure and health impacts

188

17.3.3

Uncertainties in occupational risk characterisation

191

17.3.4

Areas of concern in occupational settings

191

17.4

Data gaps




191




  1. RISK MANAGEMENT 193

    1. Environmental risk management 193

      1. Current ambient air quality controls 193

      2. Other environmental controls 197

      3. Further actions identified 198

    2. Public health risk management 199

      1. Current indoor air quality management 199

      2. Formaldehyde emission controls from wood products 203

      3. Product labelling schemes 207

      4. Current risk management for consumer products 208

      5. Further actions identified 209

    3. Occupational health and safety risk management 211

18.3.1

Current regulatory controls

211

18.3.2

Current industry controls

215

18.3.3

Further actions identified

221



  1. SECONDARY NOTIFICATION 222




REFERENCES APPENDICES

APPENDIX 1 - List of organisations and individuals consulted during this assessment



314

223


APPENDIX 2 – Questionnaire for formulators/manufacturers of formaldehyde products

227

APPENDIX 3 - Summary tables of human epidemiology data

233

APPENDIX 4 - GHS classification

238

APPENDIX 5 - Conceptual framework for considering mode-of-action of chemical carcinogenesis of formaldehyde

239


APPENDIX 6 - Modelling for atmospheric concentrations of formaldehyde

246

APPENDIX 7 - Estimates of point source emissions from industry

254

APPENDIX 8 - EASE modelling for film processing

257

APPENDIX 9 - Biologically motivated case-specific model for cancer

259

APPENDIX 10 - Worst-case scenario cancer risk estimation

264

APPENDIX 11 - Sample labels for Australian-made plywood products

267

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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