HAZARD ASSESSMENT OF PERFLUOROOCTANOIC ACID AND ITS

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SALTS

107

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2313

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

2002

rok

Table of Contents

Executive Summary 1

1.0 Chemical Identity 7

1.1 Physicochemical Properties 7

2.0 Production of PFOA and its Salts 9

2.1 Uses of PFOA and its Salts 11

2.2 Environmental Fate 12

2.2.1 Photolysis 12

2.2.2 Volatility 12

2.2.3 Biodegradation 13

2.2.4 Hydrolysis 13

2.2.5 Bioaccumulation 14

2.2.6 Soil Adsorption 15

2.3 Environmental Exposure 15

2.3.1 Discharge to Air 15

2.3.2 Discharge to Water 15

2.3.3 Discharge to Land 16

2.3.4 Environmental Monitoring 16

2.4 Human Biomonitoring 18

3.0 Human Health Hazards 23

3.1. Metabolism and Pharmacokinetics 23

3.1.1 Half-life in Humans 23

3.1.2 Absorption Studies in Animals 24

3.1.3 Distribution Studies in Animals 25

3.1.4 Metabolism Studies in Animals 28

3.1.5 Elimination Studies in Animals 28

3.2 Epidemiology Studies 32

3.2.1 Medical Surveillance Studies from Antwerp and Decatur Plants 32

3.2.2 Medical Surveillance Studies from Cottage Grove Plant 34

3.2.3 Mortality Studies 36

3.2.4 Hormone Study 39

3.2.5 Study on Episodes of Care (Morbidity) 40

3.3 Acute Toxicity Studies in Animals 42

3.3.1 Oral Studies 42

3.3.2 Inhalation Studies 43

3.3.3 Dermal Studies 43

3.3.4 Eye Irritation Studies 43

3.3.5 Skin Irritation Studies 44

3.4 Mutagenicity Studies 44

3.5 Subchronic Toxicity Studies in Animals 44

3.6 Developmental Toxicity Studies in Animals 60

3.7 Reproductive Toxicity Studies in Animals 64

3.8 Carcinogenicity Studies in Animals 74

3.8.1 Cancer Bioassays 74

3.8.2 Mode of Action Studies 75

3.8.2.1 Liver Tumors 76

3.8.2.2 Leydig Cell Tumors 76

3.8.2.3 Mammary Gland Tumors 77

3.8.2.4 Pancreatic Tumors 77

3.9 Immunotoxicology Studies in Animals 78

4.0 Hazards to the Environment 80

4.1 Introduction 80

4.2 Acute Toxicity to Freshwater Species 81

5.0 References 87

ANNEX I – Robust Summaries 104