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Perfluoroisobutylene Interim Document 1 Interim: Sep-2010 2 3 4 5 ACUTE EXPOSURE GUIDELINE LEVELS (AEGLs) 6 FOR 7 PERFLUOROISOBUTYLENE (PFIB) 8 9 (CAS Reg. No. 382-21-8) 10 11 C4F8 12 13 14 15 16 INTERIM 17 18 PERFLUOROISOBUTYLENE(PFIB) InterimSep-2010/Page2of43 1 2 3 4 ACUTE EXPOSURE GUIDELINE LEVELS (AEGLs) 5 FOR 6 PERFLUOROISOBUTYLENE (PFIB) 7 (CAS Reg. No. 382-21-8) 8 9 10 11 12 PROPOSED 13 14 15 16 17 18 19 20 21 PERFLUOROISOBUTYLENE(PFIB) InterimSep-2010/Page3of43 1 2 3 4 PREFACE 5 6 Under the authority of the Federal Advisory Committee Act (FACA) P. L. 92-463 of 7 1972, the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous 8 Substances (NAC/AEGL Committee) has been established to identify, review and interpret 9 relevant toxicologic and other scientific data and develop AEGLs for high priority, acutely toxic 10 chemicals. 11 12 AEGLs represent threshold exposure limits for the general public and are applicable to 13 emergency exposure periods ranging from 10 minutes to 8 hours. Three levels – AEGL-1, 14AEGL-2 and AEGL-3 C are developed for each of five exposure periods (10 and 30 minutes, 1 15 hour, 4 hours, and 8 hours) and are distinguished by varying degrees of severity of toxic effects. 16 The three AEGLs are defined as follows: 17 18 AEGL-1 is the airborne concentration (expressed as parts per million or milligrams per 19cubic meter [ppm or mg/m3]) of a substance above which it is predicted that the general 20 population, including susceptible individuals, could experience notable discomfort, irritation, or 21 certain asymptomatic, non-sensory effects. However, the effects are not disabling and are 22 transient and reversible upon cessation of exposure. 23 24AEGL-2 is the airborne concentration (expressed as ppm or mg/m3)ofasubstanceabove 25 which it is predicted that the general population, including susceptible individuals, could 26 experience irreversible or other serious, long-lasting adverse health effects or an impaired ability 27 to escape. 28 29AEGL-3 is the airborne concentration (expressed as ppm or mg/m3)ofasubstanceabove 30 which it is predicted that the general population, including susceptible individuals, could 31 experience life-threatening health effects or death. 32 33 Airborne concentrations below the AEGL-1 represent exposure levels that could produce 34 mild and progressively increasing but transient and nondisabling odor, taste, and sensory 35 irritation or certain asymptomatic, non-sensory effects. With increasing airborne concentrations 36 above each AEGL, there is a progressive increase in the likelihood of occurrence and the severity 37 of effects described for each corresponding AEGL. Although the AEGL values represent 38 threshold levels for the general public, including susceptible subpopulations, such as infants, 39 children, the elderly, persons with asthma, and those with other illnesses, it is recognized that 40 individuals, subject to unique or idiosyncratic responses, could experience the effects described 41 at concentrations below the corresponding AEGL. 42 PERFLUOROISOBUTYLENE(PFIB) InterimSep-2010/Page4of43 1 TABLE OF CONTENTS 2 PREFACE ....................................................................................................................... 3 3 TABLE OF CONTENTS.................................................................................................. 4 4 LIST OF TABLES ........................................................................................................... 6 5 SUMMARY...................................................................................................................... 7 6 1. INTRODUCTION..............................................................................................................................................9 7 2. HUMAN TOXICITY DATA.............................................................................................................................9 8 2.1. Acute lethality ...........................................................................................................................................9 9 2.2 Nonlethal acute toxicity..........................................................................................................................10 10 2.3. Developmental/Reproductive Toxicity..................................................................................................10 11 2.4. Genotoxicity ............................................................................................................................................10 12 2.5. Summary .................................................................................................................................................10 13 3. ANIMAL TOXICITY DATA..........................................................................................................................10 14 3.1. Acute Lethality........................................................................................................................................10 15 3.1.1. Rats .....................................................................................................................................................10 16 3.1.2. Mice.....................................................................................................................................................15 17 3.1.3. Guinea pigs .........................................................................................................................................16 18 3.1.4. Rabbits................................................................................................................................................16 19 3.1.5. Cats.........................................................................................................................................................17 20 3.2. Nonlethal Acute Toxicity........................................................................................................................17 21 3.2.1. Rats .....................................................................................................................................................17 22 3.3. Repeat Dose Studies................................................................................................................................17 23 3.4. Developmental/Reproductive Toxicity..................................................................................................18 24 3.5. Genotoxicity ............................................................................................................................................18 25 3.6. Chronic Toxicity/Carcinogenicity .........................................................................................................18 26 3.7. Summary .................................................................................................................................................18 27 4. SPECIAL CONSIDERATIONS .....................................................................................................................21 28 4.1. Metabolism and Disposition...................................................................................................................21 29 4.2. Mechanism of Toxicity ...........................................................................................................................21 30 4.3. Other Relevant Information ..................................................................................................................23 31 4.3.1. Interspecies Variability .....................................................................................................................23 32 4.3.2. Intraspecies Variability .....................................................................................................................23 33 4.3.3 Structure Activity ..............................................................................................................................24 34 4.3.4. Concentration-Exposure Duration Relationship.............................................................................24 35 5. DATA ANALYSIS FOR AEGL-1 ..................................................................................................................25 36 5.1. Summary of Human Data Relevant to AEGL-1 ..................................................................................25 37 5.2. Summary of Animal Data Relevant to AEGL-1...................................................................................25 38 5.3. Derivation of AEGL-1 ............................................................................................................................25 39 6. DATA ANALYSIS FOR AEGL-2 ..................................................................................................................25 40 6.1. Summary of Human Data Relevant to AEGL-2 ..................................................................................25 41 6.2. Summary of Animal Data Relevant to AEGL-2...................................................................................25 42 6.3. Derivation of AEGL-2 ............................................................................................................................25 PERFLUOROISOBUTYLENE(PFIB) InterimSep-2010/Page5of43 1 7. DATA ANALYSIS FOR AEGL-3 ..................................................................................................................26 2 7.1. Summary of Human Data Relevant to AEGL-3 ..................................................................................26
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