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Germane Interim AEGL Document 1 2 3 4 ACUTE EXPOSURE GUIDELINE LEVELS (AEGLs) 5 FOR 6 GERMANE 7 (CAS Reg. No. 7782-65-2) 8 9 GeH4 10 11 12 13 14 15 16 17 INTERIM 18 19 GERMANE Interim: 09-2009/ Page 2 of 31 1 2 ACUTE EXPOSURE GUIDELINE LEVELS (AEGLs) 3 FOR 4 GERMANE 5 (CAS Reg. No. 7782-65-2) 6 7 8 9 10 INTERIM 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 GERMANE Interim: 09-2009/ Page 3 of 31 1 PREFACE 2 3 Under the authority of the Federal Advisory Committee Act (FACA) P. L. 92-463 of 4 1972, the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous 5 Substances (NAC/AEGL Committee) has been established to identify, review and interpret 6 relevant toxicologic and other scientific data and develop AEGLs for high priority, acutely toxic 7 chemicals. 8 9 AEGLs represent threshold exposure limits for the general public and are applicable to 10 emergency exposure periods ranging from 10 minutes to 8 hours. Three levels C AEGL-1, 11 AEGL-2 and AEGL-3 C are developed for each of five exposure periods (10 and 30 minutes, 1 12 hour, 4 hours, and 8 hours) and are distinguished by varying degrees of severity of toxic effects. 13 The three AEGLs are defined as follows: 14 15 AEGL-1 is the airborne concentration (expressed as parts per million or milligrams per 16 cubic meter [ppm or mg/m3]) of a substance above which it is predicted that the general 17 population, including susceptible individuals, could experience notable discomfort, irritation, or 18 certain asymptomatic, non-sensory effects. However, the effects are not disabling and are 19 transient and reversible upon cessation of exposure. 20 21 AEGL-2 is the airborne concentration (expressed as ppm or mg/m3) of a substance above 22 which it is predicted that the general population, including susceptible individuals, could 23 experience irreversible or other serious, long-lasting adverse health effects or an impaired ability 24 to escape. 25 26 AEGL-3 is the airborne concentration (expressed as ppm or mg/m3) of a substance above 27 which it is predicted that the general population, including susceptible individuals, could 28 experience life-threatening health effects or death. 29 30 Airborne concentrations below the AEGL-1 represent exposure levels that could produce 31 mild and progressively increasing but transient and nondisabling odor, taste, and sensory 32 irritation or certain asymptomatic, non-sensory effects. With increasing airborne concentrations 33 above each AEGL, there is a progressive increase in the likelihood of occurrence and the severity 34 of effects described for each corresponding AEGL. Although the AEGL values represent 35 threshold levels for the general public, including susceptible subpopulations, such as infants, 36 children, the elderly, persons with asthma, and those with other illnesses, it is recognized that 37 individuals, subject to unique or idiosyncratic responses, could experience the effects described 38 at concentrations below the corresponding AEGL 39 40 GERMANE Interim: 09-2009/ Page 4 of 31 1 TABLE OF CONTENTS 2 PREFACE ..........................................................................................................................3 3 LIST OF TABLES ..............................................................................................................6 4 SUMMARY.........................................................................................................................7 5 1. INTRODUCTION..............................................................................................................................................8 6 2. HUMAN TOXICITY DATA ............................................................................................8 7 3. ANIMAL TOXICITY DATA............................................................................................................................8 8 3.1.1. Acute Toxicity ...........................................................................................................................................8 9 3.1.2. Repeated-exposure ...................................................................................................................................9 10 3.2. Developmental/Reproductive Toxicity ........................................................................................................9 11 3.3. Genotoxicity ..............................................................................................................................................9 12 3.4. Chronic Toxicity/Carcinogenicity ...........................................................................................................9 13 3.5. Summary ...................................................................................................................................................9 14 4. SPECIAL CONSIDERATIONS .......................................................................................................................9 15 4.1. Metabolism and Disposition ....................................................................................................................9 16 4.2. Mechanism of Toxicity .............................................................................................................................9 17 4.3. Structure Activity Relationships .............................................................................................................9 18 4.4. Other Relevant Information ..................................................................................................................10 19 4.4.1. Species Variability .............................................................................................................................10 20 4.4.2. Susceptible Populations.....................................................................................................................10 21 5. DATA ANALYSIS FOR AEGL-1 ..................................................................................................................10 22 5.1. Summary of Human Data Relevant to AEGL-1 ..................................................................................10 23 5.2. Summary of Animal Data Relevant to AEGL-1 ..................................................................................11 24 5.3. Derivation of AEGL-1............................................................................................................................11 25 6. DATA ANALYSIS FOR AEGL-2 ..................................................................................................................11 26 6.1. Summary of Human Data Relevant to AEGL-2 ..................................................................................11 27 6.2. Summary of Animal Data Relevant to AEGL-2 ..................................................................................11 28 6.3. Derivation of AEGL-2............................................................................................................................11 29 7. DATA ANALYSIS FOR AEGL-3 ..................................................................................................................12 30 7.1. Summary of Human Data Relevant to AEGL-3 ..................................................................................12 31 7.2. Summary of Animal Data Relevant to AEGL-3 ..................................................................................12 32 7.3. Derivation of AEGL-3............................................................................................................................12 33 8. SUMMARY OF AEGLS .................................................................................................................................13 34 8.1. AEGL Values and Toxicity Endpoints..................................................................................................13 35 8.2. Comparison with Other Standards and Guidelines ............................................................................13 36 8.3. Data Adequacy and Research Needs.....................................................................................................14 37 9. REFERENCES.................................................................................................................................................14 38 APPENDIX A: DERIVATION OF AEGL VALUES..........................................................16 GERMANE Interim: 09-2009/ Page 5 of 31 1 APPENDIX B: DERIVATION SUMMARY FOR GERMANE AEGLS..............................19 2 APPENDIX C: CATEGORY PLOT FOR GERMANE......................................................23 3 APPENDIX D: DERIVATION SUMMARY TABLES AND DERIVATION OF 10- 4 MINUTE AEGL VALUES FOR ARSINE.....................................................................26 5 GERMANE Interim: 09-2009/ Page 6 of 31 1 LIST OF TABLES 2 3 TABLE 1. SUMMARY OF AEGL VALUES FOR GERMANE ................................................................................7 4 TABLE 2. CHEMICAL AND PHYSICAL PROPERTIES .........................................................................................8 5 TABLE 3. EXPOSURE OF MICE, GUINEA PIGS AND RABBITS TO GERMANE (PANETH AND 6 JOACHIMOGLU, 1924)......................................................................................................................................8 7 TABLE 4. COMPARATIVE TOXICITY OF GERMANE AND ARSINE (PANETH AND JOACHIMOGLU, 8 1924) ..................................................................................................................................................................10
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