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Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals (2001) / Chapter Skim
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3 Format and Content of Technical Support Documents
Pages 124-138

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From page 124...
... a summary section that includes a concise summary oftoxicity information on the chemical, rationales used for time scaling and selection of uncertainty factors, and a table of AEGL values for the three tiers as well as key references; (2) a detailed discussion of the items listed in 1; and (3)
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From page 125...
... References to footnotes should be superscript and lower case. 3.1 FORMAT AND CONTENT OF TECHNICAL SUPPORT DOCUMENTS Preface The AEGL tiers are defined in the Preface of each TSD.
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From page 126...
... The reference to the key study. Uncertainty factors and modifying factors used or not used and why a specific value was chosen.
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From page 127...
... 3.1.1 Nonhuman Primates 3.1.2 Dogs 3.1.3 Rats 3.1.4 3.1.5 3.1.6 3.1.7 Mice Guinea Pigs Rabbits Other Species Sections to include relevant studies (potential key studies and supporting data) or provide overalipicture oftoxicity data as appropriate Third-leve} headers to vary, depending upon available data; exclusion of header to mean no relevant data available 3.2 Nonlethal Toxicity (include species and strain, number of animals, exposure concentrations and durations, critical effects, time-course data)
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From page 128...
... 5.2 Summary of Animal Data Relevant to AEGL-l (general summary description of selected key and supporting study or studies if avaiTable) 5.3 Derivation of AEGL-1 (key study, critical effect, dose-exposure concentration, uncertainty factor application and justification, temporal extrapolation, assumptions, confidence, consistency with human data if appropriate)
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From page 129...
... 7.2 Summary of Animal Data Relevant to AEGL-3 (general summary description of selected key and supporting study or studies if available) 7.3 Derivation of AEGL-3 (key study, critical effect, dose-exposure concentration, uncertainty factor application and justification, temporal extrapolation, assumptions, confidence, consistency with human data if appropriate)
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From page 130...
... AEGL-1 (OR-2 OR-3) Values 10min 30min | lh |4h l ppm ppm | ppm | ppm l Reference: Test Species/Strain/Number: Exposure Route/Concentrations/Durations: Effects: Endpoint;/Concen~ation/RationaTe: Uncertainty Factors/RationaTe: Modifying Factor: Animal to Human Dosimehic Adjustment: Time Scaling: Data Adequacy: a a Elements that should be included in the Data Adequacy entry are discussed in Section 2.3.3 of this SOP manual.
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From page 131...
... In Table 3-1, the severity categories fit into definitions of the AEGL health effects. The category severity definitions for the column headings are 0 = no effect; ~ = discomfort; 2 = disabling; 3 = lethal; NE = did not die at a lethal concentration (at an experimental concentration in which some ofthe animals died and some did not, the NE label refers to the animals that did not die)
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From page 132...
... 132 s~ c - O co .
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From page 133...
... 133 ~ o-~= ~ ~ ·1 /-3 i~ =~ ~V ~ · ~ ~ ~ ~ -~ ~ ~ I I T I I T I I T I 1 1 1 1 1 1 1 1 1 1 1m 1~ 1 1 1~ T~ 1- 1- T~ 1- 1 I I I I I T I I T I 1 1 1 1 1 1 1 1 1 1 1 I I I 11 T I I I I ° 1 1 1 1 1 10 10 100 1= I 1= 1o lolm T~ I I T I 1 I ~ 1 I T I I T I 1 °= l=X 1= 10 10 10 1- 1- 1- 10 o o o o o o o o o o o o o o o o o o o o 1 ~ 1 =^ 1 =^ 1 1~ 1~1 = === = = == i14 1~ Is 1= ~I.
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From page 134...
... 134 .~ En 'it ~ :~: ~ V U
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From page 135...
... 135 ~ ~ ~ 1~ 1~ ~ ~ ~ o 0 0 ____ =- ~ ~ ~ ~ _ ~ ~~ 1 1~ 1z TO Tz lm II IIII I I T T I : j:~H ~ L[~ ~ :~H IT T~III1 T T I r .
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From page 138...
... Should they be considered in the development of AEGL values or discarded because of faulty experimental technique? Does the spread of data points for a particular severity category indicate major differences between species or are the results from different species congruent?
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Key Terms

  • human data
  • data relevant
  • selected key
  • supporting study
  • summary description

  • key study
  • relevant data
  • ppm values
  • toxicity data
  • temporal extrapolation

  • critical effect
  • factor application
  • animal data
  • derivation summary
  • support document

  • animals shown
  • support documents
  • human exposures
  • severity category
  • exposure concentrations

  • vary according
  • sop appendix
  • uncertainty factors
  • summary table
  • include species

  • key studies
  • aegl tier
  • cubic meter
  • experimental result
  • items listed


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