Nineteenth Interim Report of the Committee on Acute Exposure Guideline Levels Part A (2011) / Chapter Skim
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Nineteenth Interim Report of the Committee on Acute Exposure Guideline Levels
Nineteenth Interim Report of the Committee on Acute Exposure Guideline Levels
Pages 1-59
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Subsequently, Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Substances was published in 2001; it provided updated procedures, methods, and other guidelines used by the National Advisory Committee (NAC) on Acute Exposure Guideline Levels for Hazardous Substances for assessing acute adverse health effects.
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, vinyl acetate monomer, and vinyl chloride. ACRYLONITRILE At its meeting held on October 26-29, 2010, the committee reviewed the technical support document (TSD)
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They are listed below: Page 30, line 42; page 31, line 2 and lines 18-21: A range of 12 to 15 ppm for ocular irritation and headache in occupational exposure was based on a NAC/AEGL personal communication. However, no data are presented in TSD for review.
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affirmed that occupational exposure at 12 to 15 ppm resulted in ocular irritation and headache." The use of personal communication for supporting information on human exposure is not appropriate for this document unless the information is publically available. Section 2.3.2 of the Standing Operating Procedures (SOP)
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If so, please use the term "unit risk". Page 27, Table 12, Tumor Type and Incidence Data for Rats Exposed to AN Vapor: Do these data include interim sacrifices?
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:199-207. BENZONITRILE At its meeting held on October 26-29, 2010, the committee reviewed TSD on benzonitrile.
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AEGL-1 values are not recommended for benzonitrile because of insufficient data…. The AEGL-2 was based on labored breathing and poor coordination in rats exposed to 900 ppm for 3 hours….
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1974. Acute inhalation toxicity of benzonitrile.
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AEGL-2 The TSD correctly notes that human and animal data were unavailable for the derivation of hydrogen bromide values. The TSD authors used hydrogen bromide values to develop AEGL values for boron tribromide "[b]
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:636-655. BZ At its meeting held on October 26-29, 2010, the committee reviewed the TSD on agent BZ (3-quinuclidinyl benzilate)
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The authors should eliminate the modifying factor. Modifying factors represent an adjustment for uncertainties in the overall database or for known differences in toxicity among structurally similar chemicals.
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2001. Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals.
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If there are systemic effects, modify the language on mechanism of action. The values seem appropriate as evidenced by the category plots, but the rationale does not seem to be supported by the data (there appears to be more than direct irritation occurring)
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A revised TSD should be submitted to the committee for review. Adamsite The following is excerpted from the Executive Summary of the TSD: Studies with human volunteer subjects affirm nasal and ocular irritation as the primary effect from short term low level exposure to DM [adamsite]
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The authors should explore the human data (Lawson and Temple 1922) in more detail for a more appropriate AEGL-2 POD.
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AEGL-3 values for 10 and 30 minutes, and 1 hour were developed based on a lethality threshold estimated as a 3-fold reduction of a mouse 10-minute LCt50… Limited data and uncertainties in extrapolating to exposure durations 24-fold and 48-fold greater than the 10-minute experimental time frame, preclude development of the 4-hour and 8-hour AEGL-3 values. AEGL-Specific Comments AEGL-1 The committee agrees that there are insufficient data at this time to derive AEGL-1 values for ethyldichloroarsine.
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A lower UF for intraspecies variability is typically used for direct-acting irritants. However, because the lethality studies do not indicate the cause of death, it is uncertain whether direct irritation was the cause of death.
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Consider a benchmark calculation based on the animal data as a more appropriate method. A lower UF for intraspecies variability is typically used for direct-acting irritants.
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. Where possible, compare the estimated AEGL values across time scales to determine whether differences in concentration × exposure time are consistent with the expected comparative toxicity of the chemicals in terms of structure-activity relationships as an additional check for reasonableness, given the sparseness of data for most chloroarsenicals.
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2001. Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals.
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1970b) was used as the point-of-departure for isopropyl chloroformate AEGL 3 values.
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For example, the discussion should include AEGL values and other relevant 22
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Section I.6, page I-11, lines 9-15: As indicated per the check of more recent literature (see the comment above) , the committee suggests revisiting statements regarding the toxic effect not being expected to vary greatly between species or individuals; for example, consider animal data for isopropyl chloroformate (Section V.2, pg.
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1983. Initial Submission: Acute Inhalation Toxicity of Ethyl Chlorothioformate in Rats with Cover Letter Dated 08/28/92.
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AEGL-Specific Comments The committee approved the AEGL-1, AEGL-2, and AEGL-3 derivations for the 26 selected chlorosilanes. Other Comments A recommendation in the Eighteenth Interim Report of the Committee on Acute Exposure Guidelines (NRC 2010)
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AEGL-Specific Comments The committee approved the derivation of AEGL-1, AEGL-2, and AEGL-3 values for BCME. CHLOROMETHYL ETHER At its meeting held on October 26-29, 2010, the committee reviewed the TSD on chloromethyl ether.
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Pp. 211-276 in Acute Exposure Guideline Levels for Selected Airborne Chemicals, Vol.
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. LEWISITES At its meeting held on October 26-29, 2010, the committee reviewed the TSD on lewsites 1, 2, and 3.
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The ocular irritation and lesions are an AEGL-2 impairment-of-escape effect supported by both human and animal data. The effect concentrations were 30, 150 and 600 mg-min/m3, for rabbits, humans, and dogs, respectively.
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(Please note the comment below regarding saturated vapor concentration.) Page 8, lines 33- 34: "Exposure will be to these compounds and to potential hydrolysis products, sodium arsenite and arsenic acid." Please include the chemical formulas for sodium arsenite and arsenic acid.
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ADB954935. Edgewood Arsenal, Aberdeen Proving Ground, MD.
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Review these references, the case report and the human experimental data to determine if an exposure-response estimate, even a rough one, can be identified to either derive an AEGL-1 based on human data or to support the values derived from animal data. AEGL-2 Page 17, line 13: The authors report that animal data were not available for deriving AEGL-2 values.
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This paragraph should be revised to summarize the information that was essential to derive the AEGL-3 values. Page 8, Table 1: Given the data in the table, the calculated saturated vapor concentration is about 58%, indicating great potential to generate toxic concentrations very quickly in an emergency.
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These values are considered sufficient" Page 17, lines 21-23, and page 18, lines 7-10: "(a 4 hour exposure to 2600 ppm caused 40% lethality in mice, the 4-h mouse LC50 value was 2770 ppm and at 3573 ppm for 4 hours 100% of mice died; the 4-h rat LC01 value was 3808 ppm and the 4-h rat LC50 value was 4740 ppm) ." To improve readability, consider replacing the material in the parenthetical with a reference to Table 4, "Mortality of Mice and Rats Exposed to Ethyl Mercaptan for 4 Hours," on page 12.
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for rats exposed for four hours. A revised document should be submitted to the committee for review AEGL-Specific Comments AEGL-1 The committee agrees that data are insufficient at this time for the derivation of AEGL-1 values for methyl mercaptan.
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in rats exposed to phenyl mercaptan for 4 hours. A revised document should be submitted to the committee for review.
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Note also that these TWAs permit excursions above the average value: "Excursions in worker exposure levels may exceed 3 times the TLV-TWA for no more than a total of 30 minutes during a work day, and under no circumstances should they exceed 5 times the TLV-TWA, provided that the TLV-TWA is not exceeded." Although the statement is made that there were no animal data for derivation of AEGL-2 values (page 15, lines 14-15) , several studies reported effects at exposure concentrations that did not cause lethality and that therefore might be useful for deriving AEGL-2 values.
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AEGL-Specific Comments The authors are complimented for their analysis of the data and establishment of scientifically defensible AEGL values, considering the sparse database. AEGL -1 The authors should investigate the sources used by Hazardous Substances Data Base (2006)
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were noted in male and female rats exposed to 7 ppm tert-octyl mercaptan for 4 hours 39
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. MERCURY VAPOR At its meeting held on October 26-29, 2010, the committee reviewed the TSD on mecury vapor.
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The statement "No adverse effects were reported" on page 23, line 45, is still correct. Page 9, Section 2 Human Toxicity Data: It would be useful to add that an acute exposure can lead to acute respiratory distress syndrome and chemical pneumonitis (see Lim et al.
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Simple time-scaling is not useful, given different windows of susceptibility for various effects. The committee suggests that the sentence is either deleted to avoid confusion or that the issue be addressed with specific context for key end points relevant to mercury vapor exposure.
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1994. Mercury toxicokinetics in Wistar rats exposed to elemental mercury vapor: Modeling and computer simulation.
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Other Comments Cover page: Please provide the chemical structure on the title page. Page 7, Table S 1: Please include the POD with its associated exposure duration and end point in this summary table.
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. NITROGEN DIOXIDE, NITROGEN TETROXIDE, AND NITRIC OXIDE At its meeting held on October 26-29, 2010, the committee reviewed the TSD on nitrogen dioxide (NO2)
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8:97-111. SELENIUM HEXAFLUORIDE At its meeting held on October 26-29, 2010, the committee reviewed theTSD on selenium hexafluoride.
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AEGL-3 The committee approves the derivation of AEGL-3 values for selenium hexafluoride. Other Comments Throughout the document, change "selenium moiety" to "selenium and selenium compounds." Page 11, line 23: The statement "No information on human exposure was available" appears inaccurate because of the human exposure information on page 13, lines 37-40 (see comment below)
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2009. Sixteenth Interim Report of the Committee on Acute Exposure Guideline Levels.
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Other Comments Page 5, lines 25-26: "At the next higher concentration, 5000 ppm, renal lesions were noted after both the two day and two week observations, making 2500 ppm the NOEL for irreversible effects at 4 hours." Please clarify that at 5,000 ppm, no reversibility was observed during the 2-week observation period, rather than call the renal lesions "irreversible". SULFURIC ACID, OLEUM, AND SULFUR TRIOXIDE At its meeting held on October 26-29, 2010, the committee reviewed the TSD on sulfuric acid, oleum, and sulfur trioxide.
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They include assessments of both epidemiologic studies in the general public and occupational studies without distinguishing which of these demonstrated associations between sulfuric acid exposure and cancer. Please revise this section to make it clear whether both types of studies demonstrated a causal relationship or whether a relationship is observed in just one type of study.
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, some studies that had used this species to investigate the effect of particle size and mechanisms should be included. It is possible that a super-sensitive human population exists and could respond to sulfuric acid similar to guinea pigs.
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1987. Basis for a particle size-selective TLV for sulfuric acid aerosols.
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:440-450. TEAR GAS At its meeting held on October 26-29, 2010, the committee reviewed the TSD on tear gas.
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For example, the IDLH value is so much different from the AEGL values; the ERPG-3 value is twice the AEGL-3 value. Please provide an explanation.
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Health 6:366-374. THIONYL CHLORIDE At its meeting held on October 26-29, 2010, the committee reviewed the TSD on thionyl chloride.
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relationship for inhaled thionyl chloride may differ from that for inhaled sulfur dioxide and hydrogen chloride, as the former exposure will result in deeper deposition in the respiratory tract and more severe effects. This notion is supported by the lower rat LC50 values obtained at low relative humidity (Nachreiner 1993)
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New York: McGraw-Hill. TRIMETHOXYSILANE AND TETRAMETHOXY SILANE At its meeting held on October 26-29, 2010, the committee reviewed the TSD on trimethoxysilane and tetramethoxysilane.
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:331-337. VINYL CHLORIDE At its meeting held on October 26-29, 2010, the committee reviewed the TSD on vinyl chloride.
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AEGL-Specific Comments The committee approves the derivation of the AEGL-1, AEGL-2, and AEGL-3 values for vinyl chloride. COMMENTS PERTAINING TO ALL TSDS Whenever substantial discrepancies are found between AEGL values and other guideline values (e.g., IDLHs, STELs, and WEELs)
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