Fifteenth Interim Report of the Committee on Acute Exposure Guideline Levels (2008) / Chapter Skim
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Fifteenth Interim Report of the Committee on Acute Exposure Guideline Levels
Fifteenth Interim Report of the Committee on Acute Exposure Guideline Levels
Pages 1-36
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This interim report presents the committee's comments concerning NAC's draft AEGL documents for 16 chemicals (boron trifluoride, bromine, dimethyldichlorosilane, epichlorohydrin, ethylene oxide, furan, methyl ethyl ketone, methyl mercaptan, methyltrichlorosilane, nitric acid, nitrogen dioxide, nitric oxide, perchloromethylmercaptan, phosphorus oxychloride, phosphorus trichloride, and trimethylchlorosilane) and 1 chemical mixture (jet fuel 8)
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The Bowden report appears to be a well-conducted acute inhalation study from an established laboratory recognized for the quality of its toxicology studies. The previous TSD on boron trifluoride raised a major concern for the committee because it used delayed irritancy (seen at 2 weeks after starting exposure)
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22:263-270. COMMENTS ON BROMINE At its meeting held on January 17-19, 2007, the committee reviewed the revised AEGL document on bromine.
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It states in this section that "…there was no penetration to the lower respiratory tract." There are no data to support this statement, so it should be changed to "…there is likely to be little penetration to the lower respiratory tract." COMMENTS ON DIMETHYLDICHLOROSILANE At its previous meeting held on January 17-19, 2007, the committee reviewed the revised AEGL document on dimethyldichlorosilane. The document was presented by Cheryl Bast of Oak Ridge National Laboratory.
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The text states that "Epichlorohydrin is manufactured at three sites in the United States in Louisiana and Texas." Determine whether epichlorohydrin is produced outside the United States because AEGL documents are used in countries other than the United States. Page 10, line 33.
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Perhaps this statement should be rephrased: "No definitive data were available for deriving AEGL-2 values from studies with humans or animals." However, the author should explain why severe kidney toxicity is not "definitive data." Page 42, lines 36-38. The text states, "Because kidney damage was observed after a single inhalation exposure to epichlorohydrin, clinical signs alone are considered inadequate for evaluating animal toxicity after inhalation exposure to epichlorohydrin vapor." The statement is unclear.
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If we understand this statement correctly, it would be clearer for the reader if "over a lifetime" were added ("the exposure concentration of 30 ppm (6-h duration) over a lifetime that caused no lethality …")
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8:322-323. COMMENTS ON ETHYLENE OXIDE At its meeting held on January 17-19, 2007, the committee reviewed the revised AEGL document on ethylene oxide.
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13:301-309. COMMENTS ON FURAN At its meeting held on January 17-19, 2007, the committee reviewed the revised AEGL document on furan.
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Delete "Toxicity signs during exposure"; change to: "Signs of furan intoxication during exposure included…" Page viii, line 17. The Terrill report was not inadequate because "the study actually evaluated the acute inhalation toxicity of several chemicals"; rather, the description of the results was not as precise as the reader might wish.
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:91-107. COMMENTS ON JET FUEL 8 At its meeting held on January 17-19, 2007, the committee reviewed the revised AEGL document on jet fuel 8.
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Page 43, lines 17 and 18. The committee suggests using the Alarie (1981)
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(1996) , vapor and aerosol, vapor, aerosol, single 4-h exposure, no change in body weights, eye and upper respiratory irritation.
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AL/OE-TR-1996-0136, NMRI-94-114, Armstrong Laboratory, Occupational and Environmental Health Directorate, Toxicology Division, Wright-Patterson AFB, OH. COMMENTS ON METHYL ETHYL KETONE At its previous meeting, the committee reviewed the revised AEGL document on methyl ethyl ketone.
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:264-270. COMMENTS ON METHYL MERCAPTAN At its previous meeting held on January 17-19, 2007, the committee reviewed the AEGL document on methyl mercaptan.
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toxicity with resultant albuminurea. These other possibilities are important, because of the statement that the "AEGL-2 values are considered protective because rats exposed to 57-ppm methyl mercaptan 7 h/day, 5 days/week for 3 months experienced only decreased body weight" on page 18, line 6.
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Refer to the comment above regarding page 14, lines 20-23. Change to read, "experienced only decreased body weight and decreased serum albumin …." Appendix C: Derivation of the Level of Distinct Odor Awareness (LOA)
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There is some ambiguity created by waiting to state the exposure duration until late in the sentence. Recommend that the approach used in the preceding sentence be used here: "Furthermore, in mice exposed to methyl mercaptan for 6 h, only shallow breathing …." Page 22, line 4.
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COMMENTS ON METHYLTRICHLOROSILANE At its meeting held on January 17-19, 2007, the committee reviewed the AEGL document on methyltrichlorosilane. The document was presented by Cheryl Bast of Oak Ridge National Laboratory.
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COMMENTS ON NITRIC ACID At its meeting held on January 17-19, 2007, the committee reviewed the AEGL document on nitric acid. The document was presented by Carol Wood of Oak Ridge National Laboratory.
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Page 12, lines 28-30. The authors note that because the dose-response curves for nitrogen dioxide and red fuming nitric acid (RFNA)
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It is discussing nitric oxide, not nitric acid.
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COMMENTS ON NITROGEN DIOXIDE At its meeting, January 17-19, 2007, the committee reviewed the AEGL document on nitrogen dioxide. The document was presented by Carol Wood of Oak Ridge National Laboratory.
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Page 21, line 2. The text states, "It should be noted that in the studies which found statistically significant changes with NO2 exposure, the differences were <10% and of questionable biological significance even for 3 asthmatics." The value of <10% seems to be inconsistent with the reported changes noted earlier in pulmonary function tests of asthmatic persons.
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This text states, "Because the end point in the monkey study is below the definition of AEGL-3…." Actually, the effects reported were marked changes in lung structure, 25
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1979. Effects of nitrogen dioxide on pulmonary function in human subjects: An environmental chamber study.
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General Comments Because nitric acid (HNO3) , nitrogen dioxide (NO2)
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Toxicologist 42:213. COMMENTS ON PERCHLOROMETHYL MERCAPTAN At its meeting held on January 17-19, 2007, the committee reviewed the AEGL document on perchloromethylmercaptan.
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Change to read "Human data were generally limited to described only in secondary sources; case reports describing respiratory and topical exposures …." Page vii, line 28. Change to read "the end point is a no-effect level for perchloromethyl mercaptan as a respiratory irritant." Page viii, lines 4 and 5.
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Change to read "were not used for in the derivation … Although there are acute toxicity data are available … the toxicity potency of perchloromethyl mercaptan is much greater than that of the congener as seen when examining lethality data methyl mercaptan. In rats, the 1-hour LC50 the highest nonlethal concentration of perchloromethly mercaptan is 9 ppm for 1 h, and the 1-h LC50 is reported as 11, 13, or 16 ppm, and the highest nonlethal concentration is 9 ppm for 1 hour with the next concentration of 18 ppm for 1 hour resulting in 7/10 rats dying within 24 hours of exposures.
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VII, Ch. 94, § 33, Perchloromethyl Mercaptan.
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In the case of phosphorous oxychloride, the intraspecies UF of 3 appears to result in a reasonable value for the AEGL-3, which seems in line with other published standards. COMMENTS ON PHOSPHORUS TRICHLORIDE At its meeting held on January 17-19, 2007, the committee reviewed the AEGL document on phosphorus trichloride.
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COMMENTS ON PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELING (PBPK) At its meeting held on January 17-19, 2007, the committee reviewed the document on physiologically based pharmacokinetic modeling (PBPK)
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The white paper should make clear that only peer-reviewed PBPK models are to be used in the process. If modification to the model structure or description is made, then it should undergo peer review before being used for AEGL derivation.
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General Comments The proposed AEGL values and support for their derivation appear appropriate given the limited database. Given the proposed mode or mechanism of action, reliance on the HCl database and the AEGLs derived from it is appropriate.
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If there is a citation of a common secondary source, check to see if there is a recently updated version, verify the information being referenced there, and cite the most recent version that contains the material to be referenced. This is especially appropriate for annually updated sources such as the TLVs, WEELs, or ERPGs, which can change and even withdraw certain values.
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