Tenth Interim Report of the Subcommittee on Acute Exposure Guideline Levels (2004)

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TENTH INTERIM REPORT OF THE SUBCOMMITTEE ON ACUTE EXPOSURE GUIDELINE LEVELS 22 alkylating agent with a portal of entry target (due to anatomical differences in the respiratory system)? Why is no difference in pharmacodynamics expected? Page 20, line 26. Clarification is also needed for the intraspecies uncertainty factor. Page 23, line 20. Add “not” between “do” and “take”, as the AEGL-3 does not take cancer risk into consideration. Page 24, lines 15–16. The suggestion concerning the skin notation is misguided. Given the results of the study described on page 11, lines 22–31, where no toxicity was evident after vapor exposure when inhalation was precluded, the suggestion is erroneous in the context of the AEGLs. The AEGLs are not analogous to the TLV in that the ACGIH skin designation is assigned when percutaneous contact contributes to systemic toxicity. Unless the NAC envisions public contact with liquid or neat ethylenimine under some unstated circumstance or release (page 1), the suggestion that a ‘skin designation' be assigned to this material under the AEGL conditions is mistaken. Page 24, lines 16–17. Delete—this statement is redundant to page 23, lines 20–21. Page 25, line 14. Check the most recent TLV booklet to ascertain whether this material has been assigned the SEN (sensitizer) designation, as was suggested on page 24, line 35. Page vi, lines 29–31. The statement is unsupported. While the discussion seems to attempt to account for pharmacodynamic similarities, no mention is made of the range of pharmacokinetic parameters for this material. It may be worthwhile to cite reviews discussing accumulation of damage induced by nitrogen mustards (page 1, line 6) or other alkylating agents similar to ethylenimine to support the hypothesis presented. Page A-1, lines 19–22. Is this referring to the Weightman and Hoyle (1964) study? COMMENTS ON PROPYLENIMINE At its July 21–23, 2003 meeting, the subcommittee reviewed the AEGL document on propylenimine. The document was presented by Kowetha Davidson of Oak Ridge National Laboratory. The document could be finalized if the subcommittee is satisfied with the revisions made in response to its recommendations and if the AEGL document on ethylenimine is also approved by the subcommittee because the AEGL values for propylenimine are based on ethylenimine. General Comments Section 3, page 3. The studies are very old. What is the level of confidence that the reader can place on the results and the exposure concentrations?