The AEGL-1 was based on the study of … 4-7 volunteers, two individuals experienced mild headache during 3.5 and during 7.5 hours (3.5 hours, 0.5 hours break, 3.5 hours) of exposure to 491 ppm. The time of onset of headaches is not clearly stated and was assumed to be after 3.5 hours…. The AEGL-2 was based on prenarcotic effects observed in human volunteers. After 5 minute exposure to 16,000 ppm VC [vinyl chloride], 5 of 6 persons showed dizziness, lightheadedness, nausea, and visual and auditory dulling…. The AEGL-3 was based on cardiac sensitization and the no effect level for lethality.

This document can be finalized.

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), the possible reasons should be explored and discussed in the text. The SOP, Appendix J, page 201, states, “A summary discussion of important comparisons should be presented in the text and the values for recognized standards and guidelines, if available, should be presented in the table.”

Reliance on review articles and compendia appears to have increased. The SOP states that the primary literature must be used (SOP, page 51) for key studies, supporting data, and information important to the derivation of an AEGL value. If the summarization of findings from a primary reference as described in a secondary source is used, the citation needs to be clear that it is not coming from the primary literature, that is, a paper “as cited in.” If a reference is unpublished, the citation should make clear how the information can be obtained by others.

The authors need to make sure the literature on the chemicals have been updated for documents that have been several years in the AEGL-development process. The date of the most recent literature review should be included in the TSD.

The chemical structure of the compounds should be included on the title page of every TSD.



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