Final Report: Whole Body Inhalation Developmental Toxicity Study in Rats

With Gasoline with TAME Vapor Condensate (MRD-00-715: 171534)

211(b) Research Group (RG) Response to EPA Second Draft Report

Comments dated June 24, 2008

EPA June 24, 2008 Comment #1:

Although the inferential statistics now used to analyze the fetal
examination data are valid, the report tables still inappropriately show
fetal incidences.  As currently presented, these data are still
difficult to properly evaluate.  Table 4-2 and Appendix H should present
the group mean ± SD values for the percentage affected per liter.

RG Response to EPA June 24, 2008 Comment:

The RG concurs that the present format of data presentation is
scientifically valid, and considers this to be a valuable comment. 
However, it would be a lengthy procedure for the laboratory to revise
report tables as EPA has suggested, as such revisions would require
programming changes.  Programming changes require computer validation
and subsequently also require additional Quality Assurance review. 
These tasks would need to be completed before the report could be
resubmitted for QA review as required under GLP. For those reasons, the
work group has not requested that the lab revise the report as described
in this comment.  However, the results can be presented in the suggested
format at later stages of data utilization, such as publication/risk
assessment, where the change would not delay completion of the 211(b)
testing requirement.

EPA June 24, 2008 Comment #2:  

Because of its relevance to reduced fetal weights, the slightly
increased incidences of stunted fetuses in the high-dose group should be
mentioned in the Abstract (page i), Summary (Section 1) and Results
(Section 4).

RG Response to EPA June 24, 2008 Comment:

The reduced fetal weights were mentioned in the Results.  The statement
from the Results was added to the Abstract and the Summary.

