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This is an example showing trial design and results data of Study #8325064 for the determination of the in vitro bacterial reverse mutation test  potential of 10 tobacco products in the in vitro Micronucleus Assay

The bacterial reverse mutation test uses amino acid-requiring strains of Salmonella typhimurium (S. typhimurium) and Escherichia coli (E. coli) to detect point mutations, which involve substitution, addition or deletion of one or a few DNA base pairs. The principle of this bacterial reverse mutation test is that it detects chemicals that induce mutations which revert mutations present in the tester strains and restore the functional capability of the bacteria to synthesize an essential amino acid. The revertant bacteria are detected by their ability to grow in the absence of the amino acid required by the parent tester strain.

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title tx.xpt (trial sets)
During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled;  For now, we just include good example values based on our experience Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design. Where is TK6 cell type?  is this test system (see below) needs to be allowed to vary down to the well level / result level A1: Image Removed A2:                                   Image Removed Row STUDYID ASSAYID DOMAIN SETCD SET (what sponsor calls it) TXSEQ TXPARMCD TXPARM TXVAL 123 8325064 MNvit Ames TX A1 (table 1, row 1, ST exposure with S9 P1 (plate 1) METACT Metabolic Activation  (should there be two parms? Presence, type)? +S9 None 123 8325064 MNvit Ames TX A1 P1 TRTDRTRG Treatment Duration target. (how do we show 3-6 hour range?  start/end, target and tolerance?, one text field not-analyzable)	3	123

A2