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6.3.?.1  ASSUMPTIONS FOR Genetic Toxicology In-Vitro TEST RESULTS (GT) DOMAIN MODEL

1. GT Definition: This domain captures in vitro genetic toxicology data collected by the lab executing the study or received from a provider.  This domain is designed for exchanging sample (entity) level in-vitro  Neutral Red Update, Ames, MNT, MLA assay data. Other in vitro genetic toxicology tests have not yet been modeled in this version of this domain.

2. Results Definition:
   1. GTSTRESC and the corresponding numeric GTSTRESN should generally be used to represent standardized format of original results.
   2. GTSTNRLO and GTSTNRHI for reference range in standard units are "Expected" because this is critically important to understand the results of many of the test results. Follow guidelines from OECD when appropriate.
   3. GTSTAT and GTREASND are Permissible and used to indicate when a test was not completed. In these cases GTSTAT should contain “NOT DONE”; GTORRES, GTSTRESC, and GTSTRESN should be null; and GTREASND should contain the reason for not completing the test.
3. Timing Variables:
   1. The The planned incubation time is represented in the EI variables RFENDLO and RFENDHI.
4. Other Assumptions:
   1. The discussion in Section 4.5.1.3 concerning TESTS NOT DONE does not apply to this domain.
   2. GTEXCLFL and GTREASEX are Permissible and used to indicate when a test is to be excluded from further analysis. In these cases GTREASEX should contain the reason for exclusion.

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