API TR 411 : 1996
API TR 411 : 1996
CHINESE HAMSTER OVARY (CHO)/HGPRT MUTATION ASSAY OF TERTIARY AMYL METHYL ETHER (TAME)
American Petroleum Institute
CHINESE HAMSTER OVARY (CHO)/HGPRT MUTATION ASSAY OF TERTIARY AMYL METHYL ETHER (TAME)
American Petroleum Institute
Laboratory Title Page
Laboratory Signature Page
Laboratory QA Statement
Laboratory Compliance Statement
SUMMARY
INTRODUCTION
MATERIALS AND METHODS
CHARACTERIZATION OF TEST AND CONTROL ARTICLES
TEST SYSTEM
METABOLIC ACTIVATION SYSTEM
SOLUBILITY TEST
PRELIMINARY TOXICITY ASSAY
MUTAGENESIS ASSAY
TREATMENT OF THE TARGET CELLS
EVALUATION OF CYTOTOXICITY
EXPRESSION OF THE MUTANT PHENOTYPE
SELECTION OF THE MUTANT PHENOTYPE
EVALUATION OF TEST RESULTS
CRITERIA FOA A VALID TEST
ARCHIVES
RESULTS AND CONCLUSIONS
SOLUBILITY TEST
PRELIMINARY TOXICITY ASSAY
MUTAGENESIS ASSAY
CONCLUSION
REFERENCES
Table 1: Preliminary Toxicity Assay
Table 2: Concurrent Cytotoxicity Assay
Table 3: Non-activated (-S9) Study
Table 4: Activated (+S9) Study
Appendix A: Historical Control Data
Appendix B: Study Protocol
Describes a study conducted to evaluate the mutagenic potential of the test article, tertiary amyl methyl ether (TAME) based on quantitation of forward mutations at the hypoxanthine-guanine phosphoribosyl transferase (HGPRT) locus of Chinese hamster ovary (CHO) cells. Under the conditions of this study, TAME was concluded to be negative in the CHO/HGPRT Mutation Assay.
Document Type | Standard |
Status | Current |
Publisher | American Petroleum Institute |