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API TR 411 : 1996

M00007119

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API TR 411 : 1996

CHINESE HAMSTER OVARY (CHO)/HGPRT MUTATION ASSAY OF TERTIARY AMYL METHYL ETHER (TAME)

American Petroleum Institute

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Table of Contents

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

Abstract

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.

General Product Information

Document Type Standard
Status Current
Publisher American Petroleum Institute