OECD GUIDELINE FOR THE TESTING OF CHEMICALS
Key Event-Based Test Guideline for in chemico skin sensitisation assays addressing the Adverse Outcome Pathway Key Event on Covalent Binding to Proteins
INTRODUCTION
Covalent binding to proteins Key Event based Test Guideline.
Background and principles of the test methods included in the Key Event based Test Guideline
ANNEX - DEFINITIONS
APPENDIX I
INITIAL CONSIDERATIONS, APPLICABILITY AND LIMITATIONS
PRINCIPLE OF THE TEST
PROCEDURE
Preparation of the cysteine or lysine-containing peptides
Preparation of the test chemical
Preparation of the positive control, reference controls and coelution controls
Incubation of the test chemical with the cysteine and lysine peptide solutions
Preparation of the HPLC standard calibration curve
HPLC preparation and analysis
DATA AND REPORTING
Data evaluation
Acceptance criteria
Prediction model
Test report
APPENDIX I, ANNEX 1
APPENDIX I, ANNEX 2
APPENDIX I, ANNEX 3
APPENDIX II
INITIAL CONSIDERATIONS, APPLICABILITY AND LIMITATIONS
PRINCIPLE OF THE TEST
PROCEDURE
Quality of NAC and NAL
Preparation of the NAC and NAL stock solution
Preparation of the test chemical solution
Preparation of the positive control, reference controls and co-elution controls
Incubation of the test chemical with the NAC and NAL solutions
HPLC preparation and analysis
DATA AND REPORTING
Data evaluation
Acceptance criteria
Prediction model
Test report
APPENDIX II, ANNEX 1
APPENDIX II, ANNEX 2
APPENDIX II, ANNEX 3
APPENDIX III
INITIAL CONSIDERATIONS, APPLICABILITY AND LIMITATIONS
PRINCIPLE OF THE TEST
PROCEDURE
Preparation of the cysteine-peptide
Preparation of the test chemical
Preparation of controls
Incubation of the test chemical with the cysteine peptide solution
Fluorescence measurement
DATA AND REPORTING
Data evaluation
Acceptance criteria
Prediction model
Test report
APPENDIX III, ANNEX 1
APPENDIX III, ANNEX 2