National Toxicology Program

Background Review Documents

• Main Body - [PDF]


• Appendix A: ECVAM Background Review Documents
1. THE HUMAN WHOLE BLOOD/IL-1 IN VITRO PYROGEN TEST: APPLICATION OF CRYOPRESERVED HUMAN WHOLE BLOOD
   whole blood test; endpoint Interleukin-1; cryopreserved blood
• Background Review Document (BRD) [PDF]


• Standard Operating Procedure (SOP) [PDF]


2. AN ALTERNATIVE IN VITRO PYROGEN TEST USING THE HUMAN MONOCYTOID CELL LINE MONO MAC-6 (MM6)
   monocytoid cell line; endpoint Interleukin-6
• Background Review Document (BRD) [PDF]


• Standard Operating Procedure (SOP) [PDF]


• Standard Operating Procedure for the Validation Phase (SOP) [PDF]


3. THE HUMAN PBMC/IL-6 IN VITRO PYROGEN TEST
   peripheral blood mononuclear cells; endpoint Interleukin-6
• Background Review Document (BRD) [PDF]


• Standard Operating Procedure (SOP) [PDF]


• Standard Operating Procedure for the Validation Phase (SOP) [PDF]


4. THE HUMAN WHOLE BLOOD/IL-1 IN VITRO PYROGEN TEST
   whole blood test; endpoint Interleukin-1; fresh blood
• Background Review Document (BRD) [PDF]


• Standard Operating Procedure (SOP) [PDF]


• Standard Operating Procedure for the Validation Phase (SOP) [PDF]


5. THE HUMAN WHOLE BLOOD/IL-6 IN VITRO PYROGEN TEST
   whole blood test; endpoint Interleukin-6; fresh blood
• Background Review Document (BRD) [PDF]


• Standard Operating Procedure (SOP) [PDF]


• Appendix B: ECVAM Response to the ICCVAM-PWG Questions [PDF]


• Additional Information
  • ESAC Statement on the Validity of In Vitro Pyrogen Tests [PDF]
  • Press Release: "Fewer Tests on Animals and Safer Drugs: New EU Tests Save 200,000 Rabbits per Year" [PDF]