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Published Test Batteries and in Vitro Assays Used at Inbifo

Date: No date
Length: 16 pages
2501403692-2501403707
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snapshot_pm 2501403692-2501403707

Abstract

This scientific report from Philip Morris' overseas lab in Germany (INBIFO, which stands for "Institut Fur Biologische Forschung," or Institute for Biological Research) explains what different types of toxicity tests (assays) measure, and what assays were in use at the time at INBIFO. The paper is not dated, but the last page indicates it was produced at the earliest in 1992.

Of interest in this document are the reasons it lists on how INBIFO chooses to use one type of toxicity test over another:

From Page 4 (2501403695):

"Selection Criteria for in Vitro Toxicity Assays: 1) most informative 2) best validated 3) most helpful in a legislative context."

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Notes

Many thanks to paralegal Beth York for forwarding this document to Doc-Alert.

Quotes

Published Test Batteries and In Vitro Assays Used at Inbifo

[From Page 4 of 16, Bates No. 2501403695]:

Selection criteria for In Vitro Toxicity Assays

--most informative

--best validated

--most helpful in a legal context.

Company
Philip Morris
Author
Presumed organizational author, INBIFO
Recipient
Presumed corporate recipient, Philip Morris
Region
Germany
United States
Named Organization
Comm on Mutagenicity of Chemicals in Foo
*EPA ( use United States Environmental Protection Agency)
INBIFO, Intitut Fur Biologische Forschung (Philip Morris' secret biological research lab in Europe)
"INBIFO" stands for Institut Fur Biologische Forschung, or Institute for Biological Research. It is located in Germany. Philip Morris acquired Inbifo on June 30, 1971. Its stated mission was "quantitative biological product evaluation" by using "comprehensive toxicological and physiological testing. Major activities are listed as: product evaluation and modifications, product ingredients and ETS-related technical knowledge and smoke components. Inhalation toxicology was a key feature of Inbifo. (Derived from Bates No. 2505235055/5088)
International Agency for Research on Cancer ("IARC") (International Agency for Research on Cancer ("IRAC"))
International Agency for Research on Cancer ("IARC")
Natl Toxicology Program
World Health Organization (Concerned with global public health)
International organization concered with public health worldwide
Litigation
Stmn/Produced
Named Person
Ames
Doolittle
Fielding
Frame
Hartman
Houk
Hunt
Lafi
Lee
Mckarns
Nakayama
Parry
Rosen
Sanchez
Shopsis
Willey
Type
SPCH, SPEECH, PRESENTATION
CHAR, CHART, GRAPH, TABLE, MAPS
Subject
toxicology

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Page 1: lzu29e00
Published Test Batteries and ;In Vitro' Assays Used at INBIFO
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IN VITRO TOXI ClTY ASSAYS CYTOTOXICITY GENOTOXICITY ranking screening ranking cytotoxic genotoxic genotoxic with regard to or with regard reference nongenotoxic to reference
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3 Ieve{s of genotoxicity gene mutation DNA damage chromosomal damage activation and expression of oncogenes loss or inactivation of tumor suppressor genes ~
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Selection Criteria for In Vitro Toxicity Assays most informative best validated most helpful in a legislative context
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classes of assays cytotoxicity genotoxicity - cell viability. - gene mutation - cell proliferation - DNA damage - cell morphology - sister chromatid exchange - membrane damage - chromosome aberration - uptake or incorpora- - structural tion of precursors - numerical - metabolic effects - transformation
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Published Cytotoxicity Assays Reference Assay Neutral Red Kenacid Hen's E Test Cell Inhibition . Blue orio- antoic Protein of the Uridine Rel ease Uptake Membrane Reduci:i on Uptake BGA FRAME (1986) + (fund for the rep1 acemeni'r of animals in medi ca1 experiments) (D ® d © +v ID Shopsis et al. - O (1985) N UI 0 ~ 4N 0 + + W ~ ~ J
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Cytotoxicity Assays at INBIFO Class Assays at INBIFO Automatic Neutral Red Dye Colony LDH Mitotic Distribution Cel l Excl u- ~P~1 atin~ Re- Index o`f~le~as Counting Release Uptake sion Effi- lease in RepTica_- (a) ciency (b) tion Cycles cell viability + + + + + - - - ce11 + - + + + - + + proliferation cell morphology - - - - + - membrane - + + + - + damage uptake or in- - - - - - - N U7 corporation 0 of precursors ~ .~ 0 W metabolic effects - - - - - - 10 M, ~a future development b performed in previous INBIFO study
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Cytotoxicity Assays for Smoke Assayed Material mainstream cigarette smoke condensate 11 (a) 11 (b) sidestream cig. smoke (b) sidestream cig. gas/vapor phase (b) Assay Colony Dye LDH Lucifer Inhibition Plating Exclusion Release Yellow of Metabolic Efficiency Uptake Cooperation + + + + + Reference Wille et al. (1987)~ McKarns and Dool i tt1 e (1991) Hartman and Rosen (1983) Hunt (1986) IF (a) cigarette: 1R4F and TEST menthol, solvent: DMSO (b) cigarette: 2R1
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Published Test Batteries for Genotoxicity , Reference Ames Yeast HGPRT Mouse Sister Unscheduled Chromosome Trans- Lymphoma Chromatid DNA Aberration forma- L5178Y Exchange Synthesis tion National Toxicology p Program (NTP) World Health Organi- ® zation (WHO), 1985 Committee on Mutagen- ® icity of Chemicals in Food.Consumer Products and the Environment (COM) GENE-TOX U.S. EPA ® International Agency 0 for Research on Cancer (IARC) - - G + -- ® (+) + + ~ + + ® + + - ® (+) + (9 (+) (+) ® (+) ,~, c, 0 (D + - a -~ 0 w ~ 0 0
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Salmonella typhimurium strains TA98 TA100 TA1535 TA1537 TA1538

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