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Nonanimal Assessment Approach for Evaluating Eye Irritation Potential of Antimicrobial Cleaning Products

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Submission of an In Vitro Test Method for Assessment of the Eye Irritation Potential of Antimicrobial Cleaning Products

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Nominators: Institute for In Vitro Sciences, Inc. (IIVS)

Alternatives Testing Steering Committee
Johnson Diversey
S.C. Johnson & Son, Inc.
The Procter & Gamble Company
The Accord Group

Submission Cover Letter from IIVS, Inc. [PDF]

Background Review Document (prepared by IIVS - July 2008)

  • Main Body [PDF]
  • Annex A: Protocols [PDF]
  • Annex B: Formulations and Physicochemical Properties of Formulations [PDF]
  • Annex C: Animal Data [PDF]
  • Annex D: BCOP In Vitro Data
    • Histopathology Report [PDF]
    • Final Report: BCOP, Test Article EG [PDF]
    • Final Report: BCOP, Test Articles X and Y [PDF]
    • Final Report: BCOP, Test Article EF [PDF]
    • Final Report: BCOP, Test Articles O, K, M, C, D, S [PDF]
    • Final Report: BCOP, Test Articles AD and AB [PDF]
    • Final Report: BCOP, Test Articles AE, AC, AF [PDF]
    • Final Report: BCOP, Test Articles B, L, U, F, Q, E, T, W [PDF]
    • Final Report: BCOP, Test Articles G, V, A, I, J, P, R [PDF]
    • Final Report: BCOP, Test Articles BL, BB, BM, BP, BQ, BK [PDF]
    • Final Report: BCOP, Test Articles AQ, AR, AS, AT, AU, AW, AY [PDF]
    • Final Report: BCOP with Aerosol and Liquid Dosing, Test Article BJ [PDF]
    • Final Report: BCOP with Aerosol and Liquid Dosing, Test Articles CG and BJ [PDF]
    • Final Report: BCOP, Test Article BF [PDF]
    • Draft Report: BCOP, Test Article BR [PDF]
    • Draft Report: BCOP, Test Articles Z and AA [PDF]
    • Draft Report: BCOP, Test Articles N and F [PDF]
    • Draft Report: BCOP, Test Article BS [PDF]
    • Draft Report: BCOP with Extended Post-Exposure Histology, Test Article BS [PDF]
    • Final Report: EpiOcular, Test Articles V, J, P, T, K, R, W [PDF]
    • Final Report: EpiOcular, Test Articles AT, AU, BL, BB, BM, BK [PDF]
  • Annex E: Cytosensor In Vitro Data [PDF]
  • Annex F: ICCVAM BCOP BRD [PDF]
  • Annex G: Draft BCOP Histopathology Guidance Document
    • Section 1: Guidelines for Histopathological Evaluation of Bovine Corneas as an Endpoint of the Bovine Corneal Opacity and Permeability (BCOP) Assay [PDF]
    • Section 2: Alkaline Materials [PDF]
    • Section 3: Reactive Chemistries [PDF]
    • Section 4: Solvent Materials [PDF]
    • Section 5: Surfactant Materials [PDF]
    • Section 6: Criteria and Worksheets for Histopathology Evaluation [PDF]

Supplement to the Background Review Document (BRD): Reliability Analysis Based on Predicted EPA and GHS Hazard Categories (October 2008) [PDF]


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