National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/41456

Short Time Exposure Test

The short time exposure (STE) test (Takahashi et al 2008) is an in vitro test proposed for identifying eye injury hazard potential. In this test, substances are applied to cultured rabbit corneal epithelial cells and the viability of the cells is assessed to measure eye injury hazard potential.

In 2013, NICEATM prepared a summary review document (SRD) on the STE test based on data provided by the test method sponsor, Kao Corporation. The NICEATM review compared data from the STE test to in vivo test data to evaluate the usefulness and limitations of the STE as a screening tool to identify

  • Substances that can cause severe or permanent eye injuries (“top-down” screen)
  • Substances that do not require hazard labeling (“bottom-up” screen)

NTP provided the SRD to four external reviewers, who concluded that the database of compounds tested for the evaluation was generally sufficient and the review was thorough. The final SRD includes a summary of reviewer comments.

Kao Corporation included the final SRD in a test submission package to the Organisation for Economic Co-operation and Development (OECD) for consideration as an in vitro alternative to current eye hazard identification tests in 2014. Test Guideline 491 for the STE was formally adopted by the OECD in July 2015: view on OECD website.

NICEATM Summary Review Document (June 2013)

Supplements to the Summary Review Document

Supplement A: Kao Corporation Background Review Document and Appendices

  • Supplement A1: Kao Corporation Background Review Document (BRD)
  • Supplement A2: Short Time Exposure Test Protocol
  • Supplement A3:
    • Chemical Classes of Substances Tested in the STE Test (BRD Appendix B1: Tab 1)
    • In Vivo Data Source of Substances Tested in the STE Test (BRD Appendix B2: Tab 2)
    • Solubility of Substances Tested in the STE Test (BRD Appendix B3: Tab 3)
    • Skin Corrosivity/Irritation of Substances Tested in the STE Test (BRD Appendix B4: Tab 4)
    • MTT Reduction of Substances Tested in the STE Test (BRD Appendix B5: Tab 5)
  • Supplements A4 and A5:
    • In Vitro Data for Substances Tested in the STE Test Sorted by Reference (BRD Appendix C1: Tab 1)
    • In Vitro Data for Substances Tested in the STE Test Sorted by Substance Name (BRD Appendix C2: Tab 2)
    • Comparison of In Vivo and In Vitro Ocular Irritancy Classifications Sorted by Reference (BRD Appendix D1: Tab 3)
    • Comparison of In Vivo and In Vitro Ocular Irritancy Classifications Sorted by Substance Name (BRD Appendix D2: Tab 4)
  • Supplement A6: Intralaboratory CV Analysis of STE by Study
  • Supplements A7 and A8:
    • In Vitro Data for Substances Tested in the STE Test Sorted by Reference (BRD Appendix F1: Tab 1)
    • In Vitro Data for Substances Tested in the STE Test Sorted by Substance Name (BRD Appendix F2: Tab 2)
    • Comparison of In Vivo and In Vitro Ocular Irritancy Classifications Sorted by Reference (BRD Appendix G1: Tab 3)
    • Comparison of In Vivo and In Vitro Ocular Irritancy Classifications Sorted by Substance Name (BRD Appendix G2: Tab 4)
  • Supplement A9: EpiOcular Assay Protocol
  • Supplement A10:In Vitro Data for Substances Tested in the EpiOcular Test

Supplement B: Comparison of In Vivo and In Vitro Ocular Irritancy Classification

NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.