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National Toxicology Program

National Toxicology Program

UPDATE NewsletterUPDATE NewsletterNovember 2021

The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)

By Catherine Sprankle

NICEATM releases ICE 3.5

On October 11, NICEATM released version 3.5 of the Integrated Chemical Environment (ICE). ICE provides data and tools to help develop, assess, and interpret chemical safety tests. This release adds expanded capabilities and new data to the existing ICE resources.

ICE version 3.5 includes the following expanded capabilities:

  • New result selection options in the Chemical Quest and Curve Surfer tools.
  • Application of Saagar fingerprints (described in Sedykh et al. 2021: https://doi.org/10.1021/acs.chemrestox.0c00464) to Chemical Quest searches.
  • Ability to display AC50 plots in Search results.

In addition, updated data have been added for acute oral toxicity, cancer, and skin sensitization, and modeling tools are using updated absorption, distribution, metabolism, and excretion data.

EPA calls for nominations for Board of Scientific Counselors; due by November 12

In an October 18 Federal Register notice, the U.S. Environmental Protection Agency (EPA) called for nominations for its Board of Scientific Counselors, a federal advisory committee to the Office of Research and Development. More information and links to nomination forms are available on the EPA website. Nominations are due by November 12.

The board consists of non-EPA scientists, engineers, and economists who are experts in their respective fields. EPA will consider nominees from industry, business, public and private research institutes or organizations, academia, government (federal, state, local, and tribal) and non-government organizations, and other relevant interest areas. Nominees are sought with expertise in a variety of fields, including environmental modeling, exposure science and assessment, information and data science, NAMs, physiologically based pharmacokinetic modeling, risk assessment, and toxicology.

FDA draft guidance on carcinogenicity testing; comment by December 6

In an October 5 Federal Register notice, the U.S. Food and Drug Administration (FDA) announced draft guidance for industry, “S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals.” The draft guidance expands the testing scheme for assessing human carcinogenic risk of small molecule pharmaceuticals. It introduces an integrative approach that provides specific weight-of-evidence criteria that inform whether a 2-year rat study adds value in completing a human carcinogenicity risk assessment. The draft guidance also adds a plasma exposure ratio-based approach for setting the high dose in the rasH2-Tg mouse model.

FDA is accepting comments on the draft guidance through December 6.

NICEATM activities at ASCCT; NICEATM scientist honored

The annual meeting of the American Society for Cellular and Computational Toxicology (ASCCT) was held virtually from October 12-14. NICEATM scientists and ILS contractors supporting NICEATM presented four oral presentations and nine posters. A list of NICEATM activities at ASCCT is available on the NTP website; posters presented may also be downloaded from this page.

At the meeting, Agnes Karmaus, ILS (contractor supporting NICEATM) was recognized as the inaugural winner of the Applied In Vitro Toxicology (AIVT) award for her ASCCT presentation describing annotation and visualization of high-throughput assay data used in ICE. The AIVT award, given by the journal Applied In Vitro Toxicology, recognizes an early-career scientist whose work has made a lasting impact on the implementation of NAMs..

Recent publications

  • A new article in ALTEX co-authored by Acting NICEATM Director Nicole Kleinstreuer describes opportunities to use microphysiological systems (MPS), also known as organs-on-chips, to study brain cell infection by SARS-CoV-2 and its relevance to COVID-19 effects on the human brain.
    Kang et al. 2021. COVID-19 – prime time for microphysiological systems, as illustrated for the brain. ALTEX. https://doi.org/10.14573/altex.2110131.
  • The September issue of Applied In Vitro Toxicology focuses on integrated strategy approaches in toxicology. Integrated strategy approaches provide a means for information on chemical toxicity from several sources to be combined to provide a prediction of human risk. Acting NICEATM Director Nicole Kleinstreuer is a co-author of the introduction to the special issue.
    Eskes et al. 2021. Usefulness and applicability of integrated strategy approaches in toxicology. Appl In Vitro Toxicol. https://doi.org/10.1089/aivt.2021.0021

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The Update Newsletter is produced by NTP Office of Liaison, Policy, and Review. The text is not copyrighted and can be reprinted without permission. If you use parts of the Update Newsletter in your publication, we ask that you provide us with a copy for our records. We welcome your comments and suggestions.

Director of Office of Liaison, Policy, and Review and Editor-in-Chief: Mary Wolfe | Managing Editor: Anna Lee Mosley