National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/iccvam-protocols

ICCVAM-Recommended Test Method Protocols


This page has links to current ICCVAM-recommended protocols for the listed methods, the ICCVAM Test Method Evaluation Reports in which the protocols were originally published, and pages on the ICCVAM website on which additional information about the evaluation of the method can be found.


Acute Systemic Toxicity

Revised Up-and-Down Procedure for Acute Oral Toxicity Testing

In Vitro Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Tests


Endocrine Disruptors

Protocols for the BG1Luc Estrogen Receptor Transactivation Assays

More information about the ICCVAM evaluation of the BG1Luc ER TA assay

Please note: Beginning in June 2016, the BG1Luc ER TA assay will be referred to as the VM7Luc ER TA assay. This reflects new information regarding the identity of the cell line used in the assay. Refer to the webpage summarizing the assay validation for more details.


Eye Corrosion and Irritation

In Vitro Test Methods for Assessing Potential to Cause Chemically Induced Eye Injuries
Please note: Some of the protocols listed below are recommended only for nonregulatory, validation, or optimization studies. Such limitations are noted on the title pages of the relevant protocols.

The most recent ICCVAM evaluation of these test methods was published in the ICCVAM Test Method Evaluation Report, NIH Document No. 10-7553, 2010
More information about the ICCVAM evaluation of in vitro ocular testing methods


Pyrogenicity

In Vitro Test Methods Proposed for Assessing Pyrogenicity of Pharmaceuticals and Other Products

Protocols were published as Appendix C to ICCVAM Test Method Evaluation Report, NIH Document No. 08-6392
More information about the ICCVAM evaluation of in vitro pyrogen testing methods

Please note: Availability of the Mono Mac 6 cell line for commercial testing purposes may be limited. See the in vitro pyrogen test method evaluation page for details.


Skin Sensitization

In Vitro Test Methods for Identifying Potential Skin Sensitizers

These methods were evaluated by the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM). In a July 2014 statement, ICCVAM concurred with EURL ECVAM that the methods can be used as part of an integrated testing strategy to identify potential skin sensitizers but emphasized that neither method should be used as a standalone method for the identification of potential skin sensitizers or to determine skin sensitization potency categories. Test guidelines describing the methods were accepted in 2015 by the Organisation for Economic Co-operation and Development (OECD).

Updated Protocol for the Murine Local Lymph Node Assay for Assessing Allergic Contact Dermatitis Hazard Potential

Nonradiolabeled Murine Local Lymph Node Assay Methods for Assessing Allergic Contact Dermatitis Hazard Potential

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