| Background Review Document (BRD) | Overview | Other Validation Study Documents |
| Peer Review Panel | Presentations | Recommendations and Agency Responses |
| Test Method Evaluation Report |
Recommendations and Agency Responses
On February 28, 2008, ICCVAM forwarded recommendations on the use of in vitro test methods for estimating starting doses for acute oral systemic toxicity tests. ICCVAM recommended that the in vitro basal cytotoxicity test methods tested in the joint ICCVAM/ECVAM validation study should be considered before using animals for acute oral toxicity testing, and that the methods should be used where determined appropriate. Data from the test methods should be used in a weight-of-evidence approach for determining starting doses for in vivo studies. Using these in vitro methods where appropriate is expected to reduce the number of animals required for each toxicity test. ICCVAM concluded that the in vitro test methods are not sufficiently accurate to replace animals for regulatory hazard classification purposes.
ICCVAM's recommendations are provided in the report, ICCVAM Test Method Evaluation Report: In Vitro Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Tests (NIH Publication No. 07-4519).
A Federal Register notice announced availability of the ICCVAM Test Method Evaluation Report and final Background Review Document, and transmittal of ICCVAM test method recommendations to Federal agencies (Vol. 73, No. 58, pp. 15757-15758, March 25, 2008).
The recommendations were communicated to Federal agencies in letters from Dr. Samuel H. Wilson, Acting Director, NIEHS, to each agency head. Links to these letters can be found below. Responses from the agency heads will be posted as they are received.
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Consumer Products Safety Commission (CPSC)
- Environmental Protection Agency (EPA)
- Food and Drug Administration (FDA)
- National Cancer Institute (NCI)
- National Institutes of Health (NIH)
- National Institutes of Environmental Health Sciences (NIEHS)
- Letter from Dr. Wilson to the NIEHS Record (August 25, 2008) [PDF]
- National Institute for Occupational Safety and Health (NIOSH)
- National Library of Medicine (NLM)
- Occupational Safety and Health Administration (OSHA)
- U.S. Department of Agriculture
- U.S. Department of Defense
- U.S. Department of Energy
- U.S. Department of the Interior
- U.S. Department of Transportation
