Alternative Test Methods: Validation and Regulatory Status

Conventional test method Alternative Test Method Infor- mation Last Updated
Name & Description Validation Status Regulatory Status Effect or Potential Effect on Animal Use
Carcinogenicity
Long-Term (2 year) Rodent Carcinogenicity Bioassay
(OECD TG  451)

AND
Chronic Toxicity Studies
(OECD TG 452)
Combined Chronic Toxicity/Carcinogenicity Study
Description and references

No information

OECD: TG 453
(1981)

OECD: Draft revision of TG 453 (2008)

Reduction
(Additional test groups and lengths of exposure are required, perhaps limiting the reduction gains of combining protocols)

April 2009
Long-Term (2 year) Rodent Carcinogenicity Bioassay
(OECD TG 451)

Cell Transformation Assays
Description and references

EU: ECVAM is currently conducting validation studies on SHE and Balb/3T3 cell transformation assays in collaboration with US and Japanese labs.

OECD: Draft new test guidelines proposed for SHE assay and Balb/3T3 assay

EU:  Method B.21

Replacement

OR

Reduction
(if part of a  tiered testing strategy that results in use of fewer animals)

April 2009

List of Abbreviations