Acute Mammalian Oral Toxicity

Conventional
test method

Alternative Test Method

Last Reviewed
Name & Description Validation Status Regulatory Status Effect or Potential Effect on Animal Use
Acute Oral LD50
(formerly OECD TG 401, now deleted as a test method)
Fixed-Dose Procedure
Description and references
EU: Endorsed as equivalent to scientifically validated by ESAC

US: None

OECD: TG 420 (2001) Reduction
(Reduces the number of animals used per test from 25 to 5-9)
Refinement
(Does not rely on death as an endpoint)
May 2012
Acute Toxic Class Method
Description and references
EU: Endorsed as equivalent to scientifically validated by ESAC

US: none

OECD: TG 423 (2001) Reduction
(Reduces the number of animals used per test from 25 to 5-9)
May 2012
Up-and-Down Procedure
Description and references
EU: Endorsed as equivalent to scientifically validated by ESAC (2006)

US: Endorsed as valid by ICCVAM

OECD: TG 425 (2008) Reduction
(Reduces the number of animals used per test from 25 to 5-9)
May 2012
Neutral Red Uptake (NRU) test with human cells (normal human epidermal keratinocytes (NHK))
(NHK NRU assay)
Description and references
US: Endorsed as valid by ICCVAM for the purpose of determining starting doses for in vivo acute oral toxicity tests (2006) US: Recommended by ICCVAM to regulatory agencies for approval (2008)

OECD: GD 129 (2010)
Reduction
(part of a tiered testing strategy that results in use of fewer animals)
May 2012
Neutral Red Uptake (NRU) test with rodent cells (mouse 3T3 fibroblasts)
(3T3 NRU assay)
Description and references
US: Endorsed as valid by ICCVAM for the purpose of determining starting doses for in vivo acute oral toxicity tests (2006) US: Recommended by ICCVAM to regulatory agencies for approval (2008)

OECD: GD 129 (2010)
Reduction
(part of a tiered testing strategy that results in use of fewer animals)
May 2012

 

List of Abbreviations

Test Methods Categories

Toxicity
Dermal Tests
Vaccines