Alternative Test Methods: Validation and Regulatory Status
- Acute Aquatic Toxicity
- Acute Mammalian Oral Toxicity
- Acute Mammalian Inhalation Toxicity
- Acute Mammalian Skin Toxicity
- Biologics (non-vaccine)
- Carcinogenicity
- Chronic/Repeated Dose Toxicity
| Conventional test method | Alternative Test Method | Infor- mation Last Updated | ||||
|---|---|---|---|---|---|---|
| Name & Description | Validation Status | Regulatory Status | Effect or Potential Effect on Animal Use | |||
| Acute Mammalian Oral Toxicity | ||||||
| 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) |
April 2009 | |
| 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) |
April 2009 | ||
| 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) |
April 2009 | ||
| 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) | Reduction (part of a tiered testing strategy that results in use of fewer animals) |
April 2009 | ||
| 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) | Reduction (part of a tiered testing strategy that results in use of fewer animals) |
April 2009 | ||
List of Abbreviations
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