Conventional Test Method:

Acute Oral LD50

(formerly OECD TG 401, now deleted as a test method)

Alternative Test Method:

Name & Description:

Fixed-Dose Procedure

Test compound is administered orally to single animals in a sequential manner using the fixed doses of 5, 50, 300 and 2000 mg/kg. The starting dose is typically selected based on expected toxicity (based on evidence from in vivo and in vitro data for the same chemical and for structurally related chemicals). Dosing continues until a dose causing evident toxicity is identified, when death occurs, or when no effects are seen at the highest dose.

Validation Status:

EU: Endorsed as equivalent to scientifically validated by ESAC

US: None

Regulatory Status:

OECD: TG 420 (2001)

Effect or Potential Effect on Animal Use:

Reduction
(Reduces the number of animals used per test from 25 to 5-9)

Refinement
(Does not rely on death as an endpoint)

References:
Information Last Updated:
May 2012