LD50 and lethality testing
Page revised: August 2017
LD50 tests Under the Animal Research Act 1985 an LD50 test (Lethal Dose 50 test) is defined as “the animal research procedure in which any material or substance is administered to animals for the purpose of determining the concentration or dose of the material or substance which will achieve any predetermined death rate.”
The Act (Section 26) prohibits the carrying out of LD50 tests for the purpose of product testing, except with the concurrence of the Minister for Primary Industries on the recommendation of the Animal Research Review Panel.
In addition to Ministerial concurrence, there must also be approval to carry any LD50 tests by the relevant Animal Ethics Committee.
Application for Ministerial concurrence is via Form P.
Under the Animal Research Act 1985 a Draize test is defined as “the animal research procedure involving the application of any material or substance to the eye of an animal for the purpose of determining the irritancy of that material or substance to the eye.”
The Act (Section 26) prohibits the carrying out of Draize tests unless carried out for the sole purpose of establishing that prophylactic or therapeutic eye medications are not irritant to the eye.
Lethality testsUnder the Animal Research Act 1985 (section 56A) a lethality test is defined as “an animal research procedure in which any material or substance is administered to animals for the purpose of determining whether any animals will die or how many animals will die.”
Lethality testing includes LD50 testing (as defined in the Act) but is not confined to this. It includes any procedure where substances are given to animals to test whether any animals will die or to measure how many animals will die.
Accredited Animal Research Establishments must keep records of any lethality tests approved by their Animal Ethics Committees and supply those records to the Animal Research Review Panel on an annual basis. The Panel may make public any of the information provided other than the name of the Accredited Animal Research Establishment. Information on lethality testing is published with the annual statistics on animal use.
The information to be recorded for each approved lethality test includes:
- the species of animals
- the number of animals
- the type of procedure
- the justification for the approval by the Animal Ethics Committee
- any modifications or alternatives being developed to reduce or replace the need to carry out the lethality test.
The records of lethality tests must be kept by the establishment for seven years.
The Lethality Testing Report Form may be found as part of Form L Animal Use Statistics.