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LD50 and lethality testing

The Animal Research Act 1985 (Section 26 ) prohibits:

  • LD50 tests for the purpose of product testing in animals, except with the concurrence of the Minister for Agriculture on the recommendation of the Animal Research Review Panel (ARRP)
  • Draize tests in animals unless carried out for the sole purpose of establishing that prophylactic or therapeutic eye medications are not irritant to the eye.

An LD 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.'

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 defines lethality tests and requires that specific records be kept on any lethality testing approved.

Lethality tests are defined as:

'Any 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.'

Research establishments must keep records of any lethality tests approved by an Animal Ethics Committee (AEC) and supply those records to the Animal Research Review Panel (ARRP) on an annual basis. The records must be received by 31 January for the period ending on the previous 31 December. The ARRP may make public any of the information provided other than the name of the accredited research establishment.

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
  • 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 research establishment for seven years.

For more information and application forms seeking Ministerial approval to conduct LD50 tests, contact the Animal Welfare Unit on (02) 9872 0570 or fax (02) 9871 6938.

Links to Form P and Form L

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