LD50 and draize tests
National Consultative Committee on Animal Welfare (NCCAW) Position Statement - October 1993
Definitions
LD50 test: The LD50 test is defined as any scientific procedure in which a substance is administered to an animal to determine the concentration or dose required to kill it.
Draize test: Draize tests include any test involving the application of a material or substance to the eye of an anaesthetised animal to determine the material's or substance's irritancy to the eye.
NCCAW's Position
NCCAW considers the LD50 test and the Draize test, as defined above, are unacceptable on animal welfare grounds and not in accord with the Australian Code of Practice for the Care and use of Animals for Scientific Purposes.
NCCAW also notes that a conference on international harmonisation of tests for pharmaceutical products (Brussels, 1991) agreed that the US, European or Japanese authorities would no longer require LD50 determination. Instead, the conference recommended other tests - especially 'scientifically designed increasing-dose tolerance tests' - be used. These tests can be in accord with Australian Code of Practice requirements.
NCCAW recognises there is a continuing need for lethality testing but in some other areas, notably in:
- the development of vaccines and other therapy for lethal human and animal diseases
- in the investigation of environmental contaminants and naturally occurring toxic substances, and
- in the development of pest control agents.
NCCAW therefore recommends that the LD50 test (as defined above) may only occur if approved by institutional ethics committees, and after Ministerial approval.
[Note: The Australian Code of Practice requires that death may be used as an end-point only where 'the goals of the experiment are the prevention, alleviation, treatment of cure of a life-threatening disease or situation in human beings or animals']
NCCAW considers the classical Draize test is also unacceptable on animal welfare grounds, but accepts that the irritancy of substances designed as therapeutic substances for the eye need to be tested.
Such experiments must be approved by both institutional Animal Ethics Committees (AEECs) and the relevant state Minister.