Alternatives to the use of animals in product testing include the elimination of redundant or needless study requirements, the replacement of animal tests with non-animal methods, and the modification of animal-based tests to both reduce the number of animals used and to minimise pain and distress.
Humane Society International (HSI) works closely with government regulators in the EU, the U.S., and internationally through the Organisation for Economic Co-operation and Development (OECD), the International Conference on Harmonisation (ICH) and the Veterinary International Cooperation on Harmonisation (VICH) to reduce reliance on animal testing and to encourage involvement in the development and use of sophisticated new non-animal test methods.
To this end, HSI Europe is actively supporting the vision of “twenty-first century toxicology” articulated by the U.S. National Research Council, which would see animal tests that are decades old, costly, slow and of dubious relevance to people replaced by ultra-modern, efficient and human-relevant non-animal methods. HSI is calling for a “big biology” project to meet this challenge, akin to the Human Genome Project of the 1990s, and are forging an international, multi-stakeholder consortium make this landmark vision a reality as quickly as possible.
In the meantime, HSI is working toward the abolition of unnecessary testing requirements from international regulatory frameworks, including the deletion of 1-year dog studies from pesticide regulations and acute lethality studies from ICH test guidelines. Other opportunities under discussion at OECD include limiting cancer tests to a single species (currently both rat and mouse studies are required), and evaluating reproductive toxicity using only one generation of offspring instead of two (which would save 1,200 animals per test).
To date, more than two-dozen alternative methods have been declared scientifically valid by the European Centre for the Validation of Alternative Methods (ECVAM) and/or its counterparts worldwide. Examples include the following:
Replacement methods
- EPISKIN, EpiDerm and SkinEthic tests for skin irritation
- EPISKIN, EpiDerm, SkinEthic and Transcutaneous Electrical Resistance tests for skin corrosion
- 3T3 neutral red uptake (3T3 NRU) test for sunlight-induced “photo”-toxicity
- In vitro micronucleus test for genetic mutations
- Colony forming unit granulocyte macrophage (CFU-GM) test for toxicity to the blood
- 5 human blood-based tests for fever-inducing “pyrogens” in intravenous drugs
- “ELISA” chemical tests to measure the potency of human tetanus and erysipelas vaccines
- Toxin binding inhibition (ToBI) test for vaccine potency
Reduction and/or refinement methods
- Upper threshold concentration step-down procedure for acute aquatic toxicity testing (up to 70 percent reduction in fish use)
- Reduced local lymph node assay for skin allergy testing (reduction of 50 percent or more relative to conventional animal tests)
- Cellular tests using human and mouse cell lines to set starting doses for acute lethality studies (up to 40 percent reduction)
- BCOP and ICE tests using the eyes of slaughtered cattle and chickens, respectively, for classifying severe eye irritants and corrosives
- Fixed dose, Acute toxic class, and Up-and-down procedures for acute mammalian toxicity (50 percent reduction relative to classical acute lethality tests)
- Mouse embryonic stem cell and whole embryo culture tests for embryotoxicity (a critical element in birth defects testing)