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| Animal tests may under- or over-estimate the human health hazards of chemicals. © istock.com |
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What kinds of chemicals are candidates for animal testing?
More than 100,000 chemicals are marketed globally each year, including plastics and related polymers, cleansers, paints, adhesives, lubricants, fuels, industrial solvents and additives, and numerous other varieties. Some are kept tightly contained in closed systems and never released into the environment, while others may be marketed in high volumes and/or used as ingredients in products to which human beings and the environment may be exposed (e.g., cosmetics and household cleaning products, plastic packaging, and gasoline).
Who are the major chemical manufacturers in Europe?
Among the largest EU chemical manufacturers are AkzoNobel, BASF, Bayer, Ciba, Dow, Du Pont, ExxonMobil, FMC, Novartis, Proctor & Gamble, Rhodia, Rohm and Haas and Shell Chemicals. Many of these companies are members of the EU-level lobby group, CEFIC (European Chemical Industry Council).
How are chemicals regulated in the EU?
In December 2006, the EU completely revised its regulatory framework for chemicals with the passage of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and restriction of CHemicals, or REACH. The REACH regulation was proposed by the European Commission as a means to harmonise what had been disparate regulatory frameworks for “new” and “existing” chemicals, and to establish minimal information requirements for substances produced or marketed in the EU in volumes of more than one metric tonne per year (approximately 30,000 substances at present). REACH also provided for the creation of an independent European Chemicals Agency (EChA) to administer the regulation.
REACH entered into force in June 2007, with implementation occurring in several distinct phases, including a start-up period for EChA, followed by three sets of statutory deadlines for chemical registration, based on annual production volume (i.e., December 2010 for substances produced/imported in volumes over 1,000 tonnes/year; December 2013 for substances at the ≥100 tonne/year level; and December 2018 for substances at the ≥10 tonne/year level).
What animal tests are carried out on chemicals?
Animal testing requirements vary according to a chemical’s annual production volume and the anticipated level of human and environmental exposure. Standard requirements for animal tests include the following:
Annual production volume ≥ 1 tonne
- Skin allergy in mice or guinea pigs
- Acute lethality via one exposure route (oral, inhalation or skin) in rodents or rabbits
- Genetic mutations in rodents (only if the results of non-animal gene mutation are positive)
Annual production volume ≥ 10 tonnes
All requirements listed above, plus:
- Eye and skin irritation in rabbits
- Acute lethality by a second exposure route in rodents or rabbits
- Further genetic toxicity studies in rodents (if triggered)
- 28 or 90 day repeated-dose general toxicity study in rodents
- Combined reproductive/developmental toxicity screening study in rodents
- Acute lethality to fish
Annual production volume ≥ 100 tonnes
All requirements listed above, plus:
- Further genetic toxicity studies (if triggered)
- 90 day to 18-24 month repeated-dose general toxicity study(ies) in rodents
- Prenatal developmental toxicity in rats
- Reproductive toxicity in two generations of rodents, if triggered
- Long-term aquatic toxicity to fish
- Aquatic bioaccumulation in fish
Annual production volume ≥ 1000 tonnes
All requirements listed above, plus:
- Prenatal developmental toxicity in rabbits
- Reproductive toxicity in two generations of rodents
- Lifetime (18-24 month) cancer study in rats and/or mice
- Long-term and/or reproductive toxicity to birds
How many animals may be used in chemical toxicity testing?
Some of the tests above consume hundreds or thousands of animals per study. In 2005, testing of industrial chemicals in the EU consumed 96,470 animals, or approximately 9.4% of all animals used in toxicological and other safety evaluations, according to European Commission statistics [PDF]. That same year, an additional 85,181 animals (8.3%) were used to study the effects of potential or actual environmental contaminants. Impact assessments have estimated that an additional 8-45 million animals may be killed in new tests to satisfy REACH information requirements for the 30,000 chemicals that fall within the scope of this regulation.
Are animal tests accurate predictors of chemical risks to people?
Not necessarily. Animal tests may under- or over-estimate the human health and/or ecological hazards of chemicals. Learn more »
What are the alternatives?
A number of in vitro and other alternative methods germane to chemical safety assessment have been endorsed as scientifically valid by the European Centre for the Validation of Alternative Methods (ECVAM) and its counterparts worldwide for toxic effects including skin and eye irritation, skin allergy, acute lethality studies in mammals and fish, genetic mutation, and toxicity to the developing embryo.
What other steps been taken to minimise animal testing under REACH?
Several measures have been built into the REACH regulation with the aim of minimising new animal testing, including the following:
- The principle of “one substance, one registration,” which compels chemical manufacturers and downstream users to form consortia and share available toxicity data
- Opportunities to adapt or waive standard information requirements under certain circumstances
- The requirement that companies submit proposals to EChA for review, public comment, and approval before commencing new animal testing for the two highest tiers of data requirements (i.e., ≥100 tonnes per annum)
- The mandate for EChA to regularly review and promptly revise REACH information requirements and the related EU test methods regulation to incorporate alternative methods as they are validated and achieve regulatory acceptance.
In addition, the European Commission, in co-operation with member states, the chemicals industry, and other stakeholders, has organised a series of REACH Implementation Projects (RIPs) to develop guidance and other practical tools for industry and authorities, and also helped to co-ordinate the Strategic Partnership on REACH Testing (SPORT) as a pilot study to “test the workability of the REACH proposal, identify solutions where problems are found, feed solutions into the decision-making process and the [RIPs] and improve understanding of REACH.”
What is Humane Society International (HSI) Europe doing to help animals used in chemicals testing?
HSI Europe has been at the forefront of lobbying efforts to ensure that all available, validated non-animal methods and testing strategies achieve regulatory acceptance in order to be fully utilised under REACH. Additionally, HSI Europe and affiliate organisations The Humane Society of the United States (HSUS) and Humane Society Legislative Fund have assumed a leading role in supporting implementation of 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.
Updated March 16, 2009
