In June 2007, the EU chemicals regulation REACH came into force. Thousands of long-existing chemicals - from turpentine to textile dyes, from machine oil to pesticides - had be tested for their toxicity by 2018, mostly in animal experiments.

Chemicals in everyday objects and in the environment pose an incalculable risk to human health indeed. However, animal testing is the wrong way to ensure people's safety from harmful substances. Only a careful evaluation of existing human data and the use of non-animal methods would result in an actual assessment of the risks to humans and the environment. The EU has missed a unique opportunity to finally end animal testing for toxicity. Doctors Against Animal Experiments had campaigned for a completely animal-free REACH-regulation for years.

What is REACH?

The chemicals regulation REACH stipulates that tens of thousands of long-existing chemicals that were launched onto the market before 1981 are to be checked for their potential risks for humans and the environment. Since 1981, new substances have been tested according to a specific pattern before they are approved for the market - consistently in animal experiments. With REACH, “old” chemicals should be brought into line with this pattern.

How does REACH work?

The chemicals are classified according to their production volume per year. Standard tests are provided for each of the four volume classes. The larger the quantity in which a substance is produced, the more data (i.e. the more extensive animal testing) is required.

From June to December 2008, companies had to pre-register their chemicals, i.e. they had to submit basic data such as name and production quantity to the European Chemicals Agency ECHA. 65,000 companies registered 150,000 chemicals. Many of these are made by more than one company. It is still unknown how many substances are actually involved and how many were registered more than once. So far, it was assumed that there were only around 30,000 substances.

At the end of the process, only one dossier should be submitted for each chemical. A significant achievement that can be traced back to the years of persistent work by the animal welfare and anti-animal-testing organizations. This means that the companies cannot simply start testing, but first have to check whether a certain chemical has already been pre-registered by other manufacturers. Companies that manufacture the same substances have to form consortiums, so-called SIEFs, in order to exchange their data. The implementation of SIEFs was also achieved by the animal welfare side against massive resistance from the industry.

If the existing data is not sufficient, companies have to submit a test proposal to ECHA. However, this only applies to chemicals that are particularly dangerous and produced in large quantities (100 tons per year and above). ECHA will post this request on its website for 45 days. Experts from organizations opposed to animal testing thus have the opportunity to check whether the required data is already available or can be obtained using test methods that do not incorporate animal experiments. This 45-day phase was included in REACH at the suggestion of the animal welfare side. At the end of the 45 days, ECHA decides whether the proposed animal tests can be conducted or not, or whether fewer or more animal tests must be carried out.

The 45-day phase is a realistic possibility to save many animal lives. With our experts, we made the best possible use of this opportunity to save as many animals as possible from an agonizing death. more >> (link zum REACH-Erfolgs-Artikel)

Animal experiments as a factor of uncertainty

REACH aims to protect people and the environment from harmful substances. Animal experiments, however, are completely unsuitable for this purpose. In the field of toxicity tests in particular, the various differences between humans and so-called laboratory animals are repeatedly revealed. What is toxic to or causes deformities in humans may be harmless to rats and vice versa. The idea that one animal species should serve as a biological model for another is absurd. Each animal species is unique in terms of anatomy, physiology, and metabolism, therefore the biological reaction to hazardous substances is species-specific, i.e. characteristic of only one species. In addition to the biological reaction, other factors such as housing, diet, constitution, etc. also play an important role, so the results of an animal experiment are not only valid for one species only, but strictly speaking only for one individual.

Scientists working in toxicology are aware that animal experiments are particularly unreliable in this field. The reason for hanging on to animal experiments is not their scientific value, but the fact that they have been established in the scientific world for decades.

Scientific test methods

People's legitimate interest in being protected from harmful chemicals cannot be addressed by more animal testing. A large amount of human data is already available on many chemicals that have been on the market for more than 20 years. This existing knowledge must first be evaluated. For more information, there is a large number of non-animal test methods available, which provide reliable results that are relevant to humans, but are also much cheaper and, above all, faster. For example, standard animal testing to determine the carcinogenic potential of a substance takes three to five years. The animal-free SHE test, on the other hand, delivers reliable results within just a few weeks.

The new, so-called In vitro systems (In vitro = in the test tube) are not yet being used because they have to be validated first. During validation, the results of the In-vitro tests are compared with the results from existing animal data in time-consuming studies. An animal-free method will only be recognized officially if the results are alike those from animal methods and will be included in the legal provisions only after further lengthy processes. In other words: The quality of new, sensible test systems is measured against an inadequate, outdated method that has never been validated itself. It is not surprising that so far only a few in vitro methods have been included in the legislation. The only exception was the 3T3-NRU test for determining phototoxicity (skin-damaging effect when exposed to sunlight). The comparisons between animal test results and data obtained from humans were so extremely poor that the non-animal test was not measured against animal experiments, as it usually would have to, but against human data.

The REACH animal experiments

In the following, some of the most common REACH animal experiments are briefly described and the possible animal-free systems are presented.

1. Eye mucosa test (Draize test)

Test: At least three rabbits per chemical get the test substance dripped directly in one eye. Inflammation or chemical burns occur. The degree of damage is determined up to 21 days later.

Animal-free methods: There are already a whole range of validated "alternative methods", some of which are not animal-free, however, such as the HET-CAM test, which uses incubated chicken eggs. An animal-free test is the commercially available "SkinEthic" test, which simulates the human cornea using a three-dimensional tissue model made from human cells.

2. Skin tolerance test

Test: At least three rabbits get a substance applied to their shaved skin. The result are swelling, inflammation, and chemical burns. After four hours, the changes on the skin are assessed.

Animal-free methods: Two methods that have already been validated work with human (Episkin) or rat (TER) skin cell cultures.

3. Skin allergy test

Test: The test substance is injected into the skin of 17 to 30 guinea pigs or applied to their shaved skin. Swelling, inflammation, and flaking of the skin occur.

Animal-free methods: Several test methods have been developed. One particularly promising test uses human skin samples. They are able to observe activities and movements of the so-called Langerhans cells, which play an important role in triggering allergies.

4. Acute toxicity

Test: About 15 to 30 rats are administered the test substance into the stomach with a gavage. If the substance is gaseous, the animals are forced to inhale it. Symptoms of poisoning occur: salivation, shortness of breath, convulsions, bleeding from eyes and noses, tremors, diarrhoea, or coma, possible leading to death. The animals are observed for 14 days and then killed if they have not already died from poisoning.

Animal-free methods: With the help of computer programs, important information about absorption in the body, metabolism, distribution in the body, and excretion can be obtained from the chemical structure of a substance. Cytotoxicity (cell toxicity) can be determined with cell cultures and the potential harmfulness of a chemical can thus be predicted. For more information, specific cell cultures from liver, kidney, heart, nerves, or vessels can be used.

5. Repeated dose toxicity

Test: 40-80 rats and/or 32 dogs are used. The test and symptoms are similar to the acute toxicity test, except that the animals are administered the substance daily for a period of 28-90 days. The surviving animals are killed.

Animal-free methods: See Acute Toxicity.

6. Mutagenic potential (mutagenicity)

Test: At least 40 rats, mice, or hamsters are administered the test substance orally or via injection into the abdominal cavity. A harmless substance is administered to a control group and a substance with known mutagenic potential is administered to a second control group. After 48 hours at the latest, the animals are killed, and their cells are examined for genetic damage.

Animal-free methods: Computer programs can identify potentially mutagenic substances. The Ames test, a method that works with bacteria, has been used successfully for many years. Genetic changes can also be detected in mammalian cell cultures.

7. Carcinogenic potential (carcinogenicity)

Test: At least 400 very young rats or mice are administered the test substance orally. Sometimes, it is also applied to their skin. The animals suffer from weight loss, lethargy, malaise, tumours and might even die. This test can take up to five years. Surviving animals are killed and examined for pathological changes in the organs.

Animal-free methods:  Many carcinogenic substances can already be identified using computer models or based on the fact that mutagenic substances are also often carcinogenic. The SHE test uses Syrian hamster embryo cells, which show abnormalities when carcinogenic chemicals are added to the cell culture. This test only takes a few weeks.

8. Chronic toxicity

Test: 160 rats and often an additional 32 dogs are used. The animals receive the test substance several times over a period of 1 to 2 years, either via a gavage directly into the stomach or by inhalation. Typical symptoms are: loss of appetite, aggression, restlessness, muscle weakness, salivation, vomiting (dogs), tremors, bloody diarrhoea, coma. The poisoning often leads to the death of the animal. At the end of the experiments, the animals are killed and examined for changes in organs and tissues.

Animal-free methods: Computer models indicate potentially toxic substances. A non-specific toxicity of chemicals can be revealed by various cell culture systems. With specific cell cultures of the liver, kidneys, nerves, and blood vessels, possible damage to these organs can be determined.

9. Malformation potentials (teratogenicity)

Test: At least 80 pregnant rats or 48 pregnant rabbits are gavaged the substance. Pregnant animals experience weight and appetite loss, nasal discharge, hair loss, diarrhoea, dehydration, and eventually die. Before giving birth, the mothers are killed in order to examine the embryos.

Animal-free methods: There are numerous In vitro methods, with three of them currently in the validation stage. One of them is the Embryo Stem Cell Test (EST), in which the addition of harmful chemicals prevents the embryo cells from developing further.

10. Reproductive toxicity

Test: 40 male rats and about 100 female rats, 80 of which are pregnant, are used. To determine what effect a chemical has on reproduction, it is administered to animals before and/or after mating. The symptoms are similar to those mentioned under "Teratogenicity".

Animal-free methods: A large number of test tube tests have already been developed. Most are based on human or animal testicular and ovarian cell cultures.

11. Toxicokinetics

Test: At least 8 rats and 8 dogs are given the substance orally, have it applied to their skin or administered by inhalation. The aim is to determine how the substance is distributed in the body, in which organs it accumulates, and how it is excreted. For this purpose, animals are killed at certain time points after administration in order to examine their organs. Symptoms are similar to those of other toxicity tests: loss of appetite, nasal discharge, hair loss, diarrhoea, dehydration, vomiting (dogs).

Animal-free methods: The metabolism of chemicals can be understood using human liver and intestinal cell cultures. Toxicokinetic models can also be displayed on the computer.

45 days to save animals

The 45-day comments period is one of the most important demands from the animal welfare side that has been included in REACH. For substances that are produced in quantities of more than 100 tons per year, companies cannot simply conduct animal tests, but must submit test proposals to the chemical’s authority ECHA in Helsinki, which is responsible for implementing REACH. ECHA posts these applications in a strongly abbreviated form on its website for 45 days. During those 45 days, experts from organizations opposed to animal testing have the opportunity to check whether the required data is already available or whether there are other reasons to not carry out the test.

Our REACH project

Working with our umbrella organization, the European Coalition to End Animal Testing (ECEAE), our experts comment on REACH testing proposals and research existing information on the chemicals in question. Most of the substances have been on the market for more than 30 years and have already been extensively tested in the past.

Our REACH project was one of the rare opportunities where we knew about planned animal testing in advance and were able to prevent it.

25^th of November 2008, edited on 25^th of July 2023
Dr. med. vet. Corina Gericke

References

G. Langley: The Way Forward, report compiled for the British Union for the Abolition of Vivisection (BUAV), 2001
Testing requirements for proposals under the EC white paper „Strategy for a future chemicals policy“, Institute for Environment and Health, July 2001