A new procedure developed by the German TÜV Rheinland Group is claimed to distinctly lower the financial burden the chemical industry is about to face as a result of the Reach chemical law reform.

At the same time, this ‘RE Tox’ technology will replace hundreds of thousands of animal tests in the future.

The procedure detects whether a substance damages cells and if it has negative effects on embryo development.

The technology speeds up analysis work many times over. For example, results which used to take eight months are now available in 21 days.

“The new procedure improves safety with regard to people and the environment and prevents animal testing. It combines these social progresses with economic sustainability, which will take some pressure off the chemical industry. In addition, RE Tox enhances the innovative strength of this key sector,” said Bruno O Braun, president and ceo of the TUV Rheinland Group.

The European validation centre for alternative methods, ECVAM, confirmed that the RE Tox procedure supplies valid results from a scientific point of view.

“We therefore demand that the responsible federal authorities lobby for the acceptance of the procedure in the Reach document,” stressed Braun..

Register

Consequently, the chemical industry can use the procedure to register chemicals. The new chemical Reach regulations address the assessment of approximately 30000 old chemicals.

More than likely, between 3000 and 6000 of these substances must be examined to check whether they have a negative effect on embryonal development. The costs for animal testing previously required for this represent a significant portion of the total costs of a registration.

Animal testing which clarifies whether a substance has negative effects on an embryo during pregnancy are among the most costly procedures within the Reach reforms.

These tests alone add up to at least E300000 to the total E1.5million cost of all of the tests required by Reach. RE Tox can greatly reduce these costs, saving the European chemical industry alone up to E600million.

As the developers note, this has very important implications for Germany in particular, where nearly half a million people are employed by the industry.

Due to the speed of the procedure, TÜV Rheinland Group says that the chemical industry also benefits from improved product development. RE Tox can be used in an early development phase as a screening procedure.

Companies avoid bad investments through early identification of possible hazardous properties in dyes and flavour additives, for example. Scientists could then eliminate these negative substance properties already in an early stage.

All in the stem cells

The RE Tox procedure is based on stem cell research. The stem cells used are from mice and their development into heart muscles is observed. This procedure was developed by Axiogenesis, a biotechnology company based in Cologne.

Together with Axiogenesis, the TÜV Rheinland Group last year founded the joint venture TÜV BioTech, which now has the rights to the RE Tox procedure. The TÜV Rheinland Group is majority owner of this company.

The technology is based on the possibility of producing different types of tissue from embryonic stem cells of mice. Axiogenesis has also succeeded in genetically changing cell lines without affecting their function.

“In a nutshell, this means that we insert genes of a deep-sea jellyfish into the stem cell of a mouse. The function of the cell is not affected by this. However, the cells derived from the stem cells later produce a fluorescent protein that illuminates green just like the deep-sea jellyfish,” explains the scientist and Axiogenesis board member Heribert Bohlen.

Fluorescent protein

With the help of the fluorescent protein, stem cell development into heart musculature is examined under the influence of chemicals. The scientists assess the function of the heart tissue by examining the protein formed.

In addition, it is possible to measure the smallest currents in the cell. These automated tests help Axiogenesis assess whether a substance causes damage to cells and if it has a negative influence on the development of an embryo.

The RE Tox procedure even shows the hazardous effects of Contergan (Thalidomide). Detection in animal testing only shows extremely limited results. This was the cause of one of the largest pharmaceutical scandals in Germany in the late 1950s.

Tests with different substances show that RE Tox can detect at least the same possibly toxic effects on unborn humans as animal testing on mice, rabbits, rats and guinea pigs.

RE Tox has an advantage over animal testing in that the results can be automatically read and reproduced. Since during animal testing it is relatively difficult to assess whether a substance affects the development of an animal or if this possible malformation is actually a natural mutation, approximately 150 to 300 animals would be necessary to analyse a single chemical for reproduction toxic properties.

Consumer protection

In addition to the chemical industry, the wholesale and retail sectors are showing an interest in the analysis procedure.

These sectors are primarily interested in being able to assess mixtures of materials, because textiles or plastics are often made of several thousands of different chemicals.

Due to the closely intertwined production sequences store chains do not know all of the manufacturers who deliver materials for their finished products.

As a result, it is almost impossible to ensure that no substances banned in Europe are found in toys, textiles or furniture.

The TÜV Rheinland Group offers so-called ‘bioeffect’ screening to its customers. Here, RE Tox is supplemented by additional procedures of embryonal stem cell technology during this screening.

The advantage of the screening is that in contrast to chemical analytics, it does not look for specific substances, but rather concentrates on the effects of a mixture of substances on an organism.

It therefore has two advantages over the previous method. The bioeffect screening is cheaper and also shows the negative effects of chemical substances that are not prohibited since their toxic properties are still unknown.

Disadvantage

The disadvantage of the chemical analyses previously available is that they only discover substances in textiles and plastics if they are explicitly searched for.

In Europe, there are approximately 1700 banned substances which are released by toys, textiles or food packaging due to sweat, saliva or fat. Comprehensive testing, especially of those type of products containing different materials, is extremely expensive to carry out.