Karla continued her in vitro research with the founding of KJ Scientific and participated in the validation process of this new technology in the OECD ring trial. The ring trail was under the lead of the US and European Commission (represented by the Joint Research Centre (JRC) European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM)) and coordinated and supported by the Human and Environmental Science Institute (HESI). A ring trial, is an experimentation process involving multiple laboratories around the world to determine transferability, reliability and predictive value considering interlaboratory and intralaboratory variability for the use of technology. Our lab at KJ Scientific in collaboration with SC Johnson was one of seven environmental labs chosen to take part in this multi-year evaluation of in vitro technology.
In vitro (“in the glass” or outside the organism) testing does not need to be performed using the whole organism at once – instead utilizing cells, tissues and tissue fractions from fewer animals to test how substances interact with the environment on a cellular and molecular level. Using this method, the isolated organs, tissues or cells of one organism can be used for approximately 20 to 25 different chemicals in bioaccumulation toxicology studies. Prior to the advent of the Organisation for Economic Co-operation and Development (OECD) Test Guidelines 319A and 319B (determination of intrinsic clearance using rainbow trout cryopreserved hepatocytes and liver S9 fractions), in vitro testing was not seen as a standard for chemical testing in the regulatory community. For progress to be on the use of animals in chemical testing procedures, that would need to change.
We would be remiss not to point out that in vivo testing does have value for the chemical testing field. In instances where direct biological responses to chemicals by organisms must be determined, the results of in vivo exposure to substances can be applicable and are used to compare in vitro bioaccumulation data. However, in vivo testing is costly, takes much longer to complete and uses more living organisms. In fact, the regulatory community – especially in Europe – has been pushing for in vitro testing procedures over in vivo due to their many benefits. They yield reliable results in many environmental toxicological studies with minimum use of animals. In vitro also gives scientists the advantage of doing more experimentation under controlled conditions and considering of cellular processes that can be varied.
In vitro technology had already been in use for research purposes when KJ Scientific’s founder, Karla Johanning, became part of a consortium of scientists from Europe and the US that worked on the in vitro metabolism assay based on the knowledge we already had on mammalian systems. She had previously researched endocrine disruption – how chemicals interact with estrogen receptors – and used in vitro technology to study how drugs are metabolized for the pharmaceutical industry.
The question she and other scientists sought to answer as part of the consortium is this: can you apply the same or similar in vitro model using pharmaceuticals and human liver cells to chemicals in the environment – and fish in particular – using rainbow trout liver cells? This research significantly moved the field forward regarding how we predict bioaccumulation of chemicals in the environment.
Each of the environmental labs tested six chemicals using rainbow trout cryopreserved hepatocytes and liver S9 subcellular fractions. Both assays interact with the chemical samples in unique ways. Experimentation with hepatocytes allows you to see how the chemical substance interacts with intact cells. Experimentation with liver S9 fraction allows you to see how it interacts in an environment where there is not a cell membrane it must cross over.
The ring trial resulted in the creation of the OECD Test Guidelines 319A and 319B and a Guidance Document. Before these guidelines were in place, no regulatory authority had given direction for performing in vitro toxicology studies using trout liver cells. Now, because these methods have been standardized to such a higher degree, labs all over the world can use them in research or commercial testing of chemicals used in agriculture, oil and gas, consumer products, cosmetics, fragrances and more. With these guidelines, it has become much more common for companies and researchers to use in vitro testing. This pushes the field forward – eventually, moving beyond testing requiring whole organisms at all.
At KJ Scientific, we have exclusively implemented in vitro testing methods. We utilize rainbow trout liver cells in a variety of metabolism studies to determine bioaccumulation potential, and we will be expanding our portfolio to include other experiments using in vitro technology such as endocrine disruption and metabolite identification.
In vitro testing, in our experience, has a much more minimal effect on the environment. We use far less animals in the lab, and we have more cells available to conduct an assortment of tests. Our work leads to a much safer environment for all the organisms that live in it, including ourselves. The companies that utilize our services also feel the benefits of our testing methods. Because in vitro testing requires less animal testing, the overall cost is much lower and results are received much quicker.
The environmental labs at KJ Scientific offer innovative solutions for environmental toxicology studies that yield you reliable and cost-effective results in the timeframe you need them. We provide metabolism studies on a wide variety of chemical compounds as well as lab products to assist you in performing your own in vitro studies. Our advanced testing methods ensure the safety of human and environmental health while also reducing the need for whole animal testing.
To learn more about our products and services you’re welcome to check out our YouTube channel, and you can request a webinar with KJ Scientific today!