Safety assessment

A wide range of assays is used by BDS to assess hazard profiles of chemicals and complex mixtures. Their application is in safety assessment and quality control of food, chemicals, cosmetics and pharmaceuticals, bio-based materials, water and the environment, for bioactivity profiling of clinical samples and functional foods, and any other application requiring straight forward animal-free safety assessment. These measurements are relevant to predict toxic effects like genotoxicity/carcinogenicity, endocrine disruption, reproductive toxicity, and interferences with lipid metabolism/obesogens.

Genotoxicity/carcinogenicity

Our p53 CALUX® assay detects compounds that are genotoxic by causing damage to the DNA. This assay can optionally be performed in combination with microsomal S9 fractions to detect compounds that require metabolic conversion to be active. In addition, our assay panel includes a wide range of assays involved in proliferation and differentiation steps that are relevant for non-genotoxic carcinogens, including several nuclear receptor- and dioxin-receptor pathway assays.

Endocrine disruption

Endocrine disruption has been recognized as a priority endpoint in safety evaluation of chemicals and consumer products. Endocrine disrupting compounds (EDCs) are being classified as substances of very high concern and regulations to restrict their use are being installed world-wide. EDC effects are hard to predict and are best tested using in vitro bioassays. To avoid animal studies BDS has developed a range of assays that allow screening and safety assessment of chemicals and consumer products in a rapid and cost-effective manner.

The unique CALUX® -based test panel includes

  • Assessment of interferences with estrogen-, androgen- and thyroid pathways and steroidogenesis (EATS) using robust and quantitative human CALUX reporter gene technology, and complementary assays
  • Standard operation procedures for extraction, clean-up and analysis to measure in a wide variety of products and applications
  • Used world-wide in major chemical-, pharmaceutical-, cosmetics-, food- and feed companies, and others
  • Extensively validated to demonstrate robustness and predictivity
  • Contract service or transferred to your laboratory via licensing and training

Reproductive toxicity

Reproductive toxicity, including developmental toxicity involves a large variety of possible mechanisms and endpoints. Precise predictions of these effects is challenging, also when using the golden standard cost-, animal- and labour intensive animal tests. Concordance between these regulatory animal tests in different species is known to be around 60% only, not very far away from flipping a coin. Therefore, alternatives are urgently needed.  Remarkably, when evaluated in a battery of state-of-the art relevant in vitro tests, the CALUX® high throughput battery performed equally well as the entire battery, clearly demonstrating its applicability in this important area.

Interferences with lipid metabolism/obesogens

This CALUX® panel contains assays that can measure the activity of all three members of the peroxisome proliferator activated receptors (PPARs). These are linked to beneficial health effects, but when aberrantly stimulated may also lead to adverse effects. In particular, concerns have been raised that some environmental compounds act as so-called obesogens by targeting PPARs. This opens another application area of the PPAR assays, and tests installed to further validate when possible adverse effects are found.

Other biological effects

In addition to the exemplified effect-based assays and their applications, we have a wide range of specific CALUX® assays for other major mechanistic pathways, including chemical stress-induced protective- and detoxification pathways. These are involved in a wide range of classical toxicological endpoints as assessed in animal studies, like acute toxicity and sensitisation. When overstimulated effects will become adverse, corresponding to the so-called adverse outcome pathways (AOPs).  An overview of the bioassays that are currently available is presented here. Please enquire for your specific effect class of interest.