Chemical sensitization, also referred to as chemical allergy, is a disease state induced by the human immune system in response to chemical sensitizers. Sensitized individuals that are subsequently exposed to such chemicals will suffer from disease-associated symptoms, such as itching, blistering and tissue damage in case of skin contact, and coughing, wheezing and asthma-like symptoms in case of inhalation.
It is well recognized that the route of exposure may have an impact on the observed symptoms. However, it is also becoming increasingly clear that chemical compounds may have intrinsic properties that preferentially lead to sensitization of the skin or the respiratory tract, also referred to as allergic contact dermatitis (ACD) and occupational asthma (OA), respectively. This understanding has an impact on how chemicals are safety tested and labeled for potentially hazardous effects.
In both cases, these kinds of safety assessments have historically been carried out using animal experiments. However, public opinion, concern for human environmental health and economic interests have lead to legislations within the EU that prohibits the use of animal experiments to perform safety assessments on cosmetics and any ingredients thereof, a trend that is currently spreading both globally and across market and industry segments. Thus, there is an urgent need to develop animal-free methods for assessment of chemical sensitizers. While several animal-free, so called in vitro assays for assessment of skin sensitizers have been proposed, the demand for an assay that accurately and specifically predicts and classifies chemical respiratory sensitizers remains unfulfilled.
SenzaGen AB, the beneficiary of this Horizon 2020 grant, specializes in the development of in vitro methods for assessment of immunotoxicological endpoints. Specifically, in order to meet the demand of specific and accurate assessment of chemical respiratory sensitizers, the novel assay GARDair was developed, designed as an independent application of the GARD – Genomic Allergen Rapid Detection – technology platform. Industrial implementation of the proposed methodology required substantial resources, which were granted to the beneficiary by Horizon 2020. Within the context of the herein reported project, substantial progress towards the specific objectives have been made.
As of this reporting, the project has been successfully completed. The project has generated scientific evidence of the validity and functionality of the proposed methodology, as well as novel hypotheses potentially able to fill current knowledge gaps in the field of chemical respiratory sensitization. A finalized assay has been established with standardized operating procedures, based on a technological format suitable for industrial implementation. The assay has been successfully transferred to naïve laboratories participating in an inter-laboratory ring trial, demonstrating that the method is reproducible and predictive, as compared to existing counterparts available for skin sensitization. Lastly, technical achievements have been appropriately exploited in order to maximize gain both for the beneficiary and for society.
In summary, the successful completion of this project has led to the finalization of GARDair, a novel method for assessment of chemical respiratory sensitizers. GARDair is currently offered as part of the SenzaGen product portfolio, and is readily available on the market.
