Non-Animal based Safety Assessment Methodologies in support of R&D and final Product Placement

Non-Animal based Safety Assessment Methodologies in support of R&D and final Product Placement

Traditionally, the toxicological hazards of chemical substances have been identified and assessed on the basis of experimental studies in animals and, to some extent, from reports following human use. Fuelled by a combination of societal expectations, political pressure and economic considerations, there is now an increased demand for reducing animal testing in chemical safety assessment. Regulatory-wise, this demand already manifested itself in the complete animal testing ban, as stipulated in the new EU Cosmetics Regulation or the promotion of the 3R (Reduce, Refine, Replace) concept in the EU Chemicals Regulation REACH. In response, an enormous amount of public or industry funding has been invested and collaborations have been established world-wide to address the chemical safety assessment needs without or with limited use of experimental animals.

We have to be realistic – there won’t be a single ‘alternative method’ providing all the information required to assure the safety of a chemical. Non-animal based safety assessment of chemicals in the 21st century will utilize the increasing power of computational chemistry in combination with advanced systems biology, high through-put in vitro screening and ‘omic’ technologies to predict the toxic potential and prioritize chemicals with respect to the need for further toxicological evaluation. Computational toxicology approaches such as grouping, read-across, (Q)SAR ((quantitative) structure-activity relationships), thresholds of toxicological concern (TTC), physiologically-based pharmacokinetic modelling and in vitro to in vivo extrapolation are being used, further developed and, in some cases, in the process of being validated.

While it must be recognized that current non-animal approaches are not yet suitable to fully replace animal testing for all newly developed chemicals, existing predictive non-animal based tools already offer substantial opportunities for businesses to understand the toxicity of new chemicals in development, thereby decreasing business uncertainties. These tools allow for example the prioritarisation of candidate chemicals within a group of ‘lead actives’ for further R&D qualification and investment at low cost within a short period of time (compared to traditional toxicology testing). Moreover, these tools support business decisions by early identification of remaining data gaps and costs related to further toxicology testing required across entire chemical portfolio (e.g., in context of REACH phase III registrations).

In my presentation ‘Non-animal based safety assessment methodologies in support of R&D and final product placement’ presentation at the In-Cosmetics 2015 Regulatory Workshop, I will provide an overview of predictive approaches and how they can be used in the various steps of product development, and , in safety support of products to be placed on the market. While the focus will be on presenting a transparent and reproducible SAR/analogue-based hazard assessment approach, an overview will also be provided on how remaining data gaps or uncertainties can be supplemented with additional non-animal based testing.

Dr. Thomas Petry is speaking at the Novel strategies towards regulatory compliance after Regulation (EC) 1223/2009 was set in motion workshop at in-cosmetics on Tuesday 14 April 2015, 09:00 – 13:00 Workshop Room CC5.3

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