SaferWorldbyDesign Risk Assessment Toxicological profile

Understand the toxicological profile Risk Assessment

CAAT-Europe can assist customers in meeting regulatory requirements including REACH, cosmetics, pesticides and biocides.

Our approach starts from the definition of the best strategy to fulfil the regulatory needs with the possibility of applying New Approach Methods (NAMs) with the advantage of using a procedure that can be defined as holistic, modern and ethically acceptable. Each potential project is studied carefully with tailored solutions to reduce the costs without reducing the scientific robustness.

Our service can be applied for the definition of the hazard of mixtures, to understand the toxicological profile of research products or for the justification of a Read Across approach.

Any organisation interested in the toxicological profile of substances can have benefit from our expertise on the use of new advanced methods.

Alternative strategies offer the only possible tool for risk assessment of new cosmetic products or their ingredients, as the cosmetic regulation bans any new in vivo tests for cosmetic purposes.

Chemical companies need to define the classification of mixtures, when the results derived from single ingredients may have a high level of uncertainty. This includes any type of product, whether it involves a biocide, a pesticide or any other chemical.

During the research phase of new products, the identification of possible concerns can help in saving resources. This approach is also very useful in the identification of the best substance among a list of candidates.

The launch on the market of a new product has a higher successful rate if it is supported by the demonstration of its safety through advanced models. The use of NAMs can provide marketing appeal to consumers: it involves an ethical, innovative and trustful approach.

Services offered

Assistance in the compliance of regulatory requirements for the elucidation of the toxicological profile of substances and mixtures. This activity may include:

  • New tests and strategies for CLP purposes, including classification of mixtures
  • Preparation of read across (RAx) justification reports, including strategy for new tests to support the RAx hypothesis
  • Development of a strategy for the characterization of toxicological properties of new products
  • Scouting of less toxic products during the analysis of alternative substances, in the scope of replacing substances of very high concern (SVHCs)
  • Elucidation of toxicological properties that are not directly addressed by regulatory requirements, deriving from specific concern or specific applications
  • Evaluation of a testing strategy to complement old in vivo studies for reproductive toxicity, missing important information on endocrine disruptor activity or DNT assessment.
  • Characterization of new materials, such as microplastics or nanomaterials

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References

Rovida, C., Barton-Maclaren, T., Benfenati, E., Caloni, F., Chandrasekera, C., Chesne, C., Cronin, M.T.D., De Knecht, J., Dietrich, D.R., Escher, S.E., Fitzpatrick, S., Flannery, B., Herzler, M., Hougaard Bennekou, S., Hubesch B., Kamp, H., Kisitu, J., Kleinstreuer, N., Kovarich, S., Leist, L., Maertens, A., Nugent, K., Pallocca, G., Pastor, M., Patlewicz, G., Pavan, M., Presgrave, O., Smirnova, L., Schwarz, M., Yamada, T. and Hartung, T. (2020). Internationalisation of read-across as a validated new approach method (NAM) for regulatory toxicology. ALTEX 37(4), 579-606 doi:10.14573/altex.1912181

Busquet, F., Hartung, T., Pallocca, G., Rovida, C. and Leist, M. (2020). Harnessing the power of novel animal-free test methods for the development of COVID-19 drugs and vaccines. Arch Toxicol 94, 2263–2272 https://doi.org/10.1007/s00204-020-02787-2)

Krebs, A., van Vugt-Lussenburg, B., Waldmann, T., Albrecht, W., Boei, J., Ter Braak, B., Brajnik, M., Braunbeck, T., Brecklinghaus, T., Busquet, F., Dinnyes, A., Dokler, J., Dolde, X., Exner, T. E., Fisher, C., Fluri, D., Forsby, A., Hengstler, J. G., Holzer, A. K., Janstova, Z., Jennings, P., Kisitu, J., Kobolak, J., Kumar, M., Limonciel, A., Llundqvist, J., Mihalik, B., Moritz, W., Pallocca, G., Cediel Ulloa, A.P., Pastor, M., Rovida, C., Sarkans, U., Schimming, J.P., Schmidt, B.Z., Stöber, R., Strassfeld, T., van de Water, B., Wilmes, A., van der Burg, B., Verfaillie, C.M., von Hellfeld, R., Vrieling, H., Vrijenhoek, N.G. and Leist, M. (2020). The EU-ToxRisk method documentation, data processing and chemical testing pipeline for the regulatory use of new approach methods. Archives of toxicology, 94(7), 2435–2461. https://doi.org/10.1007/s00204-020-02802-6

Busquet, F., Kleensang, A., Rovida, C., Herrmann, K., Leist, M. and Hartung, T. (2020). New European Union Statistics on Laboratory Animal Use – What Really Counts! ALTEX 37(2), 167-186

Krebs, A., Waldmann, T., Wilks, M.F., van Vugt-Lussenburg, B.M.A., van der Burg, B., Terron, A., Steger-Hartmann, T., Ruegg, J., Rovida, C., Pedersen, E., Pallocca, G., Luijten, M., Leite, S.B., Kustermann, S., Kamp, H., Hoeng, J., Hewitt, P., Herzler, M., Hengstler, J.G., Heinonen, T., Hartung, T., Hardy, B., Gantner, F., Fritsche, E., Fant, K., Ezendam, J., Exner, T., Dunkern, T., Dietrich, D.R., Coecke, S., Busquet, F., Braeuning, A., Bondarenko, O., Bennekou, S.H., Beilmann, M. and Leist, M. (2019). Template for the Description of Cell-Based Toxicological Test Methods to Allow Evaluation and Regulatory Use of the Data. ALTEX 36(4), 682-699.