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Combination of in vitro Pre-Screening Test and (Q)SAR-models for identification of the induced type of sensitization by pesticide active substances and co-formulants
Project
Project code: BfR-SiP-08-1322-667
Contract period: 01.01.2016
- 31.12.2016
Purpose of research: Basic research
In the first part of the project a database analysis of in vivo animal tests is planned. The legal basis for the classification of mixtures is the Regulation (EU) No. 1272/2008 (CLP-Regulation), the regulation specifies that a preparation has to be classified, if the mixture contains a sensitizing compound in a concentration of at least 1 % (or substance-specific limit concentrations), this calculation method will be used, if there is no test for the whole mixture available. The classification with H317 indicates that the mixture has sensitizing properties. In the authorisation process of the active substance of plant protection products (PPP) and biocides the information of sensitizing properties has to be submitted. Particularly in the authorisation of plant protection products there are often OECD adopted tests for sensitizing properties of the whole preparation available (buehler-test, M & K-test, LLNA-test) and you have the information of the composition of the preparation, therefore it is possible to compare the skin sensitizing properties of the mixture with the sensitizing properties of the single substances. So it’s possible to check the applicability of the calculation method from the CLP-Regulation at least for PPPs. An analysis of in the moment authorised PPPs, which have a classification with H317 (in most cases because of a positive in-vivo test) has shown, that at about 30 % there are no sensitizing single-compouns contained or these compounds are under the classification threshold of 1 %. That means that these preparations would not have been classified without of the existing in vivo test. Here these preparations with the described discrepancy between sensitizing properties of the preparation and non-sensitizing properties of the single-compounds could be selected for further testing by in vitro test in the second project part.
In the second project part, a new and practicable Pre-Screening Test for sensitizing properties of active substances derived from biocides and pesticides should be developed. The active substances will be administrated to dendritic cells (DCs) in vitro and differentiation of T-helper polarizing DC via detection of specific cytokines and surface molecules will be measured. Thereby, the inflammatory part of an allergic response will be implemented as the MoA into the pre-screening test system. The data collected could be used as an additional data base for the endpoint Sensitization to complete epidemiologic human data. By this, a method is provided for regulatory purposes that could be combined within the AOP dermal Sensitization together with OECD standardized methods such as DEREK and KeratinoSens.
Section overview
Subjects
- Toxicology
