Joint poster with RIFM and IFF: In vitro Skin Sensitization Potency Prediction Performance on the RCPL list

GARD®skin Dose-Response for skin sensitizing potency assessment: Performance on the Reference Chemical Potency List (RCPL)


Presented at BTS 2024.

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Conclusion

  • This study suggests that GARDskin Dose-Response is a potent predictor of skin sensitizing potency on a continuous scale.
  • Predicted potency values are in µg/cm2 and can be used for risk assessment and to establish a maximum allowable concentration of a sensitizer in various consumer products.

Abstract

New Approach methods (NAMs) for assessment of skin sensitizing hazard and GHS potency have been adopted as OECD Test Guidelines. However, NAMs able to estimate skin sensitization potency on a continous scale, and thereby generating data for use as a point of departure (PoD) in next-generation risk assessment (NGRA) strategies, are currently lacking.

GARDskin Dose-Response (DR) is based on the validated protocols of GARDskin (OECD TG 442E). The readout of the assay is a continous potency prediction, or a No Expected Sensitization Induction Level (NESIL) value (ug/cm2).

The aim of this study was to evaluate the performance of the potency predictions from GARDskin DR using the chemicals in the Reference Chemical Potency List (RCPL) as a reference. The RCPL contains curated Potency Values (PVs) and was developed to serve as a resource for evaluating potency predictions from NAM-based approaches.

GARDskin data was generated (n=27 chemicals) and potency predictions were compared to PV values from the RCPL list. The continous potency predictions from GARDskin DR correlated well with PVs (p: 0.74), with an average misprediction of 3.7-fold from reference values. Furthermore, GARDskin DR provided a very similar potency ranking compared to the ranking based on PV values in the RCPL list (ρ: 0.69).

In conclusion, based on the results in this study, GARDskin DR was demonstrated to be a potent predictor of skin sensitizing potency, increasing the confidence in using the assay to conduct NGRA on new chemical entities, ultimately reducing the need for confirmatory human and/or animal studies.

Keywords: NAM, GARDskin Dose-Response, Sensitizing potency, Quantitative risk assessment, Point of departure

SenzaGen’s Newsletter April 2024

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