Toxicological Research

Korean Society of Toxicology & Korea Environmental Mutagen Society (한국독성학회)
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Pre-validation study of spectrophotometric direct peptide reactivity assay (Spectro-DPRA) as a modified in chemico skin sensitization test method

  • Seo, Jung-Ah (Department of Public Health, Keimyung University) ;
  • Cho, Sun-A (Safety and Microbiology Lab, Amorepacific Corporation R&D Center) ;
  • Park, Chang Eon (Korea Testing and Research Institute) ;
  • Seo, Dong Hyuk (Korea Conformity Laboratories) ;
  • Choi, Myungsuk (Department of Public Health Science, Korea University) ;
  • An, Susun (Safety and Microbiology Lab, Amorepacific Corporation R&D Center) ;
  • Kim, Bae-Hwan (Department of Public Health, Keimyung University)
  • Received : 2021.12.29
  • Accepted : 2022.03.14
  • Published : 2022.10.15
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Abstract

Skin sensitization is induced when certain chemicals bind to skin proteins. Direct peptide reactivity assay (DPRA) has been adopted by the OECD as an alternative method to evaluate skin sensitization by assessing a substance's reaction to two model peptides. A modified spectrophotometric method, Spectro-DPRA, can evaluate skin sensitization, in a high throughput fashion, to obviate some limitations of DPRA. Pre-validation studies for Spectro-DPRA were conducted to determine transferability and proficiency, within- and between-laboratory reproducibility, and predictive ability based on GLP principles at three laboratories (AP, KTR, and KCL). All laboratories confirmed high (>90%) concordance for evaluating the sensitivity induced by ten chemical substances. The concordance among the three tests performed by each laboratory was 90% for AP, 100% for KTR, and 100% for KCL. The mean accuracy of the laboratories was 93.3% [compared to the standard operating procedure (SOP)]. The reproducibility among the three laboratories was as high as 86.7%; the accuracy was 86.7% for AP, 100% for KTR, and 86.7% for KCL (compared to the SOP). An additional 54 substances were assessed in 3 separate labs to verify the prediction rate. Based on the result, 29 out of 33 substances were classified as sensitizers, and 19 out of 21 identified as non-sensitizers; the corresponding sensitivity, specificity, and accuracy values were 87.9%, 90.5%, and 88.9%, respectively. These findings indicate that the Spectro-DPRA can address the molecular initiating event with improved predictability and reproducibility, while saving time and cost compared to DPRA or ADRA.

Keywords

Acknowledgement

This research was supported by grants (19182MFDS495 and 21182MFDS339) from the Ministry of Food and Drug Safety, Republic of Korea.

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