국내개발 Spectro-DPRA 시험 검증연구를 위한 숙련도평가 물질 선정
Proficiency Test Chemical Selections for Validation Study of Newly developed Spectro-DPRA
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초록
This study was conducted to select appropriate proficiency test chemicals for the validation study of the Spectro-DPRA test method developed in Korea. Spectro-DPRA, which improved the DPRA (Direct Peptide Reactive Assay) listed in the OECD guideline for skin sensitization evaluation, was conducted a preliminary validation study, and based on the results 10 proficiency test chemicals were recommended. In proficiency evaluation at each participating lab, several chemicals showed unsuitable results as proficiency evaluation, so additional test was needed to reselect alternative chemicals using other 5 test chemicals (Benzoyl peroxide, p-Benzoquinone, Metol, Hydroquinone, Glyoxal solution). As a result of 5 candidate chemicals, the Glyoxal solution with small variation between labs was selected as an alternative chemical, excluding three (Hydroquinone, Metol, p-Benzoquinone) with discoloration and one (Benzoyl peroxide) with a large variance in lysine peptide depletion rate. When proficiency tests were re-conducted, all four participating labs matched the DPRA predictive capacity for 10 test chemicals, and the range of peptide depletion rates also coincided with more than 80%, which indicating that proficiency chemicals were well selected for future validation studies.
Abstract
This study was conducted to select appropriate proficiency test chemicals for the validation study of the Spectro-DPRA test method developed in Korea. Spectro-DPRA, which improved the DPRA (Direct Peptide Reactive Assay) listed in the OECD guideline for skin sensitization evaluation, was conducted a preliminary validation study, and based on the results 10 proficiency test chemicals were recommended. In proficiency evaluation at each participating lab, several chemicals showed unsuitable results as proficiency evaluation, so additional test was needed to reselect alternative chemicals using other 5 test chemicals (Benzoyl peroxide, p-Benzoquinone, Metol, Hydroquinone, Glyoxal solution). As a result of 5 candidate chemicals, the Glyoxal solution with small variation between labs was selected as an alternative chemical, excluding three (Hydroquinone, Metol, p-Benzoquinone) with discoloration and one (Benzoyl peroxide) with a large variance in lysine peptide depletion rate. When proficiency tests were re-conducted, all four participating labs matched the DPRA predictive capacity for 10 test chemicals, and the range of peptide depletion rates also coincided with more than 80%, which indicating that proficiency chemicals were well selected for future validation studies.
참고문헌 (12)
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