Enhancing between-facility reproducibility of the SH test as an &lt;i&gt;in vitro&lt;/i&gt; skin sensitization test by the improved test method

Imai, Noriyasu; Takeyoshi, Midori; Aizawa, Sakiko; Tsurumaki, Mika; Kurosawa, Masaharu; Toyoda, Akemi; Sugiyama, Maki; Kasahara, Kaoru; Hirota, Morihiko; Ogata, Shinichi

doi:10.2131/jts.46.235

Cited by 1 publication

(11 citation statements)

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“…Because the criteria for judging each result were changed as described above, the required number of repetitions was verified again, and we examined whether the run repetition number required to make a final judgment could be reduced and the operation efficiency improved. The data obtained in the previous study (Imai et al, 2021) were recalculated by applying the new rule and statistical process proposed above, and the maximum number of repetitions required was examined. Specifically, the prediction performance was evaluated when the maximum number of repetitions was seven and when it was five.…”

Section: Resultsmentioning

confidence: 99%

“… Note : Gray shading indicates the results of correctly predicting LLNA results. These results were taken from our previously published paper (Imai et al, 2021). For a positive judgment, the results of a paired two‐sided t ‐test had to indicate significance.…”

Section: Resultsmentioning

confidence: 99%

“…The SH test was performed according to the method of Hirota et al (2013), with some modification of the conditions according to the results of our previous study (Imai et al, 2021). THP‐1 cells maintained by subculture were cultured at 37°C for 2 h in culture medium containing one of the test chemicals.…”

Section: Methodsmentioning

confidence: 99%

“…The SH test was performed according to the method of Hirota et al (2013), with some modification of the conditions according to the results of our previous study (Imai et al, 2021 The RFI was not calculated when cell viability was less than 50%.…”

Section: Sh Test Proceduresmentioning

confidence: 99%

“…The SH test also fulfills important requirements for applicable tests: suitable biomarker, reliability, high sensitivity, simple detection procedure, short assay time, and low assay cost. Furthermore, our recent research demonstrated that the SH test can detect chemicals with a log Kow value >3.5, which is beyond the applicable domain of the h‐CLAT (Imai et al, 2021). Although the SH test is not listed in the OECD test guidelines, it is recognized as one of the test methods corresponding to KE1 in the IATA for skin sensitization (OECD, 2016b).…”

Section: Introductionmentioning

confidence: 99%

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Improved performance of the SH test as an in vitro skin sensitization test with a new predictive model and decision tree

Imai

Takeyoshi

Aizawa

et al. 2021

J of Applied Toxicology

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Demands for the elimination and replacement of animal experiments for cosmetic safety assessment have increased in recent years. Evaluation of skin sensitization, however, is a critical issue in cosmetic safety assessment. The SH test is an in vitro skin sensitization test method that evaluates protein binding of chemical substances, which is an important event in skin sensitization. We previously verified the technical transferability and between-laboratory reproducibility of the SH test, a domestic test method for which no scientific research has been conducted, and improved the protocol, but also noted some unresolved issues. Therefore, in the present study, we successfully improved the operational efficiency and clarity of the final judgment of the SH test by (i) developing a new decision-making system that can make a final judgment without statistical processing, (ii) changing the statistical method, and (iii) evaluating and determining the maximum number of repetitions necessary for optimal efficiency. The improved SH test was verified by comparing it with existing test methods already adopted by the Organization for Economic Cooperation and Development. The results of this study demonstrated excellent performance of the improved SH test, with high reproducibility, reliable predictability, and good operational efficiency. The predictive performance of the improved method does not differ significantly from that of the conventional method, although it is clearer and more efficient. Therefore, the results of the present improved method are consistent with those obtained using the conventional method, with higher efficiency.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

“…The SH test was performed according to the method of Hirota et al (2013), with some modification of the conditions according to the results of our previous study (Imai et al, 2021 The RFI was not calculated when cell viability was less than 50%.…”

Section: Sh Test Proceduresmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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