ArticleNAM journal2025
Development of a tool for measuring uncertainty of acute cytotoxicity results using the methodology of OECD Guidance Document 129.
Article in NAM journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Despite the use of strict acceptance criteria in validated methods for in vitro toxicology safety non-animal methods, the evaluation of statistical uncertainties in the results and their impact on the reproducibility and reliability of these methods is limited. Technical and operational variations in intra- and inter-laboratory settings can interfere with the results, and measurement uncertainty estimations are crucial for a better understanding of the potential sources of errors and ensuring that the assays are under control. The measurement uncertainty characterizes the dispersion of values, which can be attributed to the measurement results. This study applied the Monte Carlo statistical model to calculate the measurement uncertainty for the half-maximal inhibitory concentration (IC50) of sodium dodecyl sulfate (SDS) using OECD Guidance Document 129. We focused on acute oral cytotoxicity in vitro and developed a specific tool for this purpose. The Monte Carlo method enabled the identification of the contributions to the measurement uncertainty of IC50 and their confidence intervals for the in vitro cytotoxicity assay recommended by OECD GD 129. Furthermore, the statistical tool developed in this study, although specifically applied to OECD GD 129, has the potential to be adapted and extended to other in vitro toxicological assays based on dose-response curves, thus supporting broader applications in New Approach Methodologies (NAMs) by enhancing reproducibility and confidence in alternative methods validation processes. In conclusion, this study demonstrates the effectiveness of the Monte Carlo statistical model in quantifying the measurement uncertainty of sodium dodecyl sulfate (SDS) IC50 values, with a comprehensive analysis yielding a combined IC50 of 34.6 μg/mL with a combined uncertainty of 1.21 μg/mL. These findings highlight the importance of incorporating metrological evaluations to increase the reliability of in vitro methods. By enabling more informed decision-making, this study can significantly contribute to the advancement of toxicological research and NAMs.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.