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Record W4409907075 · doi:10.1016/j.yrtph.2025.105835

HESI GTTC ring trial: Concordance between Ames and rodent carcinogenicity outcomes for N-nitrosamines (NAs) with rat and hamster metabolic conditions

2025· article· en· W4409907075 on OpenAlexaff
Joel P. Bercu, Alejandra Trejo‐Martin, Connie L. Chen, Maik Schuler, Jennifer Cheung, Tetyana Cheairs, Anthony M. Lynch, D. Thomas, Andreas Czich, Aisar Atrakchi, Timothy J. McGovern, Robert H. Heflich, Alisa Vespa, Roland Froetschl, Yi Yan Yang, Raj D. Gandhi, Joanne Elloway, Verena Ziegler, Michelle Schaefer, Rachael E. Tennant, Walter M.A. Westerink, Robert A. Jolly, Jessica Noteboom, Pavan Gollapudi, Zhanna Sobol, Katerine K McGettigan, Joel S Christensen, Stéphanie Simon, J Dieckhoff, Andreas Zeller, C Marchand, Kerstin Waese, Michelle E. Bishop, Penny Leavitt, Victoria V. Hargreaves, Connor Glick, Yang Liao, Rosalie K. Elespuru, Raechel Puglisi

Bibliographic record

VenueRegulatory Toxicology and Pharmacology · 2025
Typearticle
Languageen
FieldBiochemistry, Genetics and Molecular Biology
TopicGlutathione Transferases and Polymorphisms
Canadian institutionsHealth Canada
FundersHealth and Environmental Sciences InstituteU.S. Food and Drug AdministrationGilead SciencesU.S. Department of Health and Human Services
KeywordsConcordanceCarcinogenHamsterRodentToxicologyRing (chemistry)BiologyPharmacologyChemistryMedicineGeneticsInternal medicineOrganic chemistry

Abstract

fetched live from OpenAlex

A multi-sector study (i.e., Ring Trial) was designed to improve the in vitro detection of N -nitrosamine (NA)-associated mutagenicity by optimizing the bacterial reverse mutation (i.e., Ames) assay protocol and testing various conditions on the sensitivity and specificity for the prediction of rodent carcinogenicity. A total of 29 NAs and 3 N -nitroso drug-like compounds from different structural classes and carcinogenicity outcomes were tested (two independent laboratories per compound) across 5 bacterial strains using a 30-min pre-incubation protocol. To evaluate the impact of different metabolic activating systems (MASs), testing conditions included the use of 10 or 30 % liver S9 fractions prepared from rats or hamsters pretreated with inducers of enzymatic activity. Results indicate that E. coli and Salmonella typhimurium strains detecting single base pair mutations, coupled with MASs containing 30 % hamster S9s were the most sensitive (90 %) for identifying NAs that are rodent carcinogens. Regarding MAS combinations, the highest sensitivity was 30 % rat and 30 % hamster (93 %), but has low specificity (45 %), with good laboratory agreement for the Ames calls (91 %). DMSO and water were considered suitable solvents, except for small-molecular weight alkyl NAs. These results will support harmonized Ames testing of NAs, giving high confidence for a negative result. • 30 % hamster S9 had the highest sensitivity of all individual MASs. • 30 % S9 (rat or hamster) had a higher sensitivity than 10 % S9 (rat or hamster). • -S9 and 30 % rat and hamster S9 had high sensitivity (93 %) but low specificity (45 %). • Specificity was similar amongst S9 species or concentration. • DMSO and water were suitable solvents for NA Ames testing.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.000
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Bench or experimental · Consensus signal: Bench or experimental
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.212
Threshold uncertainty score0.815

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0000.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.000
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.015
GPT teacher head0.304
Teacher spread0.289 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designBench or experimental
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations13
Published2025
Admission routes1
Has abstractyes

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