Safety and regulatory assessment of heat-killed Lactiplantibacillus plantarum strain L-137 (HK L-137) as a food ingredient
Bibliographic record
Abstract
The safety of heat-killed Lactiplantibacillus plantarum strain L-137 (HK L-137) was evaluated in a 28-day dose range finding study and a 90-day study in Crl:CD (SD) rats administered a formulation containing 20 % HK L-137 and 80 % dextrin (LP20) at dose levels of 0, 1,000, 2000 and 3000 mg/kg bw/day by gavage. No death or moribundity occurred in any animal in any group and no effects were reported in terms of bodyweight gain or food consumption at each of the dose levels. In the 90-day study, no treatment-related adverse effects were recorded in each dose group for the functional observation battery, spontaneous activity movement or ophthalmological measurements, hematology, clinical chemistry, thyroid stimulating hormone, triiodothyronine, urinalysis, vaginal smears, gross pathology, organ weights or histopathology. While several statistically significant changes were identified including male thyroxine levels, these were shown not to be dose-dependent, were of low magnitude, with the majority of changes found to be within historical control values. As there were no histological correlates, these changes were considered incidental without toxicologic significance and not attributable to HK L-137. The NOEL for LP20 in the 90-day toxicity study was therefore considered 3000 mg/kg bw/day or 600 mg/kg bw/day for HK L-137 in both males and females for food use.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
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.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
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".