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ToxRTool — Assess toxicological study reliability

A digitised, user-friendly tool inspired by the EU/JRC ToxRTool — the EU reference standard for evaluating the quality and reliability of in vivo and in vitro toxicity studies.

21
In vivo criteria
18
In vitro criteria
4
Reliability categories
About the tool

What is ToxRTool?

ToxRTool (Toxicological data Reliability assessment Tool) was developed by the European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) at the Joint Research Centre of the European Commission. It provides a structured, transparent way to evaluate the inherent quality of toxicological studies.

I
Test Substance Identification
4 criteria
II
Test System Characterisation
3–5 criteria
III
Study Design Description
6–7 criteria
IV
Study Results Documentation
3 criteria
V
Plausibility of Design & Results
2 criteria

Reference: Schneider K. et al. (2009). ToxRTool, a new tool to assess the reliability of toxicological data. Regulatory Toxicology and Pharmacology, 54(2), 162–173.

How it works

Three steps to a reliability score

Complete an assessment in minutes. Export results as Excel or PDF for your dossier.

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Select study type & enter info

Choose between an in vivo or in vitro study. Enter authors, title, facility, and your evaluator details.

⚖️

Score each criterion

Work through all criteria grouped into five logical sections. Toggle 0 or 1 per criterion. Mandatory criteria (shown in red) must be met for Categories 1 or 2.

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Review & export

The tool calculates Categories A and B automatically. Confirm your final proposal (C) and export as a fully populated Excel file or print-ready report.

Scoring system

Reliability categories

Derived from the Klimisch et al. classification, adapted by EURL ECVAM for systematic use.

Category Label In vivo score In vitro score Typical use
Cat. 1 Reliable without restrictions 18–21 pts + all ● met 15–18 pts + all ● met Key study; check relevance
Cat. 2 Reliable with restrictions 13–17 pts + all ● met 11–14 pts + all ● met Potentially useful; check relevance
Cat. 3 Not reliable <13 pts or ● not met <11 pts or ● not met Generally not as key study
Cat. 4 Not assignable Documentation insufficient (reviews, handbooks, etc.) Not for key study use

● = mandatory criterion. If any mandatory criterion scores 0, maximum assignable category is 3, regardless of total score.

Get started

Choose your study type

Both forms follow the same five criterion groups. Select the type that matches your study.

🔬

In Vivo Study

For whole-organism toxicity studies conducted in living animals or experimental human subjects. Includes criteria specific to housing conditions, animal numbers, and administration routes.

21 criteria 8 mandatory ● Max score: 21
↗
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In Vitro Study

For cell-based or tissue-based toxicity studies performed outside of living organisms. Includes criteria for test system characterisation, replicates, and culture conditions.

18 criteria 6 mandatory ● Max score: 18
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FAQ

Frequently asked questions

Common questions about ToxRTool, the Klimisch scoring method, and how to use this tool.

What is ToxRTool?

ToxRTool (Toxicological data Reliability assessment Tool) is a standardised checklist developed by EURL ECVAM at the European Commission Joint Research Centre (JRC). It evaluates the inherent quality and reliability of in vivo and in vitro toxicological studies by scoring them across 18–21 criteria, producing a Category 1–4 reliability rating. This web implementation lets you run the assessment directly in your browser.

What is the Klimisch score?

The Klimisch score (Klimisch et al., 1997) is a widely used method for classifying the reliability of toxicological studies into four categories: Category 1 (Reliable without restrictions), Category 2 (Reliable with restrictions), Category 3 (Not reliable), and Category 4 (Not assignable). ToxRTool is a structured, criterion-based implementation of this approach, developed to make the scoring more systematic and transparent.

What is the difference between in vivo and in vitro assessments?

The in vivo assessment covers 21 criteria (8 mandatory) for studies conducted in living animals or human subjects, with a maximum score of 21. The in vitro assessment covers 18 criteria (6 mandatory) for cell- or tissue-based studies performed outside of living organisms, with a maximum score of 18. Both use the same five criterion groups and produce a Category 1–4 reliability score.

What do Categories 1, 2, 3, and 4 mean?

Category 1 — Reliable without restrictions: high-quality, well-documented study suitable as a key study. Category 2 — Reliable with restrictions: acceptable quality but with minor methodological limitations. Category 3 — Not reliable: significant deficiencies or one or more mandatory criteria not met. Category 4 — Not assignable: documentation insufficient to assess reliability (e.g. reviews, secondary sources, handbooks).

Is ToxRTool Web free to use?

Yes — completely free, open-source, and runs entirely in your browser. No account, registration, or internet connection is required after the page loads. All your assessment data stays on your device via localStorage. Nothing is sent to any server.

Can I export my assessment results?

Yes. You can download your completed assessment as an Excel (.xlsx) file with multiple sheets (Study Info, Criteria Scores, Results Summary), or print it as a PDF directly from the browser. You can also copy a shareable link that encodes the full assessment state in the URL — paste it in any browser to restore the exact same assessment.