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Updated: May 22, 2026
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Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
Published on: January 31, 2022
A study of liver toxicity within harmonised classifications under REACH
Annika Drees1, Mathieu Vinken1, Julen Sanz-Serrano1
1Department of Pharmaceutical and Pharmacological Sciences, Vrije Universiteit Brussel, Brussels, Belgium.
Regulatory Toxicology and Pharmacology : RTP
|May 20, 2026
Summary
Industrial chemicals can cause liver toxicity, as identified through harmonised classifications for specific target organ toxicity (STOT). This study analyzed chemical data, finding the liver to be a primary target organ, often impacted by repeated exposure.
Area of Science:
- Toxicology
- Chemical Safety
- Regulatory Science
Background:
- Industrial chemicals pose risks of liver toxicity, necessitating regulatory oversight.
- The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation governs chemical safety in the European Union.
- Harmonised classifications under the Classification, Labelling and Packaging (CLP) regulation communicate chemical hazards.
Purpose of the Study:
- To investigate harmonised classifications for specific target organ toxicity (STOT) focusing on the liver.
- To analyze incidences, experimental data, and structure-activity relationships for liver toxicity.
- To identify chemicals with potential cholestatic, steatogenic, and fibrotic effects based on biomarker data.
Main Methods:
- Analysis of harmonised classification data for STOT concerning the liver.
- Review of animal studies (primarily 90-day rodent studies) and human exposure data.
- Utilisation of read-across approaches and clinical biomarker fingerprints.
Main Results:
- The liver is the most sensitive target organ for STOT, predominantly linked to repeated dose exposure.
- Classifications are mainly derived from rodent studies, with rats being the most common species.
- Potentially cholestatic, steatogenic, and fibrotic chemicals were identified using clinical biomarker profiles.
Conclusions:
- Harmonised STOT classifications confirm the occurrence of liver toxicities from industrial chemicals.
- Key liver toxicity endpoints were identified, suggesting potential for new approach methodologies.
- The study underscores the importance of robust classification systems for chemical safety assessment.
Keywords:
Chemical-induced liver toxicityClassification and labellingHarmonised classificationHazard assessmentREACHMore Related Videos
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