PARC Projects

Biodiversity protection
Shift away from animal testing
Advancing chemical risk assessment for diverse populations
Human health
NGRA
Time span
-
Potential impacts
  • Analysing existing Physiologically Based Pharmacokinetic models for risk assessment and identifying where additional data is needed.
  • Developing Physiologically Based Pharmacokinetic models for specific groups, such as pregnant women, foetuses, newborns, toddlers, young children, teenagers and the elderly.
  • Adjusting models to include combined exposures through oral ingestion, inhalation, and skin contact across the three sources of occupational, consumer, and environmental exposure.
Partners involved
INERIS (FR)
AUTH (GR)
ANSES (FR)
IISPV (ES)
IRFMN (IT)
IVL (SE)
NIPH (NO)
RIVM (NL)
SLU (SE)
TNO (NL)
VITO (BE)
WR (NL)
Contacts
Aude Ratier (INERIS)
aude.ratier [at] ineris.fr
Spyros Karakitsios (INERIS)
spyros.karakitsios [at] gmail.com
Overview

Physiologically Based Pharmacokinetic modelling is a method that uses mathematical representations of the body’s biological processes to predict how chemicals are absorbed, distributed, metabolised, and excreted in different tissues and organs. It plays a crucial role in evaluating how chemicals interact with the body, helping researchers to understand how different exposure levels lead to adverse health effects.

With increasing interest in using Physiologically Based Pharmacokinetic models for risk assessment, guidelines have been developed to guide the appropriate extrapolation of species, doses, and exposure scenarios.

These models’ mechanistic foundation makes them especially useful in toxicological risk assessment, particularly for complex extrapolations, such as predicting effects from in vitro to in vivo studies (lab-based cell studies to whole body studies), translating laboratory animal data to human scenarios, and addressing various exposure or dosing patterns.

The HBM4EU ↗ project reviewed existing Physiologically Based Pharmacokinetic models for multiple compounds and found significant gaps, including a lack of toxicokinetic data for many prioritised chemicals and limited models addressing sensitive populations, such as pregnant women and their foetuses, newborns, young children, and the elderly. Within PARC, Physiologically Based Pharmacokinetic models will be refined or newly developed to address the unique sensitivities of specific population subgroups. The project will integrate multiple exposure routes and sources (e.g. ingestion, inhalation, skin contact) and support the interpretation of human biomonitoring data. A variety of data sources will be used to refine or create models that incorporate internal dose metrics for accurate risk assessment.

Related Projects

Developing toxicity roadmaps
Developing a sustainable European human biomonitoring framework
Roadmap linking chemical substances and health
Leveraging HBM4EU data for chemical safety and zero pollution in Europe
Integrating occupational and general exposure assessment
Enhancing the risk assessment of chemical mixtures
Filter by
Address chemical pollution in the natural environment
Provide protection against most harmful chemicals
Shift away from animal testing
Biodiversity protection
Developing a system to monitor chemicals in the environment
Enhancing data integration and risk assessment for chemical exposure
Environmental and multisource monitoring: Pilot study on PFAS and endocrine disruptors
Improving the environmental risk assessment for plant protection products
Innovative tools for an early warning system
Monitoring chemicals in wastewater using innovative techniques
Tracking emerging chemicals in animal species: A new monitoring approach
Understanding volatile siloxanes in Europe to support regulation
Advancing the characterisation of human chemical exposome with innovative methods
Advancing tools, knowledge and regulatory options for an improved risk assessment and management of chemical mixtures
Beyond food: Organic contaminants in daily environments
Enhancing the reusability of human biomonitoring data for improved health risk assessment
Establishment of advanced data processing methodologies and bioinformatic tools for a non-targeted screening repository
Harmonising quality of chemical and bio-effect directed suspect and non-target screening methods across fields
Health-based guideline values for indoor air
Leveraging HBM4EU data for chemical safety and zero pollution in Europe
Streamlining data processing methods for suspect and non-target screening
Testing assessment tools for hazardous substances in consumer products and articles
Toxicity of plastic-associated chemicals
Advancing detection mechanisms of hazardous chemicals in food
Assessing chemicals exposure of waste management workers
Boosting data availability for environmental burden of disease calculations of chemicals
Developing and testing new approaches for chemical exposure assessment of infants
Developing a sustainable European human biomonitoring framework
Developing indicators for chemical risk and health impact assessment
Enhancing healthy and safe working conditions in hospitals
Establishing health-based human biomonitoring guidance values
Hazard characterisation of emerging mycotoxins
Human biomonitoring studies on the general population
Implementing human biomonitoring as sentinel surveillance system
Improving chemical screening in human samples
Investigating mono-n-hexyl phthalate (MnHexP) exposure
More accurate health impact assessment methodologies for chemicals
Occupational biomonitoring of emerging chemicals: A new approach
PFAS in breast milk and infant health
Roadmap linking chemical substances and health
Tracking human exposure to environmental pollutants over time in Europe
Tracking PFAS exposure in children across Europe
Using case studies to assess health impact of exposure to chemical substances
Using general population human biomonitoring data to trace occupational exposure
Assessing the relevance of adverse outcome pathways (AOPs) and associated new approach methodologies (NAMs) for human health risk assessment
Demonstrating the applicability of New Approach Methodologies for regulatory use
Harmonisation of the risk assessment of chemicals
Improving regulatory readiness of new testing methods
Innovative testing strategies for the developing immune system
In vitro methods to assess respiratory uptake and toxicity
New tools for enforcing chemical safety in everyday items
New tools to assess fish thyroid disruption
Omics for chemical grouping and read-across
Sex-based differences in susceptibility to liver toxicants
Skin sensitisation and mixtures effects
Tools, criteria and methods for risk assessment
Towards a harmonised approach in chemical risk assessment
Understanding how chemicals can disrupt hormones and reproductive health
Advanced tools to identify metabolism-disrupting chemicals
Advancing endocrine disruptor assessment
Assessing unknown mixtures using monitoring data and new approach methods
Better tools to spot hidden cancer risks
Computational new approach methods based on machine learning and artificial intelligence
Developing toxicity roadmaps
Enhancing chemical mixture risk assessment and regulation
Enhancing the risk assessment of chemical mixtures
Harmonised workflow for human relevance assessment of Adverse Outcome Pathways (AOPs) and New Approach Methodologies (NAMs)
Improving testing methods for thyroid hormone disrupting chemicals
Innovative approaches to assess developmental and adult neurotoxicity 
Innovative testing of chemical effects on the immune system
READYAI: Setting clear rules to assess when Artificial Intelligence can be trusted and used for evaluating chemical safety
Rethinking genotoxicity testing: A non-animal approach
Trusting new ways to test chemicals – the importance of retrospective validation
Advancing chemical risk assessment for diverse populations
Alternative predictive toxicology integrative approaches for chemical safety
Closing data gaps in physiologically-based kinetic modeling and quantitative in vitro to in vivo extrapolation
From emission to impact: modelling chemical pathways to human exposure
Integrating occupational and general exposure assessment
New approaches to assess organ toxicity without animal testing
New directions in systems toxicology for chemical safety
Advancing safe pesticide use through landscape risk assessment
Assessing the effects of naturally occurring toxins on aquatic ecosystems
Benchmarking the environmental risk assessment of plant protection products
Improving chemical risk assessment with new approach methods
Improving environmental risk assessments for plant protection products
Testing less complex pesticide risk assessment models for environmental regulation
Understanding risks from BPA alternatives on the environment
Environment
Health effects
Human health
Monitoring methods
Risk assessment
NGRA
Mixtures
Human biomonitoring
Workers
Streamlining data processing methods for suspect and non-target screening
Streamlining data processing methods for suspect and non-target screening

Advancing chemical risk assessment for diverse populations

Time span
-
Potential impacts
  • Analysing existing Physiologically Based Pharmacokinetic models for risk assessment and identifying where additional data is needed.
  • Developing Physiologically Based Pharmacokinetic models for specific groups, such as pregnant women, foetuses, newborns, toddlers, young children, teenagers and the elderly.
  • Adjusting models to include combined exposures through oral ingestion, inhalation, and skin contact across the three sources of occupational, consumer, and environmental exposure.
INERIS (FR)
AUTH (GR)
ANSES (FR)
IISPV (ES)
IRFMN (IT)
IVL (SE)
NIPH (NO)
RIVM (NL)
SLU (SE)
TNO (NL)
VITO (BE)
WR (NL)
Overview

Physiologically Based Pharmacokinetic modelling is a method that uses mathematical representations of the body’s biological processes to predict how chemicals are absorbed, distributed, metabolised, and excreted in different tissues and organs. It plays a crucial role in evaluating how chemicals interact with the body, helping researchers to understand how different exposure levels lead to adverse health effects.

With increasing interest in using Physiologically Based Pharmacokinetic models for risk assessment, guidelines have been developed to guide the appropriate extrapolation of species, doses, and exposure scenarios.

These models’ mechanistic foundation makes them especially useful in toxicological risk assessment, particularly for complex extrapolations, such as predicting effects from in vitro to in vivo studies (lab-based cell studies to whole body studies), translating laboratory animal data to human scenarios, and addressing various exposure or dosing patterns.

The HBM4EU ↗ project reviewed existing Physiologically Based Pharmacokinetic models for multiple compounds and found significant gaps, including a lack of toxicokinetic data for many prioritised chemicals and limited models addressing sensitive populations, such as pregnant women and their foetuses, newborns, young children, and the elderly. Within PARC, Physiologically Based Pharmacokinetic models will be refined or newly developed to address the unique sensitivities of specific population subgroups. The project will integrate multiple exposure routes and sources (e.g. ingestion, inhalation, skin contact) and support the interpretation of human biomonitoring data. A variety of data sources will be used to refine or create models that incorporate internal dose metrics for accurate risk assessment.

Contacts
Aude Ratier (INERIS)
aude.ratier [at] ineris.fr
Spyros Karakitsios (INERIS)
spyros.karakitsios [at] gmail.com
Topics
Biodiversity protection
Shift away from animal testing
Keywords
Human health
NGRA

Related Projects

Developing toxicity roadmaps
Developing a sustainable European human biomonitoring framework
Roadmap linking chemical substances and health
Leveraging HBM4EU data for chemical safety and zero pollution in Europe
Integrating occupational and general exposure assessment
Enhancing the risk assessment of chemical mixtures