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Related Experiment Video

Updated: Jun 19, 2025

Testing of Nanoparticle Release from a Composite Containing Nanomaterial Using a Chamber System

Testing of Nanoparticle Release from a Composite Containing Nanomaterial Using a Chamber System

Published on: November 22, 2016

Next Generation Risk Assessment approaches for advanced nanomaterials: Current status and future perspectives.

Danail Hristozov¹, Elena Badetti², Paolo Bigini³

¹East European Research and Innovation Enterprise (EMERGE), Otets Paisiy Str. 46, 1303 Sofa, Bulgaria.

|July 26, 2024

Summary

This summary is machine-generated.

This study proposes a tiered framework for Next Generation Risk Assessment of advanced nanomaterials (AdNMs) using New Approach Methodologies (NAMs). This approach enhances cost-effective safety assessment and reduces vertebrate testing.

Keywords:

Advanced materials Grouping In chemico approaches In silico approaches In vitro approaches In vitro-in vivo extrapolation (IVIVE)Nanomaterials New Approach Methodologies (NAMs)Next Generation Risk Assessment (NGRA)Regulatory readiness

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Area of Science:

Toxicology
Risk Assessment
Nanomaterials Science

Background:

Advanced nanomaterials (AdNMs) present unique challenges for traditional safety and regulatory risk assessment.
Existing methodologies struggle to adequately evaluate the potential risks associated with AdNMs.
New Approach Methodologies (NAMs) offer promising alternatives but require a structured framework for application.

Purpose of the Study:

To propose a framework for Next Generation Risk Assessment (NGRA) of AdNMs utilizing NAMs.
To align NAM-based risk assessment with the conventional paradigm for regulatory acceptance.
To address the challenges in applying NAMs for safe-by-design principles in AdNM development.

Main Methods:

Development of an exposure-driven, endpoint-specific tiered framework for AdNM risk assessment.
Integration of pre-existing data with targeted testing using NAMs of increasing complexity.
Assessment of the regulatory readiness (Transparency, Reliability, Accessibility, Applicability, Relevance, Completeness) of emerging NAMs.

Main Results:

The proposed tiered framework facilitates cost-effective safety assessment of AdNMs.
The approach minimizes vertebrate use while maintaining scientific rigor.
The framework systematically evaluates NAMs for their suitability across different risk assessment steps.

Conclusions:

The NGRA framework provides a structured pathway for integrating NAMs into AdNM safety evaluation.
This approach supports regulatory acceptance by aligning with established risk assessment principles.
Future developments in NAMs and regulatory science are crucial for advancing AdNM safety assessment.