Use of alternatives to animal testing for Environmental Safety Assessment (ESA): Report from the 2023 EPAA partners' forum

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14310%2F25%3A00140810" target="_blank" >RIV/00216224:14310/25:00140810 - isvavai.cz</a>

Result on the web

<a href="https://www.sciencedirect.com/science/article/pii/S0273230025000042?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S0273230025000042?via%3Dihub</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.yrtph.2025.105774" target="_blank" >10.1016/j.yrtph.2025.105774</a>

Result language

angličtina

Original language name

Use of alternatives to animal testing for Environmental Safety Assessment (ESA): Report from the 2023 EPAA partners' forum

Original language description

Environmental Safety Assessments (ESA) are mandatory for several regulatory purposes and are an important component of stewardship/sustainability initiatives. Fish testing is used for assessing chemical toxicity and bioaccumulation potential; amphibians are included in some jurisdictions and their use is increasing to assess endocrine disruption. Alternative methods are becoming more available, covering the principles of the 3Rs (i.e., replacing, reducing and refining animal tests), but their regulatory incorporation is still limited. A cross-sector review by the European Partnership for Alternative Approaches to Animal Testing (EPAA), discussed the status and priorities for accelerating the adoption of non-animal approaches in ESA. The lack of an internationally agreed definition for "animal testing" was recognized as a challenge. For example, testing with vertebrate embryos up to specific developmental stages is a suitable refinement alternative only in some jurisdictions. Invertebrate testing offers refinement alternatives to develop tiered approaches using vertebrate testing as a last resort. Aquatic ESA was identified as a common need by all sectors and regulatory areas, while terrestrial ESA is particularly relevant for agrochemicals. The standardization and validation of some alternative methods as OECD test guidelines (TGs) for fish acute toxicity and fish bioaccumulation have not yet triggered the expected replacement in regulatory settings. Priority actions in these areas are needed to generate confidence in the regulatory use of the available OECD TGs designed as alternatives, including the identification of applicability domains and guidance/decision-trees for integrating different lines of evidence. Case studies under the OECD Integrated Approaches to Testing and Assessment (IATA) program could facilitate further global regulatory uptake. Replacement of fish chronic toxicity testing is more complex and less advanced. A dual approach was suggested, in the short-term, exploring lines of evidence that, alone or in combination, could identify when further fish testing is not needed. The second phase should focus on the application of the 3Rs in those cases where chronic information is needed. Another area of increasing interest is endocrine disruption. It represents a challenge but also an opportunity for implementing mechanistic non-animal methods, in addition to integrate human and ESA. This requires a step-by-step approach with continuous dialogue to ensure that technical developments will address regulatory needs. The review also agreed that the long-term aspiration is a new ESA paradigm, mapping the protection goals and providing connectivity between the chemical legislation and environmental protection policies.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30108 - Toxicology

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2025

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Regulatory Toxicology and Pharmacology

ISSN

0273-2300

e-ISSN

1096-0295

Volume of the periodical

156

Issue of the periodical within the volume

February 2025

Country of publishing house

US - UNITED STATES

Number of pages

10

Pages from-to

1-10

UT code for WoS article

001410616800001

EID of the result in the Scopus database

2-s2.0-85215865639