Speciality Chemicals Magazine MAY / JUN 2025 | Page 52

REGULATION & COMPLIANCE
implementing NAMs and addressing critical barriers and needs. 15
ECHA is committed“ to expand knowledge on chemical safety and to promote alternative methods for the assessment of hazards and risks of chemicals”, as outlined in its Strategy Statement 2024-2028.16 To advance this goal, the agency collaborates actively with the EU and the international scientific community through the Partnership for the Assessment of Risks from Chemicals( PARC). 17
Among its efforts to reduce reliance on animal testing, ECHA has identified key priority areas for investments, research, method development, and case studies in NAMs. These include chemical grouping and read-across, in vitro and in silico, ADME and PBK, carcinogenicity and short- and long-term fish toxicity. 18 Increased investment is also needed in specific regulatory areas, particularly neurotoxicity, immunotoxicity and endocrine disruption, as the CLP criteria for these endpoints rely primarily on animal data.
To address existing knowledge and data gaps and promote the use of NAMs, the OECD is coordinating several ongoing and upcoming projects to advance developmental neurotoxicity testing( DNT). These initiatives focus on developing new in vitro DNT assays and promoting regulatory acceptance of the DNT in vitro battery( DNT-IVB). 19
Simultaneously, the Johns Hopkins Center for Alternatives to Animal Testing( CAAT) is actively researching developmental immunotoxicity( DIT). Currently, only one validated method exists for assessing immunotoxic potential( OECD Test Guideline 444a). 20 This is intended as part of a broader test battery, but the lack of additional validated methods poses a significant challenge to integrating non-animal-based approaches into the regulatory framework.
The informative value of‘ omics’ technologies is also the focus of collaborations between scientists and regulators. One example of ongoing projects is an examination of whether the fish embryo toxicity( FET) test could be considered a valid alternative to chronic fish toxicity testing when enhanced with transcriptomics measurements. Another is developing guidance for generating‘ omics’ datasets from current OECD animal studies. 21
Some NAMs, such as‘ omics’ and high-throughput screening technologies, can generate vast amounts of complex biological data, but, the sheer volume and complexity of this data often exceed human capacity to analyse and interpret it effectively, making it challenging to extract meaningful insights for regulatory decision-making.
To address this, artificial intelligence( AI) offers a powerful solution, especially its subfield machine learning, which is about how we extract knowledge from data. Regulatory validation of these methods is not expected soon, but they should be embraced: they represent not just an opportunity but a necessity if we are to harness the full potential of NAMs and ensure that all the data generated can be transformed into actionable knowledge for advances in regulation and science.
Investing efforts and resources into cutting-edge technologies to revolutionise risk assessment brings profound rewards, not only in advancing scientific accuracy and human relevance but also in eliminating the ethical concerns of animal testing. This shift represents a win-win scenario, where science, ethics and regulatory progress align to shape a more sustainable and compassionate future. ●
Dr Letizia Carramusa
SENIOR CONSULTANT – TOXICOLOGY
YORDAS GROUP k + 44 1524 510278 J l. carramusa @ yordasgroup. com j www. yordasgroup. com |
References: 1: ECHA, New Approach Methodologies in Regulatory Science: Proceedings of a Scientific Workshop, 2016. https:// doi. org / 10.2823 / 543644 2: QSAR Toolbox. https:// qsartoolbox. org / 3: K. S. Nitsche et al., Arch. Toxicol., March 2022, 96( 3), 711 – 741. https:// doi. org / 10.1007 / s00204- 022-03234-0 4: OECD, The Adverse Outcome Pathway for Skin Sensitisation Initiated by Covalent Binding to Proteins, OECD Series on Testing & Assessment No. 168, 2022, OECD Publishing, Paris. https:// doi. org / 10.1787 / 9789264221444-en 5: OECD, Guideline No. 497: Defined Approaches on Skin Sensitisation, OECD Guidelines for the Testing of Chemicals, Section 4, 2023, OECD Publishing, Paris. https:// doi. org / 10.1787 / b92879a4-en 6: OECD, Guidance Document on Integrated Approaches to Testing & Assessment for Serious Eye Damage and Eye Irritation, 3rd Edition, 2024,
OECD Publishing, Paris. https:// doi. org / 10.1787 / cdb440be-en 7: European Commission, Second Commission Conference on the Roadmap Towards Phasing Out Animal Testing for Chemical Safety Assessments, 2024. https:// single-market-economy. ec. europa. eu / events / roadmap-phasing-out-animaltesting-chemical-safety-assessments-secondworkshop-2024-10-25 _ en 8: OECD, Guidance Document on the Validation & International Acceptance of New or Updated Test Methods for Hazard Assessment, OECD Series on Testing & Assessment No. 34, 2025, OECD Publishing, Paris. https:// doi. org / 10.1787 / e1f1244b-en 9: Tracking System for Alternative Methods( TSAR). https:// tsar. jrc. ec. europa. eu / 10: S. Brescia, C. Alexander-White, H. Li & A. Cayley, Toxicol. Res.( Camb), 10 January 2023, 12( 1), 1 – 11.
https:// doi. org / 10.1093 / toxres / tfac087 – PMID: 36866215; PMCID: PMC9972812 11: A. M. Middleton, Toxicol. Sci., September 2022, 189( 1), 124 – 147. https:// doi. org / 10.1093 / toxsci / 12: M. T. Baltazar et al., Toxicol. Sci., 2020, 176( 1), 236 – 252. https:// doi. org / 10.1093 / toxsci / kfaa048 13: G. Reynolds et al., Regul. Toxicol. Pharmacol., 2021, 127, 105075. https:// doi. org / 10.1016 / j. yrtph. 2021.105075 14: F. Sewell et al., Toxicol. Res., 2024, 13( 2). https:// doi. org / 10.1093 / toxres / tfae044 15: L. Carramusa, W. Mune, N. Hunt, L. Browne, O. Osborne & C. FSA, Research & Evidence, 2024. https:// doi. org / 10.46756 / 001c. 122591 16: ECHA Strategy 2024 – 2028. https:// echa. europa. eu / documents / 10162 / 17209 / echa _ strategy _ 2024-2028 _ en. pdf / 936c121f-9ba0-e677- 40e1-d27c0cbdbacb? t = 1706600415618
17: EU Partnership for the Assessment of Risks from Chemicals( PARC). https:// www. eu-parc. eu / 18: Key Areas of Regulatory Challenges – ECHA, 2024. https:// echa. europa. eu / documents / 10162 / 17228 / key _ areas _ regulatory _ challenges _ 2024. pdf / e9b997e1-794e-cab7-8503- ba4385070730? t = 1718103205169 19: OECD Web Archive – Developmental Neurotoxicity, 2023. https:// web-archive. oecd. org / temp / 2023-07-07 / 653068-developmentalneurotoxicity. htm 20: OECD Test No. 444A: In Vitro Immunotoxicity, 2023. https:// www. oecd. org / en / publications / 2023 / 07 / test-no-444a-in-vitroimmunotoxicity _ 1ac6720c. html 21: Fraunhofer ITEM – ECHA Research Project. https:// www. item. fraunhofer. de / en / press-andmedia / press-releases / echa-research-project. html
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