{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T11:52:18Z","timestamp":1792065138175,"version":"4.4.0"},"reference-count":65,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T00:00:00Z","timestamp":1767225600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T00:00:00Z","timestamp":1767225600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"vor","delay-in-days":273,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["NAM Journal"],"published-print":{"date-parts":[[2026]]},"DOI":"10.1016\/j.namjnl.2026.100140","type":"journal-article","created":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T22:53:09Z","timestamp":1790981589000},"page":"100140","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":1,"special_numbering":"C","title":["Technical challenges of testing polymer materials in OECD test guideline methods addressing effects on human health, biotic systems and analytics"],"prefix":"10.1016","volume":"2","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3502-1034","authenticated-orcid":false,"given":"Susanne N.","family":"Kolle","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-8753-6811","authenticated-orcid":false,"given":"Friederike","family":"L\u00fcnne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denis","family":"Botin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nora","family":"Melchin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-1010-5023","authenticated-orcid":false,"given":"Naveed","family":"Honarvar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"L\u00fcderwald","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dorothee","family":"Funk-Weyer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Schaffert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3756-1904","authenticated-orcid":false,"given":"Robert","family":"Landsiedel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"1","key":"10.1016\/j.namjnl.2026.100140_bib0001","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1111\/j.0105-1873.2004.00385.x","article-title":"Determination of skin irritation potential in the human 4-h patch test","volume":"51","author":"Basketter","year":"2004","journal-title":"Contact Dermat."},{"key":"10.1016\/j.namjnl.2026.100140_bib0002","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1016\/j.aca.2019.07.034","article-title":"Determining the water solubility of difficult-to-test substances: a tutorial review","volume":"1086","author":"Birch","year":"2019","journal-title":"Anal. Chim. Acta"},{"key":"10.1016\/j.namjnl.2026.100140_bib0003","doi-asserted-by":"crossref","DOI":"10.1016\/j.aquatox.2024.107178","article-title":"Acute and chronic toxicity of cationic polyquaterniums of varying charge density and molecular weight to Daphnia magna and Ceriodaphnia dubia","volume":"279","author":"Brill","year":"2025","journal-title":"Aquat. Toxicol."},{"issue":"3","key":"10.1016\/j.namjnl.2026.100140_bib0004","doi-asserted-by":"crossref","first-page":"205","DOI":"10.1093\/mutage\/geae010","article-title":"Adapting the in vitro micronucleus assay (OECD Test Guideline No. 487) for testing of manufactured nanomaterials: recommendations for best practices","volume":"39","author":"Burgum","year":"2024","journal-title":"Mutagenesis"},{"key":"10.1016\/j.namjnl.2026.100140_bib0005","doi-asserted-by":"crossref","DOI":"10.1016\/j.yrtph.2023.105543","article-title":"Retrospective evaluation of the eye irritation potential of agrochemical formulations","volume":"146","author":"Choksi","year":"2024","journal-title":"Regul. Toxicol. Pharmacol."},{"issue":"1","key":"10.1016\/j.namjnl.2026.100140_bib0006","first-page":"142","article-title":"Elements and development processes for test methods in toxicology and human health-relevant life science research","volume":"41","author":"Collen","year":"2024","journal-title":"ALTEX."},{"issue":"2","key":"10.1016\/j.namjnl.2026.100140_bib0007","doi-asserted-by":"crossref","first-page":"312","DOI":"10.1002\/ieam.4642","article-title":"Environmental hazard of cationic polymers relevant in personal and consumer care products: a critical review","volume":"19","author":"Connors","year":"2023","journal-title":"Integr. Env. Assess Manag."},{"key":"10.1016\/j.namjnl.2026.100140_bib0008","unstructured":"DIN (2004) DIN EN ISO 13130-1:2004-08 Materials and articles in contact with foodstuffs Plastics substances subject to limitation Part 1: Guide to test methods for the specific migration of substances from plastics to food and food simulants and the determination of substances in plastics and the selection of conditions of exposure to food simulants."},{"key":"10.1016\/j.namjnl.2026.100140_bib0009","unstructured":"DIN (2014) DIN EN ISO 10993-3:2014-02 Biological evaluation of medical devices \u2013 Part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity."},{"key":"10.1016\/j.namjnl.2026.100140_bib0010","doi-asserted-by":"crossref","unstructured":"DIN (2021a) DIN EN ISO 10993-12:2021-08 Biological evaluation of medical devices \u2013 Part 12: Sample preparation and reference materials. https:\/\/doi.org\/10.31030\/3178003.","DOI":"10.31030\/3178003"},{"key":"10.1016\/j.namjnl.2026.100140_bib0011","doi-asserted-by":"crossref","unstructured":"DIN (2021b) DIN EN ISO 10993-23:2021-10 Biological evaluation of medical devices \u2013 Part 23: tests for irritation. https:\/\/doi.org\/10.31030\/3181429.","DOI":"10.31030\/3181429"},{"key":"10.1016\/j.namjnl.2026.100140_bib0012","unstructured":"DIN (2023) DIN EN ISO 10993-10:2023-04 Biological evaluation of medical devices \u2013 Part 10: tests for skin sensitization."},{"key":"10.1016\/j.namjnl.2026.100140_bib0013","unstructured":"ECETOC (2021a) ECETOC technical report no. 133-1: the ECETOC conceptual framework for polymer risk assessment (CF4Polymers)."},{"key":"10.1016\/j.namjnl.2026.100140_bib0014","unstructured":"ECETOC (2021b) ECETOC technical report No. 133-2: applicability of analytical tools, test methods and models for polymer risk assessment."},{"key":"10.1016\/j.namjnl.2026.100140_bib0015","unstructured":"ECETOC (2021c) ECETOC technical report No. 133-3: case studies putting the ECETOC conceptual framework for polymer risk assessment (CF4Polymers) into practice."},{"key":"10.1016\/j.namjnl.2026.100140_bib0017","unstructured":"ECHA (2023a) Guidance for monomers and polymers doi:10.2823\/933."},{"key":"10.1016\/j.namjnl.2026.100140_bib0018","unstructured":"ECHA (2023b) Guidance on monomers and polymers."},{"key":"10.1016\/j.namjnl.2026.100140_bib0019","unstructured":"ECHA (2024) Key areas of regulatory challenge. doi:10.2823\/858284."},{"key":"10.1016\/j.namjnl.2026.100140_bib0020","unstructured":"ECHA (2025a) Key areas of regulatory challenge doi:10.2823\/8572710."},{"key":"10.1016\/j.namjnl.2026.100140_bib0022","unstructured":"ECHA (2026) Key areas of regulatory challenge. doi:10.2823\/7173112."},{"key":"10.1016\/j.namjnl.2026.100140_bib0023","unstructured":"EPA (2025) Polymer exemption for new chemicals under the toxic substances control act (TSCA)."},{"key":"10.1016\/j.namjnl.2026.100140_bib0068","series-title":"Probit Analysis","author":"Finney","year":"1971"},{"issue":"10","key":"10.1016\/j.namjnl.2026.100140_bib0024","doi-asserted-by":"crossref","first-page":"1408","DOI":"10.3390\/polym17101408","article-title":"Applicability domain of the sens-is in vitro assay for testing the skin sensitization potential of rheology-modifying polymers","volume":"17","author":"Hochar","year":"2025","journal-title":"Polym"},{"key":"10.1016\/j.namjnl.2026.100140_bib0025","doi-asserted-by":"crossref","DOI":"10.1016\/j.tiv.2023.105700","article-title":"Apparent limitations of OECD TG 431 for classification of acrylic- and methacrylic-based adhesives","volume":"94","author":"Hoerst","year":"2024","journal-title":"Toxicol. Vitro"},{"issue":"7","key":"10.1016\/j.namjnl.2026.100140_bib0026","doi-asserted-by":"crossref","first-page":"2047","DOI":"10.1007\/s00204-024-03736-z","article-title":"Avoiding a reproducibility crisis in regulatory toxicology-on the fundamental role of ring trials","volume":"98","author":"Jacobs","year":"2024","journal-title":"Arch. Toxicol."},{"issue":"2","key":"10.1016\/j.namjnl.2026.100140_bib0027","doi-asserted-by":"crossref","first-page":"109","DOI":"10.1111\/j.1600-0536.2009.01640.x","article-title":"Comparison of human skin irritation patch test data with in vitro skin irritation assays and animal data","volume":"62","author":"Jirova","year":"2010","journal-title":"Contact. Dermat."},{"issue":"4","key":"10.1016\/j.namjnl.2026.100140_bib0028","doi-asserted-by":"crossref","first-page":"1948","DOI":"10.1021\/acs.est.6b06456","article-title":"Are standardized test guidelines adequate for assessing waterborne particulate contaminants?","volume":"51","author":"Khan","year":"2017","journal-title":"Env. Sci Technol."},{"key":"10.1016\/j.namjnl.2026.100140_bib0029","doi-asserted-by":"crossref","DOI":"10.1016\/j.namjnl.2026.100128","article-title":"Test substance preparation determines the tested fraction and the outcome of human health NAMs for poorly-water-soluble (pre)polymers","volume":"2","author":"Kolle","year":"2026","journal-title":"NAM J."},{"key":"10.1016\/j.namjnl.2026.100140_bib0030","doi-asserted-by":"crossref","DOI":"10.1016\/j.yrtph.2022.105330","article-title":"Plant extracts, polymers and new approach methods: practical experience with skin sensitization assessment","volume":"138","author":"Kolle","year":"2023","journal-title":"Regul. Toxicol. Pharmacol."},{"key":"10.1016\/j.namjnl.2026.100140_bib0031","doi-asserted-by":"crossref","DOI":"10.1016\/j.yrtph.2025.105841","article-title":"Not yet nixing rabbit eyes from the six: the TTT is not predicting the full range of in vivo eye irritation classifications for agrochemical formulations","volume":"161","author":"Kolle","year":"2025","journal-title":"Regul. Toxicol. Pharmacol."},{"issue":"3","key":"10.1016\/j.namjnl.2026.100140_bib0032","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1177\/026119291504300307","volume":"43","author":"Kolle","year":"2015","journal-title":"Altern. Lab. Anim."},{"key":"10.1016\/j.namjnl.2026.100140_bib0033","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1186\/s12989-016-0128-6","article-title":"Eye irritation testing of nanomaterials using the EpiOcular eye irritation test and the bovine corneal opacity and permeability assay","volume":"13","author":"Kolle","year":"2015","journal-title":"Part Fibre. Toxicol."},{"key":"10.1016\/j.namjnl.2026.100140_bib0034","doi-asserted-by":"crossref","first-page":"33","DOI":"10.1016\/j.yrtph.2017.01.013","volume":"85","author":"Kolle","year":"2017","journal-title":"Regul. Toxicol. Pharmacol."},{"key":"10.1016\/j.namjnl.2026.100140_bib0035","series-title":"Polymer Chemistry (trans: Pask SD)","author":"Koltzenburg","year":"2023"},{"key":"10.1016\/j.namjnl.2026.100140_bib0036","doi-asserted-by":"crossref","first-page":"262","DOI":"10.1016\/j.yrtph.2017.09.023","article-title":"In chemico, in vitro and in vivo comparison of the skin sensitizing potential of eight unsaturated and one saturated lipid compounds","volume":"90","author":"Kreiling","year":"2017","journal-title":"Regul. Toxicol. Pharmacol."},{"issue":"1","key":"10.1016\/j.namjnl.2026.100140_bib0037","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1089\/aivt.2023.0018","article-title":"The use of toxicokinetic information for setting concentrations of in vitro toxicity tests and for interpreting their results: a proposed workflow","volume":"10","author":"Landsiedel","year":"2024","journal-title":"Appl. Vitro Toxicol."},{"issue":"2","key":"10.1016\/j.namjnl.2026.100140_bib0038","first-page":"95","article-title":"Global analysis of publicly available safety data for 9,801 substances registered under REACH from 2008-2014","volume":"33","author":"Luechtefeld","year":"2016","journal-title":"ALTEX"},{"issue":"6","key":"10.1016\/j.namjnl.2026.100140_bib0039","first-page":"2352","article-title":"Practical considerations to optimize aquatic testing of particulate material, with focus on nanomaterials","volume":"11","author":"Luederwald","year":"2024","journal-title":"Env. Sci.: Nano"},{"key":"10.1016\/j.namjnl.2026.100140_bib0040","doi-asserted-by":"crossref","first-page":"230","DOI":"10.1016\/j.jenvman.2015.04.029","article-title":"Mobility of coated and uncoated TiO2 nanomaterials in soil columns\u2013Applicability of the tests methods of OECD TG 312 and 106 for nanomaterials","volume":"157","author":"Nickel","year":"2015","journal-title":"J. Env. Manage."},{"key":"10.1016\/j.namjnl.2026.100140_bib0041","unstructured":"OECD (1995) Test no. 105: water solubility."},{"key":"10.1016\/j.namjnl.2026.100140_bib0042","unstructured":"OECD (1996a) Test No. 118: determination of the number-average molecular weight and the molecular weight distribution of polymers using gel permeation chromatography."},{"key":"10.1016\/j.namjnl.2026.100140_bib0043","unstructured":"OECD (1996b) Test No. 119: determination of the low molecular weight content of a polymer using gel permeation chromatography."},{"key":"10.1016\/j.namjnl.2026.100140_bib0044","unstructured":"OECD (2000) Test No. 120: solution\/extraction behaviour of polymers in water."},{"key":"10.1016\/j.namjnl.2026.100140_bib0045","unstructured":"OECD (2004) Test No. 202: Daphnia sp. acute immobilisation test."},{"key":"10.1016\/j.namjnl.2026.100140_bib0046","doi-asserted-by":"crossref","unstructured":"OECD (2018) No. 286: guidance document on good in vitro method practices (GIVIMP). In. https:\/\/doi.org\/10.1787\/9789264304796-en.","DOI":"10.1787\/9789264304796-en"},{"key":"10.1016\/j.namjnl.2026.100140_bib0047","unstructured":"OECD (2019) Guidance document on aquatic toxicity testing of difficult substances and mixtures."},{"key":"10.1016\/j.namjnl.2026.100140_bib0048","unstructured":"OECD (2020) Test No. 471: bacterial reverse mutation tes."},{"key":"10.1016\/j.namjnl.2026.100140_bib0049","series-title":"Proposal for Updating the OECD Guidance on Polymers of Low Concern ENV\/CBC(2023)8","year":"2023"},{"key":"10.1016\/j.namjnl.2026.100140_bib0050","unstructured":"OECD (2023b) Test No. 487: in vitro mammalian cell micronucleus test."},{"key":"10.1016\/j.namjnl.2026.100140_bib0051","doi-asserted-by":"crossref","unstructured":"OECD (2025a) No. 421: Guidance document on good in vitro method practices (GIVIMP). In. https:\/\/doi.org\/10.1787\/5ba6777b-en.","DOI":"10.1787\/5ba6777b-en"},{"key":"10.1016\/j.namjnl.2026.100140_bib0052","unstructured":"OECD (2025b) Test No. 431: In vitro skin corrosion: reconstructed human epidermis (RHE) test method."},{"key":"10.1016\/j.namjnl.2026.100140_bib0053","unstructured":"OECD (2025c) Test No. 439: In Vitro Skin Irritation."},{"key":"10.1016\/j.namjnl.2026.100140_bib0054","series-title":"Draft Detailed Review Paper on In Vitro Mammalian Cell Genotoxicity Assays Based on the Phosphorylated Histone Biomarkers \u03b3H2AX and pH3 OECD Test Guidelines Programme","year":"2026"},{"key":"10.1016\/j.namjnl.2026.100140_bib0055","series-title":"Test No. 446A: ToxTracker gene reporter assay for the identification of genotoxic hazard and genotoxic\/non-genotoxic mechanism of action","year":"2026"},{"key":"10.1016\/j.namjnl.2026.100140_bib0056","doi-asserted-by":"crossref","DOI":"10.1016\/j.yrtph.2023.105495","article-title":"Three-tiered approach for standard information requirements for polymers requiring registration under REACH","volume":"144","author":"Otte","year":"2023","journal-title":"Regul. Toxicol. Pharmacol."},{"key":"10.1016\/j.namjnl.2026.100140_bib0057","doi-asserted-by":"crossref","first-page":"64","DOI":"10.1016\/j.yrtph.2016.12.009","article-title":"Evaluation of in vitro assays for the assessment of the skin sensitization hazard of functional polysiloxanes and silanes","volume":"84","author":"Petry","year":"2017","journal-title":"Regul. Toxicol. Pharmacol."},{"issue":"3","key":"10.1016\/j.namjnl.2026.100140_bib0058","doi-asserted-by":"crossref","first-page":"369","DOI":"10.1016\/0041-008X(72)90157-3","article-title":"A comparison of rabbit and human skin response to certain irritants","volume":"21","author":"Phillips","year":"1972","journal-title":"Toxicol. Appl. Pharmacol."},{"issue":"1","key":"10.1016\/j.namjnl.2026.100140_bib0060","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1034\/j.1600-0536.2001.045001001.x","article-title":"Validity and ethics of the human 4-h patch test as an alternative method to assess acute skin irritation potential","volume":"45","author":"Robinson","year":"2001","journal-title":"Contact Dermat."},{"issue":"1","key":"10.1016\/j.namjnl.2026.100140_bib0061","first-page":"1","volume":"394","author":"Schmitt","year":"2021","journal-title":"Naunyn-Schmiedeb. Arch. Pharmacol."},{"key":"10.1016\/j.namjnl.2026.100140_bib0062","doi-asserted-by":"crossref","first-page":"616","DOI":"10.3390\/toxics12080616","article-title":"Limitations and modifications of skin sensitization NAMs for testing inorganic nanomaterials","volume":"12","author":"Wareing","year":"2024","journal-title":"Toxics"},{"issue":"2","key":"10.1016\/j.namjnl.2026.100140_bib0063","doi-asserted-by":"crossref","first-page":"276","DOI":"10.1016\/0041-008X(71)90112-8","article-title":"Study of intra- and interlaboratory variability in the results of rabbit eye and skin irritation tests","volume":"19","author":"Weil","year":"1971","journal-title":"Toxicol. Appl. Pharmacol."},{"key":"10.1016\/j.namjnl.2026.100140_bib0064","unstructured":"Wood (2020) Scientific and technical support for the development of criteria to identify and group polymers for registration\/evaluation under REACH and their impact assessment."},{"issue":"5","key":"10.1016\/j.namjnl.2026.100140_bib0065","doi-asserted-by":"crossref","first-page":"557","DOI":"10.1177\/026119290102900511","article-title":"The use of bootstrap resampling to assess the variability of Draize tissue scores","volume":"29","author":"Worth","year":"2001","journal-title":"Altern. Lab. Anim."},{"key":"10.1016\/j.namjnl.2026.100140_bib0066","doi-asserted-by":"crossref","DOI":"10.1016\/j.ecoenv.2022.114433","article-title":"Ecotoxicology of microplastics in Daphnia: a review focusing on microplastic properties and multiscale attributes of Daphnia","volume":"249","author":"Yin","year":"2023","journal-title":"Ecotoxicol. Environ. Saf."},{"issue":"12","key":"10.1016\/j.namjnl.2026.100140_bib0067","doi-asserted-by":"crossref","first-page":"1093","DOI":"10.1063\/1.1746738","article-title":"The Scattering of light and the radial distribution function of high polymer solutions","volume":"16","author":"Zimm","year":"1948","journal-title":"J. Chem. Phys."}],"container-title":["NAM Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S3050620426000655?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S3050620426000655?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T11:06:30Z","timestamp":1792062390000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S3050620426000655"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026]]},"references-count":65,"alternative-id":["S3050620426000655"],"URL":"https:\/\/doi.org\/10.1016\/j.namjnl.2026.100140","relation":{},"ISSN":["3050-6204"],"issn-type":[{"value":"3050-6204","type":"print"}],"subject":[],"published":{"date-parts":[[2026]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Technical challenges of testing polymer materials in OECD test guideline methods addressing effects on human health, biotic systems and analytics","name":"articletitle","label":"Article Title"},{"value":"NAM Journal","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.namjnl.2026.100140","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 The Authors. Published by Elsevier B.V.","name":"copyright","label":"Copyright"}],"article-number":"100140"}}