{"schema":"https://ver.cy/schemas/card/1.0.0","id":"vr.tr.dmdm-hydantoin","code":"thing-q5205613","url":"https://ver.cy/models/thing/q5205613/","name":"DMDM hydantoin","alternateNames":[],"kind":"thing","status":"published","version":"0.1.0-research.1","language":"en","classifiers":{"family":"Thing Registry","category":"Physical world and living systems","entryKind":"thing","plane":"PHY","domain":["PHY.MAT"],"industry":[],"navPath":"","tags":[],"facets":{}},"whatItIs":"DMDM hydantoin is 1,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione, a formaldehyde-releasing organic compound used as an antimicrobial preservative in cosmetic and personal-care formulations.","purpose":"Enable an agent to identify DMDM hydantoin, assess the condition of a supplied material, and determine whether evidence supports its proposed preservative use.","scope":{"in":["Chemical identity and differentiation from related hydantoins and other formaldehyde-releasing preservatives","Grade, active content, carrier, impurities, and batch-specific analytical evidence","Physical state and measured properties under specified conditions","Formaldehyde availability and release under storage and formulation conditions","Preservative performance, exposure assessment, and jurisdiction-specific use constraints"],"out":["Complete cosmetic or industrial product formulations containing DMDM hydantoin","Manufacturing plant design and synthesis-process operation","Formaldehyde as an independently registered substance","Other hydantoin derivatives and preservative ingredients as separate substances","Diagnosis or treatment of individual allergic reactions"],"boundaries":[]},"distinguishingFeatures":["Match the substance to CAS 6440-58-0 and PubChem CID 22947; a trade name alone is insufficient. Identity reference: [FDA substance record](https://precision.fda.gov/ginas/app/ui/substances/c66fc8d0-d091-47e8-bc11-eb0633f32689).","Require the 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin structure and molecular formula C7H12N2O4, distinguishing it from unsubstituted hydantoin and 5,5-dimethylhydantoin. Structure reference: [PubChem](https://pubchem.ncbi.nlm.nih.gov/compound/22947).","Distinguish this formaldehyde-donating preservative from halogenated hydantoin disinfectants by chemical structure and analytical identity, rather than antimicrobial function alone.","Separate DMDM hydantoin content from the mass of an aqueous supply preparation or preservative blend; these quantities cannot be substituted in dosing calculations.","Separate intact DMDM hydantoin from measured free formaldehyde and other hydantoin-formaldehyde species; preservation involves a composition-dependent chemical system. Background: [CIR safety assessment](https://cir-reports.cir-safety.org/view-attachment/?id=2c52792c-8d74-ec11-8943-0022482f06a6)."],"structure":{"bundles":[{"id":"identity-and-material-boundary","name":"Identity and material boundary","description":"Establish which chemical entity and supplied material a DMDM hydantoin record describes.","layers":[{"id":"molecular-identity","name":"Molecular identity","description":"Anchor the registered name to the substituted hydantoin structure.","findings":[{"id":"structure-backed-identification","name":"Structure-backed identification","description":"Recognition requires agreement between structure, identifiers, and the identity evidence for the material.","questions":[{"text":"Does the material correspond to 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin, CAS 6440-58-0?","id":"structure-backed-identification-q01","kind":"definition"},{"text":"Which authoritative identity record and supplier analytical evidence establish that correspondence?","id":"structure-backed-identification-q02","kind":"provenance"}]}]},{"id":"substance-versus-preparation","name":"Substance versus preparation","description":"Separate the registered substance from carriers, blends, and finished products.","findings":[{"id":"supply-material-boundary","name":"Supply material boundary","description":"A trade preparation must retain its relationship to DMDM hydantoin without being treated as chemically identical to the substance.","questions":[{"text":"Is the assessed material neat DMDM hydantoin, an aqueous preparation, or a blend with other preservatives?","id":"supply-material-boundary-q01","kind":"boundary"},{"text":"Which named constituents and proportions belong to the supplied preparation rather than the substance identity?","id":"supply-material-boundary-q02","kind":"definition"}]}]}]},{"id":"grade-composition-and-assay","name":"Grade, composition, and assay","description":"Describe the composition actually supplied and the evidence supporting its declared strength.","layers":[{"id":"active-content-basis","name":"Active content basis","description":"Resolve what a supplier's percentage measures.","findings":[{"id":"assay-and-dose-conversion","name":"Assay and dose conversion","description":"Declared strength must distinguish intact DMDM hydantoin from solids or another operational assay quantity.","questions":[{"text":"What does the reported assay quantify, and is its percentage expressed as supplied or on a dry basis?","id":"assay-and-dose-conversion-q01","kind":"measurement"},{"text":"What preparation addition rate delivers the intended DMDM hydantoin mass fraction using the verified assay?","id":"assay-and-dose-conversion-q02","kind":"action"}]}]},{"id":"related-species-and-batch-quality","name":"Related species and batch quality","description":"Evaluate constituents beyond the nominal ingredient.","findings":[{"id":"composition-acceptance","name":"Composition acceptance","description":"Batch assessment accounts for water, free formaldehyde, and resolved hydantoin-related species against a stated specification.","questions":[{"text":"Which methods quantify water, free formaldehyde, and related species such as monomethylol dimethylhydantoin?","id":"composition-acceptance-q01","kind":"measurement"},{"text":"Which certificate of analysis and specification revision support acceptance of this batch?","id":"composition-acceptance-q02","kind":"provenance"}]}]}]},{"id":"physical-condition-and-storage","name":"Physical condition and storage","description":"Connect observed material properties to supply form and storage history.","layers":[{"id":"conditioned-physical-properties","name":"Conditioned physical properties","description":"Record phase and property measurements without mixing neat-substance and solution data.","findings":[{"id":"property-attribution","name":"Property attribution","description":"Every physical constant must identify material composition, method, and relevant environmental conditions.","questions":[{"text":"Do reported density, solubility, and thermal-transition values describe neat DMDM hydantoin or a specified solution?","id":"property-attribution-q01","kind":"boundary"},{"text":"At what concentration, temperature, and pressure were those properties measured, and was decomposition distinguished from boiling or melting?","id":"property-attribution-q02","kind":"measurement"}]}]},{"id":"storage-history-and-retest","name":"Storage history and retest","description":"Assess whether the current batch remains represented by its original analytical evidence.","findings":[{"id":"condition-dependent-reassessment","name":"Condition-dependent reassessment","description":"Storage assessment links excursions and observed changes to decisions about assay and formaldehyde retesting.","questions":[{"text":"What temperature history, container conditions, and elapsed storage time apply to this preparation?","id":"condition-dependent-reassessment-q01","kind":"provenance"},{"text":"Which excursions or changes in appearance, pH, assay, or formaldehyde result require retesting or quarantine under the grade specification?","id":"condition-dependent-reassessment-q02","kind":"action"}]}]}]},{"id":"formaldehyde-release-and-analysis","name":"Formaldehyde release and analysis","description":"Represent formaldehyde measurements and their dependence on the tested chemical system.","layers":[{"id":"formaldehyde-measurand","name":"Formaldehyde measurand","description":"Specify exactly what each formaldehyde result represents.","findings":[{"id":"free-versus-releasable-formaldehyde","name":"Free versus releasable formaldehyde","description":"Results labeled free, releasable, or total formaldehyde require method-specific definitions before comparison.","questions":[{"text":"How does the analytical method define free, releasable, or total formaldehyde in this DMDM hydantoin matrix?","id":"free-versus-releasable-formaldehyde-q01","kind":"definition"},{"text":"Could dilution, derivatization, heating, or sample holding time alter the formaldehyde quantity measured?","id":"free-versus-releasable-formaldehyde-q02","kind":"measurement"}]}]},{"id":"release-under-use-conditions","name":"Release under use conditions","description":"Link observed release to the intended environment.","findings":[{"id":"matrix-and-time-dependence","name":"Matrix and time dependence","description":"Release evidence must cover relevant pH, temperature, elapsed time, and formulation interactions rather than assume a universal release fraction.","questions":[{"text":"What formaldehyde concentrations are measured across the intended pH, temperature, and storage-time range?","id":"matrix-and-time-dependence-q01","kind":"measurement"},{"text":"Which formulation constituents change measured formaldehyde availability, and what experiment supports that conclusion?","id":"matrix-and-time-dependence-q02","kind":"provenance"}]}]}]},{"id":"preservative-performance","name":"Preservative performance","description":"Assess whether a specified DMDM hydantoin dose provides the required preservation in a particular formulation.","layers":[{"id":"microbial-challenge-evidence","name":"Microbial challenge evidence","description":"Tie efficacy claims to organism-specific results and acceptance criteria.","findings":[{"id":"demonstrated-preservation","name":"Demonstrated preservation","description":"Performance judgments reference a tested active dose, formulation, microbial challenge, and observation period.","questions":[{"text":"Which bacteria, yeasts, and molds were challenged, and what counts or reductions occurred at each required interval?","id":"demonstrated-preservation-q01","kind":"measurement"},{"text":"Which test method and acceptance criteria support the preservation judgment for this formulation?","id":"demonstrated-preservation-q02","kind":"provenance"}]}]},{"id":"formulation-transfer-boundary","name":"Formulation transfer boundary","description":"Determine when an existing performance result can support a changed application.","findings":[{"id":"revalidation-triggers","name":"Revalidation triggers","description":"Changes to DMDM hydantoin dose, co-preservatives, matrix, processing, or storage require an explicit assessment of evidence applicability.","questions":[{"text":"Does the proposed formulation match the tested active dose, pH, co-preservatives, processing conditions, and storage period?","id":"revalidation-triggers-q01","kind":"boundary"},{"text":"Which differences require a new challenge test before relying on the existing preservation result?","id":"revalidation-triggers-q02","kind":"action"}]}]}]},{"id":"exposure-and-permitted-use","name":"Exposure and permitted use","description":"Connect material-specific hazards and formaldehyde exposure evidence to handling and market-use decisions.","layers":[{"id":"hazard-and-exposure-attribution","name":"Hazard and exposure attribution","description":"Separate substance hazards, mixture classifications, and route-specific exposure scenarios.","findings":[{"id":"donor-and-formaldehyde-assessment","name":"Donor and formaldehyde assessment","description":"Assessment distinguishes evidence for DMDM hydantoin from evidence for formaldehyde and identifies the material and route to which each conclusion applies.","questions":[{"text":"Which current classification and sensitization evidence applies to DMDM hydantoin itself, the supplied mixture, and released formaldehyde?","id":"donor-and-formaldehyde-assessment-q01","kind":"provenance"},{"text":"What dermal contact or airborne exposure is plausible during the proposed handling or use, and which measurements or controls are required?","id":"donor-and-formaldehyde-assessment-q02","kind":"action"}]}]},{"id":"jurisdiction-and-product-category","name":"Jurisdiction and product category","description":"Determine applicable use limits and communication obligations from dated legal sources.","findings":[{"id":"applicable-use-conditions","name":"Applicable use conditions","description":"Permission depends on the jurisdiction, application, ingredient concentration basis, and any requirements triggered by released formaldehyde.","questions":[{"text":"Which current legal instrument governs DMDM hydantoin in the intended jurisdiction and product category, and what concentration basis does it specify?","id":"applicable-use-conditions-q01","kind":"provenance"},{"text":"Do measured formaldehyde levels or the proposed exposure route trigger labeling, restrictions, or additional assessment under that instrument?","id":"applicable-use-conditions-q02","kind":"action"},{"text":"Does the supporting source establish a legal requirement, a supplier recommendation, or a scientific assessment?","id":"applicable-use-conditions-q03","kind":"boundary"}]}]}]},{"id":"evidence-and-external-alignment","name":"Evidence and external alignment","description":"What the world already says about this thing, gathered so the model can be checked against it.","layers":[{"id":"reported-evidence","name":"Reported evidence","description":"Findings from the breadth pass, kept separate from the structural claims.","findings":[{"id":"evidence-confidence-notes","name":"Check these first","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these check these first hold for the sense of DMDM hydantoin this model covers, and on what evidence?","id":"evidence-confidence-notes-q01","kind":"provenance"}]},{"id":"evidence-identifiers","name":"Identifiers and schemes","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these identifiers and schemes hold for the sense of DMDM hydantoin this model covers, and on what evidence?","id":"evidence-identifiers-q01","kind":"provenance"}]},{"id":"evidence-standards-and-regulation","name":"Standards and regulation","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these standards and regulation hold for the sense of DMDM hydantoin this model covers, and on what evidence?","id":"evidence-standards-and-regulation-q01","kind":"provenance"}]},{"id":"evidence-real-world-use","name":"Real-world use","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these real-world use hold for the sense of DMDM hydantoin this model covers, and on what evidence?","id":"evidence-real-world-use-q01","kind":"provenance"}]},{"id":"evidence-measurements","name":"Typical measurements","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these typical measurements hold for the sense of DMDM hydantoin this model covers, and on what evidence?","id":"evidence-measurements-q01","kind":"provenance"}]},{"id":"evidence-failure-modes-and-hazards","name":"Failure modes and hazards","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these failure modes and hazards hold for the sense of DMDM hydantoin this model covers, and on what evidence?","id":"evidence-failure-modes-and-hazards-q01","kind":"provenance"}]},{"id":"evidence-regional-variation","name":"Regional variation","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these regional variation hold for the sense of DMDM hydantoin this model covers, and on what evidence?","id":"evidence-regional-variation-q01","kind":"provenance"}]},{"id":"evidence-neighbours","name":"Neighbouring kinds and how to tell them apart","description":"Recalled without web access and unsourced; every item is a lead to verify.","questions":[{"text":"Which of these neighbouring kinds and how to tell them apart hold for the sense of DMDM hydantoin this model covers, and on what evidence?","id":"evidence-neighbours-q01","kind":"provenance"}]}]}]}]},"agentConduct":{"may":["Describe DMDM hydantoin's role as a formaldehyde-releasing preservative in cosmetics.","Read ingredient lists and tell users, especially those with formaldehyde allergy, where it is present."],"mustNot":["Use it in products above the limits or outside the uses the law allows.","Omit it from ingredient labels.","Market a product containing it as formaldehyde-free.","Dismiss allergy reports from users."],"requiresHuman":["Approving formulation changes for products sold to the public."]},"ethics":{"considerations":["People with skin allergies depend on honest labels to avoid reactions.","Preservatives prevent dangerous contamination, so trade-offs should be explained, not hidden."],"affectedParties":["Consumers with skin allergies","Cosmetic workers","Hairdressers"]},"owners":{"steward":"The product's responsible person or manufacturer; cosmetic regulators control permitted uses.","roles":[],"masterSystems":[]},"relations":[{"target":"Q11173","type":"parent","note":"registry parent class"}],"interaction":{"identity":{"applicability":"required","items":["Vercy registry: vr.tr.dmdm-hydantoin","Wikidata: Q5205613 (https://www.wikidata.org/wiki/Q5205613)"]},"properties":{"applicability":"required","items":["Verified chemical identity: Registry vr.tr.dmdm-hydantoin; CAS 6440-58-0; PubChem CID 22947; verified structure and identifier sources","Supply form and grade: Neat substance, aqueous preparation, or blend; supplier grade and specification revision","DMDM hydantoin assay: % by mass; as supplied or dry basis; analytical method and uncertainty","Carrier and related-species profile: Water, monomethylol dimethylhydantoin, dimethylhydantoin, and other identified constituents in % by mass or mg/kg","Physical state and thermal behavior: Observed phase at temperature and pressure; melting, boiling, or decomposition observations in °C with method and material composition","Solution properties: pH at stated concentration and temperature; density in g/mL; solubility in g/L with solvent and temperature","Formaldehyde analytical result: mg/kg or % by mass; free, releasable, or total formaldehyde explicitly defined; method, time, pH, and temperature","Formaldehyde release over time: Concentration versus elapsed time under specified matrix, pH, temperature, and storage conditions","Preservative performance: Organism-specific counts or log reductions at stated intervals; active dose, matrix, method, and acceptance criterion","Hazard and use-rule applicability: Substance or mixture classification; jurisdiction; product category; concentration basis; exposure route; source and effective date"]},"recognition":{"applicability":"required","items":["A clear, colourless liquid supplied as a water solution with a faint formaldehyde odour.","In products, its presence is shown only on the ingredient list."]},"capabilities":{"applicability":"required","items":["Reconcile a supplier label and analytical identity with the registered substance.","Compare a batch assay and related-species profile with an approved material specification.","Calculate delivered DMDM hydantoin concentration from preparation strength and addition rate.","Design and interpret formaldehyde measurements under intended storage and formulation conditions.","Evaluate formulation-specific preservation evidence and identify testing still required.","Screen a proposed use against applicable classification, exposure, concentration, and labeling requirements."]},"hazards":{"applicability":"required","items":["Releases formaldehyde, which can cause allergic contact dermatitis.","Formaldehyde is a known carcinogen by inhalation at sufficient exposures."]},"interfaces":{"applicability":"required","items":["Regulation (EC) No 1223/2009 on cosmetic products, European Union.","Globally Harmonized System of Classification and Labelling of Chemicals (GHS), United Nations."]},"context":{"applicability":"required","items":["DMDM hydantoin is encountered in cosmetic and personal-care formulations as a preservative that helps limit microbial growth.","It is also encountered in ingredient declarations, raw-material specifications and formulation assessments addressing preservation and compatibility."]}},"sources":[{"title":"Wikidata item Q5205613: DMDM hydantoin","url":"https://www.wikidata.org/wiki/Q5205613","note":"identity and sense of the item"},{"title":"Wikipedia: DMDM hydantoin","url":"https://en.wikipedia.org/wiki/DMDM_hydantoin","note":"general description of the item"}],"openQuestions":["Which verified EC identifier and current jurisdiction-specific substance records should accompany the established CAS and PubChem identities?","Which reliable melting, boiling or decomposition, solubility, and density measurements describe the neat substance rather than a commercial aqueous preparation?","How do validated analytical methods distinguish intact DMDM hydantoin, related hydantoin species, and free versus releasable formaldehyde in the intended matrix?","What formulation-specific release and challenge-test evidence establishes an effective dose throughout the intended storage and use conditions?","What current classifications, occupational exposure limits, permitted-use concentrations, and formaldehyde-triggered labeling requirements apply in the intended market and application?"],"resources":{"spec":"/models/things/publications/thing-q5205613/spec.json"},"provenance":{"origin":"thing registry research (pass 2)","builtFrom":["models/things/publications/thing-q5205613/spec.json"],"providers":["Codex"],"researchStatus":"unreviewed","generatedAt":"2026-09-12T09:16:21Z","builder":"tools/build_cards.py@1.0.0"},"completeness":{"sections":{"classifiers":"filled","whatItIs":"filled","purpose":"filled","distinguishingFeatures":"filled","structure":"filled","agentConduct":"filled","ethics":"filled","owners":"filled","relations":"filled","interaction.identity":"filled","interaction.properties":"filled","interaction.recognition":"filled","interaction.capabilities":"filled","interaction.hazards":"filled","interaction.interfaces":"filled","interaction.context":"filled","sources":"filled"},"notes":{"_gate":"Published through the thing publication gate 1.0 on 2026-10-07T10:10:31+00:00: completeness 1.00; sense: Wikidata description; 2 live sources; review by codex: pass"},"score":1.0}}