{"hq_id":"hq-p-chd-000080","name":"Children's Dental Sealant (BPA-Based Bis-GMA Resin)","category":{"primary":"children","secondary":"oral_care","tags":["dental sealant","BPA","bis-GMA","children","dentistry"]},"product_tier":"CHD","overall_risk_level":"high","description":"Resin-based pit-and-fissure sealants applied to children's permanent molars (typically ages 6-14) to prevent cavities. Most contain Bis-GMA (bisphenol A glycidyl methacrylate), which can leach BPA during the first 24 hours after placement and during ongoing wear. BPA is a potent endocrine disruptor linked to neurodevelopmental effects, early puberty, and metabolic disruption. Sealants also release Bis-DMA and BPA from saliva-mediated hydrolysis over months. Applied directly on tooth surfaces where saliva continuously contacts the material.","synthesis":{"derived_risk_level":"moderate","synthesis_confidence":0.849,"synthesis_method":"compound_composition","context_used":"human_infant","context_source":"product_users","exposure_modifier":1.265,"vulnerability_escalated":true,"escalation_reason":"CHD tier product","compounds_resolved":4,"compounds_total":4,"synthesis_date":"2026-03-27","synthesis_version":"1.0.0"},"hazard_summary":{"sensitive_populations":"infants, children","overall_risk":"high","primary_concerns":["BPA is a confirmed endocrine disruptor — salivary BPA levels spike 50-100x after sealant placement; developing endocrine system in children is uniquely vulnerable"],"exposure_routes":"BPA leaching into saliva from uncured surface layer (peak in first 1-3 hours); Chronic low-level BPA release from hydrolysis of Bis-GMA over 6-24 months; Ingestion of abraded sealant particles during chewing"},"exposure":{"users":["infant","child"],"routes":["inhalation","oral"],"contact_types":["inhalation","oral_direct"],"duration":"hours","frequency":"daily","scenarios":["Oral/ingestion exposure during use of Children's Dental Sealant (BPA-Based Bis-GMA Resin)","Inhalation exposure during use of Children's Dental Sealant (BPA-Based Bis-GMA Resin)","Incidental mouthing or hand-to-mouth transfer by children"],"notes":"Exposure to Children's Dental Sealant (BPA-Based Bis-GMA Resin) occurs via inhalation, oral. Children and infants face higher exposure per body weight due to developing detoxification systems, higher surface-area-to-weight ratio, and behavioral factors (mouthing, crawling)."},"consumer_guidance":{"usage_warning":"BPA-based sealants release detectable BPA into saliva, especially in the first 24 hours. Ask your dentist about BPA-free alternatives. Sealant benefits for cavity prevention are well-established — the goal is to get BPA-free versions, not avoid sealants entirely.","safer_alternatives":["Glass ionomer cement sealants (BPA-free, fluoride-releasing)","Giomer-based sealants (BPA-free composite)","BPA-free resin sealants (Bis-EMA or silorane-based)","Silver diamine fluoride as non-invasive caries prevention"]},"regulatory":{"applicable_regulations":[{"jurisdiction":"USA","regulation":"Consumer Product Safety Improvement Act (CPSIA) 2008","citation":"15 U.S.C. 2051-2089","requirements":"Lead content limited to 100 ppm in children's products. Six phthalates permanently banned (DEHP, DBP, BBP, DINP, DIBP, DPENP) in children's toys and child care articles. Third-party testing and certification required.","compliance_status":null,"effective_date":"2008-08-14","enforcing_agency":"CPSC","penalties":null,"source_ref":null},{"jurisdiction":"USA","regulation":"16 CFR Part 1501 — Small Parts Regulation","citation":"16 CFR 1501","requirements":"Products intended for children under 3 must not contain small parts that pose choking hazards.","compliance_status":null,"effective_date":null,"enforcing_agency":"CPSC","penalties":null,"source_ref":null},{"jurisdiction":"EU","regulation":"Toy Safety Directive 2009/48/EC","citation":"Directive 2009/48/EC","requirements":"EN 71 compliance required. Migration limits for 19 elements. CMR substance restrictions. REACH SVHC reporting for >0.1% w/w.","compliance_status":null,"effective_date":"2011-07-20","enforcing_agency":null,"penalties":null,"source_ref":null},{"jurisdiction":"USA -- California","regulation":"California Proposition 65","citation":"CA Health & Safety Code 25249.5-25249.13","requirements":"Products containing listed chemicals above safe harbor levels require clear and reasonable warnings.","compliance_status":null,"effective_date":null,"enforcing_agency":"OEHHA","penalties":null,"source_ref":null}],"certifications":[{"name":"CPSIA","issuer":"CPSC","standard":"Consumer Product Safety Improvement Act","scope":"Lead, phthalate content limits for children's products"},{"name":"ASTM F963","issuer":"ASTM International","standard":"Standard Consumer Safety Specification for Toy Safety","scope":"Mechanical, flammability, chemical hazards"},{"name":"EN 71","issuer":"CEN","standard":"Safety of Toys (Parts 1-13)","scope":"EU toy safety directive covering mechanical, flammability, chemical migration"}],"labeling":{"required_disclosures":[],"prop65_warning":{"required":null,"chemicals":[],"endpoint":null,"notes":null},"ghs_labeling":{"required":null,"signal_word":null,"pictograms":[],"hazard_statements":[],"notes":null},"hidden_ingredients":{"trade_secret_protected":null,"categories_hidden":[],"estimated_count":null,"known_concerns":null,"notes":null},"notes":null},"recalls":[],"regulatory_gap":null,"notes":null},"lifecycle":{"recyclable":false,"disposal_guidance":"Donate if reusable; check local recycling for hard plastics; landfill for worn items","hazardous_waste":false,"expected_lifespan":"1-3_years"},"formulation":{"form":"light-cured resin","key_ingredients":["Bis-GMA (BPA-derived monomer)","TEGDMA co-monomer"],"certifications":[]},"materials":{"common":[],"concerning":[],"preferred":[]},"compound_composition":[{"hq_id":"hq-c-org-000006","compound_name":"Bisphenol A","role":"Leached endocrine disruptor from Bis-GMA hydrolysis","typical_concentration":"0.1-30 µg leached/sealant in first 24h"},{"hq_id":"hq-c-org-000011","compound_name":"Formaldehyde","role":"Residual monomer from incomplete polymerization","typical_concentration":"trace"},{"hq_id":"hq-c-mix-000014","compound_name":"Titanium dioxide (nano form)","role":"Filler/opacifier (nano-TiO2)","typical_concentration":"1-5%"},{"hq_id":"hq-c-ino-000022","compound_name":"Fluoride (sodium fluoride)","role":"Fluoride-releasing component (some formulations)","typical_concentration":"varies"}],"identifiers":{"common_names":["children's dental sealant (bpa-based bis-gma resin)"],"aliases":[],"manufacturer":null,"brands":[]},"brand_examples":[{"brand":"3M Clinpro Sealant","manufacturer":"Unknown","market_position":"mass_market","notable":""},{"brand":"Ultradent UltraSeal XT Plus","manufacturer":"Unknown","market_position":"mass_market","notable":""},{"brand":"Kerr Helioseal F","manufacturer":"Unknown","market_position":"mass_market","notable":""}],"sources":[{"type":"expert_curation","name":"ALETHEIA Safety Database","date":"2026-03-23"},{"type":"regulation","title":"Consumer Product Safety Improvement Act (CPSIA) 2008 (15 U.S.C. 2051-2089)","jurisdiction":"USA","year":2008,"citation":"15 U.S.C. 2051-2089","id":"src_9d01b546"},{"type":"regulation","title":"16 CFR Part 1501 — Small Parts Regulation (16 CFR 1501)","jurisdiction":"USA","citation":"16 CFR 1501","id":"src_3e241b80"},{"type":"regulation","title":"Toy Safety Directive 2009/48/EC","jurisdiction":"EU","year":2011,"citation":"Directive 2009/48/EC","id":"src_6c59b098"},{"type":"regulation","title":"California Proposition 65 (CA Health & Safety Code 25249.5-25249.13)","jurisdiction":"USA -- California","citation":"CA Health & Safety Code 25249.5-25249.13","id":"src_fe1d5adc"},{"type":"regulatory","citation":"EFSA CEP Panel. Re-evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs. EFSA Journal 2023;21(4):6857.","url":"https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2023.6857","date":"2023-04-19","id":"efsa_2023","inherited_from_compound":"hq-c-org-000006"},{"type":"regulatory","citation":"ECHA Member State Committee. Identification of BPA as SVHC.","date":"2017-06-16","id":"echa_svhc_2017","inherited_from_compound":"hq-c-org-000006"},{"id":"iarc_100f_form","type":"regulatory","title":"IARC Monographs Volume 100F: Formaldehyde","year":2012,"inherited_from_compound":"hq-c-org-000011"},{"id":"epa_form_iris","type":"regulatory","title":"US EPA IRIS Assessment: Formaldehyde (draft)","year":2010,"inherited_from_compound":"hq-c-org-000011"},{"id":"iarc_93_tio2","type":"regulatory","title":"IARC Monographs Volume 93: Carbon Black, Titanium Dioxide, and Talc — Titanium Dioxide Group 2B Evaluation (Inhalation, Nano Form)","year":2010,"inherited_from_compound":"hq-c-mix-000014"},{"id":"efsa_tio2_2021","type":"regulatory","title":"EFSA: Re-evaluation of Titanium Dioxide (E 171) as a Food Additive — Safety Opinion and EU Ban Basis","year":2021,"inherited_from_compound":"hq-c-mix-000014"},{"id":"usphs_water_fluoridation_2015","type":"regulatory","title":"US Public Health Service Recommendation for Fluoride Concentration in Drinking Water — Updated 2015 (0.7 mg/L)","year":2015,"inherited_from_compound":"hq-c-ino-000022"},{"id":"epa_fluoride_drinking_water","type":"regulatory","title":"US EPA: Fluoride in Drinking Water — Maximum Contaminant Level (4 mg/L), Secondary MCL (2 mg/L), and Health Effects Review","year":2016,"inherited_from_compound":"hq-c-ino-000022"}],"meta":{"schema_version":"4.0.0","last_updated":"2026-03-25","timestamp":"2026-05-01T19:51:16.016Z"}}