{"hq_id":"hq-p-chd-000083","name":"Pediatric Dental Amalgam Filling (Mercury/Silver Alloy)","category":{"primary":"children","secondary":"oral_care","tags":["dental amalgam","mercury","filling","children","dentistry"]},"product_tier":"CHD","overall_risk_level":"severe","description":"Silver-mercury amalgam dental restorations still used in some pediatric dental settings, containing approximately 50% elemental mercury by weight. Mercury vapor is continuously released during chewing, grinding, and brushing, absorbed through lungs and oral mucosa. Children's higher respiration rate per body weight, developing nervous system, and frequent teeth grinding (bruxism) increase mercury exposure. WHO and EU have moved to phase out amalgam use in children, but it remains common in many countries and lower-cost dental settings.","synthesis":{"derived_risk_level":"moderate_to_high","synthesis_confidence":0.859,"synthesis_method":"compound_composition","context_used":"human_infant","context_source":"product_users","exposure_modifier":1.4,"vulnerability_escalated":true,"escalation_reason":"CHD tier product","compounds_resolved":3,"compounds_total":3,"synthesis_date":"2026-03-27","synthesis_version":"1.0.0"},"hazard_summary":{"sensitive_populations":"infants, children","overall_risk":"severe","primary_concerns":["Elemental mercury (50% of amalgam) — continuous vapor release; neurotoxic to developing brain; WHO advises phase-down in children; linked to kidney effects at chronic low levels"],"exposure_routes":"Continuous mercury vapor inhalation from amalgam surface (accelerated by chewing/grinding); Mercury ion release into saliva and ingestion; Systemic absorption: inhaled Hg⁰ is 80% absorbed through lungs"},"exposure":{"users":["infant","child"],"routes":["inhalation","oral"],"contact_types":["inhalation","oral_direct"],"duration":"continuous","frequency":"daily","scenarios":["Oral/ingestion exposure during use of Pediatric Dental Amalgam Filling (Mercury/Silver Alloy)","Inhalation exposure during use of Pediatric Dental Amalgam Filling (Mercury/Silver Alloy)","Incidental mouthing or hand-to-mouth transfer by children"],"notes":"Exposure to Pediatric Dental Amalgam Filling (Mercury/Silver Alloy) 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":"Dental amalgam contains 50% mercury and continuously releases mercury vapor. The EU has banned amalgam use in children under 15. Request mercury-free alternatives for all pediatric dental restorations.","safer_alternatives":["Composite resin fillings (BPA-free formulations available)","Glass ionomer cement (fluoride-releasing, mercury-free)","Ceramic inlays for larger restorations","Compomer (polyacid-modified composite) — pediatric-friendly"]},"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":"dental restoration","key_ingredients":["Elemental mercury (Hg⁰)","Silver-tin-copper alloy"],"certifications":[]},"materials":{"common":[],"concerning":[],"preferred":[]},"compound_composition":[{"hq_id":"hq-c-ino-000046","compound_name":"Mercury (inorganic/elemental)","role":"Primary matrix metal (elemental mercury)","typical_concentration":"~50% by weight"},{"hq_id":"hq-c-ino-000071","compound_name":"Zinc chloride","role":"Alloy component (zinc in some formulations)","typical_concentration":"0-2%"},{"hq_id":"hq-c-ino-000001","compound_name":"Lead (Pb)","role":"Trace contaminant in alloy powder","typical_concentration":"trace"}],"identifiers":{"common_names":["pediatric dental amalgam filling (mercury/silver alloy)"],"aliases":[],"manufacturer":null,"brands":[]},"brand_examples":[{"brand":"SDI GS-80","manufacturer":"Unknown","market_position":"mass_market","notable":""},{"brand":"Dentsply Dispersalloy","manufacturer":"Unknown","market_position":"mass_market","notable":""},{"brand":"Kerr Tytin FC","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"},{"id":"iarc_mercury_v58_1993","type":"regulatory","title":"IARC Monographs Volume 58: Beryllium, Cadmium, Mercury, and Exposures in the Glass Manufacturing Industry — Methylmercury Compounds Group 2B; Inorganic Mercury Compounds Group 3 (1993)","year":1993,"inherited_from_compound":"hq-c-ino-000046"},{"id":"zncl2_regulatory_2020","type":"regulatory","title":"Zinc Chloride ZnCl2 Essential Trace Element 300 Metalloenzymes Zinc Finger; Electroplating Flux Wood Preservation Rayon Synthesis Battery; ZnCl2 Smoke Military ARDS Pulmonary Fibrosis Inhalation Hazard; EU CLP Acute Tox 4 H302 Eye Dam 1 H318 Aquatic Acute 1 H400; RDA 8-11 mg/day UL 40 mg/day Copper Antagonism; IARC Not Evaluated Not Carcinogenic; WFD EQS Zinc Hardness-Dependent 7.8-125 μg/L; Tire Wear ZnO Urban Runoff Aquatic","year":2020,"inherited_from_compound":"hq-c-ino-000071"},{"id":"src_001","type":"cdc","title":"CDC - Lead Poisoning Prevention","url":"https://www.cdc.gov/lead-prevention/","accessed":"2026-01-13","relevance":"Blood lead reference values, no safe level doctrine","inherited_from_compound":"hq-c-ino-000001"},{"id":"src_002","type":"who","title":"WHO - Lead Poisoning Fact Sheet","url":"https://www.who.int/news-room/fact-sheets/detail/lead-poisoning-and-health","year":2024,"accessed":"2026-01-13","relevance":"Global burden statistics, health effects","inherited_from_compound":"hq-c-ino-000001"},{"type":"report","title":"World Health Organization (WHO)","jurisdiction":"International","id":"src_32f00deb","extraction":"description_reference"}],"meta":{"schema_version":"4.0.0","last_updated":"2026-03-25","timestamp":"2026-05-01T19:30:22.108Z"}}