Is Bismuth Subnitrate safe in cosmetics?
Bismuth Subnitrate has a safety rating of "MODERATE" in our database. EU status: permitted. US status: restricted. 2 toxicological study endpoint(s) are available in our database.
Bismuth Subnitrate
Also known as: Bismuth hydroxide nitrate oxide (Bi5O(OH)9(NO3)4), Basic bismuth nitrate, Bismuth Magistery, Bismuth oxynitrate, Bismuth subnitricum (+14 more)
INCI: BISMUTH SUBNITRATE
Bismuth Subnitrate (CAS 1304-85-4) is a cosmetic cosmetic ingredient functioning as Absorbent, Opacifying. NOAEL 1000 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 1304-85-4 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Bismuth Subnitrate is classified GHS Danger (H272, H315, H319, H335, H372, H371) in the chemicals database but is allowed in EU cosmetics.
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Absorbent, Opacifying
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
pentabismuth;oxygen(2-);nonahydroxide;tetranitrate
InChIKey
QGWDKKHSDXWPET-UHFFFAOYSA-E
Regulatory Status
EU EU Status
permitted
US US Status
restricted
US Notes
Not listed as approved color additive under 21 CFR Part 73. Only Bismuth Oxychloride and Bismuth Citrate are FDA-approved.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Bismuth Subnitrate.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
2 study endpoints found for Bismuth Subnitrate. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | =1000 mg/kg bw/day | oral | Rat | developmental | ToxValDB_ECHA_IUCLID |
| NOAEL | =1000 mg/kg bw/day | oral | Rat | reproduction developmental | ToxValDB_ECHA_IUCLID |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Bismuth Subnitrate across SCCS product categories, with measured dermal absorption where available.
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Absorbent
Opacifer
Expert Verdict
Expert safety assessment and concern-level summary for Bismuth Subnitrate.
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Bismuth Subnitrate by CAS number or substance name.
Studies
2
Lowest NOAEL
1000 mg/kg bw/day
Highest NOAEL
1000 mg/kg bw/day
ToxValDB_ECHA_IUCLID
Known Synonyms
Bismuth hydroxide nitrate oxide (Bi5O(OH)9(NO3)4)
Basic bismuth nitrate
Bismuth Magistery
Bismuth oxynitrate
Bismuth subnitricum
Bismuth white
Bismuthyl nitrate
Blanc de fard
C.I. 77169
C.I. Pigment White 17
Cosmetic White
Flake White
Magistery of bismuth
Novismuth
OrbeSeal
Pigment White 17
Roter
Snowcal 5SW
Spanish white
Chemical Function
Absorbent
Opacifer
Regulatory Lists
Canada; consumer_product; Substances in Products - Canada (4/2014)
active_ingredient; animal_products; Europe; pharmaceutical; residue
Canada; pharmaceutical
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
bismuth subnitrate
ChEMBL ID
CHEMBL3833348
Adverse Event Associations
678
Frequently Asked Questions
Is Bismuth Subnitrate allowed in the EU?
Bismuth Subnitrate EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Bismuth Subnitrate do in cosmetics?
Bismuth Subnitrate functions as: Absorbent, Opacifying. It is classified as a cosmetic ingredient in our database. CAS number: 1304-85-4.
What is the NOAEL for Bismuth Subnitrate?
The NOAEL (No Observed Adverse Effect Level) for Bismuth Subnitrate is =1000 mg/kg bw/day based on a developmental study via oral route in Rat. A total of 2 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.
Is Bismuth Subnitrate used outside cosmetics?
Bismuth Subnitrate also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Bismuth Subnitrate have different safety status in cosmetics vs industrial chemicals?
Bismuth Subnitrate is classified GHS Danger (H272, H315, H319, H335, H372, H371) in the chemicals database but is allowed in EU cosmetics.
Compliance Tools
Check Bismuth Subnitrate compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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