Poor Active Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed

Colloidal Silver

Also known as: Amalgum, Caswell No. 735, EINECS 231-131-3, EPA Pesticide Chemical Code 072501, Germany: C-Pigment 2 (+12 more)

INCI: SILVER (NANO)

Colloidal Silver (CAS 7440-22-4) is a cosmetic active ingredient functioning as Antimicrobial; preservative; used historically in deodorants, anti-acne. NOAEL 0.0045 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: prohibited, max Nano silver particles prohibited under EU Omnibus VIII (Regulation EU 2024/2564); compliance deadline 1 May 2026; GHS signal word WARNING. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.

View industrial chemical safety profile for CAS 7440-22-4 →

Auto-generated CPSR Part A draft with source citations
Function
Antimicrobial; preservative; used historically in deodorants, anti-acne products, and preservation systems due to broad-spectrum antibacterial activity
Safety Rating
POOR

Chemistry & Identifiers

EC Number
231-131-3

Regulatory Status

EU EU Status prohibited
EU Max Conc. Nano silver particles prohibited under EU Omnibus VIII (Regulation EU 2024/2564); compliance deadline 1 May 2026
US US Status prohibited
US Notes FDA 1999 final rule: OTC colloidal silver products are not generally recognized as safe and effective (not GRASE) for any condition. Products marketed with health/wound-healing claims are considered misbranded drugs. No approved cosmetic or OTC drug status.

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Colloidal Silver.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Colloidal Silver. 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 =0.00056 mg/kg bw/d oral human NOAEL study SCCS_vision_codex
NOAEL =0.00056 mg/kg bw/d oral human NOAEL study SCCS_vision_codex
NOAEL =0.00056 mg/kg bw/d oral human NOAEL study SCCS_vision_codex
NOAEL =0.00056 mg/kg bw/d oral human NOAEL study SCCS_vision_codex
NOAEL =0.0045 mg/kg bw/d oral rat repeated dose toxicity SCCS_vision_codex
NOAEL =0.0045 mg/kg bw/d oral rat repeated dose toxicity SCCS_vision_codex
NOAEL =0.0045 mg/kg bw/d oral rat repeated dose toxicity SCCS_vision_codex
NOAEL =0.0045 mg/kg bw/d oral rat repeated dose toxicity SCCS_vision_codex
NOAEL =0.0045 mg/kg bw/d oral rat repeated dose toxicity SCCS_vision_codex
NOAEL =0.0045 mg/kg bw/d oral rat repeated dose toxicity SCCS_vision_codex

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Signal Word
WARNING
Pictograms
EnviroAqua
Hazard Statements
Very toxic to aquatic life with long lasting effects
Short-term Exposure Effects
May cause mechanical irritation to the eyes and respiratory tract.
Long-term Exposure Effects
The substance may cause a grey-blue discolouration of the eyes, nose, throat and skin (argyria/argyrosis).
Routes of Exposure
The substance can be absorbed into the body by inhalation and by ingestion.

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

sccs SCCS/1665/24 20 June 2024
Verdict: not safe
NOAEL: 0.0045 mg/kg bw/d (not specified)
Max Concentration: 0.2% in leave-on

classification as toxic for reproduction Cat. 2, the SCCS considers micron-sized particulate Silver not safe at concentrations up to 0.2 % in rinse-off and 0.3 % in leave-on cosmetic products when used alone or in combination. However, the use of micron-sized particulate Silver in eye shadow and oral

sccs SCCS/1665/24 20 June 2024
Verdict: not safe
NOAEL: 0.0045 mg/kg bw/d (not specified)
Max Concentration: 0.3% in leave-on

classification as toxic for reproduction Cat. 2, the SCCS considers micron-sized particulate Silver not safe at concentrations up to 0.2 % in rinse-off and 0.3 % in leave-on cosmetic products when used alone or in combination. However, the use of micron-sized particulate Silver in eye shadow and oral

sccs SCCS/1665/24 20 June 2024
Verdict: not safe
NOAEL: 0.0045 mg/kg bw/d (oral)
Max Concentration: 0.2% in leave-on

classification as toxic for reproduction Cat. 2, the SCCS considers micron-sized particulate Silver not safe at concentrations up to 0.2 % in rinse-off and 0.3 % in leave-on cosmetic products when used alone or in combination. However, the use of micron-sized particulate Silver in eye shadow and oral

sccs SCCS/1665/24 20 June 2024
Verdict: not safe
NOAEL: 0.0045 mg/kg bw/d (oral)
Max Concentration: 0.3% in leave-on

classification as toxic for reproduction Cat. 2, the SCCS considers micron-sized particulate Silver not safe at concentrations up to 0.2 % in rinse-off and 0.3 % in leave-on cosmetic products when used alone or in combination. However, the use of micron-sized particulate Silver in eye shadow and oral

sccs SCCS/1687/25 17 December 2025
Verdict: unknown
NOAEL: 0.0045 mg/kg bw/d (not specified)
Max Concentration: 0.2% in leave-on

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Colloidal Silver across SCCS product categories, with measured dermal absorption where available.

EU CLP Annex VI Harmonized Classification

Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.

Signal Word
Warning
Pictograms
Health Hazard
Hazard Class and Category
Repr. 2; STOT RE 2
Hazard Statements
  • H361f
  • H373 (nervous system)

Inserted via ATP: ATP22

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
10,000 - 100,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex II — Prohibited
Ref: 1727
(EU) 2026/78
Annex IV — Permitted Colorants
Product type: White
Max: (a) Lip products (b) Eye shadow

Expanded Jurisdictional Detail

Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.

Additional Jurisdictional Restrictions (5)
Jurisdiction Status Max % Product Type
CN permitted_colorant - All cosmetics (Class 1)
BR permitted_colorant - Column 3: Not near mucous membranes
UK restricted - -
CA restricted 0.04% (mouthwash only) Mouthwash only
ASEAN permitted_colorant - All products

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

Aggregated DA Values (5 records across 5 sources)
Type DA % Method Skin Model SCCS Ref
default 1.76 method=default; type=in_vitro - -
measured 1.0 method=measured - -
measured 4.0 method=measured - -
measured 5.0 method=measured; type=in_vitro - -
default 1.76 method=default - -

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Biocide Catalyst Deodorizer Dye Plating agent Softener and conditioner Surface modifier
Regulatory List Membership (2)
EU Regulated in Personal Care EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Colloidal Silver.

Regulatory Flags

eu-prohibited-2026 fda-not-grase cytotoxic impairs-healing nano-form do-not-formulate regulatory-high-risk eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Colloidal Silver by CAS number or substance name.

Studies
71
Lowest NOAEL
0.00056
Highest NOAEL
1000

Units vary across source rows: mg/kg bw/d, mg/kg, mg/kg bw/day

SCCS_vision_codex ToxValDB_ECHA_IUCLID

Dermal Absorption

View details ->
Absorption % Method Vehicle
1.76 method=default; type=in_vitro -
1.0 method=measured -
4.0 method=measured -
5.0 method=measured; type=in_vitro -
1.76 method=default -

Known Synonyms

Amalgum Caswell No. 735 EINECS 231-131-3 EPA Pesticide Chemical Code 072501 Germany: C-Pigment 2 Silver, colloidal Silver Granufoam UNII-3M4G523W1G Argentum metallicum Ag(0) Agn silver(0) 47Ag Ag Silber argent plata

Chemical Function

Dye Biocide Deodorizer Softener and conditioner Surface modifier Catalyst

Regulatory Lists

Arts and crafts/Office supplies - body paint - tattoo ink; detected; Europe Arts and crafts/Office supplies - body paint - tattoo ink; detected; Europe Arts and crafts/Office supplies - body paint - tattoo ink; detected; Europe Arts and crafts/Office supplies - body paint - tattoo ink; detected; Europe Arts and crafts/Office supplies - body paint - tattoo ink; detected; Europe Arts and crafts/Office supplies - body paint - tattoo ink; detected; Europe Arts and crafts/Office supplies - body paint - tattoo ink; detected; Europe active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides active_ingredient; Pesticides

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical and food safety data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA count match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

Adverse Event Associations
16
View full pharmaceutical profile →
SOURCE EFSA / FDA GRAS food_additives

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name
Silver
E Number
E174
ADI
DECISION POSTPONED mg/kg bw
Food Category
colorant
View full food safety profile →

Frequently Asked Questions

Is Colloidal Silver safe in cosmetics?

Colloidal Silver has a safety rating of "POOR" in our database. EU status: prohibited. US status: prohibited. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.

Is Colloidal Silver allowed in the EU?

Colloidal Silver EU regulatory status: prohibited. Maximum allowed concentration: Nano silver particles prohibited under EU Omnibus VIII (Regulation EU 2024/2564); compliance deadline 1 May 2026. This is based on EU Regulation 1223/2009 and its amendments.

What does Colloidal Silver do in cosmetics?

Colloidal Silver functions as: Antimicrobial; preservative; used historically in deodorants, anti-acne products, and preservation systems due to broad-spectrum antibacterial activity. It is classified as a Active Ingredient in our database. CAS number: 7440-22-4.

What is the NOAEL for Colloidal Silver?

The NOAEL (No Observed Adverse Effect Level) for Colloidal Silver is =0.00056 mg/kg bw/d based on a NOAEL study study via oral route in human. A total of 10 study endpoints are available. Source: SCCS_vision_codex.

Is Colloidal Silver classified as hazardous under GHS?

Colloidal Silver carries a GHS signal word of "WARNING". Hazard statements: Very toxic to aquatic life with long lasting effects. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.

Is Colloidal Silver used outside cosmetics?

Colloidal Silver also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Does Colloidal Silver have different safety status in cosmetics vs industrial chemicals?

Colloidal Silver is prohibited in EU cosmetics at max Nano silver particles prohibited under EU Omnibus VIII (Regulation EU 2024/2564); compliance deadline 1 May 2026 but has active industrial GHS classifications (H400, H410).

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