Good Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed

Hexamidine

Also known as: Benzenecarboximidami​de, 4,​4'-​[1,​6-​hexanediylbis(oxy)​]​bis-, Benzamidine, 4,4'-(hexamethylenedioxy)di, 1,6-Bis(4-amidinophenoxy)-n-hexane, 1,6-Bis(4-amidinophenoxy)hexane, 4,4-Diamidino-1,6-diphenoxyhexane (+7 more)

INCI: HEXAMIDINE

Hexamidine (CAS 3811-75-4) is a cosmetic cosmetic ingredient functioning as Preservative / antimicrobial (biocide). Reported NOAEL =50 mg/kg/day in rat (CIR_vision_codex); EU Regulation 1223/2009 status: restricted, max 0.1%; 2 safety opinions reviewed (cir). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.

View industrial chemical safety profile for CAS 3811-75-4 →

Auto-generated CPSR Part A draft with source citations
Function
Preservative / antimicrobial (biocide)
Safety Rating
GOOD

Chemistry & Identifiers

Formula
C20H26N4O2
MW
354.4 g/mol
PubChem CID
65130
IUPAC Name
4-[6-(4-carbamimidoylphenoxy)hexoxy]benzenecarboximidamide
InChIKey
OQLKNTOKMBVBKV-UHFFFAOYSA-N

Regulatory Status

EU EU Status restricted
EU Max Conc. 0.1%
US US Status permitted
US Notes Permitted — no specific CFR restriction; CIR assessed as safe as used

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

4 study endpoints found for Hexamidine. 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 =50 mg/kg/day oral rat repeated dose toxicity CIR_vision_codex
NOAEL =50 mg/kg/day oral rat repeated dose toxicity CIR_vision_codex
NOAEL =50 mg/kg/day oral rat repeated dose toxicity CIR_vision_codex
NOAEL =50 mg/kg/day oral rat repeated dose toxicity CIR_vision_codex

Safety Opinions

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

cir
Verdict: unknown
NOAEL: 50 mg/kg/day (dermal)
cir
Verdict: unknown
NOAEL: 0.4 % (dermal)

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Preservative

Expert Verdict

Expert safety assessment and concern-level summary for Hexamidine.

Regulatory Flags

preservative

NOAEL Studies Summary

View details ->

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

Studies
4
Lowest NOAEL
50 mg/kg/day
Highest NOAEL
50 mg/kg/day
CIR_vision_codex

Known Synonyms

Benzenecarboximidami​de, 4,​4'-​[1,​6-​hexanediylbis(oxy)​]​bis- Benzamidine, 4,4'-(hexamethylenedioxy)di 1,6-Bis(4-amidinophenoxy)-n-hexane 1,6-Bis(4-amidinophenoxy)hexane 4,4-Diamidino-1,6-diphenoxyhexane Desmodine Hexamidine (antiseptic) 4,4'-(1,6-Hexanediylbis(oxy))bis-benzenecarboximidamide Hexamidina Hexamidinum UNII-3483C2H13H 4,4'-(Hexamethylenedioxy)dibenzamidine

Chemical Function

Preservative

Regulatory Lists

pharmaceutical Canada; pharmaceutical

Australian Status

AICIS status: listed

Frequently Asked Questions

Is Hexamidine safe in cosmetics?

Hexamidine has a safety rating of "GOOD" in our database. EU status: restricted. US status: permitted. 4 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is Hexamidine allowed in the EU?

Hexamidine EU regulatory status: restricted. Maximum allowed concentration: 0.1%. This is based on EU Regulation 1223/2009 and its amendments.

What does Hexamidine do in cosmetics?

Hexamidine functions as: Preservative / antimicrobial (biocide). It is classified as a cosmetic ingredient in our database. CAS number: 3811-75-4.

What is the NOAEL for Hexamidine?

The NOAEL (No Observed Adverse Effect Level) for Hexamidine is =50 mg/kg/day based on a repeated dose toxicity study via oral route in rat. A total of 4 study endpoints are available. Source: CIR_vision_codex.

Is Hexamidine used outside cosmetics?

Hexamidine also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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