Is Chlorhexidine Dihydrochloride safe in cosmetics?
Chlorhexidine Dihydrochloride has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted.
Moderate
Cosmetic Ingredient
Chlorhexidine Dihydrochloride
Also known as: Biguanide, 1,1'-hexamethylenebis(5-(p-chlorophenyl)-, dihydrochloride, Caswell No. 481F, EINECS 223-026-6, EPA Pesticide Chemical Code 481700, 1,1'-Hexamethylenebis(5-(p-chlorophenyl)biguanide) dihydrochloride (+2 more)
INCI: CHLORHEXIDINE DIHYDROCHLORIDE
Chlorhexidine Dihydrochloride (CAS 3697-42-5) is a cosmetic cosmetic ingredient functioning as Preservative, antimicrobial (oral care, skin antisepsis). EU Regulation 1223/2009 status: permitted, max 0.3%. 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 3697-42-5 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Chlorhexidine Dihydrochloride is classified GHS Danger (H315, H319, H335, H373, H400, H410, H411, H317) in the chemicals database but is allowed in EU cosmetics at max 0.3%.
Source: Cosmetics: ingredients.eu_status/eu_max; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Preservative, antimicrobial (oral care, skin antisepsis)
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
(1E)-2-[6-[[amino-[(E)-[amino-(4-chloroanilino)methylidene]amino]methylidene]amino]hexyl]-1-[amino-(4-chloroanilino)methylidene]guanidine;dihydrochloride
InChIKey
WJLVQTJZDCGNJN-UHFFFAOYSA-N
Regulatory Status
EU EU Status
permitted
EU Max Conc.
0.3%
US US Status
permitted
US Notes
FDA: permitted in OTC drug products and cosmetics; monographed antimicrobial
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Chlorhexidine Dihydrochloride.
Calculate MoS for your specific formulation with the MoS Calculator.
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
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.
JPKR Japan/Korea Cosmetics
Japan (Positive (Preservative)): max 0.0010
Japan (Restricted): max Wash-away: 0.10% | Leave-on: 0.10% | Mucosa: 0.0010%
Additional Jurisdictional Restrictions (1)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| JP | restricted | Wash-away: 0.10% | Leave-on: 0.10% | Mucosa: 0.0010% | Wash-away: 0.10% | Leave-on: 0.10% | Mucosa: 0.0010% |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Preservative
Expert Verdict
Expert safety assessment and concern-level summary for Chlorhexidine Dihydrochloride.
Regulatory Flags
preservative
Known Synonyms
Biguanide, 1,1'-hexamethylenebis(5-(p-chlorophenyl)-, dihydrochloride
Caswell No. 481F
EINECS 223-026-6
EPA Pesticide Chemical Code 481700
1,1'-Hexamethylenebis(5-(p-chlorophenyl)biguanide) dihydrochloride
Chlorhexidine HCl
UNII-E64XL9U38K
Chemical Function
Biocide
Preservative
Regulatory Lists
active_ingredient; Australia
Canada; Personal care; Substances in PCP - Canada (4/2014)
active_ingredient; Europe; Pesticides
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
CHLORHEXIDINE HYDROCHLORIDE
ChEMBL ID
CHEMBL1484251
Max Phase
-1
Frequently Asked Questions
Is Chlorhexidine Dihydrochloride allowed in the EU?
Chlorhexidine Dihydrochloride EU regulatory status: permitted. Maximum allowed concentration: 0.3%. This is based on EU Regulation 1223/2009 and its amendments.
What does Chlorhexidine Dihydrochloride do in cosmetics?
Chlorhexidine Dihydrochloride functions as: Preservative, antimicrobial (oral care, skin antisepsis). It is classified as a cosmetic ingredient in our database. CAS number: 3697-42-5.
Is Chlorhexidine Dihydrochloride used outside cosmetics?
Chlorhexidine Dihydrochloride 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 Chlorhexidine Dihydrochloride have different safety status in cosmetics vs industrial chemicals?
Chlorhexidine Dihydrochloride is classified GHS Danger (H315, H319, H335, H373, H400, H410, H411, H317) in the chemicals database but is allowed in EU cosmetics at max 0.3%.
Compliance Tools
Check Chlorhexidine Dihydrochloride compliance across multiple jurisdictions:
Ingredient Decoder
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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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