Is Chlorhexidine Digluconate safe in cosmetics?
Chlorhexidine Digluconate has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted.
Chlorhexidine Digluconate
Also known as: 2,4,11,13-Tetraazatetradecanediimidamide, N,N′′-bis(4-chlorophenyl)-3,12-diimino-, di-D-gluconate, D-Gluconic acid, compd. with 1,1′-hexamethylenebis[5-(p-chlorophenyl)biguanide] (2:1), D-Gluconic acid, compd. with N,N′′-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide (2:1), 1,1′-Hexamethylenebis[5-(p-chlorophenyl)biguanide] digluconate, Biguanide, 1,1'-hexamethylenebis(5-(p-chlorophenyl)-, digluconate (+15 more)
INCI: CHLORHEXIDINE DIGLUCONATE
Chlorhexidine Digluconate (CAS 18472-51-0) is a cosmetic preservative functioning as preservative; antimicrobial; antifungal. EU Regulation 1223/2009 status: restricted, 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 18472-51-0 →
Cross-Vertical Regulatory Divergence
Chlorhexidine Digluconate is classified GHS Danger (H302, H318, H400, H410, H317, H334) in the chemicals database but is restricted 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; antifungal
Editorial assessment
MODERATE
Preliminary editorial note — not a computed safety verdict.
Chemistry & Identifiers
IUPAC Name
(1E)-2-[6-[[amino-[(E)-[amino-(4-chloroanilino)methylidene]amino]methylidene]amino]hexyl]-1-[amino-(4-chloroanilino)methylidene]guanidine;bis((2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoic acid)
InChIKey
YZIYKJHYYHPJIB-UUPCJSQJSA-N
Regulatory Status
EU EU Status
restricted
EU Max Conc.
0.3%
US US Status
permitted
US Notes
Not covered under OTC antiseptic monograph; NDA required for drug claims; cosmetic use permitted per CIR at max 0.20% as chlorhexidine digluconate. No FDA ban on cosmetic use.
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 Digluconate.
Calculate MoS for your specific formulation with the MoS Calculator.
Sensitization Profile
Contact sensitization data for Chlorhexidine Digluconate based on clinical patch test studies and IFRA standards.
Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.3%
Cross-reactivity Group
none
Reaction Type
urticaria
Source: ESSCA; IVDK; NACDG
Dermal Penetration Profile
Skin absorption and penetration characteristics of Chlorhexidine Digluconate, relevant to systemic exposure and MoS calculations.
Absorption %
1-3%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
897.8 Da
Log P
-5.2
Systemic Absorption
minimal
Topical Bioavailability
0.5-2%
Safety Margin Factor
low
Vehicle Dependent
Yes — absorption varies by formulation
Source: SCCS Opinion
EPA ToxValDB — Toxicity Values
2 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | =1260 mg/kg | Mouse | oral | - | ChemIDplus |
| LD50 | =2000 mg/kg | Rat | oral | - | ChemIDplus |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100 - 1,000 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 0.050
Japan (Restricted): max Wash-away: No limit | Leave-on: 0.050% | Mucosa: 0.050%
Korea (Restricted): max 0.3%
Additional Jurisdictional Restrictions (2)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| JP | restricted | Wash-away: No limit | Leave-on: 0.050% | Mucosa: 0.050% | Wash-away: No limit | Leave-on: 0.050% | Mucosa: 0.050% |
| BR | permitted_preservative | 0.3 | 0.3% as chlorhexidine |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Fragrance
Preservative
Regulatory List Membership (1)
IFRA Fragrance Transparency List
Editorial summary
Preliminary editorial summary for Chlorhexidine Digluconate — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
contact-allergen
echa-regulatory-review
environmental-persistence
annex-v-preservative
concentration-restricted
endocrine-disruption-suspected
ifra_fragrance
Known Synonyms
2,4,11,13-Tetraazatetradecanediimidamide, N,N′′-bis(4-chlorophenyl)-3,12-diimino-, di-D-gluconate
D-Gluconic acid, compd. with 1,1′-hexamethylenebis[5-(p-chlorophenyl)biguanide] (2:1)
D-Gluconic acid, compd. with N,N′′-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide (2:1)
1,1′-Hexamethylenebis[5-(p-chlorophenyl)biguanide] digluconate
Biguanide, 1,1'-hexamethylenebis(5-(p-chlorophenyl)-, digluconate
1,6-Bis(5-(p-chlorophenyl)biguandino)hexane digluconate
Caswell No. 481G
EINECS 242-354-0
EPA Pesticide Chemical Code 045504
1,1'-Hexamethylenebis(5-(p-chlorophenyl)biguanide) gluconate
1,1'-Hexamethylenebis(5-(p-chlorophenyl)biguanide)digluconate
Orahexal
Plurexid
Dyna-hex
Periogard
Bactoshield CHG 2%
Exidine
Bioscrub
Brian Care
CHG Scrub
Chemical Function
Preservative
Biocide
Fragrance
Regulatory Lists
Europe; Personal care - body hygiene - hand soap
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
IFRA Transparency
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 GLUCONATE
ChEMBL ID
CHEMBL4297088
Max Phase
4
Adverse Event Associations
1999
Frequently Asked Questions
Is Chlorhexidine Digluconate allowed in the EU?
Chlorhexidine Digluconate EU regulatory status: restricted. Maximum allowed concentration: 0.3%. This is based on EU Regulation 1223/2009 and its amendments.
What does Chlorhexidine Digluconate do in cosmetics?
Chlorhexidine Digluconate functions as: preservative; antimicrobial; antifungal. It is classified as a Preservative in our database. CAS number: 18472-51-0.
Is Chlorhexidine Digluconate used outside cosmetics?
Chlorhexidine Digluconate 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 Digluconate have different safety status in cosmetics vs industrial chemicals?
Chlorhexidine Digluconate is classified GHS Danger (H302, H318, H400, H410, H317, H334) in the chemicals database but is restricted in EU cosmetics at max 0.3%.
Compliance Tools
Check Chlorhexidine Digluconate 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
Related Ingredients
4-Hydroxybenzoic Acid
EXCELLENT
Same category
Preservative, pH Balancer
Caprylhydroxamic Acid
EXCELLENT
Same category
preservative booster, chelating agent
Glyceryl Caprylate
EXCELLENT
Same category
Antimicrobial agent; emollient; prese...
Levulinic Acid
EXCELLENT
Same category
Preservative (combination systems); a...
Potassium Sorbate
EXCELLENT
Same category
preservative
Sodium Benzoate
EXCELLENT
Same category
preservative
(20S)-Protopanaxadiol
MODERATE
Similar safety
(Cnidium Officinale/Coptis Chinensis/Glycyrrhiza Uralensis) Root Extract
MODERATE
Similar safety
Skin conditioning
(Cryptomeria Japonica/Chamaecyparis Obtusa) Stem Ferment Extract
MODERATE
Similar safety
Antimicrobial, antioxidant, humectant
(Eclipta Prostrata/Houttuynia Cordata) Leaf Extract
MODERATE
Similar safety
Skin conditioning
(Lepidium Meyenii/Sarcodon Aspratus) Root Water
MODERATE
Similar safety
Skin conditioning
(Licorice/Reynoutria Japonica) Root/Stem Extract
MODERATE
Similar safety
Skin conditioning, antioxidant
Acid Red 92
GOOD
Chemical family
Colorant (halogenated xanthene dye; P...
Acid Red 92 (Phloxine B)
GOOD
Chemical family
Colorant (red/fluorescent pink), Hair...
CI 45405
GOOD
Chemical family
Colorant
Is Chlorhexidine Digluconate in Your Products?
Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.
Try Piro Free →Analyze Your Full Ingredient List
Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Chlorhexidine Digluconate in your formulation.