Is Chlorhexidine safe in cosmetics?
Chlorhexidine has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted.
Moderate
Preservative
Chlorhexidine
Also known as: 2,4,11,13-Tetraazatetradecanediimidamide, N,N''-bis(4-chlorophenyl)-3,12-diimino-, 2,4,11,13-Tetraazatetradecanediimidamide, N1,N14-bis(4-chlorophenyl)-3,12-diimino-, N1,N14-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide, 4-12-00-01201, 1,6-Bis(5-(p-chlorophenyl)biguandino)hexane (+14 more)
INCI: CHLORHEXIDINE
Chlorhexidine (CAS 55-56-1) is a cosmetic preservative functioning as Preservative. NOAEL 360 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 55-56-1 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Chlorhexidine is classified GHS Danger (H302, H315, H318, H319, H334, H335, H373, H400) in the chemicals database but is allowed in EU cosmetics.
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Preservative
Safety Rating
MODERATE
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
FDA-regulated antiseptic; permitted in clinical/medical applications. Contraindicated for routine intimate deodorizing use due to broad-spectrum antimicrobial activity that eliminates protective Lactobacillus populations alongside pathogens.
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.
Calculate MoS for your specific formulation with the MoS Calculator.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Chlorhexidine across SCCS product categories, with measured dermal absorption where available.
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Cosmetic-Specific Mechanism
Category: preservative
Receptor targets: AR, TR (limited)
LOEC: 1 µM
EU status: restricted (max 0.3%)
modulator (weak)
Dose-Response Data Points
| Endpoint | Target | Value | Direction |
|---|---|---|---|
| AR antagonism (inhibition of DHT-induced activation) | AR | EC50/IC50: IC50 = 1.66 µM (anti-androgenic, BMAEREluc/AR); LOEC: ~0.5 µM; NOEC: not established mixed | antagonist |
| ERα antagonism (anti-estrogenic, inhibits E2 response) | ERα | EC50/IC50: IC50 = 2.9 µM (anti-estrogenic, T47D-KBluc); LOEC: ~1 µM; NOEC: not established mixed | antagonist |
| TR and ER/AR signaling interactions | AR / ERα / thyroid (indirect via lipid peroxidation / mitochondrial) | EC50/IC50: IC50 (AR antagonism) = 1.66 µM; IC50 (ER antagonism) = 2.9 µM; thyroid IC50 not established; LOEC: 0.5 µM (AR); 1 µM (ER); NOEC: not established mixed | pleiotropic disruptor |
| Cortisol and E2 production in H295R cells | Steroidogenesis (adrenal / gonadal) | EC50/IC50: LOEC ~1 µM for cortisol effects; EC50 not reported; LOEC: ~1 µM; NOEC: not established mixed | modulator (E2↓ at high doses; cortisol pathway effects) |
| AhR transactivation (indirect / weak) | AhR (aryl hydrocarbon receptor) | EC50/IC50: No formal EC50 reported; low-level AhR activation noted in some studies at ≥10 µM; LOEC: ~10 µM (estimated); NOEC: not established mixed | weak inducer |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Intermediate
Tonnage Band
Intermediate use only
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
Korea (Restricted): max 0.3
Japan (Restricted): max Wash-away: 0.10% | Leave-on: 0.050% | Mucosa: 0.050%
Additional Jurisdictional Restrictions (4)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| JP | restricted | Wash-away: 0.10% | Leave-on: 0.050% | Mucosa: 0.050% | Wash-away: 0.10% | Leave-on: 0.050% | Mucosa: 0.050% |
| CN | permitted_preservative | 0.3 | (a) Oral care (b) Other cosmetics |
| IN | permitted_preservative | 0.3 | all cosmetics |
| BR | permitted_preservative | 0.3 | 0.3% as chlorhexidine |
Additional Ingredient Properties
4 property records from structured ingredient metadata.
microbiome_impact
{"microbiome_effect": "negative", "prebiotic": "no", "probiotic_compatible": "no", "antimicrobial_spectrum": "broad", "preservative_effect_on_microbiome": "Broad-spectrum antiseptic; severe commensal disruption", "skin_flora_disruption": "severe", "gut_microbiome_risk": "moderate", "microbiome_recovery_time": "14-21 days", "selective_antimicrobial": "no", "pathogen_inhibition": "S. aureus, S. epid…
pediatric_safety
{"safe_for_newborn_0_6m": "caution", "safe_for_infant_6_12m": "caution", "safe_for_toddler_1_3y": "yes", "safe_for_child_3_12y": "yes", "safe_for_teen_12_18y": "yes", "pediatric_max_concentration_pct": "0.3", "adult_max_concentration_pct": "4.0", "pediatric_dermal_absorption_factor": "moderate", "immature_skin_barrier_risk": "low", "oral_ingestion_risk": "low", "eye_irritation_risk": "moderate", "…
pregnancy_detail
{"pregnancy_safe": "yes", "breastfeeding_safe": "insufficient-data", "risk_category": "FDA-B", "reason": "Safe topically; antiseptic", "source": "FDA"}
uv_stability
{"uv_stable": "yes", "uv_degradation_rate": "stable", "photosensitizer": "no", "phototoxic": "no", "photoallergic": "no", "requires_uv_protection_packaging": "no", "color_change_uv": "no", "odor_change_uv": "no", "efficacy_loss_uv_pct": "0", "spf_contribution": "no", "uva_protection": "no", "uvb_protection": "no", "photostable_sunscreen": "no", "boost_spf_of_others": "no", "antioxidant_under_uv": …
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Preservative
Expert Verdict
Expert safety assessment and concern-level summary for Chlorhexidine.
Regulatory Flags
intimate-avoid
microbiome-disruptive
antimicrobial
lactobacillus-killer
contact-sensitizer
anaphylaxis-risk
routine-use-contraindicated
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Chlorhexidine by CAS number or substance name.
Studies
6
Lowest NOAEL
0.18 mg/kg bw/day
Highest NOAEL
10 mg/kg bw/day
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip
Known Synonyms
2,4,11,13-Tetraazatetradecanediimidamide, N,N''-bis(4-chlorophenyl)-3,12-diimino-
2,4,11,13-Tetraazatetradecanediimidamide, N1,N14-bis(4-chlorophenyl)-3,12-diimino-
N1,N14-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide
4-12-00-01201
1,6-Bis(5-(p-chlorophenyl)biguandino)hexane
1,6-Bis(p-chlorophenyldiguanido)hexane
BRN 2826432
1,6-Di(4'-chlorophenyldiguanido)hexane
EINECS 200-238-7
1,1'-Hexamethylenebis(5-(p-chlorophenyl)biguanide)
Chlorhexidinum
Cloresidina
UNII-R4KO0DY52L
1,1'-Hexamethylene bis(5-(p-chlorophenyl)biguanide)
Chlorhexidin [Czech]
Chlorhexidinum [INN-Latin]
Cloresidina [DCIT]
Clorhexidina [INN-Spanish]
N,N'-Bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide
Chemical Function
Biocide
Preservative
Regulatory Lists
Canada; consumer_product; Substances in Products - Canada (4/2014)
pharmaceutical
active_ingredient; animal_products; Europe; pharmaceutical; residue
Europe; pharmaceutical
Canada; pharmaceutical
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
ChEMBL ID
CHEMBL790
Max Phase
4
Adverse Event Associations
3208
Frequently Asked Questions
Is Chlorhexidine allowed in the EU?
Chlorhexidine EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Chlorhexidine do in cosmetics?
Chlorhexidine functions as: Preservative. It is classified as a Preservative in our database. CAS number: 55-56-1.
Is Chlorhexidine used outside cosmetics?
Chlorhexidine 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 have different safety status in cosmetics vs industrial chemicals?
Chlorhexidine is classified GHS Danger (H302, H315, H318, H319, H334, H335, H373, H400) in the chemicals database but is allowed in EU cosmetics.
Compliance Tools
Check Chlorhexidine 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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