Moderate Preservative Sensitization Data Dermal Penetration

Chlorhexidine Digluconate

INCI: CHLORHEXIDINE DIGLUCONATE

CAS Number
18472-51-0
Function
preservative; antimicrobial; antifungal
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.3%
๐Ÿ‡บ๐Ÿ‡ธ 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 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
high

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 โ€” absorption varies by formulation

Source: SCCS Opinion

Expert Verdict

Chlorhexidine digluconate is a restricted preservative in the EU (Annex V, max 0.3% as chlorhexidine) with regulatory concerns regarding environmental persistence and potential endocrine disruption. In the US, cosmetic use is permitted per CIR at concentrations up to 0.20%, though it does not qualify for OTC antiseptic monograph use.

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Concern Level: Moderate

Regulatory Flags

contact-allergen echa-regulatory-review environmental-persistence annex-v-preservative concentration-restricted endocrine-disruption-suspected ifra_fragrance

Frequently Asked Questions

Is Chlorhexidine Digluconate safe in cosmetics?

Chlorhexidine digluconate is a restricted preservative in the EU (Annex V, max 0.3% as chlorhexidine) with regulatory concerns regarding environmental persistence and potential endocrine disruption. In the US, cosmetic use is permitted per CIR at concentrations up to 0.20%, though it does not qualify for OTC antiseptic monograph use. The EU classifies Chlorhexidine Digluconate as "restricted". Safety rating: MODERATE.

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.

What is the Margin of Safety for Chlorhexidine Digluconate?

adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

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