Moderate Preservative NOAEL Data

Chlorhexidine

INCI: CHLORHEXIDINE

CAS Number
55-56-1
Function
Preservative
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ 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 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

4 study endpoints found for Chlorhexidine. 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
NOEL 360 mg/kg bw/day dermal code:3484 dermal REACH
LOAEL 8.88 mg/kg bw/day oral rat oral REACH
LOAEL 50 other oral rat oral REACH
NOAEL 0.5 other other dog oral REACH

Expert Verdict

Avoid for routine intimate deodorizing. Broad-spectrum antimicrobial activity eliminates protective Lactobacillus populations, disrupting vaginal microbiome community state types and increasing susceptibility to BV, Candida, and UTIs. Contact sensitization risk is documented, including anaphylaxis in sensitive individuals, and is amplified by intimate skin characteristics. Appropriate only for clinical/surgical antisepsis, not for intimate hygiene products.

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Concern Level: Moderate

Regulatory Flags

intimate-avoid microbiome-disruptive antimicrobial lactobacillus-killer contact-sensitizer anaphylaxis-risk routine-use-contraindicated

Frequently Asked Questions

Is Chlorhexidine safe in cosmetics?

Avoid for routine intimate deodorizing. Broad-spectrum antimicrobial activity eliminates protective Lactobacillus populations, disrupting vaginal microbiome community state types and increasing susceptibility to BV, Candida, and UTIs. Contact sensitization risk is documented, including anaphylaxis in sensitive individuals, and is amplified by intimate skin characteristics. Appropriate only for clinical/surgical antisepsis, not for intimate hygiene products. The EU classifies Chlorhexidine as "permitted". Safety rating: MODERATE. 4 toxicological study endpoint(s) are available in our database.

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.

What is the Margin of Safety for Chlorhexidine?

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.

What is the NOAEL for Chlorhexidine?

The NOAEL (No Observed Adverse Effect Level) for Chlorhexidine is 360 mg/kg bw/day based on a dermal study via dermal route in code:3484. A total of 4 study endpoints are available. Source: REACH.

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