Good Preservative NOAEL Data SCCS/CIR Reviewed Sensitization Data Dermal Penetration

Chlorphenesin

INCI: CHLORPHENESIN

CAS Number
104-29-0
Function
Preservative; antimicrobial
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.3%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted; no concentration cap under FDA/MoCRA; cited as a preferable alternative to benzalkonium chloride for eye-area formulations

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for Chlorphenesin. 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
NOAEL ca.100 mg/kg bw/day oral rat oral REACH

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir
Verdict: safe

ailable data demonstrated an absence of toxicity. The Panel concluded that chlorphenesin is safe in the present practices of use and concentration. Keywords chlorphenesin, safety, cosmetics Introduction As stated in the International Cosmetic Ingredient Dictionary and Handbook,1 chlorphenesin fu

Sensitization Profile

Contact sensitization data for Chlorphenesin based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.2%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis

Source: ESSCA; IVDK; NACDG

Dermal Penetration Profile

Skin absorption and penetration characteristics of Chlorphenesin, relevant to systemic exposure and MoS calculations.

Absorption %
12-20%
Penetration Level
epidermis
Penetration Depth
epidermis/dermis
Molecular Weight
202.6 Da
Log P
1.88
Systemic Absorption
yes
Topical Bioavailability
8-16%
Safety Margin Factor
moderate
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: SCCS Opinion

Expert Verdict

Broad-spectrum preservative with better ocular compatibility than benzalkonium chloride (BAK), making it a preferred option in eye cosmetic formulations. EU Annex V listed at a maximum of 0.3%. Ophthalmological literature specifically identifies chlorphenesin alongside phenoxyethanol as alternatives to BAK for eye-area products, given BAK's documented corneal and conjunctival toxicity. Does not carry the tear film destabilization or meibomian gland damage associated with BAK. Suitable for mascara and eye-area rinse-off product preservation.

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Concern Level: Low

Regulatory Flags

preservative eu-annex-v eye-area-compatible bak-alternative better-ocular-compatibility mascara eu_cosing_listed

Frequently Asked Questions

Is Chlorphenesin safe in cosmetics?

Broad-spectrum preservative with better ocular compatibility than benzalkonium chloride (BAK), making it a preferred option in eye cosmetic formulations. EU Annex V listed at a maximum of 0.3%. Ophthalmological literature specifically identifies chlorphenesin alongside phenoxyethanol as alternatives to BAK for eye-area products, given BAK's documented corneal and conjunctival toxicity. Does not carry the tear film destabilization or meibomian gland damage associated with BAK. Suitable for mascara and eye-area rinse-off product preservation. The EU classifies Chlorphenesin as "restricted". Safety rating: GOOD. 1 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is Chlorphenesin allowed in the EU?

Chlorphenesin EU regulatory status: restricted. Maximum allowed concentration: 0.3%. This is based on EU Regulation 1223/2009 and its amendments.

What does Chlorphenesin do in cosmetics?

Chlorphenesin functions as: Preservative; antimicrobial. It is classified as a Preservative in our database. CAS number: 104-29-0.

What is the Margin of Safety for Chlorphenesin?

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 Chlorphenesin?

The NOAEL (No Observed Adverse Effect Level) for Chlorphenesin is ca.100 mg/kg bw/day based on a oral study via oral route in rat. Source: REACH.

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