Good Preservative NOAEL Data Sensitization Data Dermal Penetration

Ethylparaben

INCI: ETHYLPARABEN

CAS Number
120-47-8
Function
preservative
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.4% as acid in finished product; 0.8% cap for total paraben mixture
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR Panel: safe as used. No legal concentration caps under FDA/MoCRA.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

8 study endpoints found for Ethylparaben. 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 >=1000 mg/kg bw/day oral rat oral REACH
NOEL 1000 mg/kg bw/day oral rat oral REACH
NOAEL >=1000 mg/kg bw/day oral - oral REACH
NOAEL >=900 mg/kg bw/day oral rat oral REACH
NOAEL >=1200 mg/kg bw/day oral rat oral REACH
LOAEL 4000 mg/kg bw/day oral rabbit oral REACH
NOAEL >=1000 mg/kg bw/day oral dog oral REACH
NOAEL >1000 mg/kg bw/day oral - oral REACH

Sensitization Profile

Contact sensitization data for Ethylparaben 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
paraben-group
Reaction Type
contact-dermatitis

Source: ESSCA; IVDK; SCCS/1348/10

Dermal Penetration Profile

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

Absorption %
25-35%
Penetration Level
dermis
Penetration Depth
epidermis/dermis
Molecular Weight
166.2 Da
Log P
2.47
Systemic Absorption
yes
Topical Bioavailability
18-30%
Safety Margin Factor
very-high
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: SCCS/1348/10, CIR

Expert Verdict

SCCS grouped ethylparaben with methylparaben in its EDC reassessment and confirmed safety at the existing 0.4% limit. Estrogenic potency is marginally greater than methylparaben due to slightly longer alkyl chain, but remains well below biological significance at permitted concentrations. Aggregate exposure across multiple concurrent products is the key risk consideration.

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Concern Level: Low

Regulatory Flags

paraben restricted eu-annex-v sccs-edc-assessed estrogenic-activity eu_children_restricted ifra_fragrance

Frequently Asked Questions

Is Ethylparaben safe in cosmetics?

SCCS grouped ethylparaben with methylparaben in its EDC reassessment and confirmed safety at the existing 0.4% limit. Estrogenic potency is marginally greater than methylparaben due to slightly longer alkyl chain, but remains well below biological significance at permitted concentrations. Aggregate exposure across multiple concurrent products is the key risk consideration. The EU classifies Ethylparaben as "restricted". Safety rating: GOOD. 8 toxicological study endpoint(s) are available in our database.

Is Ethylparaben allowed in the EU?

Ethylparaben EU regulatory status: restricted. Maximum allowed concentration: 0.4% as acid in finished product; 0.8% cap for total paraben mixture. This is based on EU Regulation 1223/2009 and its amendments.

What does Ethylparaben do in cosmetics?

Ethylparaben functions as: preservative. It is classified as a Preservative in our database. CAS number: 120-47-8.

What is the Margin of Safety for Ethylparaben?

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 Ethylparaben?

The NOAEL (No Observed Adverse Effect Level) for Ethylparaben is >=1000 mg/kg bw/day based on a oral study via oral route in rat. A total of 8 study endpoints are available. Source: REACH.

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