Moderate Preservative NOAEL Data Sensitization Data Dermal Penetration

Propylparaben

INCI: PROPYLPARABEN

CAS Number
94-13-3
Function
Preservative
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.14% (as acid)
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR concludes safe as used; no legal cap. Propyl+butyl aggregate concern noted by SCCS but not reflected in US rules.

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

10 study endpoints found for Propylparaben. 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 1500 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 5700 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 1000 mg/kg bw/day oral hamster Developmental COSMOS_DB
NOAEL 4000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 1000 mg/kg bw/day oral dog Chronic COSMOS_DB
NOAEL 3000 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 100 mg/kg bw/day oral mouse Special Toxicology Study COSMOS_DB
NOAEL 12 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
LOAEL 12 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB

SCCS NOAEL Values

NOAEL/LOAEL values cited in official SCCS opinions for Propylparaben.

NOAEL LOAEL Route Species Study DA% (SCCS) Opinion
1000 mg/kg/day - Oral Rat (Wistar) Extended one-generation reproductive (OECD 443) (~10 weeks premating + gestation + lactation) 100 SCCS/1623/20 (2021)

Sensitization Profile

Contact sensitization data for Propylparaben 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 Propylparaben, relevant to systemic exposure and MoS calculations.

Absorption %
30-40%
Penetration Level
dermis
Penetration Depth
full dermis
Molecular Weight
180.2 Da
Log P
3.04
Systemic Absorption
yes
Topical Bioavailability
20-35%
Safety Margin Factor
very-high
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: SCCS/1348/10, CIR

Expert Verdict

Moderate concern paraben restricted to 0.14% in EU and banned in leave-on nappy-area products for infants under 3 years due to aggregate exposure risk across multiple products and higher absorption in infant skin; acceptable in adult rinse-off formulations with transparent labeling.

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Concern Level: Moderate

Regulatory Flags

eu-restricted paraben endocrine-concern child-safety sccs-reviewed nappy-area-ban eu_children_restricted ifra_fragrance fda_food_additive jecfa_concern

Frequently Asked Questions

Is Propylparaben safe in cosmetics?

Moderate concern paraben restricted to 0.14% in EU and banned in leave-on nappy-area products for infants under 3 years due to aggregate exposure risk across multiple products and higher absorption in infant skin; acceptable in adult rinse-off formulations with transparent labeling. The EU classifies Propylparaben as "restricted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.

Is Propylparaben allowed in the EU?

Propylparaben EU regulatory status: restricted. Maximum allowed concentration: 0.14% (as acid). This is based on EU Regulation 1223/2009 and its amendments.

What does Propylparaben do in cosmetics?

Propylparaben functions as: Preservative. It is classified as a Preservative in our database. CAS number: 94-13-3.

What is the Margin of Safety for Propylparaben?

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 Propylparaben?

The NOAEL (No Observed Adverse Effect Level) for Propylparaben is 1500 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

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