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

Butylparaben

INCI: BUTYLPARABEN

CAS Number
94-26-8
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. SCCS aggregate-exposure concerns not captured in US framework.

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 Butylparaben. 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 =160 mg/kg/day oral rat reproductive CIR
NOAEL 1875 mg/kg bw/day oral mouse Short Term Toxicity COSMOS_DB
NOAEL 900 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
NOAEL 4000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 800 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 10 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 14 mg/kg bw/day oral mouse Short Term Toxicity COSMOS_DB
LOAEL 14.3999996185 mg/kg bw/day oral mouse Subchronic COSMOS_DB
LOAEL 10 mg/kg bw/day oral rat Subchronic COSMOS_DB
dose_tested 900 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB

Safety Opinions

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

sccs SCCS/1674/25 30 April 2025
Verdict: unknown
Max Concentration: 0.14% in general
sccs SCCS/1674/25 30 April 2025
Verdict: unknown
Max Concentration: 0.197% in general
sccs SCCS/1651/23 26 October 2023
Verdict: unknown
NOAEL: 325 mg/kg bw/day (not specified)
Max Concentration: 0.14% in general
sccs SCCS/1651/23 26 October 2023
Verdict: unknown
NOAEL: 325 mg/kg bw/day (not specified)
Max Concentration: 0.197% in general
sccs SCCS/1651/23 26 October 2023
Verdict: unknown
NOAEL: 325 mg/kg bw/day (not specified)
Max Concentration: 0.6% in general

SCCS NOAEL Values

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

NOAEL LOAEL Route Species Study DA% (SCCS) Opinion
1000 mg/kg/day - Oral Rat (Wistar) Extended one-generation reproductive (OECD 443) (Multi-generation) 100 SCCS/1651/23 (2023)

Sensitization Profile

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

Absorption %
35-45%
Penetration Level
dermis
Penetration Depth
full dermis/systemic
Molecular Weight
194.2 Da
Log P
3.57
Systemic Absorption
yes
Topical Bioavailability
25-40%
Safety Margin Factor
very-high
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: SCCS/1348/10, CIR

Expert Verdict

Highest-concern paraben in current science. SCCS 2025: not safe for children 0.5โ€“10 when used across multiple product categories due to aggregate endocrine exposure. Unsuitable for any product line targeting children or families. The clean-beauty market has largely moved away from butylparaben even in adult formulations. Avoid unless there is a specific technical reason and adult-only positioning can be guaranteed.

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Concern Level: High

Regulatory Flags

eu-restricted paraben endocrine-disruptor child-safety sccs-reviewed nappy-area-ban avoid-in-children high-aggregate-exposure-risk eu_children_restricted ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Butylparaben safe in cosmetics?

Highest-concern paraben in current science. SCCS 2025: not safe for children 0.5โ€“10 when used across multiple product categories due to aggregate endocrine exposure. Unsuitable for any product line targeting children or families. The clean-beauty market has largely moved away from butylparaben even in adult formulations. Avoid unless there is a specific technical reason and adult-only positioning can be guaranteed. The EU classifies Butylparaben as "restricted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.

Is Butylparaben allowed in the EU?

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

What does Butylparaben do in cosmetics?

Butylparaben functions as: Preservative. It is classified as a Preservative in our database. CAS number: 94-26-8.

What is the Margin of Safety for Butylparaben?

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 Butylparaben?

The NOAEL (No Observed Adverse Effect Level) for Butylparaben is =160 mg/kg/day based on a reproductive study via oral route in rat. A total of 10 study endpoints are available. Source: CIR.

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