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

Methylparaben

INCI: METHYLPARABEN

CAS Number
99-76-3
Function
preservative
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.4% (as acid); mixture cap all parabens 0.8%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR Panel concludes safe as used; no legal concentration cap 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

10 study endpoints found for Methylparaben. 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/day oral rat subchronic CIR
NOAEL 800 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 5700 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 550 mg/kg bw/day oral mouse Developmental COSMOS_DB
NOAEL 550 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 300 mg/kg bw/day oral hamster Developmental COSMOS_DB
NOAEL 300 mg/kg bw/day oral rabbit Developmental COSMOS_DB
NOAEL 1180 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 650 mg/kg bw/day oral hamster Developmental COSMOS_DB
NOAEL 4000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB

Safety Opinions

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

sccs SCCS/1652/23 14 December 2023
Verdict: unknown
NOAEL: 1000 mg/kg/day (oral)
Max Concentration: 0.4% in general
sccs SCCS/1652/23 14 December 2023
Verdict: unknown
NOAEL: 1000 mg/kg bw/day (not specified)
Max Concentration: 0.4% in general
sccs SCCS/1652/23 14 December 2023
Verdict: unknown
NOAEL: 250 mg/kg bw/day (not specified)
Max Concentration: 0.4% in general
sccs SCCS/1652/23 14 December 2023
Verdict: unknown
NOAEL: 300 mg/kg bw/day (not specified)
Max Concentration: 0.4% in general
sccs SCCS/1652/23 14 December 2023
Verdict: unknown
NOAEL: 300 mg/kg bw/day (oral)
Max Concentration: 0.4% in general

SCCS NOAEL Values

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

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/1652/23 (2023)

Sensitization Profile

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

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.5%
Cross-reactivity Group
paraben-group
Reaction Type
contact-dermatitis

Source: ESSCA; IVDK; SCCS/1348/10

Dermal Penetration Profile

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

Absorption %
20-30%
Penetration Level
dermis
Penetration Depth
epidermis/dermis
Molecular Weight
152.1 Da
Log P
1.96
Systemic Absorption
yes
Topical Bioavailability
15-25%
Safety Margin Factor
high
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: SCCS/1348/10, CIR

Expert Verdict

Well-studied paraben; SCCS confirmed safe at EU limit of 0.4%. Lowest concern among the paraben family with no child-use restrictions at this level. Reasonable choice where paraben-free positioning is not required.

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Concern Level: Low

Regulatory Flags

eu-restricted paraben endocrine-concern sccs-reviewed eu_children_restricted ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Methylparaben safe in cosmetics?

Well-studied paraben; SCCS confirmed safe at EU limit of 0.4%. Lowest concern among the paraben family with no child-use restrictions at this level. Reasonable choice where paraben-free positioning is not required. The EU classifies Methylparaben as "restricted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.

Is Methylparaben allowed in the EU?

Methylparaben EU regulatory status: restricted. Maximum allowed concentration: 0.4% (as acid); mixture cap all parabens 0.8%. This is based on EU Regulation 1223/2009 and its amendments.

What does Methylparaben do in cosmetics?

Methylparaben functions as: preservative. It is classified as a Preservative in our database. CAS number: 99-76-3.

What is the Margin of Safety for Methylparaben?

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 Methylparaben?

The NOAEL (No Observed Adverse Effect Level) for Methylparaben is =1000 mg/kg/day based on a subchronic study via oral route in rat. A total of 10 study endpoints are available. Source: CIR.

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