Moderate Cosmetic Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed

Maleic Acid

INCI: MALEIC ACID

CAS Number
110-16-7
Function
pH adjuster, buffering agent
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Safety limited to neutralized form. Unneutralized acid causes severe irritation.

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Maleic Acid. 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
LOAEL 20 mg/kg bw/day oral rat oral REACH
NOAEL ca.250 mg/kg bw/day oral rat oral REACH
NOEL 100 mg/kg bw/day oral rat oral REACH
NOEL 10 other oral rat oral REACH
NOEL 60 other oral dog oral REACH
NOEL 60 mg/kg bw/day oral dog oral REACH
LOEL 32 mg/kg bw/day oral rat oral REACH
NOEL 40 mg/kg bw/day oral rat oral REACH
LOEL 100 mg/kg bw/day oral rat oral REACH
LOEL 250 mg/kg bw/day oral rat oral REACH

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Signal Word
WARNING
Pictograms
corr; excl mark;warn
Hazard Statements
May be osive to metals Harmful if swallowed or in contact with skin Causes skin and eye irritation May cause an allergic skin reaction May cause respiratory irritation Toxic to aquatic life
Short-term Exposure Effects
The substance is severely irritating to the eyes. The substance is irritating to the skin and respiratory tract.
Long-term Exposure Effects
Repeated or prolonged contact with skin may cause dermatitis. Repeated or prolonged contact may cause skin sensitization.
Routes of Exposure
The substance can be absorbed into the body by inhalation and by ingestion.

Safety Opinions

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

cir 30 November 2006
Verdict: unknown

Expert Verdict

Safe only as pH adjuster in neutralized form; unneutralized acid causes severe irritation and vesicular dermatitis at 20% concentration.

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Concern Level: Moderate

Regulatory Flags

CONTROVERSIAL

Frequently Asked Questions

Is Maleic Acid safe in cosmetics?

Safe only as pH adjuster in neutralized form; unneutralized acid causes severe irritation and vesicular dermatitis at 20% concentration. The EU classifies Maleic Acid as "permitted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is Maleic Acid allowed in the EU?

Maleic Acid EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Maleic Acid do in cosmetics?

Maleic Acid functions as: pH adjuster, buffering agent. It is classified as a cosmetic ingredient in our database. CAS number: 110-16-7.

What is the Margin of Safety for Maleic Acid?

not established 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 Maleic Acid?

The NOAEL (No Observed Adverse Effect Level) for Maleic Acid is 20 mg/kg bw/day based on a oral study via oral route in rat. A total of 10 study endpoints are available. Source: REACH.

Is Maleic Acid classified as hazardous under GHS?

Maleic Acid carries a GHS signal word of "WARNING". Hazard statements: May be osive to metals Harmful if swallowed or in contact with skin Causes skin and eye irritation May cause an allergic skin reaction May cause respiratory irritation Toxic to aquatic life. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance โ€” at cosmetic use concentrations, hazard thresholds may not be met.

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