Moderate Cosmetic Ingredient NOAEL Data GHS Classified Sensitization Data

HEMA (2-Hydroxyethyl Methacrylate)

INCI: 2-HYDROXYETHYL METHACRYLATE

CAS Number
868-77-9
Function
Monomer in artificial nail modelling systems (UV/LED gel nails)
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 35%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted โ€” no FDA-specific concentration limit or professional-use restriction for cosmetic nail products; however, MoCRA general safety provisions apply

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for HEMA (2-Hydroxyethyl Methacrylate). 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 >=161.3 mg/kg bw/day oral - oral REACH
NOAEL >=124.1 mg/kg bw/day oral rat oral REACH
NOAEL 0.5 other 1991 rat inhalation REACH
NOAEL 100 mg/kg bw/day oral rat oral REACH
NOAEL >=600 mg/kg bw/day oral rat oral REACH
NOAEL 3230 mg/kg bw/day oral mouse oral REACH
NOAEL 150 mg/kg bw/day oral rat oral REACH
NOAEL 1500 mg/kg bw/day oral mouse oral REACH
NOAEL >=1258 mg/kg bw/day oral - oral REACH
NOAEL 6762 mg/kg bw/day oral - 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
excl mark;warn; cancer;health haz
Hazard Statements
May be harmful if swallowed Causes skin and eye irritation May cause allergic skin reaction May be harmful if swallowed and enters airways
Short-term Exposure Effects
The substance is irritating to the eyes, skin and respiratory tract. If this liquid is swallowed, aspiration into the lungs may result in chemical pneumonitis.
Long-term Exposure Effects
Repeated or prolonged contact may cause skin sensitization. See Notes.

Sensitization Profile

Contact sensitization data for HEMA (2-Hydroxyethyl Methacrylate) based on clinical patch test studies and IFRA standards.

Sensitization Rate
moderate
Allergen Class
other
EU Allergen Listed
no
Patch Test Positive Rate
2.3%
Cross-reactivity Group
acrylate-group
Reaction Type
contact-dermatitis

Source: ESSCA 2019/20

Expert Verdict

Contact dermatitis epidemic among nail technicians and consumers with cross-sensitization to other methacrylates; impurity profiling needed (methacrylic acid, EGDMA); restricted in EU to professional use only; occupational exposure monitoring recommended; 55% of products surveyed lacked required allergic reaction warning.

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Concern Level: Moderate

Regulatory Flags

potential-allergen

Frequently Asked Questions

Is HEMA (2-Hydroxyethyl Methacrylate) safe in cosmetics?

Contact dermatitis epidemic among nail technicians and consumers with cross-sensitization to other methacrylates; impurity profiling needed (methacrylic acid, EGDMA); restricted in EU to professional use only; occupational exposure monitoring recommended; 55% of products surveyed lacked required allergic reaction warning. The EU classifies HEMA (2-Hydroxyethyl Methacrylate) as "restricted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.

Is HEMA (2-Hydroxyethyl Methacrylate) allowed in the EU?

HEMA (2-Hydroxyethyl Methacrylate) EU regulatory status: restricted. Maximum allowed concentration: 35%. This is based on EU Regulation 1223/2009 and its amendments.

What does HEMA (2-Hydroxyethyl Methacrylate) do in cosmetics?

HEMA (2-Hydroxyethyl Methacrylate) functions as: Monomer in artificial nail modelling systems (UV/LED gel nails). It is classified as a cosmetic ingredient in our database. CAS number: 868-77-9.

What is the Margin of Safety for HEMA (2-Hydroxyethyl Methacrylate)?

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 HEMA (2-Hydroxyethyl Methacrylate)?

The NOAEL (No Observed Adverse Effect Level) for HEMA (2-Hydroxyethyl Methacrylate) is >=161.3 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 HEMA (2-Hydroxyethyl Methacrylate) classified as hazardous under GHS?

HEMA (2-Hydroxyethyl Methacrylate) carries a GHS signal word of "WARNING". Hazard statements: May be harmful if swallowed Causes skin and eye irritation May cause allergic skin reaction May be harmful if swallowed and enters airways. 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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