Moderate Cosmetic Ingredient NOAEL Data GHS Classified Sensitization Data

HEMA (2-Hydroxyethyl Methacrylate)

Also known as: 2-propenoic acid, 2-methyl-, 2-hydroxyethyl ester, Ethylene glycol monomethacrylate, 4-02-00-01530, BRN 1071583, EINECS 212-782-2 (+12 more)

INCI: 2-HYDROXYETHYL METHACRYLATE

HEMA (2-Hydroxyethyl Methacrylate) (CAS 868-77-9) is a cosmetic cosmetic ingredient functioning as Monomer in artificial nail modelling systems (UV/LED gel nails). NOAEL 0.5 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 35%; GHS signal word WARNING. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.

View industrial chemical safety profile for CAS 868-77-9 →

Auto-generated CPSR Part A draft with source citations
Function
Monomer in artificial nail modelling systems (UV/LED gel nails)
Safety Rating
MODERATE

Chemistry & Identifiers

Formula
C6H10O3
MW
130.14 g/mol
EC Number
212-782-2
PubChem CID
13360
IUPAC Name
2-hydroxyethyl 2-methylprop-2-enoate
InChIKey
WOBHKFSMXKNTIM-UHFFFAOYSA-N

Regulatory Status

EU EU Status restricted
EU Max Conc. 35%
US US Status permitted
US Notes Permitted — no FDA-specific concentration limit or professional-use restriction for cosmetic nail products; however, MoCRA general safety provisions apply

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for HEMA (2-Hydroxyethyl Methacrylate).

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 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 =100 mg/kg bw/day oral Rat subchronic ToxValDB_ECHA_IUCLID
NOAEL =300 mg/kg bw/day oral Rat subchronic ToxValDB_ECHA_IUCLID

GHS Hazard Classification

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

Signal Word
WARNING
Pictograms
Excl markWarnCancerHealth 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.

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for HEMA (2-Hydroxyethyl Methacrylate) across SCCS product categories, with measured dermal absorption where available.

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

EU CLP Annex VI Harmonized Classification

Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.

Signal Word
Warning
Pictograms
Harmful / Irritant
Hazard Class and Category
Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
Hazard Statements
  • H315 Causes skin irritation
  • H319 Causes serious eye irritation
  • H317 May cause an allergic skin reaction

Inserted via ATP: CLP00

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
10,000 - 100,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)

Expanded Jurisdictional Detail

Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.

SA Saudi SFDA (III - Restricted)
Product type: Nail products.
BRIN Brazil/India Cosmetics
India: Restricted

Additional Ingredient Properties

1 property record from structured ingredient metadata.

allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "other", "cross_reactivity_group": "acrylate-group", "patch_test_frequency_pct": "2.3", "sensitization_rate": "moderate", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "ESSCA 2019/20"}

PubChem Annotations

Safety and regulatory annotations from PubChem (NCBI) aggregated sources.

Safety (2)
ICSC Safety Card
1724
Source: ILO-WHO International Chemical Safety Cards (ICSCs)
Skin Eye Respiratory Irritation
Irritating to eyes and skin.
Source: Hazardous Substances Data Bank (HSDB)

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Film former Thickening agent
Regulatory List Membership (1)
FDA Indirect Food Contact Additives

Expert Verdict

Expert safety assessment and concern-level summary for HEMA (2-Hydroxyethyl Methacrylate).

Regulatory Flags

potential-allergen

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to HEMA (2-Hydroxyethyl Methacrylate) by CAS number or substance name.

Studies
71
Lowest NOAEL
0.5 mg/kg bw/day
Highest NOAEL
16773 mg/kg bw/day
ToxValDB_ECHA_IUCLID ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip

Known Synonyms

2-propenoic acid, 2-methyl-, 2-hydroxyethyl ester Ethylene glycol monomethacrylate 4-02-00-01530 BRN 1071583 EINECS 212-782-2 Ethylene glycol, monomethacrylate Mhoromer Monomer MG-1 Monomethacrylic ether of ethylene glycol UNII-6E1I4IV47V (hydroxyethyl)methacrylate 1,2-Ethanediol mono(2-methyl)-2-propenoate 2-Hydroxyethyl 2-methylacrylate 2-Hydroxyethylmethacrylate Ethylene glycol methacrylate HEMA beta-Hydroxyethyl methacrylate

Chemical Function

Film former

Regulatory Lists

Indirect additives food contact (10/2018) Arts and crafts/Office supplies; Europe air; Cons electronics mech appliances and machinery; detected; emissions; Europe Europe; Personal care - nails

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

ChEMBL ID
CHEMBL1730239
View full pharmaceutical profile →

Frequently Asked Questions

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

HEMA (2-Hydroxyethyl Methacrylate) has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted. 2 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 NOAEL for HEMA (2-Hydroxyethyl Methacrylate)?

The NOAEL (No Observed Adverse Effect Level) for HEMA (2-Hydroxyethyl Methacrylate) is =100 mg/kg bw/day based on a subchronic study via oral route in Rat. A total of 2 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.

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 — at cosmetic use concentrations, hazard thresholds may not be met.

Is HEMA (2-Hydroxyethyl Methacrylate) used outside cosmetics?

HEMA (2-Hydroxyethyl Methacrylate) also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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