HEMA
Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Toxicological Studies
10 study endpoints found for HEMA. 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.
Expert Verdict
HEMA is listed in the EU CosIng database with functions: Nail Sculpting It is permitted in the EU without specific restrictions.
Regulatory Flags
Frequently Asked Questions
Is HEMA safe in cosmetics?
HEMA is listed in the EU CosIng database with functions: Nail Sculpting It is permitted in the EU without specific restrictions. The EU classifies HEMA as "Permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.
Is HEMA allowed in the EU?
HEMA EU regulatory status: Permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does HEMA do in cosmetics?
HEMA functions as: Nail Sculpting. It is classified as a cosmetic ingredient in our database. CAS number: 868-77-9.
What is the NOAEL for HEMA?
The NOAEL (No Observed Adverse Effect Level) for HEMA 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 classified as hazardous under GHS?
HEMA 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.
Compliance Tools
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