Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
3 study endpoints found for Acetaminophen. 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 |
|---|---|---|---|---|---|
| LOEL | 12500 ppm | oral | rat | oral | REACH |
| LOAEL | 3000 other | oral | rat | oral | REACH |
| LOEL | 25000 ppm | oral | mouse | oral | REACH |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Expert Verdict
Hepatotoxicity risk at systemic doses; borderline cosmetic/drug classification as any therapeutic claim triggers drug regulation in both EU and US.
Frequently Asked Questions
Is Acetaminophen safe in cosmetics?
Hepatotoxicity risk at systemic doses; borderline cosmetic/drug classification as any therapeutic claim triggers drug regulation in both EU and US. The EU classifies Acetaminophen as "permitted". Safety rating: MODERATE. 3 toxicological study endpoint(s) are available in our database.
Is Acetaminophen allowed in the EU?
Acetaminophen EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Acetaminophen do in cosmetics?
Acetaminophen functions as: Skin conditioning; primarily a pharmaceutical (paracetamol). It is classified as a cosmetic ingredient in our database. CAS number: 103-90-2.
What is the Margin of Safety for Acetaminophen?
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 Acetaminophen?
The NOAEL (No Observed Adverse Effect Level) for Acetaminophen is 12500 ppm based on a oral study via oral route in rat. A total of 3 study endpoints are available. Source: REACH.
Is Acetaminophen classified as hazardous under GHS?
Acetaminophen carries a GHS signal word of "WARNING". Hazard statements: May cause damage to liver and kidneys through prolonged or repeated exposure if swallowed 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.
Compliance Tools
Check Acetaminophen compliance across multiple jurisdictions:
Related Ingredients
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