Moderate Cosmetic Ingredient NOAEL Data GHS Classified

Acetaminophen

Also known as: 4-Acetamidophenol, Paracetamol, 4-hydroxyacetanilide, APAP, 4-13-00-01091 (+15 more)

INCI: ACETAMINOPHEN

Acetaminophen (CAS 103-90-2) is a cosmetic cosmetic ingredient functioning as Skin conditioning; primarily a pharmaceutical (paracetamol). Reported NOAEL =650 mg/kg bw/day in Rat (ToxValDB_ECHA_IUCLID); EU Regulation 1223/2009 status: permitted; GHS signal word WARNING. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.

View industrial chemical safety profile for CAS 103-90-2 →

Auto-generated CPSR Part A draft with source citations
Function
Skin conditioning; primarily a pharmaceutical (paracetamol)
Safety Rating
MODERATE

Chemistry & Identifiers

EC Number
203-157-5

Regulatory Status

EU EU Status permitted
US US Status permitted
US Notes FDA-regulated as an OTC drug (analgesic/antipyretic). Cosmetic use is uncommon and may trigger drug classification depending on claims.

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Acetaminophen.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint 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
NOAEL =650 mg/kg bw/day oral Rat chronic 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
CancerHealth haz
Hazard Statements
May cause damage to liver and kidneys through prolonged or repeated exposure if swallowed Toxic to aquatic life
Long-term Exposure Effects
Ingestion may cause effects on the kidneys and liver. This may result in impaired functions.
Routes of Exposure
The substance can be absorbed into the body by ingestion.

IARC Carcinogenicity

International Agency for Research on Cancer (WHO) monograph evaluation.

IARC Group
3
Volume
50, 73
Evaluation Year
1998

ECHA REACH Registration

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

Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Pharmaceutical Softener and conditioner Stabilizing agent

Expert Verdict

Expert safety assessment and concern-level summary for Acetaminophen.

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Acetaminophen by CAS number or substance name.

Studies
1
Lowest NOAEL
650 mg/kg bw/day
Highest NOAEL
650 mg/kg bw/day
ToxValDB_ECHA_IUCLID

Known Synonyms

4-Acetamidophenol Paracetamol 4-hydroxyacetanilide APAP 4-13-00-01091 Acetamide, N-(p-hydroxyphenyl)- p-Acetaminophenol EINECS 203-157-5 NCI-C55801 Pyregesic-C Apitrelal Children's Acetaminophen Elixir Solution Codicet Croix Blanche Dafalgan Codeine Dolotec Febridol Fluparmol Malex N Paracetamol Harkley

Chemical Function

Pharmaceutical Softener and conditioner Stabilizing agent

Regulatory Lists

pharmaceutical pharmaceutical pharmaceutical pharmaceutical pharmaceutical pharmaceutical pharmaceutical pharmaceutical pharmaceutical pharmaceutical pharmaceutical detected; pharmaceutical; wastewater detected; pharmaceutical; soil detected; pharmaceutical; wastewater detected; pharmaceutical; wastewater detected; MN Chemical Screening; surface_water detected; ground_water; MN Chemical Screening; pharmaceutical detected; MN Chemical Screening; surface_water

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.

Compound
ACETAMINOPHEN
ChEMBL ID
CHEMBL112
Max Phase
4
Adverse Event Associations
27587
View full pharmaceutical profile →

Frequently Asked Questions

Is Acetaminophen safe in cosmetics?

Acetaminophen has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted. 1 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 NOAEL for Acetaminophen?

The NOAEL (No Observed Adverse Effect Level) for Acetaminophen is =650 mg/kg bw/day based on a chronic study via oral route in Rat. Source: ToxValDB_ECHA_IUCLID.

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

Is Acetaminophen used outside cosmetics?

Acetaminophen also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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