Moderate Fragrance NOAEL Data GHS Classified Sensitization Data

Methyl Salicylate

INCI: METHYL SALICYLATE

CAS Number
119-36-8
Function
fragrance; counterirritant; flavoring
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status restricted
EU Max Conc. 0.001% (leave-on); 0.01% (rinse-off)
🇺🇸 US Status permitted
US Notes Permitted as OTC drug active for topical analgesic use at defined concentrations. Cosmetic use permitted with labelling requirements. High dermal absorption profile.

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
high
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Methyl Salicylate. 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 984 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 1727 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 2000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 600 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 2000 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 2000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 1063 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 1200 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 900 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 150 mg/kg bw/day oral dog Chronic COSMOS_DB

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
Harmful if swallowed May cause an allergic skin reaction Suspected of damaging fertility or the unborn child Harmful to aquatic life
Short-term Exposure Effects
The substance is irritating to the eyes. The substance may cause effects on the central nervous system and acid-base balance in the body when ingested in large amounts. This may result in delirium, tremors and coma.
Long-term Exposure Effects
Repeated or prolonged contact may cause skin sensitization. Animal tests show that this substance possibly causes toxicity to human reproduction or development.
Routes of Exposure
The substance can be absorbed into the body by inhalation, through the skin and by ingestion.

SCCS NOAEL Values

NOAEL/LOAEL values cited in official SCCS opinions for Methyl Salicylate.

NOAEL LOAEL Route Species Study DA% (SCCS) Opinion
75 mg/kg/day - Oral Rat Developmental toxicity (read-across from salicylic acid) (GD 8-14) 100 SCCS/1633/21 (2021)

Sensitization Profile

Contact sensitization data for Methyl Salicylate based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
fragrance
EU Allergen Listed
yes
Patch Test Positive Rate
0.3%
Cross-reactivity Group
salicylate-group
Reaction Type
contact-dermatitis
IFRA Restricted

Source: EU 2023/1545; SCCS/1459/11

Expert Verdict

Newly declarable EU allergen under Regulation 2023/1545 (effective 31 July 2026). High dermal absorption with systemic salicylate accumulation risk; restrict concentration in leave-on products covering large body areas. Dominant constituent of wintergreen and sweet birch oils (>90%). Update CPSR, PIF, and labels for affected formulations. Exercise caution in pediatric and salicylate-sensitive formulations.

⚠️
Concern Level: Moderate

Regulatory Flags

allergen-eu eu-2023-1545-newly-listed eu-labelling-required sensitization-risk high-absorption systemic-toxicity-concern pediatric-caution endocrine_disruptor ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Methyl Salicylate safe in cosmetics?

Newly declarable EU allergen under Regulation 2023/1545 (effective 31 July 2026). High dermal absorption with systemic salicylate accumulation risk; restrict concentration in leave-on products covering large body areas. Dominant constituent of wintergreen and sweet birch oils (>90%). Update CPSR, PIF, and labels for affected formulations. Exercise caution in pediatric and salicylate-sensitive formulations. The EU classifies Methyl Salicylate as "restricted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.

Is Methyl Salicylate allowed in the EU?

Methyl Salicylate EU regulatory status: restricted. Maximum allowed concentration: 0.001% (leave-on); 0.01% (rinse-off). This is based on EU Regulation 1223/2009 and its amendments.

What does Methyl Salicylate do in cosmetics?

Methyl Salicylate functions as: fragrance; counterirritant; flavoring. It is classified as a Fragrance in our database. CAS number: 119-36-8.

What is the Margin of Safety for Methyl Salicylate?

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 Methyl Salicylate?

The NOAEL (No Observed Adverse Effect Level) for Methyl Salicylate is 984 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Is Methyl Salicylate classified as hazardous under GHS?

Methyl Salicylate carries a GHS signal word of "WARNING". Hazard statements: Harmful if swallowed May cause an allergic skin reaction Suspected of damaging fertility or the unborn child Harmful 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.

Compliance Tools

Check Methyl Salicylate compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
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