Is Methyl Salicylate safe in cosmetics?
Methyl Salicylate has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Methyl Salicylate
Also known as: Benzoic acid, 2-hydroxy-, methyl ester, Methyl 2-hydroxybenzoate, 2-Carbomethoxyphenol, PredaLure, 4-10-00-00143 (+15 more)
INCI: METHYL SALICYLATE
Methyl Salicylate (CAS 119-36-8) is a cosmetic fragrance functioning as fragrance; counterirritant; flavoring. Reported NOAEL =0.5 mg/kg/day in dog (SCCS Opinion); EU Regulation 1223/2009 status: restricted, max 0.001% (leave-on); 0.01% (rinse-off); 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 119-36-8 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Methyl Salicylate is classified GHS Danger (H302, H317, H361d, H412, H314, H318, H319) in the chemicals database but is restricted in EU cosmetics at max 0.001% (leave-on); 0.01% (rinse-off).
Source: Cosmetics: ingredients.eu status/eu max; Chemicals: ghs classifications.signal word/hazard statement code
Function
fragrance; counterirritant; flavoring
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
methyl 2-hydroxybenzoate
InChIKey
OSWPMRLSEDHDFF-UHFFFAOYSA-N
Regulatory Status
EU EU Status
restricted
EU Max Conc.
0.001% (leave-on); 0.01% (rinse-off)
US 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 multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Methyl Salicylate.
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 | =0.5 mg/kg/day | oral | dog | reproductive toxicity | SCCS Opinion |
| NOAEL | =0.5 mg/kg/day | oral | dog | reproductive toxicity | SCCS Opinion |
| NOAEL | =0.5 mg/kg/day | oral | dog | reproductive toxicity | SCCS Opinion |
| NOAEL | =0.5 mg/kg/day | oral | dog | reproductive toxicity | SCCS Opinion |
| NOAEL | =75 mg/kg bw/day | - | rat | reproductive toxicity | SCCS Opinion |
| NOAEL | =75 mg/kg bw/d | oral | rat | NOAEL study | SCCS Opinion |
| NOAEL | =75 mg/kg | - | - | NOAEL study | SCCS Opinion |
| NOAEL | =75 mg/kg bw/d | oral | rat | developmental toxicity | SCCS Opinion |
| NOAEL | =75 mg/kg bw/day | - | rat | reproductive toxicity | SCCS Opinion |
| NOAEL | =75 mg/kg bw/d | oral | rat | NOAEL study | SCCS Opinion |
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
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: SCCS Opinion
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Warning
Pictograms
Health HazardHarmful / Irritant
Hazard Class and Category
Repr. 2; Acute Tox. 4; Skin Sens. 1B; Aquatic Chronic 3
Hazard Statements
- H361d
- H302 Harmful if swallowed
- H317 May cause an allergic skin reaction
- H412 Harmful to aquatic life with long lasting effects
Specific Concentration Limits / M-factors
oral: ATE = 890.0 mg/kg bw
Inserted via ATP: ATP17
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
DPRA Cys %
0.4%
DPRA Lys %
1.6%
KeratinoSens IC50
2000 µM
hCLAT CV75
318.7 µg/mL
LLNA EC3
20%
NESIL
969 µg/cm²
LLNA: Weak (1B)
GHS: 1B
Human: positive
Source: LLNA: Gerberick et al. (1992) | Howell et al. (2000); DPRA: Gerberick et al. 2004 [DOI:10.1093/toxsci/kfh213] | Joint Research Centre of the European Union 2013; KS: Joint Research Centre of the European Union 2014 | Emter et al. 2010 [DOI:10.1016/j.taap.2010.03.009]; hCLAT: Bauch et al. 2011 [DOI:10.1016/j.tiv.2011.05.030] | Ashikaga et al. 2010 [DOI:10.1177/026119291003800403]; HPPT: [292] Epstein WL (1973): Report to RIFM, 26 November, unpublished.
HRIPT Human Patch Test Studies
2 human repeat insult patch tests aggregated from dermatological literature.
| Test Type | N | Sensitized | Dose µg/cm² | NESIL µg/cm² | Potency |
|---|---|---|---|---|---|
| HMT | - | 0 | 5184 | - | - |
| HRIPT | - | 0 | 968.75 | - | - |
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Cosmetic-Specific Mechanism
Category: fragrance
Receptor targets: ERα (weak)
LOEC: 100 µM
EU status: allowed (max 0.004% in products)
weak agonist
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 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.
Additional Jurisdictional Restrictions (2)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| UK | restricted | - | - |
| CA | restricted | 1% | All cosmetics |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Roberts Skin Permeation (Mendeley 2022)
MW: 152
Log Kow: 2.23
Log Kp: -1.4436974992327127
Log Jmax: -6.458223752429309
Source: Roberts Cheruvu Mendeley 2022
Aggregated DA Values (4 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| default | 50.0 | method=default | - | - |
| measured_sccs_opinion | 50.0% | - | - | SCCS/1633/21 |
| measured_sccs_opinion | 50.0% | - | - | SCCS/1633/21 |
| measured_sccs_opinion | 50.0% | - | - | SCCS/1633/21 |
Additional Ingredient Properties
3 property records from structured ingredient metadata.
allergen_detail
{"eu_allergen_listed": "yes", "allergen_class": "fragrance", "cross_reactivity_group": "salicylate-group", "patch_test_frequency_pct": "0.3", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "yes", "source": "EU 2023/1545; SCCS/1459/11"}
pediatric_safety
{"safe_for_newborn_0_6m": "avoid", "safe_for_infant_6_12m": "avoid", "safe_for_toddler_1_3y": "avoid", "safe_for_child_3_12y": "caution", "safe_for_teen_12_18y": "caution", "pediatric_max_concentration_pct": "0.0", "adult_max_concentration_pct": "0.02", "pediatric_dermal_absorption_factor": "very high", "immature_skin_barrier_risk": "high", "oral_ingestion_risk": "very high", "eye_irritation_risk"…
pregnancy_detail
{"pregnancy_safe": "avoid", "breastfeeding_safe": "avoid", "trimester_restriction": "all", "risk_category": "not-rated", "reason": "Salicylate; systemic absorption; aspirin-equivalent risk", "alternative_ingredient": "Menthol (low dose)", "source": "toxicology literature"}
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (2)
Carcinogen Classification
No indication of carcinogenicity to humans (not listed by IARC).
Source: Toxin and Toxin Target Database (T3DB)
ICSC Safety Card
1505
Source: WHO/JECFA
Regulatory (2)
JECFA Number
899
Source: WHO/JECFA
JECFA Evaluation
METHYL o-HYDROXYBENZOATE | 2001 | 0-0.5 mg/kg bw (1967) | No safety concern at current levels of intake when used as a flavouring agent. The 1967 ADI of 0-0.5 mg/kg bw was maintained at the fifty-seventh meeting (2001). | TRS 909-JECFA 57/84 | FAS 48-JECFA 57/273
Source: WHO/JECFA
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Flavouring and nutrient
Fragrance
Humectant
No specific technical function
Pharmaceutical
Regulatory List Membership (2)
IFRA Fragrance Transparency List
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Methyl Salicylate.
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
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Methyl Salicylate by CAS number or substance name.
Studies
37
Lowest NOAEL
0.5
Highest NOAEL
500
Units vary across source rows: mg/kg/day, mg/kg bw/day, mg/kg bw/d
SCCS Opinion
ECHA
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 50.0 | method=default | - |
| 50.0% | SCCS opinion extraction | - |
| 50.0% | SCCS PDF direct extraction | - |
| 50.0% | SCCS PDF direct extraction | - |
Known Synonyms
Benzoic acid, 2-hydroxy-, methyl ester
Methyl 2-hydroxybenzoate
2-Carbomethoxyphenol
PredaLure
4-10-00-00143
Betula Lenta
BRN 0971516
Caswell No. 577
EINECS 204-317-7
EPA Pesticide Chemical Code 076601
FEMA No. 2745
FEMA Number 2745
Gaultheria oil, artificial
Gaultheriaoel
Synthetic wintergreen oil
Wintergreen oil, synthetic
Wintergruenoel
Methylester kyseliny salicylove
Metylester kyseliny salicylove
Betula oil
Chemical Function
Fragrance
Flavouring and nutrient
Humectant
Regulatory Lists
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Australia
inert_ingredient; non_food_use; Pesticides
active_ingredient; Europe; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
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
METHYL SALICYLATE
ChEMBL ID
CHEMBL108545
Max Phase
4
Adverse Event Associations
105
Frequently Asked Questions
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 NOAEL for Methyl Salicylate?
The NOAEL (No Observed Adverse Effect Level) for Methyl Salicylate is =0.5 mg/kg/day based on a reproductive toxicity study via oral route in dog. A total of 10 study endpoints are available. Source: SCCS Opinion.
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.
Is Methyl Salicylate used outside cosmetics?
Methyl Salicylate 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.
Does Methyl Salicylate have different safety status in cosmetics vs industrial chemicals?
Methyl Salicylate is classified GHS Danger (H302, H317, H361d, H412, H314, H318, H319) in the chemicals database but is restricted in EU cosmetics at max 0.001% (leave-on); 0.01% (rinse-off).
Compliance Tools
Check Methyl Salicylate compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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