Is Menthol safe in cosmetics?
Menthol has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 2 toxicological study endpoint(s) are available in our database.
Menthol
Also known as: Cyclohexanol, 5-methyl-2-(1-methylethyl)-, (1R,2S,5R)-rel-, 2-06-00-00052, 4-06-00-00151, BRN 1902288, BRN 3194263 (+15 more)
INCI: MENTHOL
Menthol (CAS 89-78-1) is a cosmetic active ingredient functioning as Cooling agent; antipruritic; sensory modifier; scalp vasodilator. NOAEL 375 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted, max No specific Annex III limit for scalp/shampoo use at standard concentrations (typically ≤1%); higher concentrations require safety assessment. 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 89-78-1 →
Auto-generated CPSR Part A draft with source citations
Function
Cooling agent; antipruritic; sensory modifier; scalp vasodilator
Safety Rating
GOOD
Regulatory Status
EU EU Status
permitted
EU Max Conc.
No specific Annex III limit for scalp/shampoo use at standard concentrations (typically ≤1%); higher concentrations require safety assessment
US US Status
permitted
US Notes
FDA OTC Monograph M032: 1.5% menthol permitted in combination with coal tar (1.8% solution) in anti-dandruff shampoos as external analgesic
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Menthol.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
2 study endpoints found for Menthol. 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 | =1250 mg/kg bw/day | oral | Mouse | subchronic | ToxValDB_ECHA_IUCLID |
| NOAEL | =1477.5 mg/kg bw/day | oral | Mouse | subchronic | ToxValDB_ECHA_IUCLID |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Menthol across SCCS product categories, with measured dermal absorption where available.
Sensitization Profile
Contact sensitization data for Menthol based on clinical patch test studies and IFRA standards.
Sensitization Rate
low
Allergen Class
fragrance
EU Allergen Listed
yes
Patch Test Positive Rate
0.2%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis
IFRA Restricted
Source: EU 2023/1545; SCCS/1459/11
Dermal Penetration Profile
Skin absorption and penetration characteristics of Menthol, relevant to systemic exposure and MoS calculations.
Absorption %
18-30%
Penetration Level
epidermis
Penetration Depth
epidermis/dermis
Molecular Weight
156.3 Da
Log P
3.4
Systemic Absorption
yes
Topical Bioavailability
12-25%
Safety Margin Factor
high
Vehicle Dependent
Yes — absorption varies by formulation
Source: J Pharm Sci 1996
HRIPT Human Patch Test Studies
1 human repeat insult patch test aggregated from dermatological literature.
| Test Type | N | Sensitized | Dose µg/cm² | NESIL µg/cm² | Potency |
|---|---|---|---|---|---|
| HMT | - | 0 | 5184 | - | - |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10,000 - 100,000 tonnes
Substance Type
GROUP; SUBSTANCE
SVHC Candidate
No
Additional Ingredient Properties
10 property records from structured ingredient metadata.
acne
{"cas_number": "89-78-1", "anti_acne_mechanism": "antibacterial", "comedogenicity_rating_0_to_5": "2", "acne_type_efficacy": "inflammatory", "p_acnes_mic_ug_per_ml": "100-500", "sebum_reduction_pct_clinical": "5-10", "prescription_required_usa": "No", "otc_drug_monograph_category": "No", "max_otc_concentration_pct": "Max 1%", "japan_quasi_drug_anti_acne": "No", "korea_functional_cosmetic_acne": "N…
allergen_detail
{"eu_allergen_listed": "yes", "allergen_class": "fragrance", "patch_test_frequency_pct": "0.2", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "yes", "source": "EU 2023/1545; SCCS/1459/11"}
baby_pediatric
{"cas_number": "89-78-1/2216-51-5", "ingredient_class": "other", "pediatric_safety_rating": "contraindicated", "minimum_age_months": "0", "neonatal_safe": "no", "premature_infant_safe": "no", "skin_barrier_maturity_consideration": "CONTRAINDICATED: Respiratory distress, apnea risk <2yr; neurotoxic", "transepidermal_absorption_risk_pediatric": "high", "systemic_exposure_concern_pediatric": "high", …
deodorant
{"cas_number": "89-78-1", "ingredient_class": "antimicrobial_deodorant", "mechanism_of_action": "bacterial_growth_inhibition", "antiperspirant_efficacy_sweat_reduction_pct": "0", "deodorant_efficacy_hours": "4-8", "odor_reduction_pct": "30-50", "bacteriostatic": "yes", "bactericidal": "limited", "target_bacteria": "limited", "microbiome_impact": "selective", "axillary_microbiome_effect": "varies b…
dermal_absorption
{"molecular_weight_da": "156.3", "log_p_value": "3.4", "skin_penetration_level": "epidermis", "penetration_depth": "epidermis/dermis", "absorption_pct": "18-30", "systemic_absorption": "yes", "penetration_enhancer": "yes", "occlusion_effect": "no", "vehicle_dependent": "yes", "skin_barrier_effect": "weakens", "bioavailability_topical_pct": "12-25", "safety_margin_factor": "high", "source": "J Phar…
fragrance_ifra
{"cas_number": "2216-51-5", "ifra_amendment_number": "49", "ifra_restriction_type": "Restricted", "ifra_max_use_level_category_1_pct": "0.18", "ifra_max_use_level_category_4_pct": "2.8", "ifra_max_use_level_category_7_pct": "0.42", "ifra_max_use_level_category_11_pct": "0.085", "eu_allergen_declaration_required": "No", "eu_26_allergens_list": "No", "sccs_opinion_available": "Yes", "sensitization_p…
oral_care
{"cas_number": "2216-51-5", "ingredient_class": "flavoring", "function_primary": "Flavoring/cooling agent", "function_secondary": "Mild antimicrobial", "fluoride_content_ppm_if_applicable": "0", "anti_plaque_mechanism": "Mild antimicrobial", "biofilm_disruption": "Low", "anti_inflammatory_oral": "Mild", "desensitizing_mechanism": "Counterirritant (cooling sensation masks sensitivity)", "onset_of_d…
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": "yes", "pediatric_max_concentration_pct": "0.0", "adult_max_concentration_pct": "1.0", "pediatric_dermal_absorption_factor": "higher", "immature_skin_barrier_risk": "high", "oral_ingestion_risk": "high", "eye_irritation_risk": "moderate",…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Fragrance
Regulatory List Membership (2)
IFRA Fragrance Transparency List
EPA Safer Chemical Ingredients List (SCIL)
Expert Verdict
Expert safety assessment and concern-level summary for Menthol.
Regulatory Flags
trpm8-agonist
cooling-agent
antipruritic
scalp-vasodilator
epa_safer_alternative
ifra_fragrance
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Menthol by CAS number or substance name.
Studies
2
Lowest NOAEL
1250 mg/kg bw/day
Highest NOAEL
1477.5 mg/kg bw/day
ToxValDB_ECHA_IUCLID
Known Synonyms
Cyclohexanol, 5-methyl-2-(1-methylethyl)-, (1R,2S,5R)-rel-
2-06-00-00052
4-06-00-00151
BRN 1902288
BRN 3194263
EINECS 201-939-0
EINECS 239-388-3
Headache crystals
(+-)-Menthol
Menthol natural
Menthol natural, brazilian
Menthol racemic
5-Methyl-2-(1-methylethyl)cyclohexanol, (1alpha,2beta,5alpha)-
NCI-C50000
Tra-kill tracheal mite killer
Menthol racemique
Racementholum
Racementol
(1R,2S,5R)-Menthol
UNII-YS08XHA860
Chemical Function
Fragrance
Regulatory Lists
active_ingredient; Europe; Pesticides
detected; drinking_water; MN Chemical Screening
detected; drinking_water; MN Chemical Screening
Europe; Other direct contact consumer goods
IFRA Transparency
SCIL (9/2019)
pharmaceutical
Canada; pharmaceutical
Canada; pharmaceutical
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
LEVOMENTHOL
ChEMBL ID
CHEMBL470670
Max Phase
3
Adverse Event Associations
59
Frequently Asked Questions
Is Menthol allowed in the EU?
Menthol EU regulatory status: permitted. Maximum allowed concentration: No specific Annex III limit for scalp/shampoo use at standard concentrations (typically ≤1%); higher concentrations require safety assessment. This is based on EU Regulation 1223/2009 and its amendments.
What does Menthol do in cosmetics?
Menthol functions as: Cooling agent; antipruritic; sensory modifier; scalp vasodilator. It is classified as a Active Ingredient in our database. CAS number: 89-78-1.
What is the NOAEL for Menthol?
The NOAEL (No Observed Adverse Effect Level) for Menthol is =1250 mg/kg bw/day based on a subchronic study via oral route in Mouse. A total of 2 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.
Is Menthol used outside cosmetics?
Menthol 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.
Compliance Tools
Check Menthol 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
Related Ingredients
Acetyl Tetrapeptide-5
Excellent
Same category
Anti-edema peptide for periorbital ar...
Activated Charcoal
Excellent
Same category
Adsorbent; skin cleanser; pore-cleans...
Adenosine
Excellent
Same category
Skin-conditioning agent, anti-aging, ...
Allantoin
Excellent
Same category
Skin conditioner, keratolytic, anti-i...
Alpha-Glucan Oligosaccharide
Excellent
Same category
prebiotic, skin-conditioning
Ascophyllum Nodosum Extract
Excellent
Same category
Skin Brightening, Tyrosinase Inhibito...
(AGARICUS BLAZEI FERMENT + GANODERMA LUCIDUM FERMENT + GANODERMA MULTIPILEUM FERMENT) EXTRACT
Good
Similar safety
Anti-sebum, Antioxidant, Skin Protecting
(ANGELICA ACUTILOBA/PAEONIA LACTIFLORA/REHMANNIA GLUTINOSA) ROOT/CNIDIUM OFFICINALE RHIZOME EXTRACT
Good
Similar safety
Skin Conditioning, Skin Conditioning ...
(ANGELICA ACUTILOBA/PAEONIA LACTIFLORA/REHMANNIA GLUTINOSA/SCUTELLARIA BAICALENSIS) ROOT/(CNIDIUM OFFICINALE/COPTIS CHINENSIS) RHIZOME/GARDENIA JASMINOIDES FRUIT/PHELLODENDRON CHINENSE BARK EXTRACT
Good
Similar safety
(ANGELICA GIGAS/GLYCYRRHIZA URALENSIS/REHMANNIA GLUTINOSA ROOT)/ANGELICA GIGAS STEM/CARTHAMUS TINCTORIUS FLOWER/(CARTHAMUS TINCTORIUS/PRUNUS PERSICA SEED)PORIA COCOS WATER
Good
Similar safety
Humectant, Skin Conditioning, Skin Pr...
(ANGELICA KEISKEI/CHRYSANTHEMUM ZAWADSKII) LEAF/STEM/CINNAMOMUM CASSIA BARK/TRICHOSANTES KIRILOWII FRUIT/ULMUS DAVIDIANA BARK/ROOT/(PAEONIA JAPONICA/BUPLEURUM FALCATUM/POLYGALA TENUIFOLIA ROOT)/VISCUS ALBUM STEM EXTRACT
Good
Similar safety
Anti-seborrheic, Anti-sebum, Antioxid...
(APPLE/CITRUS JUNOS/LENTIL/PEAR/PUMPKIN/STRAWBERRY/TOMATO FRUIT)/CORN KERNEL/(ARCTIUM LAPPA/BRASSICA OLERACEA ACEPHALA/CABBAGE/CAMELLIA SINENSIS/MORINGA OLEIFERA/RADISH/SPINACH LEAF)/(SORGHUM BICOLOR LEAF/STEM)/OAT MEAL/POTATO PULP/(CARROT/NELUMBO NUCIFERA/RADISH/WILD YAM ROOT)/(AMARANTHUS HYPOCHONDRIACUS/CASHEW/CICER ARIETINUM/COIX LACRYMA-JOBI MA-YUEN /MACADAMIA TERNIFOLIA/PHASEOLUS ANGULARIS/PISTACIA VERA/RHYNCHOSIA NULUBILIS/RICE/SESAME/SETARIA ITALICA/SOYBEAN/SWEET ALMOND/WHEAT SEED)/HORDEUM VULGARE SPROUT/CYPERUS ESCULENTUS TUBER/ARTEMISIA PRINCEPS/BROCCOLI/CHENOPODIUM QUINOA/ENTEROMORPHA COMPRESSA/HORDEUM VULGARE/IPOMOEA BATATAS/LAMINARIA JAPONICA/LENTINUS EDODES/PLEUROTUS OSTREATUS/PORPHYRA TENERA/UNDARIA PINNATIFIDA EXTRACT
Good
Similar safety
Antioxidant
Chlorothymol
Moderate
Chemical family
Preservative, denaturant, deodorizing...
D-Pulegone
Poor
Chemical family
Fragrance and flavor component presen...
Erythorbic Acid
Good
Chemical family
Antioxidant
Is Menthol in Your Products?
Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.
Try Piro Free →Analyze Your Full Ingredient List
Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Menthol in your formulation.