Good Active Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed Dermal Penetration

Salicylic Acid

INCI: SALICYLIC ACID

CAS Number
69-72-7
Function
Beta hydroxy acid (BHA) exfoliant, keratolytic, and anti-acne active. Oil-soluble unlike AHAs, enabling penetration into sebaceous follicles and dissolution of intercellular lipids — the gold standard for acne and comedonal exfoliation. Optimal pH 3.0–4.0 for professional peels (typically 20–30%). Also has anti-inflammatory and mild antimicrobial properties. At 0.5% functions as a cosmetic preservative.
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status restricted
EU Max Conc. 2.0% general cosmetics (non-leave-on); 3.0% rinse-off hair products; 0.5% body lotion, eye shadow, mascara, eyeliner, lipstick, non-spray deodorant. Not for use in products for children under 3 years (except shampoo). Not for oral products or inhalation products. pH ≥3.5 required.
🇺🇸 US Status permitted
US Notes FDA OTC Monograph M006: 0.5–2.0% GRASE for topical acne drug products. Classified as an OTC drug (not cosmetic) when acne disease claims are made — requires drug labelling, GMP, NDC number. When marketed for exfoliation only without acne claims, may remain cosmetic. FDA scrutinises intended use classification carefully.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
high
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Salicylic Acid. 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 =90 mg/kg/day oral rat developmental CIR
LOAEL 75 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL =75 mg/kg/day oral rat developmental SCCS
NOAEL =75 mg/kg/day oral rat developmental SCCS
NOAEL 75 mg/kg bw/day dermal - - SCCS_PDF_extraction
NOAEL 75 mg/kg bw/day oral - reproductive SCCS_PDF_extraction
NOAEL 75 mg/kg bw/day - - reproductive SCCS_PDF_extraction
NOAEL 150 mg/kg bw/day - - - SCCS_PDF_extraction
NOAEL 75 mg/kg bw/day - rat reproductive SCCS_PDF_extraction
NOAEL 75 mg/kg bw/day oral - reproductive SCCS_PDF_extraction

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Signal Word
DANGER
Pictograms
corr; excl mark;warn; cancer;health haz
Hazard Statements
Harmful if swallowed Causes serious eye damage Suspected of damaging fertility or the unborn child
Short-term Exposure Effects
The substance is severely irritating to the eyes. The substance may cause effects on the central nervous system, acid-base balance in the body and gastrointestinal tract when ingested in large amounts. This may result in delirium, tremors and coma.
Long-term Exposure Effects
Repeated or prolonged contact with skin may cause dermatitis. 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, by ingestion and through the skin.

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

sccs SCCS/1646/22 7 June 2023
Verdict: safe
NOAEL: 75 mg/kg bw/d (dermal)
Max Concentration: 0.5% in general

including the potential endocrine effects: - the SCCS is of the opinion that salicylic acid (CAS 69-72-7) is safe when used as preservative at a concentration of 0.5 % in cosmetic products, considering its current restrictions in place. The provided information shows that salicylic acid is an eye irritant wit

sccs SCCS/1646/22 7 June 2023
Verdict: safe
NOAEL: 75 mg/kg bw/d (dermal)
Max Concentration: 0.5% in oral care

including the potential endocrine effects: - the SCCS is of the opinion that salicylic acid (CAS 69-72-7) is safe when used as preservative at a concentration of 0.5 % in cosmetic products, considering its current restrictions in place. The provided information shows that salicylic acid is an eye irritant wit

sccs SCCS/1646/22 7 June 2023
Verdict: safe
NOAEL: 75 mg/kg bw/d (dermal)
Max Concentration: 0.5% in eye area

including the potential endocrine effects: - the SCCS is of the opinion that salicylic acid (CAS 69-72-7) is safe when used as preservative at a concentration of 0.5 % in cosmetic products, considering its current restrictions in place. The provided information shows that salicylic acid is an eye irritant wit

sccs SCCS/1646/22 7 June 2023
Verdict: safe
NOAEL: 75 mg/kg/day (oral)
Max Concentration: 0.5% in general

including the potential endocrine effects: - the SCCS is of the opinion that salicylic acid (CAS 69-72-7) is safe when used as preservative at a concentration of 0.5 % in cosmetic products, considering its current restrictions in place. The provided information shows that salicylic acid is an eye irritant wit

sccs SCCS/1646/22 7 June 2023
Verdict: safe
NOAEL: 75 mg/kg/day (oral)
Max Concentration: 0.5% in oral care

including the potential endocrine effects: - the SCCS is of the opinion that salicylic acid (CAS 69-72-7) is safe when used as preservative at a concentration of 0.5 % in cosmetic products, considering its current restrictions in place. The provided information shows that salicylic acid is an eye irritant wit

SCCS NOAEL Values

NOAEL/LOAEL values cited in official SCCS opinions for Salicylic Acid.

NOAEL LOAEL Route Species Study DA% (SCCS) Opinion
75 mg/kg/day 165 mg/kg/day Oral Rat (Wistar) Developmental toxicity (OECD 414 equivalent) (GD 8-14 (gestational days)) 100 SCCS/1646/22 (2023)
75 mg/kg/day 165 mg/kg/day Oral Rat (Wistar) Developmental toxicity (OECD 414 equivalent) (GD 8-14 (gestational days)) 100 SCCS/1601/18 (2018)

Dermal Penetration Profile

Skin absorption and penetration characteristics of Salicylic Acid, relevant to systemic exposure and MoS calculations.

Absorption %
18-30%
Penetration Level
epidermis
Penetration Depth
epidermis/dermis
Molecular Weight
138.1 Da
Log P
2.26
Systemic Absorption
yes
Topical Bioavailability
12-25%
Safety Margin Factor
high
Vehicle Dependent
Yes — absorption varies by formulation

Source: SCCS/1538/14, CIR

Expert Verdict

Salicylic acid is the definitive BHA for acne, congestion, and oily skin. Lipophilicity is a genuine differentiator from AHAs — no other common cosmetic acid penetrates sebaceous follicles as effectively. EU concentration limits by product type require careful label compliance. US OTC vs cosmetic drug boundary demands precise claim management. Eye and lip product use must not exceed 0.5%. Not for children under 3 years.

⚠️
Concern Level: Low

Regulatory Flags

eu-restricted us-otc-drug-acne-claims lipophilic keratolytic anti-acne not-for-children-under-3 eye-irritant not-for-oral not-for-inhalation ph-critical ifra_fragrance fda_food_additive eu_cosing_listed jecfa_concern

Frequently Asked Questions

Is Salicylic Acid safe in cosmetics?

Salicylic acid is the definitive BHA for acne, congestion, and oily skin. Lipophilicity is a genuine differentiator from AHAs — no other common cosmetic acid penetrates sebaceous follicles as effectively. EU concentration limits by product type require careful label compliance. US OTC vs cosmetic drug boundary demands precise claim management. Eye and lip product use must not exceed 0.5%. Not for children under 3 years. The EU classifies Salicylic Acid as "restricted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.

Is Salicylic Acid allowed in the EU?

Salicylic Acid EU regulatory status: restricted. Maximum allowed concentration: 2.0% general cosmetics (non-leave-on); 3.0% rinse-off hair products; 0.5% body lotion, eye shadow, mascara, eyeliner, lipstick, non-spray deodorant. Not for use in products for children under 3 years (except shampoo). Not for oral products or inhalation products. pH ≥3.5 required.. This is based on EU Regulation 1223/2009 and its amendments.

What does Salicylic Acid do in cosmetics?

Salicylic Acid functions as: Beta hydroxy acid (BHA) exfoliant, keratolytic, and anti-acne active. Oil-soluble unlike AHAs, enabling penetration into sebaceous follicles and dissolution of intercellular lipids — the gold standard for acne and comedonal exfoliation. Optimal pH 3.0–4.0 for professional peels (typically 20–30%). Also has anti-inflammatory and mild antimicrobial properties. At 0.5% functions as a cosmetic preservative.. It is classified as a Active Ingredient in our database. CAS number: 69-72-7.

What is the Margin of Safety for Salicylic Acid?

adequate 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 Salicylic Acid?

The NOAEL (No Observed Adverse Effect Level) for Salicylic Acid is =90 mg/kg/day based on a developmental study via oral route in rat. A total of 10 study endpoints are available. Source: CIR.

Is Salicylic Acid classified as hazardous under GHS?

Salicylic Acid carries a GHS signal word of "DANGER". Hazard statements: Harmful if swallowed Causes serious eye damage Suspected of damaging fertility or the unborn child. 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.

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