Moderate Fragrance NOAEL Data SCCS/CIR Reviewed Sensitization Data Dermal Penetration

Benzyl Salicylate

INCI: BENZYL SALICYLATE

CAS Number
118-58-1
Function
fragrance; UV-absorber
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. Declarable EU allergen; labelling required >10 ppm leave-on / >100 ppm rinse-off
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted; RIFM-assessed; allergen declaration required for EU market

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

9 study endpoints found for Benzyl 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 =166 mg/kg/day oral rat (male) subchronic SCCS
NOAEL 166 mg/kg bw/day oral - reproductive SCCS_PDF_extraction
NOAEL 214 mg/kg bw/day oral rat reproductive SCCS_PDF_extraction
NOAEL 214 mg/kg bw/day - - - SCCS_PDF_extraction
NOAEL 214 mg/kg bw/day oral - - SCCS_PDF_extraction
NOAEL 400 mg/kg bw/day oral - chronic SCCS_PDF_extraction
NOAEL 166 mg/kg bw/day - - reproductive SCCS_PDF_extraction
NOAEL 75 mg/kg bw/day - - - SCCS_PDF_extraction
NOAEL 204 mg/kg bw/day oral - subchronic SCCS_PDF_extraction

Safety Opinions

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

cir June 26, 2019
Verdict: safe
NOAEL: 360 mg/kg bw/day (oral)

meeting, issued a Final Amended Report with the conclusion that salicylic acid and salicylate ingredients are safe in cosmetics in the present practices of use and concentration described in the safety assessment when formulated to be non-irritating and non- sensitizing, which may be based on a quantitative risk

cir June 26, 2019
Verdict: safe
NOAEL: 360 mg/kg bw/day (oral)

meeting, issued a Final Amended Report with the conclusion that salicylic acid and salicylate ingredients are safe in cosmetics in the present practices of use and concentration described in the safety assessment when formulated to be non-irritating and non- sensitizing, which may be based on a quantitative risk

sccs SCCS/1656/23 26 October 2023
Verdict: unknown
NOAEL: 166 mg/kg/day (oral)
Max Concentration: 0.001% in leave-on
sccs SCCS/1656/23 26 October 2023
Verdict: unknown
NOAEL: 166 mg/kg/day (oral)
Max Concentration: 0.01% in leave-on
sccs SCCS/1656/23 26 October 2023
Verdict: unknown
NOAEL: 214 mg/kg/day (oral)
Max Concentration: 0.001% in leave-on

SCCS NOAEL Values

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

NOAEL LOAEL Route Species Study DA% (SCCS) Opinion
75 mg/kg/day - Oral Rat (Wistar) Developmental toxicity (read-across from salicylic acid) (GD 8-14) 100 SCCS/1656/23 (2023)

Sensitization Profile

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

Sensitization Rate
low
Allergen Class
fragrance
EU Allergen Listed
yes
Patch Test Positive Rate
0.5%
Cross-reactivity Group
balsam-of-peru-group
Reaction Type
contact-dermatitis
IFRA Restricted

Source: ESSCA/IVDK

Dermal Penetration Profile

Skin absorption and penetration characteristics of Benzyl Salicylate, relevant to systemic exposure and MoS calculations.

Absorption %
16-28%
Penetration Level
epidermis
Penetration Depth
epidermis/dermis
Molecular Weight
228.2 Da
Log P
4.31
Systemic Absorption
yes
Topical Bioavailability
12-24%
Safety Margin Factor
high
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: SCCS/1459/11, IFRA

Expert Verdict

EU declarable fragrance allergen with mandatory labelling above threshold limits; restricted as a key IFRA component in ylang ylang and other floral fragrances with moderate to high sensitization risk.

โš ๏ธ
Concern Level: Moderate

Regulatory Flags

allergen-eu sensitization-risk eu-labelling-required ifra-restricted original-26-allergen endocrine_disruptor eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive eu_cosing_listed jecfa_safe

Frequently Asked Questions

Is Benzyl Salicylate safe in cosmetics?

EU declarable fragrance allergen with mandatory labelling above threshold limits; restricted as a key IFRA component in ylang ylang and other floral fragrances with moderate to high sensitization risk. The EU classifies Benzyl Salicylate as "restricted". Safety rating: MODERATE. 9 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir and sccs.

Is Benzyl Salicylate allowed in the EU?

Benzyl Salicylate EU regulatory status: restricted. Maximum allowed concentration: Declarable EU allergen; labelling required >10 ppm leave-on / >100 ppm rinse-off. This is based on EU Regulation 1223/2009 and its amendments.

What does Benzyl Salicylate do in cosmetics?

Benzyl Salicylate functions as: fragrance; UV-absorber. It is classified as a Fragrance in our database. CAS number: 118-58-1.

What is the Margin of Safety for Benzyl 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 Benzyl Salicylate?

The NOAEL (No Observed Adverse Effect Level) for Benzyl Salicylate is =166 mg/kg/day based on a subchronic study via oral route in rat (male). A total of 9 study endpoints are available. Source: SCCS.

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