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

Benzyl Salicylate

Also known as: Benzoic acid, 2-hydroxy-, phenylmethyl ester, 4-10-00-00157, Benzyl o-hydroxybenzoate, BRN 2115365, EINECS 204-262-9 (+5 more)

INCI: BENZYL SALICYLATE

Benzyl Salicylate (CAS 118-58-1) is a cosmetic fragrance functioning as fragrance; UV-absorber. NOAEL 123 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max Declarable EU allergen; labelling required >10 ppm leave-on / >100 ppm rinse-off; 5 safety opinions reviewed (cir). 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 118-58-1 →

Auto-generated CPSR Part A draft with source citations
Function
fragrance; UV-absorber
Safety Rating
MODERATE

Chemistry & Identifiers

EC Number
204-262-9

Regulatory Status

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

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Benzyl Salicylate.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 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 =4 mg/kg/day oral - repeated dose toxicity SCCS_vision_codex
NOAEL =4 mg/kg/day oral - repeated dose toxicity SCCS_vision_codex
NOAEL =4 mg/kg/day oral - repeated dose toxicity SCCS_vision_codex
NOAEL =4 mg/kg/day oral - repeated dose toxicity SCCS_vision_codex
NOAEL =75 mg/kg/day - - NOAEL study SCCS_vision_codex
NOAEL =75 mg/kg/day - - NOAEL study SCCS_vision_codex
NOAEL =75 mg/kg/day - - NOAEL study SCCS_vision_codex
NOAEL =75 mg/kg/day - - NOAEL study SCCS_vision_codex
NOAEL =158 mg/kg/day oral rat developmental toxicity SCCS_vision_codex
NOAEL =158 mg/kg/day oral rat developmental toxicity SCCS_vision_codex

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

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Benzyl Salicylate across SCCS product categories, with measured dermal absorption where available.

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 — absorption varies by formulation

Source: SCCS/1459/11, IFRA

EU CLP Annex VI Harmonized Classification

Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.

Signal Word
Warning
Pictograms
Harmful / Irritant
Hazard Class and Category
Skin Sens. 1B
Hazard Statements
  • H317 May cause an allergic skin reaction

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 %
2.6%
DPRA Lys %
1.5%
KeratinoSens IC50
110.98 µM
hCLAT CV75
38 µg/mL
LLNA EC3
2.9%
NESIL
6200 µg/cm²
LLNA: Moderate (1B) GHS: 1B Human: positive

Source: LLNA: Kern et al. (2010) (RIFM DB#47378); DPRA: Urbisch et al. 2015 [DOI:10.1016/j.yrtph.2014.12.008] | ECVAM Validation Study Report; KS: Urbisch et al. 2015 [DOI:10.1016/j.yrtph.2014.12.008]; hCLAT: Urbisch et al. 2015 [DOI:10.1016/j.yrtph.2014.12.008]; HPPT: [283] RIFM (1980): RIFM report number 3305, January 21, unpublished.

HRIPT Human Patch Test Studies

5 human repeat insult patch tests aggregated from dermatological literature.

Test Type N Sensitized Dose µg/cm² NESIL µg/cm² Potency
HRIPT 101 0 17715 17715 non-sensitizer
HRIPT - 0 17715 17715 weak
HMT - 0 13500 - -
HMT - 0 13500 - -
HMT - 0 19440 - -

Endocrine Disruptor Evidence (Expanded)

Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.

Under investigation Evidence: Limited (2024)
Health effects: Yes
Affected pathways: Estrogenic
Regulatory framework: REACH/Cosmetics

Source list: II (former)

Cosmetic-Specific Mechanism
Category: fragrance
Receptor targets: ERα
LOEC: 100 µM
EU status: restricted (allergen labeling; ED review ongoing; SCCS 2023 concluded safe)

partial agonist (very weak; EC50 21,000,000x less than E2)

Dose-Response Data Points
Endpoint Target Value Direction
NOAEL general 2500 ppm ppm -
EC_ER_range ERα 1×10⁻⁴ to 2×10⁻⁴ M M agonist
Displacement of [3H]-E2 from ERa ERa EC50/IC50: IC50 ~10-100 uM (very low RBA); LOEC: 10 uM; NOEC: 1 uM mixed agonist (weak binding)

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.

SA Saudi SFDA (III - Restricted)
BRIN Brazil/India Cosmetics
Brazil: Restricted (Fragrance Allergen) · max >0.001% leave-on / >0.01% rinse-off requires labeling
India: Restricted

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

Aggregated DA Values (4 records across 5 sources)
Type DA % Method Skin Model SCCS Ref
measured 10.0 method=measured - -
default 10.0 method=default; type=in_vitro - -
measured 10.5 method=measured - -
measured 10.5 method=measured; type=in_vitro - -

IFRA Concentration Limits (12 Product Categories)

International Fragrance Association standards per product category. Restriction: Restriction. Effective: 2021-02-10.

Category Max % Category Max %
1 (Lip products) 0.05% 7a (Deodorant – not spray) 0.2%
2 (Body spray) 0.015% 7b (Deodorant spray) 0.2%
3 (Body cream) 0.1% 8 (Face cream) 0.025%
4 (Fine fragrance) 0.5% 9 (Soap) 0.5%
5a (Body lotion) 0.1% 10a (Household – non-spray) 0.5%
5b (Face cream leave-on) 0.1% 10b (Household – spray) 2.5%
5c (Hand cream) 0.1% 11a (Intimate – leave-on) 0.025%
5d (Baby cream) 0.025% 11b (Intimate – rinse) 0.025%
6 (Mouthwash) 0.1% 12 (Not for consumer exposure) No Restriction%

Additional Ingredient Properties

9 property records from structured ingredient metadata.

allergen_detail
{"eu_allergen_listed": "yes", "allergen_class": "fragrance", "cross_reactivity_group": "balsam-of-peru-group", "patch_test_frequency_pct": "0.5", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "yes", "source": "ESSCA/IVDK"}
dermal_absorption
{"molecular_weight_da": "228.2", "log_p_value": "4.31", "skin_penetration_level": "epidermis", "penetration_depth": "epidermis/dermis", "absorption_pct": "16-28", "systemic_absorption": "yes", "penetration_enhancer": "yes", "occlusion_effect": "no", "vehicle_dependent": "yes", "skin_barrier_effect": "neutral", "bioavailability_topical_pct": "12-24", "safety_margin_factor": "high", "source": "SCCS/…
ecotoxicity
{"biodegradable": "yes", "biodegradation_days": "60-120", "bioaccumulative": "no", "aquatic_toxicity_level": "low", "coral_reef_safe": "yes", "marine_toxicity": "low aquatic toxicity", "freshwater_toxicity": "moderate at high conc", "endocrine_disruptor": "no", "persistent_organic_pollutant": "no", "microplastic": "no", "nano_particle": "no", "hawaii_banned": "no", "eu_restricted_environmental": "…
fragrance
{"cas_number": "118-58-1", "ingredient_class": "aroma_chemical", "chemical_class": "ester", "odor_family": "floral", "odor_description": "Faint balsamic, slightly floral", "odor_strength": "light", "odor_tenacity_hours": "24.0", "top_note": "no", "heart_note": "yes", "base_note": "yes", "blending_factor_1_10": "5.0", "threshold_of_detection_ppb": "350.0", "molecular_weight_Da": "228.24", "boiling_…
pediatric_safety
{"safe_for_newborn_0_6m": "caution", "safe_for_infant_6_12m": "caution", "safe_for_toddler_1_3y": "caution", "safe_for_child_3_12y": "yes", "safe_for_teen_12_18y": "yes", "pediatric_max_concentration_pct": "0.5", "adult_max_concentration_pct": "unlimited", "pediatric_dermal_absorption_factor": "higher", "immature_skin_barrier_risk": "moderate", "oral_ingestion_risk": "low", "eye_irritation_risk": …
pregnancy_detail
{"pregnancy_safe": "avoid", "breastfeeding_safe": "insufficient-data", "trimester_restriction": "all", "risk_category": "not-rated", "reason": "Salicylate derivative; endocrine disruption concern", "alternative_ingredient": "Fragrance-free", "source": "dermatology literature"}
regulatory
{"eu_status": "restricted", "us_status": "allowed", "eu_max_concentration": "0.001", "restricted_in": "rinse-off: >0.01%, leave-on: >0.001%", "regulation_reference": "Annex III/205"}
skin_suitability
{"oily_skin": "caution", "dry_skin": "caution", "sensitive_skin": "caution", "combination_skin": "caution", "normal_skin": "caution", "acne_prone": "caution", "rosacea": "caution", "eczema": "caution", "hyperpigmentation": "caution", "aging_mature": "caution", "dehydrated": "caution", "skin_benefit_primary": "fragrance", "skin_benefit_secondary": "UV-filter", "mechanism_of_action": "Ester, floral …

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Biocide Deodorizer Flavouring and nutrient Fragrance UV stabilizer
Regulatory List Membership (7)
EU Regulated in Personal Care EU Restricted for Children (Cosmetics) IFRA Fragrance Transparency List EPA Safer Chemical Ingredients List (SCIL) FDA Substances Added to Food (EAFUS) Consumer Product Chemical EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Benzyl Salicylate.

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

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Benzyl Salicylate by CAS number or substance name.

Studies
46
Lowest NOAEL
4
Highest NOAEL
540

Units vary across source rows: mg/kg/day, mg/kg/d, mg/kg bw/day

SCCS_vision_codex ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip

Dermal Absorption

View details ->
Absorption % Method Vehicle
10.0 method=measured -
10.0 method=default; type=in_vitro -
10.5 method=measured -
10.5 method=measured; type=in_vitro -

Known Synonyms

Benzoic acid, 2-hydroxy-, phenylmethyl ester 4-10-00-00157 Benzyl o-hydroxybenzoate BRN 2115365 EINECS 204-262-9 FEMA No. 2151 NSC 6647 Salicyclic acid, benzyl ester Salicylsaeurebenzylester UNII-WAO5MNK9TU

Chemical Function

Fragrance

Regulatory Lists

Europe inert_ingredient; non_food_use; Pesticides Cleaning products and household care - air freshener; Cleaning products and household care - laundry and fabric treatment - fabric deodorizer; detected; Europe; Vehicle - car interior - auto air freshener Europe; Personal care - body hygiene - hand soap children; Europe; Personal care children; Europe; Personal care - specialized bath products - bath salts children; Europe; Personal care children; Europe; Personal care - general moisturizing - hand/body lotion children; Europe; Personal care - hair styling and care - shampoo children; Europe; Personal care children; Europe; Personal care children; Europe; Personal care children; detected; Europe; Personal care - body hygiene - body wash; Personal care - fragrance; Personal care - general moisturizing - hand/body lotion; Personal care - specialized bath products - bubble bath Cleaning products and household care - general household cleaning; Cleaning products and household care - laundry and fabric treatment; detected; Europe consumer_product; detected; Europe Europe; Personal care - deodorant detected; Europe; Personal care - deodorant detected; Europe; Personal care - deodorant

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
BENZYL SALICYLATE
ChEMBL ID
CHEMBL460124
View full pharmaceutical profile →

Frequently Asked Questions

Is Benzyl Salicylate safe in cosmetics?

Benzyl 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. 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 NOAEL for Benzyl Salicylate?

The NOAEL (No Observed Adverse Effect Level) for Benzyl Salicylate is =4 mg/kg/day based on a repeated dose toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS_vision_codex.

Is Benzyl Salicylate used outside cosmetics?

Benzyl 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.

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