Is Homosalate safe in cosmetics?
Homosalate has a safety rating of "MODERATE" in our database. EU status: restricted. US status: restricted. 10 toxicological study endpoint(s) are available in our database.
Homosalate
Also known as: 3,3,5-Trimethylcyclohexylsalicylate (Homosalate), Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester, Caswell No. 482B, Coppertone, EINECS 204-260-8 (+9 more)
INCI: HOMOSALATE
Homosalate (CAS 118-56-9) is a cosmetic active ingredient functioning as Oil-soluble UVB UV filter; peak absorption ~306 nm; used as SPF booster in. NOAEL 10 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 7.34%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
Cross-Vertical Regulatory Divergence
Homosalate is classified GHS CMR hazard (H315, H319, H335, H361d, H410) in the chemicals database but is restricted in EU cosmetics at max 7.34%.
Source: Cosmetics: ingredients.eu status/eu max; Chemicals: ghs classifications.signal word/hazard statement code
Function
Oil-soluble UVB UV filter; peak absorption ~306 nm; used as SPF booster in combination formulations; UVB-only spectrum with no UVA coverage
Editorial assessment
MODERATE
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
restricted
EU Max Conc.
7.34%
US US Status
restricted
US Notes
Historically marketed in the US; FDA states existing data is not sufficient to determine GRASE. Regulatory limbo alongside seven other chemical filters. Final determination pending additional safety data. Previously permitted up to 15% in the US monograph.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Homosalate.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Homosalate. 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 | =10 mg/kg bw/day | oral | - | repeated dose toxicity | SCCS Opinion |
| NOAEL | =10 mg/kg bw/d | oral | rat | dermal absorption | SCCS Opinion |
| NOAEL | =10 mg/kg bw/day | oral | - | repeated dose toxicity | SCCS Opinion |
| NOAEL | =10 mg/kg bw/day | oral | - | repeated dose toxicity | SCCS Opinion |
| NOAEL | =10 mg/kg bw/d | oral | rat | dermal absorption | SCCS Opinion |
| NOAEL | =10 mg/kg bw/day | oral | - | repeated dose toxicity | SCCS Opinion |
| NOAEL | =10 mg/kg bw/day | oral | - | repeated dose toxicity | SCCS Opinion |
| NOAEL | =10 mg/kg bw/d | oral | rat | dermal absorption | SCCS Opinion |
| NOAEL | =10 mg/kg bw/day | oral | - | repeated dose toxicity | SCCS Opinion |
| NOAEL | =10 mg/kg bw/day | oral | - | repeated dose toxicity | SCCS Opinion |
Pre-Calculated Safety Assessment
Conditional — safe only within SCCS limits: not 10%; safe up to 7.34% in face cream and pump-spray face products
Pre-calculated NOAEL → SED → MoS audit trail for Homosalate across SCCS product categories, with measured dermal absorption where available.
SCCS NOAEL Values
NOAEL/LOAEL values cited in official SCCS opinions for Homosalate.
| NOAEL | LOAEL | Route | Species | Study | DA% (SCCS) | Opinion |
|---|---|---|---|---|---|---|
| 300 mg/kg/day | 750 mg/kg/day | Oral | Rat (Wistar RccHan) | Combined repeated dose + reproductive screening (OECD 422) (28 days) | 100 | SCCS/1622/20 (2021) |
| 10 mg/kg/day | 60 mg/kg/day | Oral | Rat (Wistar) | Combined repeated dose + reproductive screening (OECD 422) (28 days) | 100 | SCCS/1638/21 (2021) |
Dermal Penetration Profile
Skin absorption and penetration characteristics of Homosalate, relevant to systemic exposure and MoS calculations.
Absorption %
8-14%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum/epidermis
Molecular Weight
262.3 Da
Log P
6.2
Systemic Absorption
yes
Topical Bioavailability
5-12%
Safety Margin Factor
high
Vehicle Dependent
Yes — absorption varies by formulation
Source: SCCS Opinion
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LEL | =750 mg/kg-day | Rat | oral | subchronic (developmental) | EPA TSCA 8e |
| LOAEL | =750 mg/kg-day | Rat | oral | subchronic (developmental) | EPA TSCA 8e |
| LOAEL | =750 mg/kg-day | Rat | oral | subchronic (developmental) | EPA TSCA 8e |
| LOAEL | =750 mg/kg-day | Rat | oral | subchronic (developmental) | EPA TSCA 8e |
| LOAEL | =300 mg/kg-day | Rat | oral | subchronic (developmental) | EPA TSCA 8e |
| LOAEL | =300 mg/kg-day | Rat | oral | subchronic (developmental) | EPA TSCA 8e |
| LOAEL | =300 mg/kg-day | Rat | oral | subchronic (developmental) | EPA TSCA 8e |
| LOAEL | =750 mg/kg-day | Rat | oral | subchronic (developmental) | EPA TSCA 8e |
| LOAEL | =750 mg/kg-day | Rat | oral | subchronic (developmental) | EPA TSCA 8e |
| LOAEL | =300 mg/kg-day | Rat | oral | subchronic (developmental) | EPA TSCA 8e |
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 |
|---|---|---|---|---|---|
| HRIPT | - | 0 | - | - | non-sensitizer |
| HMT | - | 0 | - | - | - |
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: Moderate
(2021)
Health effects: Yes
Affected pathways: Estrogenic, Anti-androgenic
Regulatory framework: Cosmetics
Source list: II (former)
Cosmetic-Specific Mechanism
Category: UV filter
Receptor targets: ERα, AR
LOEC: 1.56 µM
EU status: restricted (max 0.5%; SCCS concluded not safe at 10%)
agonist (ERα); antagonist (AR)
Dose-Response Data Points
| Endpoint | Target | Value | Direction |
|---|---|---|---|
| IC50_AR | AR | 5.87 µM | antagonist |
| Cell proliferation | ER | EC50/IC50: ~3 uM (EC50, weaker than 4-MBC); LOEC: 1 uM; NOEC: 0.3 uM mixed | agonist |
| Estrogen response element reporter activation | ERa | EC50/IC50: AC50 14.20 uM; LOEC: ~8.86 uM (ACC); NOEC: ~1 uM mixed | agonist |
| AR/PR-mediated transcription (antagonist) | AR; PR | EC50/IC50: IC50 ~3-10 uM (AR); IC50 ~1-3 uM (PR); LOEC: 1 uM; NOEC: 0.1 uM mixed | antagonist |
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
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex VI — Permitted UV Filters
Product type: Face products with the exception of propellent spray products
Max: 7,34 %
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.
KR Korea MFDS Annex 2 (Restricted)
Category: UV Filter. Max: 10%.
SA Saudi SFDA (VI - UV Filters)
Max: 0.1.
JPKR Japan/Korea Cosmetics
Japan (Positive (UV Absorber)): max 10.0
Japan (Restricted): max 10%
Korea (Restricted): max 10%
BRIN Brazil/India Cosmetics
India: Permitted UV Filter · max 0.1
Additional Jurisdictional Restrictions (9)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| JP | restricted | 10% | All cosmetics |
| CN | permitted_uv_filter | 10 | All cosmetics |
| IN | permitted_uv_filter | 10.0 | sunscreen and other cosmetic products |
| AU | restricted | - | sunscreens (therapeutic) |
| GCC | restricted | 7.34 | Sunscreen products |
| BR | permitted_uv_filter | 15 | Sunscreen products; EU max 10% |
| UK | restricted | - | - |
| ID | permitted_uv_filter | 10% (ASEAN-wide); Indonesia reducing per PerBPOM 25/2025 | - |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (2 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured_in_vitro | 5.3 | In vitro — flow-through diffusion cells | - | SCCS/1622/20; SCCS/1260/22 (2020) |
| measured_in_vitro | 11.0 | - | - | SCCS/1564/15 |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Fragrance
Softener and conditioner
UV stabilizer
Regulatory List Membership (3)
EU Regulated in Personal Care
IFRA Fragrance Transparency List
EU CosIng Cosmetics Ingredient Database
Editorial summary
Preliminary editorial summary for Homosalate — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
uv-filter
uvb
oil-soluble
fda-limbo
systemic-absorption
endocrine-disruption-concern
eu-restricted
eu-face-only
spf-booster
regulatory-downgrade-2025
product-withdrawal-july-2025
ifra_fragrance
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Homosalate by CAS number or substance name.
Studies
36
Lowest NOAEL
10
Highest NOAEL
100
Units vary across source rows: mg/kg bw/day, mg/kg bw/d, mg/kg/day
SCCS Opinion
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 5.3 | In vitro — flow-through diffusion cells | Standard sunscreen formulation (o/w) |
| 11.0 | - | - |
Known Synonyms
3,3,5-Trimethylcyclohexylsalicylate (Homosalate)
Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester
Caswell No. 482B
Coppertone
EINECS 204-260-8
EPA Pesticide Chemical Code 076603
Filtersol ''A''
Heliopan
m-Homomenthyl salicylate
NSC 164918
Salicylic acid, m-homomenthyl ester
Homosalato
Homosalatum
UNII-V06SV4M95S
Chemical Function
UV stabilizer
Softener and conditioner
Fragrance
Regulatory Lists
Europe; Personal care
Canada; consumer_product; Substances in Products - Canada (4/2014)
inert_ingredient; non_food_use; Pesticides
IFRA Transparency
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
HOMOSALATE
ChEMBL ID
CHEMBL1377575
Max Phase
2
Adverse Event Associations
95
Frequently Asked Questions
Is Homosalate allowed in the EU?
Homosalate EU regulatory status: restricted. Maximum allowed concentration: 7.34%. This is based on EU Regulation 1223/2009 and its amendments.
What does Homosalate do in cosmetics?
Homosalate functions as: Oil-soluble UVB UV filter; peak absorption ~306 nm; used as SPF booster in combination formulations; UVB-only spectrum with no UVA coverage. It is classified as a Active Ingredient in our database. CAS number: 118-56-9.
What is the NOAEL for Homosalate?
The NOAEL (No Observed Adverse Effect Level) for Homosalate is =10 mg/kg bw/day based on a repeated dose toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS Opinion.
Is Homosalate used outside cosmetics?
Homosalate 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 Homosalate have different safety status in cosmetics vs industrial chemicals?
Homosalate is classified GHS CMR hazard (H315, H319, H335, H361d, H410) in the chemicals database but is restricted in EU cosmetics at max 7.34%.
Compliance Tools
Check Homosalate compliance across multiple jurisdictions:
Ingredient Decoder
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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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