Is Octisalate safe in cosmetics?
Octisalate has a safety rating of "MODERATE" in our database. EU status: permitted. US status: restricted.
Moderate
Active Ingredient
Octisalate
Also known as: BRN 2730664, EINECS 204-263-4, Ethyl hexyl salicylate, UNII-4X49Y0596W
INCI: ETHYLHEXYL SALICYLATE
Octisalate (CAS 118-60-5) is a cosmetic active ingredient functioning as Oil-soluble UVB UV filter with peak absorption ~307 nm; functions as a. EU Regulation 1223/2009 status: permitted, max 5%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
View industrial chemical safety profile for CAS 118-60-5 →
Auto-generated CPSR Part A draft with source citations
Function
Oil-soluble UVB UV filter with peak absorption ~307 nm; functions as a solubilizer for avobenzone in oil-phase formulation, improving avobenzone physical stability and prolonging UVA coverage
Safety Rating
MODERATE
Regulatory Status
EU EU Status
permitted
EU Max Conc.
5%
US US Status
restricted
US Notes
Historically marketed in the US; FDA states existing data is not sufficient to determine GRAS. Regulatory limbo alongside seven other chemical filters. Final determination pending additional safety data.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Octisalate.
Calculate MoS for your specific formulation with the MoS Calculator.
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 | 2592 | - | - |
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
(2022)
Health effects: Yes
Affected pathways: Estrogenic
Regulatory framework: REACH/Cosmetics
Source list: II (former)
Cosmetic-Specific Mechanism
Category: UV filter
Receptor targets: ERα
LOEC: 10 µM
EU status: allowed (max 5%)
agonist
Dose-Response Data Points
| Endpoint | Target | Value | Direction |
|---|---|---|---|
| ERa luciferase reporter | ERa | EC50/IC50: AC50 16.48 uM (above cytotox burst 5.86 uM); LOEC: 17.64 uM (ACC); NOEC: 5 uM mixed | agonist (above cytotoxic burst) |
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
Max: 5%
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: 5%.
SA Saudi SFDA (VI - UV Filters)
Max: 0.05.
JPKR Japan/Korea Cosmetics
Japan (Positive (UV Absorber)): max 10.0
Japan (Restricted): max Wash-away: 10% | Leave-on: 10% | Mucosa: 5.0%
Korea (Restricted): max 5%
BRIN Brazil/India Cosmetics
India: Permitted UV Filter · max 0.05
Additional Jurisdictional Restrictions (5)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| JP | restricted | Wash-away: 10% | Leave-on: 10% | Mucosa: 5.0% | Wash-away: 10% | Leave-on: 10% | Mucosa: 5.0% |
| CN | permitted_uv_filter | 5 | All cosmetics |
| IN | permitted_uv_filter | 5.0 | sunscreen and other cosmetic products |
| BR | permitted_uv_filter | 5 | Sunscreen products |
| ASEAN | permitted_uv_filter | 5% | - |
Additional Ingredient Properties
1 property record from structured ingredient metadata.
preservative
{"preservative_class": "Organic acid ester", "antimicrobial_spectrum_bacteria_gp": "Weak", "antimicrobial_spectrum_bacteria_gn": "Weak", "antimicrobial_spectrum_yeast": "Weak", "antimicrobial_spectrum_mold": "Weak", "mic_staph_aureus_ppm": "5000", "mic_e_coli_ppm": "5000", "mic_pseudomonas_ppm": "5000", "mic_candida_albicans_ppm": "5000", "mic_aspergillus_niger_ppm": "5000", "challenge_test_pass_c…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Fragrance
UV stabilizer
Regulatory List Membership (4)
EU Regulated in Personal Care
IFRA Fragrance Transparency List
Consumer Product Chemical
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Octisalate.
Regulatory Flags
uv-filter
uvb
oil-soluble
fda-limbo
systemic-absorption
avobenzone-solubilizer
photostable
salicylate-class
low-concern-relative-to-class
ifra_fragrance
eu_cosing_listed
Known Synonyms
BRN 2730664
EINECS 204-263-4
Ethyl hexyl salicylate
UNII-4X49Y0596W
Chemical Function
UV stabilizer
Fragrance
Regulatory Lists
inert_ingredient; non_food_use; Pesticides
Canada; consumer_product; Substances in Products - Canada (4/2014)
IFRA Transparency
consumer_product
Canada; pharmaceutical
Canada; pharmaceutical
Europe; Personal care
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
OCTISALATE
ChEMBL ID
CHEMBL1329203
Max Phase
2
Adverse Event Associations
100
Frequently Asked Questions
Is Octisalate allowed in the EU?
Octisalate EU regulatory status: permitted. Maximum allowed concentration: 5%. This is based on EU Regulation 1223/2009 and its amendments.
What does Octisalate do in cosmetics?
Octisalate functions as: Oil-soluble UVB UV filter with peak absorption ~307 nm; functions as a solubilizer for avobenzone in oil-phase formulation, improving avobenzone physical stability and prolonging UVA coverage. It is classified as a Active Ingredient in our database. CAS number: 118-60-5.
Is Octisalate used outside cosmetics?
Octisalate also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Octisalate 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
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