Is Octocrylene safe in cosmetics?
Octocrylene has a safety rating of "MODERATE" in our database. EU status: permitted. US status: restricted. 10 toxicological study endpoint(s) are available in our database.
Octocrylene
Also known as: 2-Ethylhexyl 2-cyano-3,3-diphenylacrylate, EINECS 228-250-8, 2-Ethylhexyl 2-cyano-3,3-diphenyl-2-acrylate, Octocrilenum, UNII-5A68WGF6WM
INCI: OCTOCRYLENE
Octocrylene (CAS 6197-30-4) is a cosmetic active ingredient functioning as Oil-soluble UVB and short-wave UVA UV filter; triplet-state quencher and. NOAEL 76.5 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted, max 10%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
Function
Oil-soluble UVB and short-wave UVA UV filter; triplet-state quencher and radical scavenger that photostabilizes avobenzone by accepting triplet energy and dissipating it harmlessly; peak absorption ~303 nm; may hydrolyze to benzophenone as a degradation product over product shelf life
Editorial assessment
MODERATE
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
permitted
EU Max Conc.
10%
US US Status
restricted
US Notes
Historically marketed in the US; FDA states existing data is not sufficient to determine GRASE. Regulatory limbo. 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 Octocrylene.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Octocrylene. 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 | =76.5 mg/kg bw/day | oral | - | reproductive toxicity | SCCS Opinion |
| NOAEL | =76.5 mg/kg bw/day | oral | - | reproductive toxicity | SCCS Opinion |
| NOAEL | =76.5 mg/kg bw/day | oral | - | reproductive toxicity | SCCS Opinion |
| NOAEL | =76.5 mg/kg bw/day | oral | - | reproductive toxicity | SCCS Opinion |
| NOAEL | =130 mg/kg/day | - | rabbit | NOAEL study | SCCS Opinion |
| NOAEL | =130 mg/kg/day | - | rabbit | NOAEL study | SCCS Opinion |
| NOAEL | =130 mg/kg/day | - | rabbit | NOAEL study | SCCS Opinion |
| NOAEL | =130 mg/kg/day | - | rabbit | NOAEL study | SCCS Opinion |
| NOAEL | =153 mg/kg bw/day | oral | rat | developmental toxicity | SCCS Opinion |
| NOAEL | =153 mg/kg | - | - | reproductive toxicity | SCCS Opinion |
Pre-Calculated Safety Assessment
Conditional — safe only within SCCS limits: up to 10% individually/combined in listed products; propellant spray combined use at 10% not safe, <=9% when combined
Pre-calculated NOAEL → SED → MoS audit trail for Octocrylene across SCCS product categories, with measured dermal absorption where available.
SCCS NOAEL Values
NOAEL/LOAEL values cited in official SCCS opinions for Octocrylene.
| NOAEL | LOAEL | Route | Species | Study | DA% (SCCS) | Opinion |
|---|---|---|---|---|---|---|
| 153 mg/kg/day | 534 mg/kg/day | Oral | Rat | Extended one-generation reproductive (EOGRTS, OECD 443) (~10 weeks premating + gestation + lactation (GLP)) | 50 | SCCS/1627/21 (2021) |
| 175 mg/kg/day | - | Oral | Rat (Wistar) | Subchronic (90-day, OECD 407) (90 days (dietary)) | 50 | SCCS/1627/21 (2021) |
Sensitization Profile
Contact sensitization data for Octocrylene based on clinical patch test studies and IFRA standards.
Sensitization Rate
low
Allergen Class
other
EU Allergen Listed
no
Patch Test Positive Rate
0.5%
Cross-reactivity Group
benzophenone-group
Reaction Type
photosensitivity
Source: ESSCA
Dermal Penetration Profile
Skin absorption and penetration characteristics of Octocrylene, relevant to systemic exposure and MoS calculations.
Absorption %
5-10%
Penetration Level
stratum-corneum
Penetration Depth
stratum corneum
Molecular Weight
361.5 Da
Log P
6.9
Systemic Absorption
minimal
Topical Bioavailability
3-8%
Safety Margin Factor
moderate
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 | =221771 mg/m3 | Rat | inhalation | subchronic (developmental) | EPA TSCA 8e |
| LEL | =221771 mg/m3 | Rat | inhalation | subchronic (developmental) | EPA TSCA 8e |
| LEL | =73923.7 mg/m3 | Rat | inhalation | subchronic (developmental) | EPA TSCA 8e |
| LD50 | >5000 mg/kg | Rat | oral | - | ChemIDplus |
| LEL | =7000 ppm | Rat | oral | chronic (developmental) | EPA TSCA 8e |
| LEL | =7000 ppm | Rat | oral | chronic (developmental) | EPA TSCA 8e |
| LEL | =7000 ppm | Rat | oral | chronic (developmental) | EPA TSCA 8e |
| LEL | =7000 ppm | Rat | oral | chronic (developmental) | EPA TSCA 8e |
| LEL | =7000 ppm | Rat | oral | chronic (developmental) | EPA TSCA 8e |
| LEL | =7000 ppm | Rat | oral | chronic (developmental) | EPA TSCA 8e |
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
DPRA Cys %
1.9%
DPRA Lys %
3.3%
KeratinoSens IC50
2000 µM
hCLAT CV75
500 µg/mL
LLNA EC3
7.7%
NESIL
1925 µg/cm²
LLNA: Moderate (1B)
GHS: 1B
Source: LLNA: CosmEur database; DPRA: Cosmetics Europe; KS: Cosmetics Europe; hCLAT: Cosmetics Europe
HRIPT Human Patch Test Studies
1 human repeat insult patch test aggregated from dermatological literature.
| Test Type | N | Sensitized | Dose µg/cm² | NESIL µg/cm² | Potency |
|---|---|---|---|---|---|
| HRIPT | - | 0 | - | - | non-sensitizer |
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, Thyroid
Regulatory framework: Cosmetics
Source list: II (former)
Cosmetic-Specific Mechanism
Category: UV filter
Receptor targets: ERα, ERβ, AR, PR
LOEC: 3 µM
EU status: restricted (max 9% body; 10% face); under review
antagonist (ER, AR, PR)
Dose-Response Data Points
| Endpoint | Target | Value | Direction |
|---|---|---|---|
| Cell proliferation | ER | EC50/IC50: EC50 not achieved; partial response >3 uM; LOEC: 1 uM; NOEC: 0.3 uM mixed | weak agonist |
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: a) Propellant spray products
b) Other products
Max: a) 9%
b) 10%
Footnote (*3): Benzophenone as an impurity and/or degradation product of Octocrylene shall be kept at trace level.
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: 10%(as acid).
JPKR Japan/Korea Cosmetics
Japan (Positive (UV Absorber)): max 10.0
Korea (Restricted): max 10.0
Japan (Restricted): max 10%
BRIN Brazil/India Cosmetics
India: Permitted UV Filter · max 10%(as acid)
Additional Jurisdictional Restrictions (8)
| 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 | 10.0 | Sunscreen/UV products |
| BR | permitted_uv_filter | 10 | Sunscreen products |
| UK | restricted | - | - |
| ASEAN | permitted_uv_filter | 10% as acid | - |
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 | 0.25 | In vitro — static diffusion cells | - | SCCS 2021 opinion (2021) |
| measured_in_vitro | 7.5 | - | - | SCCS/1627/21 |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Sunscreen | 2–10 | 10 | CIR Safety Assessment |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Fragrance
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 Octocrylene — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
uv-filter
uvb
short-wave-uva
oil-soluble
avobenzone-stabilizer
triplet-quencher
fda-limbo
systemic-absorption
benzophenone-formation
endocrine-disruption-concern
photocontact-allergen
fatty-tissue-accumulation
sccs-reassessment-ongoing
endocrine_disruptor
ifra_fragrance
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Octocrylene by CAS number or substance name.
Studies
24
Lowest NOAEL
76.5
Highest NOAEL
1000
Units vary across source rows: mg/kg bw/day, mg/kg/day, mg/kg
SCCS Opinion
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 0.25 | In vitro — static diffusion cells | Sunscreen formulation |
| 7.5 | - | - |
Known Synonyms
2-Ethylhexyl 2-cyano-3,3-diphenylacrylate
EINECS 228-250-8
2-Ethylhexyl 2-cyano-3,3-diphenyl-2-acrylate
Octocrilenum
UNII-5A68WGF6WM
Chemical Function
UV stabilizer
Fragrance
Regulatory Lists
CEDI
inert_ingredient; non_food_use; Pesticides
IFRA Transparency
Canada; consumer_product; Substances in Products - Canada (4/2014)
pharmaceutical
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
OCTOCRYLENE
ChEMBL ID
CHEMBL1201147
Max Phase
4
Adverse Event Associations
95
Frequently Asked Questions
Is Octocrylene allowed in the EU?
Octocrylene EU regulatory status: permitted. Maximum allowed concentration: 10%. This is based on EU Regulation 1223/2009 and its amendments.
What does Octocrylene do in cosmetics?
Octocrylene functions as: Oil-soluble UVB and short-wave UVA UV filter; triplet-state quencher and radical scavenger that photostabilizes avobenzone by accepting triplet energy and dissipating it harmlessly; peak absorption ~303 nm; may hydrolyze to benzophenone as a degradation product over product shelf life. It is classified as a Active Ingredient in our database. CAS number: 6197-30-4.
What is the NOAEL for Octocrylene?
The NOAEL (No Observed Adverse Effect Level) for Octocrylene is =76.5 mg/kg bw/day based on a reproductive toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS Opinion.
Is Octocrylene used outside cosmetics?
Octocrylene 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.
Compliance Tools
Check Octocrylene 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
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