Moderate Active Ingredient NOAEL Data SCCS/CIR Reviewed

Octinoxate

Also known as: 2-Ethylhexyl 3-(4-methoxyphenyl)prop-2-enoate, 2-Ethylhexyl-4-methoxycinnamate, Ethylhexyl p-methoxycinnamate, 2-Propenoic acid, 3-(4-methoxyphenyl)-, 2-ethylhexyl ester, Octyl methoxycinnamate (+2 more)

INCI: ETHYLHEXYL METHOXYCINNAMATE

Octinoxate (CAS 5466-77-3) is a cosmetic active ingredient functioning as Oil-soluble UVB UV filter; peak absorption ~311 nm; undergoes trans-to-cis. NOAEL 450 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted, max 10%; 5 safety opinions reviewed (sccs). 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 5466-77-3 →

Auto-generated CPSR Part A draft with source citations

CAS Number

5466-77-3

View industrial chemical safety profile →

Function

Oil-soluble UVB UV filter; peak absorption ~311 nm; undergoes trans-to-cis photoisomerization under UV exposure causing progressive SPF loss

Safety Rating

MODERATE

Chemistry & Identifiers

ChEBI: CHEBI:134750 Wikidata: Q60311884

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 alongside seven other chemical filters. Banned by local legislation in Hawaii (2021), US Virgin Islands, and other coastal jurisdictions due to coral reef toxicity. Final GRASE 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 Octinoxate.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Octinoxate. 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	=100 mg/kg bw/day	oral	rat	NOAEL study	SCCS_vision_codex
NOAEL	=100 mg/kg bw/day	oral	rat	NOAEL study	SCCS_vision_codex
NOAEL	=100 mg/kg bw/day	oral	rat	NOAEL study	SCCS_vision_codex
NOAEL	=100 mg/kg bw/day	oral	rat	NOAEL study	SCCS_vision_codex
NOAEL	=450 mg/kg bw/day	-	-	NOAEL study	SCCS_vision_codex
NOAEL	=450 mg/kg bw/day	-	-	NOAEL study	SCCS_vision_codex
NOAEL	=450 mg/kg bw/day	-	-	NOAEL study	SCCS_vision_codex
NOAEL	=450 mg/kg bw/day	-	-	NOAEL study	SCCS_vision_codex
NOAEL	=500 mg/kg bw/day	-	-	reproductive toxicity	SCCS_vision_codex
NOAEL	=500 mg/kg bw/day	-	-	reproductive toxicity	SCCS_vision_codex

Safety Opinions

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

sccs SCCS/1671/24 26 June 2025

Verdict: safe

NOAEL: 450 mg/kg bw/day (oral)

Max Concentration: 10% in general

otential endocrine disrupting properties of EHMC, the SCCS is of the opinion that EHMC is safe when used as a UV filter up to a maximum concentration of 10% in sunscreen lotion, face and hand cream, lipstick, sunscreen propellant spray and pump spray, when used separately or in combination.

sccs SCCS/1671/24 26 June 2025

Verdict: safe

NOAEL: 450 mg/kg bw/day (oral)

Max Concentration: 10% in spray/aerosol

otential endocrine disrupting properties of EHMC, the SCCS is of the opinion that EHMC is safe when used as a UV filter up to a maximum concentration of 10% in sunscreen lotion, face and hand cream, lipstick, sunscreen propellant spray and pump spray, when used separately or in combination.

sccs SCCS/1671/24 26 June 2025

Verdict: safe

NOAEL: 450 mg/kg bw/day (not specified)

Max Concentration: 10% in general

otential endocrine disrupting properties of EHMC, the SCCS is of the opinion that EHMC is safe when used as a UV filter up to a maximum concentration of 10% in sunscreen lotion, face and hand cream, lipstick, sunscreen propellant spray and pump spray, when used separately or in combination.

sccs SCCS/1671/24 26 June 2025

Verdict: safe

NOAEL: 450 mg/kg bw/day (not specified)

Max Concentration: 10% in spray/aerosol

otential endocrine disrupting properties of EHMC, the SCCS is of the opinion that EHMC is safe when used as a UV filter up to a maximum concentration of 10% in sunscreen lotion, face and hand cream, lipstick, sunscreen propellant spray and pump spray, when used separately or in combination.

sccs SCCS/1671/24 26 June 2025

Verdict: safe

NOAEL: 1000 mg/kg bw/day (not specified)

Max Concentration: 10% in general

otential endocrine disrupting properties of EHMC, the SCCS is of the opinion that EHMC is safe when used as a UV filter up to a maximum concentration of 10% in sunscreen lotion, face and hand cream, lipstick, sunscreen propellant spray and pump spray, when used separately or in combination.

Pre-Calculated Safety Assessment

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

Sensitization AOP Dashboard

Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.

DPRA Cys %

0.3%

DPRA Lys %

0%

KeratinoSens IC50

130.588 µM

hCLAT CV75

1000 µg/mL

GHS: inconclusive

Source: DPRA: Cosmetics Europe; KS: Cosmetics Europe; hCLAT: Cosmetics Europe

Endocrine Disruptor Evidence (Expanded)

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

Cosmetic-Specific Mechanism

Category: UV filter

Receptor targets: ERα, ERβ, AR, TR, PR

LOEC: 1.56 µM

EU status: restricted (max 10%)

antagonist (ER, AR, TR, PR)

Dose-Response Data Points

Endpoint	Target	Value	Direction
dermal_RF_16h	skin	0.03 ± 0.07 µg/cm²	-
dermal_systemic	skin	0.002% %	-
plasma_conc	systemic	10–20 ng/mL ng/mL	-
Cell proliferation	ER	EC50/IC50: ~1.6 uM; LOEC: 0.3 uM; NOEC: 0.1 uM mixed	agonist
Luciferase ERE transcriptional activation	ER	EC50/IC50: ~0.5-1 uM (ERa); LOEC: 0.1 uM; NOEC: 0.01 uM mixed	agonist

SIN List ED: Endocrine Disruptor Cosmetic relevance: direct

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex VI — Permitted UV Filters

Max: 10%

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: 7.5%.

SA Saudi SFDA (VI - UV Filters)

Max: 0.1.

JPKR Japan/Korea Cosmetics

Japan (Positive (UV Absorber)): max 20.0

Korea (Restricted): max 7.5

Japan (Restricted): max Wash-away: 20% | Leave-on: 20% | Mucosa: 8.0%

BRIN Brazil/India Cosmetics

India: Permitted UV Filter · max 0.1

Additional Jurisdictional Restrictions (6)

Jurisdiction	Status	Max %	Product Type
JP	restricted	Wash-away: 20% \| Leave-on: 20% \| Mucosa: 8.0%	Wash-away: 20% \| Leave-on: 20% \| Mucosa: 8.0%
CN	permitted_uv_filter	10	All cosmetics
IN	permitted_uv_filter	10.0	sunscreen and other cosmetic products
AU	restricted	-	sunscreens (therapeutic)
BR	permitted_uv_filter	10	Sunscreen products
ASEAN	permitted_uv_filter	10%	-

Expanded Dermal Absorption Data

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

Aggregated DA Values (1 records across 5 sources)

Type	DA %	Method	Skin Model	SCCS Ref
measured_in_vitro	1.5	In vivo — human volunteers (plasma/urine monitoring)	-	SCC 1996; SCCS 2025 (EHMC) (1996)

Typical Use Concentrations

Reported concentration ranges per product category from SCCS/CIR/industry sources.

Product Category	Typical Range	Max Reported	Source
Sunscreen	3–7.5	7.5	CIR/FDA OTC
Foundation	1–3	7.5	CIR/VCRP

Additional Ingredient Properties

3 property records from structured ingredient metadata.

anti_pollution

{"cas_number": "5466-77-3", "ingredient_class": "blue_light_filter", "primary_mechanism": "film_forming_barrier", "pollution_types_targeted": "UV_B/partial_HEV", "IR_A_protection": "no", "visible_light_protection": "no", "digital_screen_protection_claim": "no", "PAH_neutralization": "no", "ozone_protection": "no", "mitochondrial_protection": "no", "Nrf2_activation": "no", "AhR_pathway_modulation":…

hair_care

{"hair_function": "color-protection", "hair_type_suitability": "all", "curl_pattern_suitability": "all", "porosity_suitability": "all", "protein_sensitivity": "neutral", "moisture_protein_balance": "yes", "cg_method_approved": "not-a-silicone", "silicone_type": "not-a-sulfate", "sulfate_type": "no", "drying_alcohol": "no", "fatty_alcohol": "yes", "heat_protectant": "yes", "color_safe": "neutral", …

regulatory

{"eu_status": "restricted", "us_status": "allowed", "eu_max_concentration": "0.1", "restricted_in": "max 10%", "regulation_reference": "Annex VI/22"}

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

Expert Verdict

Expert safety assessment and concern-level summary for Octinoxate.

Regulatory Flags

uv-filter uvb oil-soluble photounstable trans-cis-isomerization fda-limbo systemic-absorption endocrine-disruption-concern anti-androgenic reef-toxic banned-hawaii banned-palau banned-us-virgin-islands coral-bleaching photocontact-allergen sccs-2025-safe-at-10pct ifra_fragrance eu_cosing_listed

NOAEL Studies Summary

View details ->

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

Studies

32

Lowest NOAEL

100 mg/kg bw/day

Highest NOAEL

5000 mg/kg bw/day

SCCS_vision_codex

Dermal Absorption

View details ->

Absorption %	Method	Vehicle
1.5	In vivo — human volunteers (plasma/urine monitoring)	o/w sunscreen formulation

Known Synonyms

2-Ethylhexyl 3-(4-methoxyphenyl)prop-2-enoate 2-Ethylhexyl-4-methoxycinnamate Ethylhexyl p-methoxycinnamate 2-Propenoic acid, 3-(4-methoxyphenyl)-, 2-ethylhexyl ester Octyl methoxycinnamate EINECS 226-775-7 UNII-4Y5P7MUD51

Chemical Function

Fragrance UV stabilizer

Regulatory Lists

children; WA Children's Safe Product Act (4/2020) children children children detected; Europe; Personal care - nails - nail polish IFRA Transparency detected; Europe; Toys and children's products Europe; Personal care Europe; Personal care Canada; pharmaceutical Canada; pharmaceutical active_ingredient; Australia inert_ingredient; non_food_use; Pesticides 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

OCTINOXATE

ChEMBL ID

CHEMBL3183184

Max Phase

4

Adverse Event Associations

44

View full pharmaceutical profile →

Frequently Asked Questions

Is Octinoxate safe in cosmetics?

Octinoxate 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. This ingredient has been reviewed by sccs.

Is Octinoxate allowed in the EU?

Octinoxate EU regulatory status: permitted. Maximum allowed concentration: 10%. This is based on EU Regulation 1223/2009 and its amendments.

What does Octinoxate do in cosmetics?

Octinoxate functions as: Oil-soluble UVB UV filter; peak absorption ~311 nm; undergoes trans-to-cis photoisomerization under UV exposure causing progressive SPF loss. It is classified as a Active Ingredient in our database. CAS number: 5466-77-3.

What is the NOAEL for Octinoxate?

The NOAEL (No Observed Adverse Effect Level) for Octinoxate is =100 mg/kg bw/day based on a NOAEL study study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS_vision_codex.

Is Octinoxate used outside cosmetics?

Octinoxate also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Compliance Tools

Check Octinoxate compliance across multiple jurisdictions:

Ingredient Decoder

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Substance Compliance

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Calculate Margin of Safety using SCCS methodology

Heavy Metal Limits

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Ethylhexyl Methoxycinnamate

Moderate Chemical family

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OCTACARBOXYMETHYL DIPEPTIDE-12 LYSINAMIDE

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