Good Active Ingredient NOAEL Data

Avobenzone

Also known as: 1,3-Propanedione, 1-[4-(1,1-dimethylethyl)phenyl]-3-(4-methoxyphenyl)-, 1-(4-(1,1-Dimethylethyl)phenyl)-3-(4-methoxyphenyl)-1,3-propanedione, EINECS 274-581-6, Avobenzona, Avobenzonum (+2 more)

INCI: BUTYL METHOXYDIBENZOYLMETHANE

Avobenzone (CAS 70356-09-1) is a cosmetic active ingredient functioning as Oil-soluble UVA1 UV filter; primary UVA absorber in US-market sunscreens; peak. NOAEL 33.3333 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); 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 industrial chemical safety data.

View industrial chemical safety profile for CAS 70356-09-1 →

Auto-generated CPSR Part A draft with source citations
Function
Oil-soluble UVA1 UV filter; primary UVA absorber in US-market sunscreens; peak absorption ~357 nm; photounstable — undergoes keto-enol tautomerization and Norrish type I/II photocleavage upon UV absorption; requires co-formulation with a photostabilizer for sustained UVA protection
Safety Rating
GOOD

Chemistry & Identifiers

EC Number
274-581-6

Regulatory Status

EU EU Status permitted
EU Max Conc. 5%
US US Status restricted
US Notes FDA OTC monograph active ingredient. Max concentration 3% in US. Classified NOT GRAS per September 27, 2021 proposed administrative order (86 FR 53546) due to systemic absorption exceeding 0.5 ng/mL threshold. FDA stated this does NOT mean the ingredient is unsafe — products remain on market and recommended for continued use. Additional nonclinical toxicology data (carcinogenicity, reproductive) required by FDA.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

3 study endpoints found for Avobenzone. 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 =360 mg/kg bw/day dermal Rabbit acute ToxValDB_ECHA_IUCLID
NOAEL =450 mg/kg bw/day oral Rat chronic ToxValDB_ECHA_IUCLID
NOAEL =1000 mg/kg bw/day oral Rat developmental ToxValDB_ECHA_IUCLID

Pre-Calculated Safety Assessment

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

EPA ToxValDB — Toxicity Values

8 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).

Endpoint Value Species Route Duration Source
LD50 >1000 mg/kg Rat dermal acute ECHA IUCLID
LD50 >16000 mg/kg Rat oral - ECHA IUCLID
LOAEL >360 mg/kg-day Rabbit dermal acute ECHA IUCLID
LOAEL =100 mg/kg-day Rabbit dermal acute ECHA IUCLID
LOAEL =1000 mg/kg-day Rat oral chronic ECHA IUCLID
NOAEL =1000 mg/kg-day Rat oral - ECHA IUCLID
NOAEL =360 mg/kg-day Rabbit dermal acute ECHA IUCLID
NOAEL =450 mg/kg-day Rat oral chronic ECHA IUCLID

Sensitization AOP Dashboard

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

DPRA Cys %
0%
DPRA Lys %
0%
KeratinoSens IC50
119.712 µM
hCLAT CV75
250 µg/mL
GHS: inconclusive

Source: 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 38950 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.

Suspected Evidence: Moderate (2015)
Health effects: Yes
Affected pathways: Estrogenic/Thyroid
Regulatory framework: REACH

Source list: II

Cosmetic-Specific Mechanism
Category: UV filter
Receptor targets: none confirmed in vitro
LOEC: N/A
EU status: allowed (max 5%)

no ER/AR binding detected

Dose-Response Data Points
Endpoint Target Value Direction
Cell proliferation ER EC50/IC50: N/A (no significant proliferation observed); LOEC: N/A; NOEC: >=3 uM mixed inactive
ERb luciferase transcription ERb EC50/IC50: ~10-100 uM (EC50 not formally reported); LOEC: 10 uM; NOEC: 1 uM mixed partial agonist (~60% E2 max)

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
Korea (Restricted): max 5.0
Japan (Restricted): max 10%
BRIN Brazil/India Cosmetics
India: Permitted UV Filter · max 0.05
Additional Jurisdictional Restrictions (5)
Jurisdiction Status Max % Product Type
CN permitted_uv_filter 5 All cosmetics
IN permitted_uv_filter 5.0 sunscreen and other cosmetic products
GCC restricted 5.0 Sunscreen products
BR permitted_uv_filter 5 Sunscreen products
ASEAN permitted_uv_filter 5% -

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 0.59 In vivo — clinical (plasma monitoring) - SCC/EC 2000; CIR review 2025 (2000)
measured_in_vitro 11.5 - - SCCS/1617/20

Typical Use Concentrations

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

Product Category Typical Range Max Reported Source
Sunscreen 1–3 5 CIR/VCRP

Additional Ingredient Properties

1 property record from structured ingredient metadata.

sunscreen_uv
{"cas_number": "70356-09-1", "uv_filter_type": "organic_UVA", "chemical_class": "avobenzone_derivative", "absorption_spectrum_nm_range": "320-400", "peak_absorption_wavelength_nm": "358", "molar_extinction_coefficient": "54000", "critical_wavelength_nm": "380", "UVA_PF": "12-18", "SPF_contribution_per_percent": "2.5", "photostability_rating": "photolabile", "photodegradation_half_life_hours": "0.5…

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 Avobenzone.

Regulatory Flags

systemic-absorption fda-not-grase photostability-concern photoallergy-risk uva-filter annex-vi endocrine_disruptor ifra_fragrance eu_cosing_listed

NOAEL Studies Summary

View details ->

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

Studies
3
Lowest NOAEL
360 mg/kg bw/day
Highest NOAEL
1000 mg/kg bw/day
ToxValDB_ECHA_IUCLID

Dermal Absorption

View details ->
Absorption % Method Vehicle
0.59 In vivo — clinical (plasma monitoring) Commercial sunscreen
11.5 - -

Known Synonyms

1,3-Propanedione, 1-[4-(1,1-dimethylethyl)phenyl]-3-(4-methoxyphenyl)- 1-(4-(1,1-Dimethylethyl)phenyl)-3-(4-methoxyphenyl)-1,3-propanedione EINECS 274-581-6 Avobenzona Avobenzonum UNII-G63QQF2NOX BMDBM

Chemical Function

UV stabilizer Fragrance

Regulatory Lists

Europe; Personal care IFRA Transparency pharmaceutical Canada; pharmaceutical Canada; pharmaceutical Canada; consumer_product; Substances in Products - Canada (4/2014)

Australian Status

AICIS status: listed

Frequently Asked Questions

Is Avobenzone safe in cosmetics?

Avobenzone has a safety rating of "GOOD" in our database. EU status: permitted. US status: restricted. 3 toxicological study endpoint(s) are available in our database.

Is Avobenzone allowed in the EU?

Avobenzone EU regulatory status: permitted. Maximum allowed concentration: 5%. This is based on EU Regulation 1223/2009 and its amendments.

What does Avobenzone do in cosmetics?

Avobenzone functions as: Oil-soluble UVA1 UV filter; primary UVA absorber in US-market sunscreens; peak absorption ~357 nm; photounstable — undergoes keto-enol tautomerization and Norrish type I/II photocleavage upon UV absorption; requires co-formulation with a photostabilizer for sustained UVA protection. It is classified as a Active Ingredient in our database. CAS number: 70356-09-1.

What is the NOAEL for Avobenzone?

The NOAEL (No Observed Adverse Effect Level) for Avobenzone is =360 mg/kg bw/day based on a acute study via dermal route in Rabbit. A total of 3 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.

Is Avobenzone used outside cosmetics?

Avobenzone also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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