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.
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 and pharmaceutical data.
View industrial chemical safety profile for CAS 70356-09-1 →
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
Editorial assessment
GOOD
Preliminary editorial note — not a computed safety verdict.
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 | ECHA |
| NOAEL | =450 mg/kg bw/day | oral | Rat | chronic | ECHA |
| NOAEL | =1000 mg/kg bw/day | oral | Rat | developmental | ECHA |
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 |
| LD50 | >16000 mg/kg | Rat | oral | - | ECHA |
| LOAEL | >360 mg/kg-day | Rabbit | dermal | acute | ECHA |
| LOAEL | =100 mg/kg-day | Rabbit | dermal | acute | ECHA |
| LOAEL | =1000 mg/kg-day | Rat | oral | chronic | ECHA |
| NOAEL | =1000 mg/kg-day | Rat | oral | - | ECHA |
| NOAEL | =360 mg/kg-day | Rabbit | dermal | acute | ECHA |
| NOAEL | =450 mg/kg-day | Rat | oral | chronic | ECHA |
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 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 Avobenzone — not a computed safety verdict. See the sourced toxicological data above.
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
ECHA
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
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
AVOBENZONE
ChEMBL ID
CHEMBL1200522
Max Phase
4
Adverse Event Associations
95
Frequently Asked Questions
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: ECHA.
Is Avobenzone used outside cosmetics?
Avobenzone 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 Avobenzone 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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