Is Ensulizole safe in cosmetics?
Ensulizole 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.
Ensulizole
Also known as: 2-Phenyl-1H-benzimidazole-5-sulfonic acid, EINECS 248-502-0, UNII-9YQ9DI1W42
INCI: PHENYLBENZIMIDAZOLE SULFONIC ACID
Ensulizole (CAS 27503-81-7) is a cosmetic active ingredient functioning as Water-soluble UVB UV filter; peak absorption ~310 nm; unique sulfonic acid. NOAEL 40 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted, max 4%. 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 27503-81-7 →
Auto-generated CPSR Part A draft with source citations
Function
Water-soluble UVB UV filter; peak absorption ~310 nm; unique sulfonic acid moiety confers water-solubility — enables use in lightweight aqueous formulations; preferred for facial moisturizers, primers, and fluids requiring non-greasy SPF
Safety Rating
MODERATE
Regulatory Status
EU EU Status
permitted
EU Max Conc.
4%
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. 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 Ensulizole.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Ensulizole. 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 | =0.125 mg/kg | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =0.125 mg/kg | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =0.125 mg/kg | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =0.125 mg/kg | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =40 mg/kg bw | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =40 mg/kg bw | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =40 mg/kg bw | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =40 mg/kg bw | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =200 mg/kg bw | oral | rat | dermal absorption | SCCS_vision_codex |
| NOAEL | =200 mg/kg bw | oral | rat | dermal absorption | SCCS_vision_codex |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Ensulizole 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.
KeratinoSens IC50
2000 µM
hCLAT CV75
3500 µg/mL
GHS: inconclusive
Source: 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 (limited)
LOEC: 10 µM
EU status: allowed (max 8%)
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
Max: 8%(as acid)
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: 4%.
SA Saudi SFDA (VI - UV Filters)
Max: 8%(as acid).
JPKR Japan/Korea Cosmetics
Japan (Positive (UV Absorber)): max 3.0
Japan (Restricted): max Wash-away: 3.0% | Leave-on: 3.0% | Mucosa: Prohibited
Korea (Restricted): max 8%
BRIN Brazil/India Cosmetics
India: Permitted UV Filter · max 8%(as acid)
Additional Jurisdictional Restrictions (6)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| JP | restricted | Wash-away: 3.0% | Leave-on: 3.0% | Mucosa: Prohibited | Wash-away: 3.0% | Leave-on: 3.0% | Mucosa: Prohibited |
| CN | permitted_uv_filter | 4 | All cosmetics |
| IN | permitted_uv_filter | 8.0 | sunscreen and other cosmetic products |
| BR | permitted_uv_filter | 8 | Sunscreen products; 8% as acid |
| ASEAN | permitted_uv_filter | 8% as acid | - |
| ASEAN | permitted_uv_filter | 8% 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 (1 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured | 0.259% | in_vitro | - | SCCP/0079 |
Additional Ingredient Properties
1 property record from structured ingredient metadata.
anti_pollution
{"cas_number": "27503-81-7", "ingredient_class": "other", "primary_mechanism": "film_forming_barrier", "pollution_types_targeted": "UV_B", "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": "no", "NF_kB_inhibitio…
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 Ensulizole.
Regulatory Flags
uv-filter
uvb
water-soluble
sulfonic-acid
fda-limbo
systemic-absorption
lightweight
daily-spf
non-greasy
aqueous-phase
low-concern-relative-to-class
ifra_fragrance
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Ensulizole by CAS number or substance name.
Studies
20
Lowest NOAEL
0.125
Highest NOAEL
1000
Units vary across source rows: mg/kg bw/day, mg/kg bw, mg/kg
SCCS_vision_codex
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 0.259% | in_vitro | - |
Known Synonyms
2-Phenyl-1H-benzimidazole-5-sulfonic acid
EINECS 248-502-0
UNII-9YQ9DI1W42
Chemical Function
UV stabilizer
Fragrance
Regulatory Lists
Canada; pharmaceutical
Canada; consumer_product; Substances in Products - Canada (4/2014)
IFRA Transparency
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
ENSULIZOLE
ChEMBL ID
CHEMBL1987518
Max Phase
2
Frequently Asked Questions
Is Ensulizole allowed in the EU?
Ensulizole EU regulatory status: permitted. Maximum allowed concentration: 4%. This is based on EU Regulation 1223/2009 and its amendments.
What does Ensulizole do in cosmetics?
Ensulizole functions as: Water-soluble UVB UV filter; peak absorption ~310 nm; unique sulfonic acid moiety confers water-solubility — enables use in lightweight aqueous formulations; preferred for facial moisturizers, primers, and fluids requiring non-greasy SPF. It is classified as a Active Ingredient in our database. CAS number: 27503-81-7.
What is the NOAEL for Ensulizole?
The NOAEL (No Observed Adverse Effect Level) for Ensulizole is =0.125 mg/kg based on a dermal absorption study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS_vision_codex.
Is Ensulizole used outside cosmetics?
Ensulizole 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 Ensulizole 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
Related Ingredients
Acetyl Tetrapeptide-5
Excellent
Same category
Anti-edema peptide for periorbital ar...
Activated Charcoal
Excellent
Same category
Adsorbent; skin cleanser; pore-cleans...
Adenosine
Excellent
Same category
Skin-conditioning agent, anti-aging, ...
Allantoin
Excellent
Same category
Skin conditioner, keratolytic, anti-i...
Alpha-Glucan Oligosaccharide
Excellent
Same category
prebiotic, skin-conditioning
Ascophyllum Nodosum Extract
Excellent
Same category
Skin Brightening, Tyrosinase Inhibito...
(20S)-Protopanaxadiol
Moderate
Similar safety
(Cnidium Officinale/Coptis Chinensis/Glycyrrhiza Uralensis) Root Extract
Moderate
Similar safety
Skin conditioning
(Cryptomeria Japonica/Chamaecyparis Obtusa) Stem Ferment Extract
Moderate
Similar safety
Antimicrobial, antioxidant, humectant
(Eclipta Prostrata/Houttuynia Cordata) Leaf Extract
Moderate
Similar safety
Skin conditioning
(Lepidium Meyenii/Sarcodon Aspratus) Root Water
Moderate
Similar safety
Skin conditioning
(Licorice/Reynoutria Japonica) Root/Stem Extract
Moderate
Similar safety
Skin conditioning, antioxidant
Phenylbenzimidazole Sulfonic Acid
Excellent
Chemical family
UV Filter (UVB)
ENTEROCOCCUS FAECIUM/LACTOBACILLUS/SALIX PURPUREA BARK/LEAF/STEM/WOOD/ASCORBIC ACID/ GLUCONOLACTONE FERMENT EXTRACT FILTRATE
Good
Browse nearby
Anti-seborrheic, Antiplaque, Humectan...
ENTEROCOCCUS FAECIUM/LAETIPORUS SULPHUREUS MYCELIUM/POLYGONUM CUSPIDATUM ROOT EXTRACT FERMENT FILTRATE
Good
Browse nearby
Antioxidant
Is Ensulizole in Your Products?
Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.
Try Piro Free →Analyze Your Full Ingredient List
Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Ensulizole in your formulation.