Also known as: 2-Phenyl-1H-benzimidazole-5-sulfonic acid, EINECS 248-502-0, UNII-9YQ9DI1W42
INCI: PHENYLBENZIMIDAZOLE SULFONIC ACID
Phenylbenzimidazole Sulfonic Acid (CAS 27503-81-7) is a cosmetic cosmetic ingredient functioning as UV Filter (UVB). NOAEL 40 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 8%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
US NotesListed as Ensulizole; not GRAS (additional data needed per FDA 2021 Proposed Order); max 4% under existing US monograph
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Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Phenylbenzimidazole Sulfonic Acid.
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Toxicological Studies
10 study endpoints found for Phenylbenzimidazole Sulfonic Acid. 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 Phenylbenzimidazole Sulfonic Acid 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
Is Phenylbenzimidazole Sulfonic Acid safe in cosmetics?
Phenylbenzimidazole Sulfonic Acid has a safety rating of "EXCELLENT" in our database. EU status: restricted. US status: restricted. 10 toxicological study endpoint(s) are available in our database.
Is Phenylbenzimidazole Sulfonic Acid allowed in the EU?
Phenylbenzimidazole Sulfonic Acid EU regulatory status: restricted. Maximum allowed concentration: 8%. This is based on EU Regulation 1223/2009 and its amendments.
What does Phenylbenzimidazole Sulfonic Acid do in cosmetics?
Phenylbenzimidazole Sulfonic Acid functions as: UV Filter (UVB). It is classified as a cosmetic ingredient in our database. CAS number: 27503-81-7.
What is the NOAEL for Phenylbenzimidazole Sulfonic Acid?
The NOAEL (No Observed Adverse Effect Level) for Phenylbenzimidazole Sulfonic Acid 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 Phenylbenzimidazole Sulfonic Acid used outside cosmetics?
Phenylbenzimidazole Sulfonic Acid 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
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