Moderate Cosmetic Ingredient NOAEL Data

METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL

Also known as: UNII-8NT850T0YS

METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL (CAS 103597-45-1) is a cosmetic cosmetic ingredient functioning as Light Stabilizer, Uv Filter. Reported NOAEL =0.0144 mg/kg bw/d in rat (SCCS_vision_codex); EU Regulation 1223/2009 status: restricted, max VI/23. 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 103597-45-1 →

Auto-generated CPSR Part A draft with source citations
CAS Number
103597-45-1
View industrial chemical safety profile →
Function
Light Stabilizer, Uv Filter
Safety Rating
MODERATE

Chemistry & Identifiers

EC Number
403-800-1
ChEBI: CHEBI:135865 UNII: 8NT850T0YS Wikidata: Q4918369

Regulatory Status

EU EU Status restricted
EU Max Conc. VI/23
US US Status Not specifically regulated

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

Toxicological Studies

10 study endpoints found for METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL. 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 =0.0144 mg/kg bw/d dermal rat dermal absorption SCCS_vision_codex
NOAEL =0.0144 mg/kg bw/d dermal rat dermal absorption SCCS_vision_codex
NOAEL =0.0144 mg/kg bw/d dermal rat dermal absorption SCCS_vision_codex
NOAEL =0.0144 mg/kg bw/d dermal rat dermal absorption SCCS_vision_codex
NOAEL =59.2 mg/kg bw/d dermal rat dermal absorption SCCS_vision_codex
NOAEL =59.2 mg/kg bw/d dermal rat dermal absorption SCCS_vision_codex
NOAEL =59.2 mg/kg bw/d dermal rat dermal absorption SCCS_vision_codex
NOAEL =59.2 mg/kg bw/d dermal rat dermal absorption SCCS_vision_codex
NOAEL =800 mg/kg bw/d dermal rat NOAEL study SCCS_vision_codex
NOAEL =800 mg/kg bw dermal rat carcinogenicity SCCS_vision_codex

EU CLP Annex VI Harmonized Classification

Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.

Pictograms
?
Hazard Class and Category
Aquatic Chronic 4
Hazard Statements
  • H413 May cause long lasting harmful effects to aquatic life

Inserted via ATP: CLP00

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: none confirmed
LOEC: N/A
EU status: allowed (max 10%)

no significant ER/AR activity

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
Hazard classification: Restricted (Annex XVII)

EU CosIng Annex Listing

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

Annex VI — Permitted UV Filters
Max: 10 %(*) (*) In case of combined use of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol and Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano), the sum shall not exceed the limit given in column g.’.

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: 10%.
SA Saudi SFDA (VI - UV Filters)
Max: 0.1.
JPKR Japan/Korea Cosmetics
Japan (Positive (UV Absorber)): max 10.0
Japan (Restricted): max Wash-away: 10% | Leave-on: 10% | Mucosa: Prohibited
Korea (Restricted): max 10%
BRIN Brazil/India Cosmetics
India: Permitted UV Filter · max 0.1
India: Permitted UV Filter · max 10 %(*) (*) In case of combined use of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol and Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano), the sum shall not exceed the limit given in column g.’.
Additional Jurisdictional Restrictions (4)
Jurisdiction Status Max % Product Type
CN permitted_uv_filter 10 All cosmetics
IN permitted_uv_filter 10.0 sunscreen and other cosmetic products
BR permitted_uv_filter 10 Sunscreen products; only non-nano form
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 (5 records across 5 sources)
Type DA % Method Skin Model SCCS Ref
measured 0.07% in_vitro - SCCS/0168
measured 10.0% - - SCCS/0168
measured 0.048% - - SCCS/0168
default 0.35% - - SCCS/0168
default 5.92% - - SCCS/0168

Typical Use Concentrations

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

Product Category Typical Range Max Reported Source
Sunscreen 2–10 10 SCCS

Additional Ingredient Properties

2 property records from structured ingredient metadata.

anti_pollution
{"cas_number": "103597-45-1", "ingredient_class": "blue_light_filter", "primary_mechanism": "film_forming_barrier", "pollution_types_targeted": "blue_light_HEV/UV_A/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_mo…
baby_pediatric
{"cas_number": "103597-45-1", "ingredient_class": "sunscreen_baby", "pediatric_safety_rating": "acceptable", "minimum_age_months": "12", "neonatal_safe": "no", "premature_infant_safe": "insufficient_data", "skin_barrier_maturity_consideration": "Tinosorb M - nano", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_weight_concern": "S…

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Stabilizing agent UV stabilizer
Regulatory List Membership (2)
EU Regulated in Personal Care EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL.

Regulatory Flags

cosing-sourced eu-restricted uv-filter needs-enrichment eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL by CAS number or substance name.

Studies
20
Lowest NOAEL
0.0144
Highest NOAEL
1000

Units vary across source rows: mg/kg bw/d, mg/kg bw

SCCS_vision_codex

Dermal Absorption

View details ->
Absorption % Method Vehicle
0.07% in_vitro -
10.0% - -
0.048% - -
0.35% - -
5.92% - -

Known Synonyms

UNII-8NT850T0YS

Chemical Function

UV stabilizer Stabilizing agent

Regulatory Lists

Europe; Personal care Europe; plastic_additive pharmaceutical Canada; pharmaceutical Europe; Personal care CEDI

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
BISOCTRIZOLE
ChEMBL ID
CHEMBL2104957
Max Phase
2
View full pharmaceutical profile →

Frequently Asked Questions

Is METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL safe in cosmetics?

METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL has a safety rating of "MODERATE" in our database. EU status: restricted. 10 toxicological study endpoint(s) are available in our database.

Is METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL allowed in the EU?

METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL EU regulatory status: restricted. Maximum allowed concentration: VI/23. This is based on EU Regulation 1223/2009 and its amendments.

What does METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL do in cosmetics?

METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL functions as: Light Stabilizer, Uv Filter. It is classified as a cosmetic ingredient in our database. CAS number: 103597-45-1.

What is the NOAEL for METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL?

The NOAEL (No Observed Adverse Effect Level) for METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL is =0.0144 mg/kg bw/d based on a dermal absorption study via dermal route in rat. A total of 10 study endpoints are available. Source: SCCS_vision_codex.

Is METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL used outside cosmetics?

METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL 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 METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL compliance across multiple jurisdictions:

Ingredient Decoder
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82 Allergen Checker
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MoS Calculator
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