Excellent UV Filter / Sunscreen NOAEL Data

Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Tinosorb M)

INCI: METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL

Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Tinosorb M) (CAS 103597-45-1) is a cosmetic uv filter / sunscreen functioning as UV filter. Reported NOAEL =0.0144 mg/kg bw/d in rat (SCCS_vision_codex); EU Regulation 1223/2009 status: permitted, max 6%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.

View industrial chemical safety profile for CAS 103597-45-1 →

Auto-generated CPSR Part A draft with source citations
Function
UV filter
Safety Rating
EXCELLENT

Chemistry & Identifiers

EC Number
403-800-1

Regulatory Status

EU EU Status permitted
EU Max Conc. 6%
US US Status permitted
US Notes Order Request (OMOR) in October 2024

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Tinosorb M).

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Tinosorb M). 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
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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 (Tinosorb M).

Regulatory Flags

eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Tinosorb M) 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% - -

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 (Tinosorb M) safe in cosmetics?

Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Tinosorb M) has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.

Is Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Tinosorb M) allowed in the EU?

Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Tinosorb M) EU regulatory status: permitted. Maximum allowed concentration: 6%. This is based on EU Regulation 1223/2009 and its amendments.

What does Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Tinosorb M) do in cosmetics?

Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Tinosorb M) functions as: UV filter. It is classified as a UV Filter / Sunscreen in our database. CAS number: 103597-45-1.

What is the NOAEL for Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Tinosorb M)?

The NOAEL (No Observed Adverse Effect Level) for Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Tinosorb M) 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 (Tinosorb M) used outside cosmetics?

Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Tinosorb M) also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Is Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Tinosorb M) in Your Products?

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