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.
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Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Tinosorb M).
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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
?
Hazard Class and Category
Aquatic Chronic 4
Hazard Statements
H413May 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.
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.
Compliance Tools
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