Is Tinosorb M safe in cosmetics?
Tinosorb M has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Tinosorb M
Also known as: UNII-8NT850T0YS
INCI: TINOSORB M
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. 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
Function
UV Filter
Safety Rating
GOOD
Regulatory Status
EU EU Status
permitted
US US Status
permitted
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Tinosorb M.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for 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
- 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 |
Additional Ingredient Properties
4 property records from structured ingredient metadata.
comedogenicity_detail
{"comedogenicity_rating": "0", "irritancy_rating": "0", "skin_type_suitability": "all,oily,sensitive,combination,normal,acne-prone", "acne_safe": "yes", "source": "Broad spectrum - EU"}
regulatory
{"eu_status": "allowed", "us_status": "allowed"}
sensory
{"silky": "powdery", "smooth, glides easily": "smooth, broad spectrum", "dry-touch, non-greasy": "protected, minimal-white", "instant": "fast", "low": "low", "w/o": "o/w", "very-high": "high", "no": "no", "yes": "yes", "light-diffusing": "matte", "1.40": "1.65", "transparent": "opaque", "colorless": "white", "excellent": "good", "light": "light", "synthetic": "synthetic"}
skin_suitability
{"oily_skin": "recommended", "dry_skin": "acceptable", "sensitive_skin": "recommended", "combination_skin": "recommended", "normal_skin": "recommended", "acne_prone": "acceptable", "rosacea": "recommended", "eczema": "acceptable", "hyperpigmentation": "acceptable", "aging_mature": "acceptable", "dehydrated": "acceptable", "skin_benefit_primary": "UV-protection", "skin_benefit_secondary": "broad-sp…
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 Tinosorb M.
Regulatory Flags
eu_cosing_listed
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to 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% | - | - |
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
Frequently Asked Questions
Is Tinosorb M allowed in the EU?
Tinosorb M EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Tinosorb M do in cosmetics?
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 Tinosorb M?
The NOAEL (No Observed Adverse Effect Level) for 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 Tinosorb M used outside cosmetics?
Tinosorb M 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 Tinosorb M 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
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Chemical family
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Chemical family
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