Also known as: TiO2, Atlas white titanium dioxide, Blend White 9202, Brookite, Calcotone White T (+15 more)
INCI: CI 77891
CI 77891 (Titanium Dioxide) (CAS 13463-67-7) is a cosmetic cosmetic ingredient functioning as Colorant; UV Filter; Opacifying Agent. Inorganic pigment (TiO2) used as a white. NOAEL 1000 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 25% as UV filter; 1.4% in hair aerosol sprays for consumers, 1.1% for professional use; GHS signal word DANGER. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
CI 77891 (Titanium Dioxide) is classified GHS CMR hazard (H351) in the chemicals database but is restricted in EU cosmetics at max 25% as UV filter; 1.4% in hair aerosol sprays for consumers, 1.1% for professional use.
Colorant; UV Filter; Opacifying Agent. Inorganic pigment (TiO2) used as a white colorant and opacity agent in foundations, sunscreens, face powders, eye shadows, lipsticks, and toothpaste. Functions as a physical UV filter in sunscreen formulations. Produced synthetically in anatase or rutile crystal forms.
EU Max Conc.25% as UV filter; 1.4% in hair aerosol sprays for consumers, 1.1% for professional use
US US Statuspermitted
US NotesListed as a color additive exempt from certification under 21 CFR 73.2575. May be safely used for coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with good manufacturing practice. Also permitted as a UV filter in OTC sunscreen drug products (21 CFR 352).
For full compliance data across multiple jurisdictions, use the
Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for CI 77891 (Titanium Dioxide).
Calculate MoS for your specific formulation with the
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Toxicological Studies
10 study endpoints found for CI 77891 (Titanium Dioxide). 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
1250 mg/kg bw/day
oral
rat
Carcinogenicity
COSMOS_DB
NOAEL
5000 mg/kg bw/day
oral
mouse
Special Toxicology Study
COSMOS_DB
NOAEL
7500 mg/kg bw/day
oral
mouse
Carcinogenicity
COSMOS_DB
NOAEL
=250 mg/kg bw/day
-
-
Toxicology study
INCHEM_WHO_jecfa_jecmono_v1051je01
NOAEL
=250 mg/kg bw/day
-
-
Toxicology study
INCHEM_WHO_jecfa_jecmono_v1051je01
NOAEL
=260 mg/kg bw/day
-
Mouse
Chronic toxicity
INCHEM_WHO_jecfa_jecmono_v1051je01
NOAEL
=260 mg/kg bw/day
-
Mouse
Chronic toxicity
INCHEM_WHO_jecfa_jecmono_v1051je01
NOAEL
=1251 mg/kg bw/day
-
-
Toxicology study
INCHEM_WHO_jecfa_jecmono_v1051je01
NOAEL
=1251 mg/kg bw/day
-
-
Toxicology study
INCHEM_WHO_jecfa_jecmono_v1051je01
NOAEL
=62.5 mg/kg bw/d
oral
rat
repeated dose toxicity
SCCS_vision_codex
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Signal Word
DANGER
Pictograms
CancerHealth haz
Hazard Statements
Causes damage to respiratory system through prolonged or repeated exposure if inhaled Suspected of causing cancer
Long-term Exposure Effects
Lungs may be affected by repeated or prolongated exposure. This may result in chronic inflammation. This substance is possibly carcinogenic to humans if inhaled.
Routes of Exposure
The substance can be absorbed into the body by inhalation of dust.
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
sccsSCCS/1667/2425 October 2024
Verdict: safe
NOAEL: 1742 mg/kg bw/day (not specified)
Max Concentration: 25% in general
. The CIR Expert Panel concluded that dimethicone is safe in cosmetics in the present practices of use and reported concentration ranges when formulated to be non- irritating, with the exception that the available data are insufficient to make a determination of safety for use in products that
sccsSCCS/1661/2313 May 2024
Verdict: safe
Max Concentration: 16% in general
n light of this and given the many uncertainties, the panel concluded that E171 should no longer be considered as safe when used as a food additive. In May 2022, the Commission services received a dossier submission by industry accompanied by a comprehensive and up to date review of the genetic toxicity database fo
sccsSCCS/1661/2313 May 2024
Verdict: safe
Max Concentration: 6% in general
n light of this and given the many uncertainties, the panel concluded that E171 should no longer be considered as safe when used as a food additive. In May 2022, the Commission services received a dossier submission by industry accompanied by a comprehensive and up to date review of the genetic toxicity database fo
sccsSCCS/1661/2313 May 2024
Verdict: safe
Max Concentration: 7% in general
n light of this and given the many uncertainties, the panel concluded that E171 should no longer be considered as safe when used as a food additive. In May 2022, the Commission services received a dossier submission by industry accompanied by a comprehensive and up to date review of the genetic toxicity database fo
sccsSCCS/1661/2313 May 2024
Verdict: safe
Max Concentration: 0.7% in general
n light of this and given the many uncertainties, the panel concluded that E171 should no longer be considered as safe when used as a food additive. In May 2022, the Commission services received a dossier submission by industry accompanied by a comprehensive and up to date review of the genetic toxicity database fo
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for CI 77891 (Titanium Dioxide) across SCCS product categories, with measured dermal absorption where available.
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
Endpoint
Value
Species
Route
Duration
Source
NOAEL
=2250 mg/kg-day
Rat
oral
chronic
EFSA
LC50
>2280 mg/m3
Rat
inhalation
-
ECHA IUCLID
LC50
=5090 mg/m3
Rat
inhalation
-
ECHA IUCLID
LC50
=3430 mg/m3
Rat
inhalation
-
ECHA IUCLID
LC50
>3560 mg/m3
Rat
inhalation
-
ECHA IUCLID
LC50
>6820 mg/m3
Rat
inhalation
-
ECHA IUCLID
LD50
>2000 mg/kg
Rat
oral
-
ECHA IUCLID
LD50
>25000 mg/kg
Rat
oral
-
ECHA IUCLID
LD50
>5000 mg/kg
Mouse
oral
-
ECHA IUCLID
LD50
>5000 mg/kg
Rat
oral
-
ECHA IUCLID
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
2B
Volume
47, 93
Evaluation Year
2006
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
EU status:allowed (non-nano); nano forms restricted in aerosolized products
weak modulator (oxidative stress pathway)
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000,000 - 10,000,000 tonnes
Substance Type
SUBSTANCE; GROUP
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 IV — Permitted Colorants
Product type: White
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: 25%.
SA Saudi SFDA (IV - Colorants)
Purity criteria as set out in Commission Directive 95/45/EC (E 171)
JPKR Japan/Korea Cosmetics
Korea (Restricted): max 25.0
BRIN Brazil/India Cosmetics
India: Permitted Colorant
Additional Jurisdictional Restrictions (9)
Jurisdiction
Status
Max %
Product Type
CN
restricted
25
Rinse-off and leave-on products (UV use)
CN
permitted_uv_filter
25
All cosmetics (no aerosol for nano)
CN
permitted_colorant
-
All cosmetics (Class 1)
IN
permitted_uv_filter
25.0
sunscreen and other cosmetic products
BR
permitted_uv_filter
25
Sunscreen products; nano form NOT permitted in Brazil (unlike EU)
BR
permitted_colorant
-
Column 1: All cosmetic products
UK
restricted
-
-
ASEAN
permitted_uv_filter
25%
-
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (4 records across 5 sources)
Type
DA %
Method
Skin Model
SCCS Ref
measured_in_vitro
0.0
In vivo — human & animal studies
(tape-stripping, histology, ICP-MS)
-
SCCS/1516/13 (2013) (2013)
measured_in_vitro
0.03
-
-
SCCS/1516/13
measured_in_vitro
0.175
-
-
SCCS/1516/13
measured_in_vitro
0.03
-
-
SCCS/1516/13
Additional Ingredient Properties
1 property record from structured ingredient metadata.
California Proposition 65 (OEHHA)EU Regulated in Personal CareEU Restricted for Children (Cosmetics)IFRA Fragrance Transparency ListEPA Safer Chemical Ingredients List (SCIL)FDA Substances Added to Food (EAFUS)EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for CI 77891 (Titanium Dioxide).
In vivo — human & animal studies
(tape-stripping, histology, ICP-MS)
Sunscreen formulations (various)
0.03
-
-
0.175
-
-
0.03
-
-
Known Synonyms
TiO2Atlas white titanium dioxideBlend White 9202BrookiteCalcotone White TCI Pigment white 6Cosmetic Hydrophobic TiO2 9428Cosmetic Micro Blend TiO2 9228Cosmetic White C47-5175Cosmetic White C47-9623EINECS 236-675-5HombitanHorse head a-410Horse head a-420Horse head r-710Kronos titanium dioxideLevanox White RKBNCI-C0424ONCI-C04240Orgasol 1002D White 10 Extra Cos
Chemical Function
PigmentDyeBrightener
Regulatory Lists
Europe; Personal carechildren; Europe; Personal carechildren; Europe; Personal care - specialized bath products - bath saltschildren; Europe; Personal care - dental care - toothpastechildren; Europe; Personal carechildren; Europe; Personal careEurope; Personal careEurope; Personal careCleaning products and household care - dishwasher and dishes - automatic dishwashing detergent; EuropeEurope; Personal care - oral and dental care - teeth whitenerEurope; Personal care - oral and dental care - teeth whitenerEurope; Personal care - oral and dental care - teeth whitenerconsumer_product; EuropeArts and crafts/Office supplies - body paint - tattoo ink; EuropeEuropeArts and crafts/Office supplies - body paint - tattoo ink; EuropeArts and crafts/Office supplies - body paint - tattoo ink; EuropeArts and crafts/Office supplies - general arts and crafts supplies - arts and crafts paint; Europe
Australian Status
AICIS status:listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCEChEMBL / DrugCentral / FAERSDB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
CI 77891 (Titanium Dioxide) has a safety rating of "GOOD" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.
Is CI 77891 (Titanium Dioxide) allowed in the EU?
CI 77891 (Titanium Dioxide) EU regulatory status: restricted. Maximum allowed concentration: 25% as UV filter; 1.4% in hair aerosol sprays for consumers, 1.1% for professional use. This is based on EU Regulation 1223/2009 and its amendments.
What does CI 77891 (Titanium Dioxide) do in cosmetics?
CI 77891 (Titanium Dioxide) functions as: Colorant; UV Filter; Opacifying Agent. Inorganic pigment (TiO2) used as a white colorant and opacity agent in foundations, sunscreens, face powders, eye shadows, lipsticks, and toothpaste. Functions as a physical UV filter in sunscreen formulations. Produced synthetically in anatase or rutile crystal forms.. It is classified as a cosmetic ingredient in our database. CAS number: 13463-67-7.
What is the NOAEL for CI 77891 (Titanium Dioxide)?
The NOAEL (No Observed Adverse Effect Level) for CI 77891 (Titanium Dioxide) is 1250 mg/kg bw/day based on a Carcinogenicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.
Is CI 77891 (Titanium Dioxide) classified as hazardous under GHS?
CI 77891 (Titanium Dioxide) carries a GHS signal word of "DANGER". Hazard statements: Causes damage to respiratory system through prolonged or repeated exposure if inhaled Suspected of causing cancer. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.
Is CI 77891 (Titanium Dioxide) used outside cosmetics?
CI 77891 (Titanium Dioxide) also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does CI 77891 (Titanium Dioxide) have different safety status in cosmetics vs industrial chemicals?
CI 77891 (Titanium Dioxide) is classified GHS CMR hazard (H351) in the chemicals database but is restricted in EU cosmetics at max 25% as UV filter; 1.4% in hair aerosol sprays for consumers, 1.1% for professional use.
Compliance Tools
Check CI 77891 (Titanium Dioxide) compliance across multiple jurisdictions:
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