Good Cosmetic Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed

CI 77891 (Titanium Dioxide)

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.

View industrial chemical safety profile for CAS 13463-67-7 →

Auto-generated CPSR Part A draft with source citations
Function
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.
Safety Rating
GOOD

Chemistry & Identifiers

EC Number
236-675-5

Regulatory Status

EU EU Status restricted
EU Max Conc. 25% as UV filter; 1.4% in hair aerosol sprays for consumers, 1.1% for professional use
US US Status permitted
US Notes Listed 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 MoS Calculator.

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).

sccs SCCS/1667/24 25 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

sccs SCCS/1661/23 13 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

sccs SCCS/1661/23 13 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

sccs SCCS/1661/23 13 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

sccs SCCS/1661/23 13 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.

Cosmetic-Specific Mechanism
Category: other
Receptor targets: ERα (limited), steroidogenic interference
LOEC: 10 µg/mL
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.

colorant
{"Common_Name": "TiO2 Micronized (<100nm)", "Chemical_Name": "Titanium dioxide nano", "CAS_Number": "13463-67-7", "Colorant_Type": "Inorganic Pigment", "Approved_Uses": "All cosmetics", "Max_Concentration_%": "No limit", "EU_Status": "Approved (with restrictions)", "US_FDA_Status": "Approved", "Notes": "Transparent, nano-size"}

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Anti-adhesive/cohesive Anti-caking agent Antioxidant Binder Brightener Catalyst Degradant/impurity Deodorizer Dispersing agent Drier
Regulatory List Membership (7)
California Proposition 65 (OEHHA) EU Regulated in Personal Care EU Restricted for Children (Cosmetics) IFRA Fragrance Transparency List EPA 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).

Regulatory Flags

inorganic-colorant mineral-pigment eu-annex-iv eu-annex-iii-restricted fda-exempt-certification eye-area-permitted uv-filter inhalation-restricted-eu nano-scrutiny widely-used prop65 eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to CI 77891 (Titanium Dioxide) by CAS number or substance name.

Studies
29
Lowest NOAEL
62.5
Highest NOAEL
7500

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

SCCS_vision_codex INCHEM_WHO_jecfa_jecmono_v1051je01 COSMOS_DB

Dermal Absorption

View details ->
Absorption % Method Vehicle
0.0 In vivo — human & animal studies (tape-stripping, histology, ICP-MS) Sunscreen formulations (various)
0.03 - -
0.175 - -
0.03 - -

Known Synonyms

TiO2 Atlas white titanium dioxide Blend White 9202 Brookite Calcotone White T CI Pigment white 6 Cosmetic Hydrophobic TiO2 9428 Cosmetic Micro Blend TiO2 9228 Cosmetic White C47-5175 Cosmetic White C47-9623 EINECS 236-675-5 Hombitan Horse head a-410 Horse head a-420 Horse head r-710 Kronos titanium dioxide Levanox White RKB NCI-C0424O NCI-C04240 Orgasol 1002D White 10 Extra Cos

Chemical Function

Pigment Dye Brightener

Regulatory Lists

Europe; Personal care children; Europe; Personal care children; Europe; Personal care - specialized bath products - bath salts children; Europe; Personal care - dental care - toothpaste children; Europe; Personal care children; Europe; Personal care Europe; Personal care Europe; Personal care Cleaning products and household care - dishwasher and dishes - automatic dishwashing detergent; Europe Europe; Personal care - oral and dental care - teeth whitener Europe; Personal care - oral and dental care - teeth whitener Europe; Personal care - oral and dental care - teeth whitener consumer_product; Europe Arts and crafts/Office supplies - body paint - tattoo ink; Europe Europe Arts and crafts/Office supplies - body paint - tattoo ink; Europe Arts and crafts/Office supplies - body paint - tattoo ink; Europe Arts 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.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

Compound
titanium dioxide
ChEMBL ID
CHEMBL1201136
Adverse Event Associations
46
View full pharmaceutical profile →
SOURCE EFSA / FDA GRAS food_additives

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name
Titanium dioxide (FDA)
Food Category
colorant
View full food safety profile →

Frequently Asked Questions

Is CI 77891 (Titanium Dioxide) safe in cosmetics?

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.

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