Good Cosmetic Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed

CI 77891 (Titanium Dioxide)

INCI: CI 77891

CAS Number
13463-67-7
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

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 25% as UV filter; 1.4% in hair aerosol sprays for consumers, 1.1% for professional use
๐Ÿ‡บ๐Ÿ‡ธ 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 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

4 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 7500 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
NOAEL 5000 mg/kg bw/day oral mouse Special Toxicology Study COSMOS_DB
dose_tested 5000 mg/kg bw/day oral mouse Special Toxicology Study COSMOS_DB

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Signal Word
DANGER
Pictograms
cancer;health 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

Expert Verdict

Broadly permitted and widely used inorganic colorant and UV filter with a strong overall safety profile for dermal use. EU and US both permit topical application. EU applies specific Annex III restrictions on inhalable formats (powders, sprays) to address lung exposure risk. The inhalation carcinogenicity concern (IARC 2B) is route-specific and does not apply to dermal use.

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Concern Level: Low

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

Frequently Asked Questions

Is CI 77891 (Titanium Dioxide) safe in cosmetics?

Broadly permitted and widely used inorganic colorant and UV filter with a strong overall safety profile for dermal use. EU and US both permit topical application. EU applies specific Annex III restrictions on inhalable formats (powders, sprays) to address lung exposure risk. The inhalation carcinogenicity concern (IARC 2B) is route-specific and does not apply to dermal use. The EU classifies CI 77891 (Titanium Dioxide) as "restricted". Safety rating: GOOD. 4 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 Margin of Safety for CI 77891 (Titanium Dioxide)?

adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

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 4 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 โ€” at cosmetic use concentrations, hazard thresholds may not be met.

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