Good UV Filter / Sunscreen NOAEL Data GHS Classified Sensitization Data Dermal Penetration

Nano Zinc Oxide

INCI: ZINC OXIDE

CAS Number
1314-13-2
Function
UV Filter
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR Expert Panel (Belsito DV et al.) 2024 Safety Assessment of Zinc Salts as Used in Cosmetics. International Journal of Toxicology. Zinc oxide permitted as OTC drug ingredient.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Nano Zinc Oxide. 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 606 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 600 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 400 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 400 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 172 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 99 mg/kg bw/day oral sheep Short Term Toxicity COSMOS_DB
NOAEL 149 mg/kg bw/day oral cattle Special Toxicology Study COSMOS_DB
NOAEL 45 mg/kg bw/day oral swine Short Term Toxicity COSMOS_DB

GHS Hazard Classification

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

Signal Word
WARNING
Pictograms
enviro;aqua
Hazard Statements
Very toxic to aquatic life with long lasting effects
Short-term Exposure Effects
May cause mechanical irritation to the eyes and respiratory tract. The fume is irritating to the respiratory tract. Inhalation of fumes may cause metal fume fever. See Notes.
Routes of Exposure
The substance can be absorbed into the body by inhalation of fume.

Sensitization Profile

Contact sensitization data for Nano Zinc Oxide based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
metal
EU Allergen Listed
no
Patch Test Positive Rate
0.1%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis

Source: ESSCA 2019/20; NACDG 2021-22

Dermal Penetration Profile

Skin absorption and penetration characteristics of Nano Zinc Oxide, relevant to systemic exposure and MoS calculations.

Absorption %
0.01-0.1%
Penetration Level
surface
Penetration Depth
surface only
Molecular Weight
81.4 Da
Log P
n/a
Systemic Absorption
minimal
Topical Bioavailability
0.01%
Safety Margin Factor
none

Source: SCCS/1518/13

Expert Verdict

Nano Zinc Oxide is generally considered safe for use as a mineral broadband UV filter protecting skin against both UVA and UVB radiation.

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Concern Level: Low

Regulatory Flags

EU Restricted eu_children_restricted ifra_fragrance fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is Nano Zinc Oxide safe in cosmetics?

Nano Zinc Oxide is generally considered safe for use as a mineral broadband UV filter protecting skin against both UVA and UVB radiation. The EU classifies Nano Zinc Oxide as "restricted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Nano Zinc Oxide allowed in the EU?

Nano Zinc Oxide EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does Nano Zinc Oxide do in cosmetics?

Nano Zinc Oxide functions as: UV Filter. It is classified as a UV Filter / Sunscreen in our database. CAS number: 1314-13-2.

What is the Margin of Safety for Nano Zinc Oxide?

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 Nano Zinc Oxide?

The NOAEL (No Observed Adverse Effect Level) for Nano Zinc Oxide is 606 mg/kg bw/day based on a Special Toxicology Study study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Is Nano Zinc Oxide classified as hazardous under GHS?

Nano Zinc Oxide carries a GHS signal word of "WARNING". Hazard statements: Very toxic to aquatic life with long lasting effects. 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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