Good Active Ingredient NOAEL Data Dermal Penetration

Zinc Gluconate

INCI: ZINC GLUCONATE

CAS Number
4468-02-4
Function
5-alpha-reductase inhibitor; hair-follicle cycle regulator; anti-seborrheic; antioxidant; scalp micronutrient
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted cosmetic active. Zinc salts (gluconate, PCA, sulfate) used in scalp and hair formulations. No OTC drug monograph for hair growth use.

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

5 study endpoints found for Zinc Gluconate. 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
NOEL 3000 ppm oral mouse oral REACH
NOAEL 2 mg/kg bw/day 2011 rat other REACH
NOEL 3000 ppm oral rat oral REACH
NOEL 3000 ppm oral - oral REACH
NOEL 3000 ppm oral - oral REACH

Dermal Penetration Profile

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

Absorption %
1-3%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
455.7 Da
Log P
-3.2
Systemic Absorption
minimal
Topical Bioavailability
0.5-2%
Safety Margin Factor
low
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: Cosmetic Science

Expert Verdict

Zinc gluconate is an essential micronutrient for hair follicle function. It inhibits 5ฮฑ-reductase (reducing DHT at the follicle), regulates hair follicle keratinocyte proliferation, and supports multiple enzyme systems involved in follicle cycling. Zinc deficiency is associated with alopecia areata and diffuse hair loss; deficiency-driven hair loss responds to zinc repletion. Topical cosmetic zinc gluconate is used in scalp formulations with a GOOD safety profile at cosmetic concentrations.

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Concern Level: Low

Regulatory Flags

hair-follicle-support 5ar-inhibitor deficiency-associated-hair-loss scalp-micronutrient cosmetic-classified fda_food_additive

Frequently Asked Questions

Is Zinc Gluconate safe in cosmetics?

Zinc gluconate is an essential micronutrient for hair follicle function. It inhibits 5ฮฑ-reductase (reducing DHT at the follicle), regulates hair follicle keratinocyte proliferation, and supports multiple enzyme systems involved in follicle cycling. Zinc deficiency is associated with alopecia areata and diffuse hair loss; deficiency-driven hair loss responds to zinc repletion. Topical cosmetic zinc gluconate is used in scalp formulations with a GOOD safety profile at cosmetic concentrations. The EU classifies Zinc Gluconate as "permitted". Safety rating: GOOD. 5 toxicological study endpoint(s) are available in our database.

Is Zinc Gluconate allowed in the EU?

Zinc Gluconate EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Zinc Gluconate do in cosmetics?

Zinc Gluconate functions as: 5-alpha-reductase inhibitor; hair-follicle cycle regulator; anti-seborrheic; antioxidant; scalp micronutrient. It is classified as a Active Ingredient in our database. CAS number: 4468-02-4.

What is the Margin of Safety for Zinc Gluconate?

not established 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 Zinc Gluconate?

The NOAEL (No Observed Adverse Effect Level) for Zinc Gluconate is 3000 ppm based on a oral study via oral route in mouse. A total of 5 study endpoints are available. Source: REACH.

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