Excellent Active Ingredient NOAEL Data Dermal Penetration

Gluconolactone

CAS Number
90-80-2
Function
Antioxidant; Chelating agent; Chemical reaction regulator; Flavouring and nutrient; Food preservative; Fragrance; Humectant; Leavening agent; Preservative; Processing aids not otherwise specified; Softener and conditioner; Solvent; pH regulating agent
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR assessed glycolactones with maximum reported use concentration 15%. Safe as used. Not classified as AHA by CIR โ€” PHA class has a distinct, gentler regulatory and safety profile. No photosensitivity concerns noted in clinical literature.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Gluconolactone. 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 500 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 695 mg/kg bw/day oral mouse Developmental COSMOS_DB
NOAEL 594 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 560 mg/kg bw/day oral hamster Developmental COSMOS_DB
NOAEL 780 mg/kg bw/day oral rabbit Developmental COSMOS_DB
dose_tested 500 mg/kg bw/day oral rat Chronic COSMOS_DB
dose_tested 695 mg/kg bw/day oral mouse Developmental COSMOS_DB
dose_tested 594 mg/kg bw/day oral rat Developmental COSMOS_DB
dose_tested 560 mg/kg bw/day oral hamster Developmental COSMOS_DB
dose_tested 780 mg/kg bw/day oral rabbit Developmental COSMOS_DB

Dermal Penetration Profile

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

Absorption %
2-5%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
178.1 Da
Log P
-2.1
Systemic Absorption
minimal
Topical Bioavailability
1-3%
Safety Margin Factor
minimal
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: Dermatol Surg 2004

Expert Verdict

Gluconolactone is the premier PHA, offering comparable antiaging and exfoliating efficacy to glycolic acid with substantially superior tolerability, no photosensitivity, and added antioxidant and humectant activity. The preferred exfoliant for sensitive skin, Fitzpatrick IVโ€“VI, post-procedure skin, and rosacea.

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Concern Level: None

Regulatory Flags

pha no-photosensitivity barrier-strengthening antioxidant humectant sensitive-skin-safe fitzpatrick-iv-vi-preferred sodium-citrate-required epa_safer_alternative fda_food_additive

Frequently Asked Questions

Is Gluconolactone safe in cosmetics?

Gluconolactone is the premier PHA, offering comparable antiaging and exfoliating efficacy to glycolic acid with substantially superior tolerability, no photosensitivity, and added antioxidant and humectant activity. The preferred exfoliant for sensitive skin, Fitzpatrick IVโ€“VI, post-procedure skin, and rosacea. The EU classifies Gluconolactone as "permitted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.

Is Gluconolactone allowed in the EU?

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

What does Gluconolactone do in cosmetics?

Gluconolactone functions as: Antioxidant; Chelating agent; Chemical reaction regulator; Flavouring and nutrient; Food preservative; Fragrance; Humectant; Leavening agent; Preservative; Processing aids not otherwise specified; Softener and conditioner; Solvent; pH regulating agent. It is classified as a Active Ingredient in our database. CAS number: 90-80-2.

What is the Margin of Safety for Gluconolactone?

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 Gluconolactone?

The NOAEL (No Observed Adverse Effect Level) for Gluconolactone is 500 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

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