Good Active Ingredient Sensitization Data

Piroctone Olamine

INCI: PIROCTONE OLAMINE

CAS Number
68890-66-4
Function
Antifungal; anti-dandruff active; preservative
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status restricted
EU Max Conc. 1.0% rinse-off / 0.5% leave-on
🇺🇸 US Status permitted
US Notes Cosmetic ingredient in the US; no OTC monograph coverage — anti-dandruff claims must remain cosmetic in nature

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

Contact sensitization data for Piroctone Olamine based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.2%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis

Source: ESSCA; IVDK; NACDG

Expert Verdict

Leading ZPT replacement in EU and global markets. Effective against all major Malassezia species. EU-permitted at 1% rinse-off and 0.5% leave-on as preservative under Annex V. Enhances caffeine follicular penetration in combination shampoos. Preferred anti-dandruff active for EU-compliant formulations.

⚠️
Concern Level: Low

Regulatory Flags

eu-restricted antifungal zpt-replacement malassezia-active

Frequently Asked Questions

Is Piroctone Olamine safe in cosmetics?

Leading ZPT replacement in EU and global markets. Effective against all major Malassezia species. EU-permitted at 1% rinse-off and 0.5% leave-on as preservative under Annex V. Enhances caffeine follicular penetration in combination shampoos. Preferred anti-dandruff active for EU-compliant formulations. The EU classifies Piroctone Olamine as "restricted". Safety rating: GOOD.

Is Piroctone Olamine allowed in the EU?

Piroctone Olamine EU regulatory status: restricted. Maximum allowed concentration: 1.0% rinse-off / 0.5% leave-on. This is based on EU Regulation 1223/2009 and its amendments.

What does Piroctone Olamine do in cosmetics?

Piroctone Olamine functions as: Antifungal; anti-dandruff active; preservative. It is classified as a Active Ingredient in our database. CAS number: 68890-66-4.

What is the Margin of Safety for Piroctone Olamine?

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.

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