Bispyrithione

INCI: BISPYRITHIONE

CAS Number
3696-28-4
Function
Antimicrobial, anti-dandruff agent, preservative (disulfide dimer of pyrithione)
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA: Zinc pyrithione is an approved OTC anti-dandruff active (21 CFR 358.710). Bispyrithione itself does not have separate FDA monograph status. CIR has not issued a standalone review.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Bispyrithione is prohibited in EU cosmetics due to CMR 1B classification (reproductive toxicity); harmful if swallowed with aquatic toxicity concerns. In the US, use is limited to rinse-off anti-dandruff products only.

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Concern Level: High

Regulatory Flags

preservative

Frequently Asked Questions

Is Bispyrithione safe in cosmetics?

Bispyrithione is prohibited in EU cosmetics due to CMR 1B classification (reproductive toxicity); harmful if swallowed with aquatic toxicity concerns. In the US, use is limited to rinse-off anti-dandruff products only. The EU classifies Bispyrithione as "prohibited". Safety rating: MODERATE.

Is Bispyrithione allowed in the EU?

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

What does Bispyrithione do in cosmetics?

Bispyrithione functions as: Antimicrobial, anti-dandruff agent, preservative (disulfide dimer of pyrithione). It is classified as a cosmetic ingredient in our database. CAS number: 3696-28-4.

What is the Margin of Safety for Bispyrithione?

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.

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