Protamine Sulfate

INCI: PROTAMINE SULFATE

CAS Number
9009-65-8 (from salmon sperm) / 53597-25-4 (synthetic)
Function
Skin conditioning, hair conditioning
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA-approved as a pharmaceutical (heparin reversal agent). Permitted in cosmetics

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

๐Ÿ”ด GHS-classified skin and respiratory sensitizer . Known to cause anaphylaxis via injection (pharmaceutical use). Fish-derived (salmon) โ€” allergen disclosure required. NOT for use in aerosolized or spray products. IARC: no carcinogenicity concern

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Concern Level: High

Regulatory Flags

potential-allergen

Frequently Asked Questions

Is Protamine Sulfate safe in cosmetics?

๐Ÿ”ด GHS-classified skin and respiratory sensitizer . Known to cause anaphylaxis via injection (pharmaceutical use). Fish-derived (salmon) โ€” allergen disclosure required. NOT for use in aerosolized or spray products. IARC: no carcinogenicity concern The EU classifies Protamine Sulfate as "permitted". Safety rating: MODERATE.

Is Protamine Sulfate allowed in the EU?

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

What does Protamine Sulfate do in cosmetics?

Protamine Sulfate functions as: Skin conditioning, hair conditioning. It is classified as a cosmetic ingredient in our database. CAS number: 9009-65-8 (from salmon sperm) / 53597-25-4 (synthetic).

What is the Margin of Safety for Protamine Sulfate?

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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