Kopirox is known for its bacteriostatic and fungistatic properties specifically working against Pityrosporum ovale, which lives on the skin and is associated with dandruff and other manifestations of flaking on the face and scalp. It is often used in shampoo as a replacement of commonly used Zinc Pyrithione. It is used over 30 years in the personal care formulations and also used as preservative and thickening agent.

Hair shedding and hair thinning have been reported to be affected by dandruff and seborrheic dermatitis. In a comparative clinical study, it was demonstrated that Piroctone Olamine outperformed Ketoconazole and zinc pyrithione based shampoo in its ability to increase hair shaft diameter in androgenic alopecia. Piroctone Olamine also reduced sebum production.

Piroctone Olamine is the ethanolamine salt of the hydroxamic acid derivative of piroctone.

1-Hydroxy-4methyl-6-(2,4,4-trimethylpentyl)-2(1H) pyridinone, 2-aminoethanol salt

Molecular Formula	C14H23NO2.C2H7NO
CAS #	68890-66-4
Molar Mass	298.42
EINECS	272 – 574 – 2

Physico – Chemical Properties:

Appearance	White to Creamish powder
Assay (on dried basis)	98.0 – 101.5 % (w/w)
Ph (1% suspension in water)	8.5 – 10.0
Melting Point	130 – 136 C
Solubility	Freely soluble in 10% ethanol, Slightly soluble in water.

Regulation:
Europe: Approved for use in cosmetic products at a maximum concentration of 1 % (rinse-off products) and 0.5 % in other products.

USA: Not approved as antidandruff

Japan: Approved for use as a Quasi-Drug
Rest of the World: Approved for use in Mexico, many Asian, South American and African countries

Consult your regulatory authority for use level and restrictions.

Selected Safety Data:
Piroctone olamine is a non-sensitizing, non-genotoxic, and non-teratogenic material. The systemic toxicity has been measured in a 90-day oral test NOEL in rats: 100 mg/kg/day; in 90-day topical application NOEL in rabbits: 16 mg/kg/day (one dose test) and showed no adverse effects. The percutaneous penetration rate in rats was in the order to 4.5 % of a topically applied dose. Since 1983, no reports have appeared in the literature indicating that the substance could be attributed to have any adverse effects.

In HRIPT, the test compound Piroctone Olamine at 0.5 % in a vehicle did not induce irritation or sensitization. In a human use test, at 0.2 % or 1.0 % in shampoos provided no evidence of adverse reactions. Rabbit irritation tests indicated that Piroctone Olamine was slightly irritating to the skin (at 1 %) and eye (0.5 %). In “other uses” (within the EU) and outside the EU, Piroctone Olamine was used widely in skin creams (up to 1 %) for a long period of time without any user complaints or even reports in the literature.

Packaging Sizes : 25 Kg HDPE drums
Shelf Life : Minimum 2 years
Storage Conditions : Store in original, sealed container, avoid light and heat.

Literature References:
[1] P. Bourdeau, P. Blumstein, A.-M. Marchand, L. Gardey, P. Jasmin and H. Gatto, An in vivo procedure to evaluate antifungal agents on Malassezia pachydermatis in dogs: example with a piroctone olamine containing shampoo, J Medical Mycology, 16(1):9-15, 2006.
[2] B Dreno, A Khamari, JP Ortonne, A new alternative in the treatment of superficial inflammatory lesions in acne patients during summer, J American Academy of Dermatology, 52(3): Suppl P11, 2005.
[3] A Georgalas, Enhanced delivery of an anti-dandruff active in a shampoo vehicle, J Cosmetic Science, 55: Suppl S207-214, 2004.
[4] C Pierard-Franchimont, V Goffin, F Henry, I Uhoda, C Braham, GE Perard, Nudging hair shedding by antidandruff shampoos of 1% ketoconazole, 1% piroctone olamine and 1% zinc pyrithione formulations, International J Cosmetic Science, 24(5):249-256, 2002.
[5] M Loden and C Wessman, The antidandruff efficacy of a shampoo containing piroctone olamin and salicylic acid in comparison to that of a zinc pyrithione shampoo, International J Cosmetic Science, 22(4):285-289, 2000.

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