04N-0050
RPT 1
Volume 3-8
Volume 3
Cover Page
Safety and Effectiveness Information
for Piroctone Olamine
List of References
Volume 4
Safety References
Report on a single-dose oral
toxicity study of H 72 6146 A in female SPF Wistar rats
Report on a single-dose oral
toxicity study of H 72 6146 A in male and female Beagle dogs
Octopirox testing of acute
dermal toxicity in male and female Wistar rats
Octopirox test for primary
dermal irritation in the rabbit
Primary Skin Irritation of
a preparation of 0.5 % Octopirox, 12.5 % Steinapol SBFA 30 (40 %), 0.11 % citric
acid and 86.89 % water (pH 7.0) in rabbits (patch test)
Primary Skin Irritation of
a preparation of 1 % Octopirox, 0.33 % citric acid, 75, 0 % PEG 400 and 23.67
% water (pH 7.0) in rabbits (patch test)
Skin tolerance of a preparation
of 1.0 % Octopirox (Op. E. 001), 0.3 % citric acid and 98.7 % 1, 2-propylene
glycol (pH 7.0) in rabbits
Primary Skin Irritation of
a preparation of 0.5 % Octopirox, 12.5 % Steinapol SBFA 30 (40 %), 0.11 % citric
acid and 86.89 % water (pH 7.0) in New Zealand rabbits (patch test)
Primary Skin Irritation of
a preparation of 1 % Octopirox, 0.33 % citric acid, 75 % PEG 400 and 23.67 %
water (pH 7.0) in New Zealand rabbits (patch test)
Skin tolerance of a preparation
of 1 % Octopirox (Op. E 001), 0.3 % citric acid and 98.7 % 1,2-propylene glycol
(pH 7) in New Zealand rabbits
Mucosal tolerance to Ma Ref
0370 in the rabbit
Mucosal tolerance to Ma Ref
03701 in the rabbit
Mucosal tolerance to Ma Ref
0380 in the rabbit
Mucosal tolerance to Ma Ref
03801 in the rabbit
Mucosal tolerance to Shampoo
Hs Ref 03790 in the rabbit
Mucosal tolerance to Shampoo
Hs Ref 037901 in the rabbit
Mucosal tolerance to a preparation
of 0.2 % (w/w) Octopirox and 50 % (w/w) Isopropanol in water (pH 7.0)
in the rabbit
Mucosal tolerance to 50 %
(w/w) isopropanol in aqueous solution in the rabbit
Study of Sensitizing Properties
of Octopirox in Guinea Pigs
Maximization Test of Piroctone
Olamine in the Guinea Pig
Report on the testing of the
dandruff active substance ASM-D (H 72 61 46 A) for sensitizing properties in
humans
Photocontact Allergy Test
of Piroctone Olamine in the Guinea Pig
Phototoxicity study of Octopirox
Report on oral range-finding
study (30 days) of Octopirox in SPF Wistar rats, part
2, part 3
Report on a repeated-dose
(30 days) oral toxicity study of Octopirox in beagle dogs
Five Weeks Subacute Subcutaneous Toxicity of Piroctone Olamine in Rats
Volume 5
References
Subacute (30 times) dermal
toxicity study of Octopirox as hair lotion and shampoo in rabbits, part
2
Report on a repeated-dose
(90 days) oral toxicity study of Octopirox in rats, part
2, part 3, part
4, part 5
Report on a repeated-dose
(90 days) oral toxicity study of Octopirox in beagle dogs
6 months chronic percutaneous
toxicity of piroctone olamine in rats
One-year chronic percutaneous
toxicity of piroctone olamine in rats
Volume 6
References
Test for mutagenicity in bacteria
strains in the absence and presence of a liver preparation
Mutagenicity test of Piroctone
Olamine
Study of the mutagenic potential
of the compound Octopirox Charge W 020 in strains of Salmcnella typhimurium
(Ames Test)
Study of the mutagenic potential
of the compound Octopirox OP. A 038 in strains of Salmonella typhimurium (Ames
Test)
Report on an oral mutagenicity
study (micronucleus test) with octopirox in mice
Micronucleus Test of Piroctone
Olamine in Mice
Mutagenicity
evaluation of PKOD-A038 in the Chinese hamster bone marrow cytogenetic assay
Lack of in Viva Binding
to DNA of Piroctone-olamine
An oral embryotoxicity study
of octopirox in rabbits
Teratological Study of Piroctone
Olamine in Rats - Subcutaneous Administra:ion during Organogenesis -
(Experimental period: March - April, 1981)
Teratological Study of Piroctone
Olamine (PO) in Rats - Subcutaneous Administration at Different Times during
Organogenesis
Subcutaneous administration of
piroctone olamine to rats from preconceptional period through early stage of
gestation
Effects of piroctone olamine
subcutaneously given during the last third of gestation and the period of lactation
in the rats
Pharmacokinetic studies of
Octopirox-14C after dermal, oral and intravenous administration to rats
Kinetics of Octopirox after
oral administration to dogs and rats
Percutaneous absorption of
Octopirox
Report on general pharmacology
of Octopirox
The effect
of Piroctone Olamine on reproduction of male and female rats; Allgood, G.S.
et al., Fundamental and Applied Toxicology 16, 3 l-40, 1991.
The effects
of dietary iron supplementation on the toxicity of Piroctone Olamine in the
growing rat; Nolen, G.A. et al., Drug and Chemical Toxicology 12: 111-121, 1989
Percutaneous
Absorption of Octopirox; Black, J.G. and Kamat, V.B., Fd Chem. Toxic. 26: 53-58,
1988
Patch
test for investigating the skin-irritant effect of cosmetic products in humans;
Tronnier, H., Institute for experimental dermatology, June 17, 1991
Patch test for investigating
the skin-irritant effect of cosmetic products in humans; Trormier, H., Institute
for experimental dermatology, June 17, 1991
OECD
Acute Inhalation Toxicity Evaluation of Octopirox; Study No. 191-1456, International
Research and Development Corporation, 2 1.2.1990
Volume 7
References
The aetiology
of dandruff and the mode of action of the therapeutic agents. S. Shuster, British
Journal of Dermatology 111 (1984) 235-242
Fast, noninvasive
method for molecular detection and differentiation of Malassezia yeast species
on human skin and application of the method to danduff microbiology. C. M. Gemmer,
Y. M. DeAngelis, B. Theelen, T. Boekhout, T. L. Dawson, Journal of Clinical
Microbiology, 40 (2002) 3350-3357
Brochure Olctopirox, Hoechst
AG, 1991
Brochure Antidandruff
Active Ingredient Octopirox, Clariant GmbH, 2003
Specification Piroctone Olamine,
Hoechst AG, 1983
Specification Octopirox
(Piroctone Olamine) Clariant GmbH, 2001
Report Hoechst AG, H 726146A,
January 5, 1977
Report Hoechst AG, H 726146A,
October 26, 1981
Testing of Octopirox against
Pityrosorum Ovale (orbiculare) in vitro/Dr. Hanel, Hoechst AG, 1990
Report on tests for the determination
of the substantivity of Octopirox on the scalp, Dr. Futterer, Hoechst AG, December
20, 1976
Stability test of Octopirox
(piroctone olamine) substance for 3 years at room temperature, Dr. Futterer,
Hoechst AG, June 30, 1981
Stability
test of Octopirox shampoo (0,5 % w/w) for 3 years at room temperature, Dr. Futterer,
Hoechst AG, September 25, 1981
In vitro
susceptibility of Malassezia furfur. A. Schmidt, B. Ruhl-Horster, Arzneim.-
Forsch./Drug Res;. 46 (1996) 442-444
Radiometrische
Untersuchungen zur Substantivitat des Antischuppenwirkstoffs Piroctone Olamine
an Humanhaar. K. Lotsch, J. Herok, 11th International ISFCC Congress, Cosmetics:
Reserach and
Technology, Venezia-Lido, September 23-26, 1980
Comparaison
de la thermostabilite d’antipelliculaires naturels et de synthese (climbazole
et piroctone olamine). C. Coiffard, L. Coiffard, Y. de Roeck-Holtzhauer, Ann.
Pharm. Fr. 57 (1999) 392-396
Photodegredation
of piroctone olamine in aqueous diluted solutions - Effect of the presence of
anionic surfactants, M. T. Le, L. J. M. Coiffard, F. Peigne, Y. de Roeck-Holtzhauer,
S.T.P. Pharma Sciences 6 (1996) 455-458
HPLC determination
of Ciclopirox, Octopirox and Pyrithiones in Pharmaceuticals and Antidandruff
Preparations. L. Gagliardi, G. Multari, G. Cavazzutti, D. De Orsi, D. Tonelli,
J.
Liq. Chrom & REI. Technol. 21 (1998) 2365-2373
Simultaneous
determination of four anti-dandruff agents including octopirox in shampoo products
by reversed-phase liquid chromatography. L. Chao, International Journal of Cosmetics
Science, 23 (2001) 183-188
Spectrophotometric
determination of Octopirox in cosmetic compositions (e.g. Shampoo), Clariant
GmbH, May 2000
Determination of
Octopirox in Shampoos by HPLC, Clariant GmbH, March 2, 2001
Dr. Futterer, Antidandruff
activity of Octopirox, Hoechst AG, April 18, 1978
Piroctone
Olamine shampoo vs. an inactive shampoo anti-dandruff activity using the half-head
technique/Life Science Research, April 24, 1980. Continued
Piroctone
Olamine shampoo vs. a competitor’s shampoo, anti-dandruff activity using
the half-head-technique. Life Science Research, 1981
Piroctone
Olamine shampoo vs. 1 % DTPD/MgSO4 Shampoo, comparative trial of antidandruff
efficacy using the half-head technique/Life Science Research Ltd, June 27, 1984
Volume 8
References
Shampoo HAG 099A Hair Tonics HAG 099B, HAG 099C and HAG 099D. Comparative Trial
of antidandruff efficacy using the whole-head technique. Life Science Research,
December 19, 1986
Bericht tiber die vergleichende
Prufung von Octopyrox und Climbazol auf Antischuppen-Wirkung, Cosmital SA, Marly
13.12.1994
Efficacy
report: A double-blind placebo-controlled four-way parallel group trial to evaluate
the efficacy of Octopirox 0.75 % compared to Zinc Pyrithione 1 % and Climbazole
0.75 % in the treatment of seborrhoeic dandruff on the scalp, Hoechst AG and
Parexel GmbH, January 8, 1997. Continued
Clinical Study
to evaluate the anti-dandruff efficacy of Shampoos, proDerm Instutute, study
99. 110-11, February 4, 2000
A practice-oriented
test method of active ingredients to control dandruff, G. Dietrich, V. Biillert,
Medical Cosmetology 10 (1980) 34-45
Evaluation
of the efficacy of antidandruff agents, E. Futterer, J. Soc. Cosmet. Chem. 32
(1981) 327-338
Clinical
Evaluation of Hair Shampoo and Hair rinse containing piroctone olamine parts
I, II and III, Y. Watanabe, M. Yokoyama, K. Yamada, M. Arima, T. Hori, M. Sadai,
J. Japanese Cosmet. Science Soc. 6 (1982) 79-99
Investigations
into the efficacy of soluble anti-dandruff agents, Dr. E. Futterer, Medical
Cosmetology, 15 (1985) 421-435
Antidandruff
Hair Tonic containing piroctone olamine, Dr. Eberhard Futterer, Cosmetics &
Toiletries 103 (1988), 47-49
The role
of the resident microflora in the pathogenesis of dandruff, D. Saint Leger,
A.M. Kligman, T. J. Stoudemayer, J. Soc. Cosmet. Chem 40 (1989) 109-117
Comparative
anti-dandruff efficacy between a tar and a non-tar shampoo, C. Pierard- Franchimont,
G. E. Pierard, V. Vroome, G. C. Lin, Dermatology 200 (2000), 181-184
Synergistic
behaviour between AHA and BHA’s esters with MEA-Piroctone Olamine for
antidandruff shampoo formulation, F. Montesion, C. Genova, G. Calloni, The world
directory for the cosmetic industry 2000, pp. 54-56
The antidandruff
efficacy of a shampoo containing piroctone olamine and salicylic acid in comparison
to that of a zinc pyrithione shampoo, M. Loden, C. Wessman, International Journal
of Cosmetic Science, 22 (2000) 285-289
Head &
Shoulders - New Improved Head & Shoulders, Product Brochure, Procter &
Gamble 2000
Nudging hair
shedding by antidandruff shampoos. A comparison of 1 % ketoconazole, 1 % piroctone
olamine and 1 % zinc pyrithione formulations, C. Pierard-Franchimont, V. Goffin,
F. Henry, I. Uhoda, C. Braham, G. E. Pierard, International Journal of Cosmetic
Science 24 (2002), 249-256
Efficacy
and skin tolerability of saliker in the treatment of dandruff, S. Humke, M.-A.
Budde, T. Ruzicka, A. Richard, A. Rougier, J. Krutrnanrr, Eur. J. Dermatology,
12 (2002) LII-LIII
Effect of
residence time on the efficacy of antidandruff shampoos, C. Pierard-Franchimont,
E. Uhoda, G. Loussouam, D. Saint-Leger, G. E. Pierard, International Journal
of Cosmetic Science, 25 (2003) 267-271
Intemet page
www.wella.de, June 2003
Sperimentazione
di nuovi farmaci: Attivita antipitiriasica di una linea di prodott contenente
piroctone olamina (Trials on new drugs, Antipyriasis activity of a product line
containing piroctone olamine), P. Bartalini, R. Bilenchi, F. Dina, Giomale Italiano
di Dermatologia e Venereologia, 122 (1987) 11-19
Certificate of Analysis H
72 6146 A, Hoechst AG, February 18, 1974
Certificate of Analysis H
72 6146 A, Hoechst AG, September 10, 1975
Certificate of Analysis Octopirox
(H 72 6146 A), Hoechst AG, January 16, 1976
Product
documentation Octopirox, 1976