List of References
(Volumes 2 - 6)
Safety: (Vol. 2)
(Rl) Acute oral toxicity of H 72 6146 A (Octopirox) in female SPF-Wistar rats, Study-No. 74.0229, Hoechst AG. (R2) Acute oral toxicity of H 72 6146 A (Octopirox) in male and female beagle-dogs; Study No. 74.0205, Hoechst AG. (R3) Acute dermal toxicity 86.1448, Hoechst AG. (R4) OctopiroxB Hoechst AG. (R5) 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); Report No. 79.0735, Hoechst AG. (R6) Primary skin irritation of a preparation of 1 % Octopirox, 0.33 % citric acid, 75 % PEG 400 and 23.67 % water (PH 7.0) in rabbits (patch test); Report No. 79.0736, Hoechst AG. (R7) Skin tolerance of a preparation of 1.0 % Octopirox (Op. E OOl), 0.3 % citric acid and 98.7 % 1,2-propylene glycol (pH 7.0) in rabbits; Report-No. 79.0737, Hoechst AG. (R8) 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); Report-No. 79.0763, Hoechst AG. (R9) Primary skin irritation of 1 % Octopirox, 0.33 % citric acid, 75 % PEG 400 and 23.67 % water (pH 7.0) in Zew Zealand rabbits (patch-test); Report-No. 79.0764, Hoechst AG. (R 10) Skin tolerance of a preparation of 1 % Octopirox (Op. e OOl), = 0.3 % citric acid and 98.7 % 1,2-propylene glycol (pH 7.0) in New Zealand rabbits; Report-No. 79.0765, Hoechst AG. (R 11) Study of eye irritation of MA REF 0370 (Shampoo with 0.3 % Octopirox) in rabbits; Report-No. 77.1099, Hoechst AG. (R 12) Study of eye irritation of MA REF 03701 (Shampoo without Octopirox) in rabbits; Report-No. 77.1126, Hoechst AG, (R 13) Study of eye irritation of MA REF 0380 (Shampoo with 0.3 Octopirox) in rabbits; Report-No. 77.1092, Hoechst AG. - Test for primary dermal irritation in the rabbit; Study-No. 86.1390, of OctopiroxB in male and female Wistar rats; Study-No.
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(R 14) Study of eye irritation of MA REF 03801 (Shampoo without Octopirox) in rabbits; Report-No. 77.1128, Hoechst AG. (R 15) Study of eye irritation of HS REF 03790 (Shampoo with 0,5 % Octopirox) in rabbits; Report-No. 77.1127, Hoechst AG. (R 16) Study of eye irritation of HS REF 037901 (Shampoo without Octopirox) in rabbits; Report-No. 77.1129, Hoechst AG. (R 17) Study of eye irritation of Octopirox in aqueous Isopropanol in rabbits; Report-No. 79.0026, Hoechst AC. (R 18) Study of eye irritation of aqueous Isopropanol in rabbits; Report-No. 79.0027, Hoechst AG. (R 19) Testing for sensitizing properties of the substance H 72 6146 A (Octopirox) in the guinea pig (by the method of E.V. Buehler); Report-No. 76.0027, Hoechst AG. (R 20) Maximization test of Piroctone Olamine in the guinea pig; Report of S. Tanaka, H. Morioka, M. Miyamoto and T. Sakaguchi, Hoechst Japan Ltd., Department of Biological Science, May 3 1:)1983. (R 21) Testing for sensitizing properties of the antidandruff substance H 72 6146 A (Octopirox) in humans; Report-No. 75.088 1, Hoechst AG. (R 22) Photocontact allergy test of Piroxtone Olamine; Tamaka, S.: Morioka, H.; Myamoto, M.: Skaguch, T.; Hoechst Japan Ltd., Department of Biological Science, June 1, 1983. (R 23) Phototoxicity study with Octopirox in humans; H. Tronier, Hautklinik Dortmund, 8. September 1976. (R 24) Oral range-finding study (30 days) of Octopirox in SPF-Wistar-rats; Report-No. 76.0450, Hoechst AG. (R 25) A repeated-dose (30 days) oral toxicity study of Octopirox in beagle dogs; Report-No. 76.0400, Hoechst AG. (R 26) Five weeks subcutaneous toxicity of Piroxtone Olamine in rats; Report of Toyoshima (Kejo S. Gijuku University, Department of Medical Science), H. Sato (Sasaki
Research Institute), R. Sato, H. Sato and M. Motoyama (Japan Experimental Medical Research Institute Co., Ltd.), August 18, 198 1.
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Safety: (Vol. 3)
(R 27) Subacute dermal toxicity study in male and female rabbits with a hair-lotion and shampoo-preparation containing H 72 6146 A (Octopirox); Report-No. 76.0294, Hoechst AG. (R 28) Repeated-dose (90 days) oral toxicity study of Octopirox in rats; Report-No. 77.0752, Hoechst AG. (R 29) Repeated-dose (90 days) oral toxicity study of Octopirox in beagle dogs, Report-No. 77.02 15, Hoechst AG. (R 30) 6 month chronic percutaneous toxicity of Piroctone Olamine on rats; Report No. T368-1 of R. Itoh and S. Kajawara, February 15, 1983. (R 31) One year chronic peructaneous toxicity of Piroctone Olamine in rats, Report-No. T368-2 of R. Itoh and S. Kajawara, September 20, 1983.
Safely: (Vol. 4)
(R 32) Octopirox: Test for mutagenicity in bacteria strains in the absence and presence of a liver preparation, Report No. 77.0815, Hoechst AG. (R 33) Mutagenicity test of Piroctone Olamine; 0. Nahanishi, H. Morioha, M. Miyamato,
Hoechst Japan Ltd., Department of Biological Science, April 27, 1982. (R 34) Study of mutagenic potential of the compound Octopirox Charge W 020 in strains of Salmonella typhimurium (Ames-Test); Report-No. 82.0692, Hoechst AG. (R 35) Study of mutagenic potential of the compound Octopirox OP. A 038 in strains of Salmonella typhimurium (Ames-Test); Report-No. 82.0693, Hoechst AG. (R 36) An oral mutagenicity study (Micronucleus-test) 77.0677, Hoechst AG. (R 37) Micronucleus-test of Piroctone Olamine in mice; M. Harusaka, K. Nabeshima; with Octopirox in mice; Report-No.
Biological Science Laboratories, Lion Corporation, 198 1. (R 38) Mutagenicity evaluation of PKOD-A038 in the Chinese hamster bone marrow
cytogenetic assay; Report of Litton Bionetics, Inc., march 1984. (R 39) Lack of in vivo binding to DNA of Piroctone Olamine; P. Sagelsdorff, W.K. Lutz, Ch. Schlatter; Swiss Federal Institute of Technology and University of Ztirich, Sept. 16, 1983. (R 40) An oral embryotoxicity AG. (R 41) Teratological study of Piroctone Olamine in rats; S. Toyoshima (Keio University), R. study with Octopirox in rabbits; Report-No. 79.0603, Hoechst
Satch, M. Kashima, M. Takahashi (Japan Experimental Medical Research Institute), June 30, 1981.
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(R 42) Teratological study of Piroctone Olamine in rats - Subcutaneously administration
at
different times during organogenesis; T. Kitatani, M. Akaike, K. Takayama, M. Miyamoto; Research and Development Laboratories, Hoechst Japan Ltd., april 19, 1982. (R 43) Subcutaneous administration of Piroctone Olamine to rats from pre-conceptional
period through early stage of gestation. R. Sato, M. Kajima, Nippon Experimental Medical Research Institute, March 22, 1983. (R 44) Effects of Piroctone Olamine subcutaneously given during the last third of gestation and the period of lactation in the rat; R. Sato, M. Kajma, Nippon Experimental Research Institute; March 22, 1983. (R 45) Pharmacokinetic studies of Octopirox-14C after dermal, oral and intravenous Medical
administration to rats. Report-No. Ol-L42-032580,
Hoechst AG, November 27, 1980.
(R 46) Kinetics of Octopirox after oral administration to dogs and rats. Hoechst AG, Pharma Research Biochemistry, March 3,, 1980. (R 47) Percutaneous absorption of Octopirox; W.E. Parish, Unilever Research, Environmental Safety Laboratory, August 1983. (R 48) Report on general pharmacology Hoechst AC, December 10, 1976. (R 49) 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. of Octopirox; Pharma Research Pharmacology,
(R 50) 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 (R 51) Percutaneous Absorption Toxic. 26: 53-58, 1988. (R 52) Patch test for investigating the skin-irritant effect of cosmetic products in humans; 12: 11 l-121, 1989.
of Octopirox@ ; Black, J.G. and Kamat, V.B., Fd Chem.
Tronnier, H., Institute for experimental dermatology, June 17, 1991 (R 53) Patch test for investigating the skin-irritant effect of cosmetic products in humans;
Trormier, H., Institute for experimental dermatology, June 17, 199 1 (R 54) OECD Acute Inhalation Toxicity Evaluation of Octopirox; Study No. 191-1456,
International Research and Development Corporation, 21.2.1990
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Efficacy:
(El)
(Vol. 5)
The aetiology of dandruff and the mode of action of the therapeutic agents.
S. Shuster, British Journal of Dermatology 111 (1984) 235-242. (E2) 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. (E3) Brochure Octopirox 0, Hoechst AG, 1991. (E4) Brochure Antidandruff Active Ingredient Octopirox @, Clariant GmbH, 2003. (E5) Specification Piroctone Olamine, Hoechst AG, 1983. (E6) Specification Octopirox @ (Piroctone Olamine) Clariant GmbH, 2001. (E7) Report Hoechst AG, H 726146A, 05.01.1977. (E8) Report Hoechst AG, H 726146A, 26. IO. 198 1. (E9) Testing of Octopirox against Pityrosorum Ovale (orbiculare) in vitro/Dr. Hanel, Hoechst AG, 1990. (ElO) Report on tests for the determination of the substantivity of Octopirox @ on the scalp, Dr. Futterer, Hoechst AG, 20.12.1976. (El 1) Stability test of Octopirox @ (piroctone olamine) substance for 3 years at room temperature, Dr. Futterer, Hoechst AG, 30.06.1981. (E12) Stability test of Octopirox @ shampoo (0,5 % w/w) for 3 years at room temperature, Dr. Futterer, Hoechst AG, 25.09.198 1. (E13) In vitro susceptibility of Malassezia fur&r. A. Schmidt, B. Rtihl-Horster, Arzneim.Forsch./Drug Res. 46 (1996) 442-444. (E14) Radiometrische Untersuchungen zur Substantivittit des Antischuppenwirkstoffs Piroctone Olamine an Humanhaar. K. Lotsch, J. Herok, 1 lth International ISFCC Congress, ,,Cosmetics: Reserach and Technology, Venezia-Lido, 23-26.09.1980. (El 5) Comparaison de la thermostabilite d’ antipelliculaires Pharm. Fr. 57 (1999) 392-396. (E16) 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 RoeckHoltzhauer, S.T.P. Pharma Sciences 6 (1996) 455-458. naturels et de synthese (climbazole et piroctone olamine;). C. Coiffard, L. Coiffard, Y. de Roeck-Holtzhauer, Ann.
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(E17) 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 & REl. Technol. 21(1998) 2365-2373. (E18) Simultaneous determination of four anti-dandruff agents including octopirox in shampoo products by reversed-phaseliquid chromatography. L. Chao, International Journal of Cosmetics Science, 23 (2001) 183-I 88. (E 19) Spectrophotometric determination of Octopirox in cosmetic compositions (e.g. Shampoo), Clariant GmbH, May 2000. (E 20) Determination of Octopirox in Shampoos by HPLC, Clariant GmbH, 02.03.2001. (E 21) Dr. Futterer, Antidandruff activity of Octopirox, Hoechst AG, 18.04.1978. (E 22) Piroctone Olamine shampoo vs. an inactive shampoo anti-dandruff activity using the half-head technique/Life Science Research, 24.04.1980. (E 23) Piroctone Olamine shampoo vc. a competitior’ shampoo, anti-dandruff activity using s the half-head-technique. Life Science Research, 1981. (E 24) Piroctone Olamine shampoo vs. 1 % DTPDh4gS04 Shampoo, comparative trial of antidandruff efficacy using the half-head technique/Life Science Research Ltd, 27.06.1984.
Efficacy:
(Vol. 6)
(E 25) 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, 19.12.1986. (E 26) Bericht tiber die vergleichende Prtimng von Octopyrox und Climbazol auf Antischuppen-Wirkung, Cosmital SA, Marly 13.12.1994. (E 27) 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, 08.01.1997. (E 28) Clinical Study to evaluate the anti-dandruff efficacy of Shampoos, proDerm Instutute, study 99.110-l 1, 04.02.2000. (E 29) A practice-oriented test method of active ingredients to control dandruff, G. Dietrich, V. Bollert, Medical Cosmetology 10 (1980) 34-45. (E 30) Evaluation of the efficacy of antidandmff agents/, E. Futterer, J. Sot. Cosmet. Chem. 32 (1981) 327-338.
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(E 3 1) 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 Sot. 6 (1982) 79-99. (E 32) Investigations into the efficacy of soluble anti-dandruff agents, Dr. E. Futterer, Medical Cosmetology, 15 (1985) 421-435. (E 33) Antidandruff Cosmetics&Toiletries Hair Tonic containing 103 (1988), 47-49. in the pathogenesis of dandruff, D. Saint Leger, piroctone olamine, Dr. Eberhard Futterer,
(E 34) The role of the resident microflora
A.M. Kligman, T.J. Stoudemayer, J. Sot. Cosmet. Chem 40 (1989) 109-l 17. (E 35) Comparative anti-dandruff efficacy between a tar and a non-tar shampoo, C. PierardFranchimont, G. E. Pierard, V. Vroome, G. C. Lin, Dermatology 200 (2000), 181-l 84. (E 36) Synergistic behaviour between AHA and BHA’ esters with MEA-Piroctone s for antidandruff shampo formulation, F. Montesion, C. Genova, G. Calloni, Olamine The world
directory for the cosmetic industry 2000, pp. 54-56. (E 37) 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. (E 38) Head&Shoulders-New Improved Head&Shoulders, Product Brochure,
Procter&Gamble 2000. (E 39) 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. (E 40) Efficacy and skin tolerability of saliker in the treatment of dandruff, S. Humke, M.-A. Budde, T. Ruzicka, A. Richard, A. Rougier, J. Krutmarm, Eur. J. Dermatology, 12 (2002) LIILIII. (E 41) Effect of residence time on the efficacy of antidandruff shampoos, C. Pierard-
Franchimont, E. IJhoda, G. Loussouam, D. Saint-Leger, G. E. Pierard, International Journal of Cosmetic Science, 25 (2003) 267-27 1. (E 42) Internetpage www.wella.de, June 2003.
antipitiriasica di una linea di prod&t line
(E 43) Sperimentazione di nuovi farmaci: Attivita
contenente piroctone olamina (Trials on new drugs, Antipyriasis containing piroctone olamine), 1’ Bartalini, . R. Bilenchi,
activity of a product Italian0
F. Dina, Giomale
di
Dermatologia e Venereologia, 122 (1987) 1 l-1 9.
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(E 44) Certificate of Analysis H 72 6 146 A, Hoechst AG, 18.02.1974. (E 45) Certificate of Analysis H 72 6146 A, Hoechst AG, 10.09.1975. (E 46) Certificate of Analysis Octopirox (H 72 6146 A), Hoechst AG, 16.01.1976. (E 47) Product documentation Octopirox, 1976.
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