Subchronic (26- and 52-week) toxicity and irritation studies of a novel microbicidal gel formulation containing sodium lauryl sulfate in animal models

Journal of Applied Toxicology

Volumn 28, Issue 2, 2008, Pages 164-174

  Piret, Jocelyne ^a   Laforest, Geneviève ^a   Bussières, Martin ^a   Bergeron, Michel G ^a  

^a LAVAL UNIVERSITY   (Canada)

Author keywords

Gel formulation; Irritation; Microbicide; Sodium lauryl sulphate; Subchronic toxicity; Vaginal

Indexed keywords

DODECYL SULFATE SODIUM; ETHYLENE OXIDE; MICROBICIDE; PROPYLENE OXIDE;

ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; BLOOD CLOTTING TEST; BODY WEIGHT; CHRONIC TOXICITY; CONTROLLED STUDY; DRUG SAFETY; EYE IRRITATION; FEMALE; HISTOPATHOLOGY; IRRITANT DERMATITIS; MALE; MUCOSA INFLAMMATION; NONHUMAN; PRIORITY JOURNAL; RAT; SCORING SYSTEM;

ADMINISTRATION, BUCCAL; ADMINISTRATION, INTRAVAGINAL; ADMINISTRATION, RECTAL; ANIMALS; ANTI-INFECTIVE AGENTS, LOCAL; CHEMISTRY, PHARMACEUTICAL; CRICETINAE; DRUG ADMINISTRATION SCHEDULE; DRUG COMPOUNDING; EPOXY COMPOUNDS; ETHYLENE OXIDE; EYE; FEMALE; GELS; MALE; MOUTH MUCOSA; PENIS; RABBITS; RATS; RATS, SPRAGUE-DAWLEY; RECTUM; RISK ASSESSMENT; SKIN; SKIN IRRITANCY TESTS; SODIUM DODECYL SULFATE; TIME FACTORS; TOXICITY TESTS; VAGINA;

ANIMALIA; CRICETINAE; ORYCTOLAGUS CUNICULUS; RATTUS;

EID: 41149131806     PISSN: 0260437X     EISSN: 10991263     Source Type: Journal    
DOI: 10.1002/jat.1262     Document Type: Article

References (45)

1. Asculai SS, Weis MT, Rancourt MW, Kupferberg AB. 1978. Inactivation of herpes simplex viruses by nonionic surfactants. Antimicrob. Agents Chemother. 13: 686-690.
2. Baert JH, Veys RJ, Ampe K, De Boever JA. 1996. The effect of sodium lauryl sulphate and triclosan on hamster cheek pouch mucosa. Int. J. Exp. Pathol. 77: 73-78.
3. Basketter DA, Whittle E, Griffiths HA, York M. 1994. The identification and classification of skin irritation hazard by a human patch test. Food Chem. Toxicol. 32: 769-775.
4. Benes S, McCormack WM. 1985. Inhibition of growth of Chlamydia trachomatis by nonoxynol-9 in vitro. Antimicrob. Agents Chemother. 27: 724-726.
5. Bestman-Smith J, Piret J, Désormeaux A, Tremblay MJ, Omar RF, Bergeron MG. 2001. Sodium lauryl sulfate abrogates human immunodeficiency virus infectivity by affecting viral attachment. Antimicrob. Agents Chemother. 45: 2229-2237.
6. Bourinbaiar AS, Lee-Huang S. 1994. Comparative in vitro study of contraceptive agents with anti-HIV activity: Gramicidin, nonoxynol-9 and gossypol. Contraception 49: 131-137.
7. Ciuchta HP, Dodd T. 1978. The determination of the irritancy potential of surfactants using various methods of assessment. Drug Chem. Toxicol. 1: 305-324.
8. Cosmetic, Toiletry and Fragrance Association. 1983. Final Report on the Safety Assessment of Sodium Lauryl Sulfate and Ammonium Lauryl Sulfate. 127-181.
9. Dahl MV, Trancik RJ. 1977. Sodium lauryl sulfate irritant patch tests: degree of inflammation at various times. Contact Dermatitis. 3: 263-266.
10. Davies RE, Harper KH, Kynoch SR. 1972. Inter-species variation in dermal reactivity. J. Soc. Cosmet. Chem. 23: 371-381.
11. Davies RE, Kynoch SR, Liggett MP. 1976. Eye irritation tests - an assessment of the maximum delay time for remedial irrigation. J. Soc. Cosmet. Chem. 27: 301-306.
12. Draize JH, Woodward G, Calvery HO. 1944. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. Exp. Ther. 32: 377-390.
13. Eckstein P, Jackson MCN, Millman N, Sobrero AJ. 1969. Comparison of vaginal tolerance tests of spermicidal preparations in rabbits and monkey. J. Reprod. Fert. 20: 85-93.
14. Etter JC, Wildhaber A. 1985. Biopharmaceutical test of ocular irritation in the mouse. Food Chem. Toxicol. 23: 321-323.
15. Feldblum PJ, Weir SS. 1994. The protective effect of nonoxynol-9 against HIV infection. Am. J. Public Health 84: 1032-1034.
16. Final Report of the Cosmetic Ingredient Review Expert Panel. 2005. Safety Assessment of Poloxamers 101, 105, 108, 122, 123, 124, 181, 182, 183, 185, 188, 212, 215, 217, 231, 234, 235, 237, 238, 282, 284, 288, 331, 333, 334, 335, 338, 401, 402, 403, 407, Poloxamer 105 Benzoate and Poloxamer 182 Dibenzoate. Cosmetic Ingredient Review: Washington, DC.
17. Gagné N, Cormier H, Omar RF, Désormeaux A, Gourde P, Tremblay MJ, Juhász J, Beauchamp D, Rioux JE, Bergeron MG. 1999. Protective effect of a thermoreversible gel against the toxicity of nonoxynol-9. Sex.Transm. Dis. 26: 177-183.
18. Griffith JF, Nixon GA, Bruce RD, Reer PJ, Bannan EA. 1980. Dose-response studies with chemical irritants in the albino rabbit eye as a basis for selecting optimum testing conditions for predicting hazard to the human eye. Toxicol. Appl. Pharmacol. 55: 501-513.
19. Haineault C, Gourde PG, Perron S, Désormeaux A, Piret J, Omar RF, Tremblay RF, Bergeron MG. 2003. Thermoreversible gel formulation containing sodium lauryl sulfate as a potential contraceptive device. Biol. Reprod. 69: 687-694.
20. Hecht E, Mortensen K, Gradzielski M, Hoffmann H. 1995. Interaction of ABA block copolymers with ionic surfactants: influence on micellization and gelation. J. Phys. Chem. 99: 4866-4874.
21. Howett MK, Neely EB, Christensen ND, Wigdahl B, Krebs FC, Malamud D, Patrick SD, Pickel MD, Welsh PA, Reed CA, Ward MG, Budgeon LR, Kreider JW. 1999. A broad-spectrum microbicide with virucidal activity against sexually transmitted viruses. Antimicrob. Agents. Chemother. 43: 314-321.
22. Jennings R, Clegg A. 1993. The inhibitory effect of spermicidal agents on replication of HSV-2 and HIV-I in vitro. J. Antimicrob. Chemother. 32:71-82.
23. Kabanov AV, Batrakova EV, Alakhov VY. 2002. Pluronic block co-polymers as novel polymer therapeutics for drug and gene delivery. J. Control. Release 82: 189-212.
24. Klebanoff SJ. 1992. Effects of the spermicidal agent nonoxynol-9 on vaginal microbial flora. J. Infect. Dis. 165: 19-25.
25. Krebs FC, Miller SR, Malamud D, Howett MK, Wigdahl B. 1999. Inactivation of human immunodeficiency virus type 1 by nonoxynol-9, C31G, or an alkyl sulfate, sodium dodecyl sulfate. Antiviral Res. 43: 157-173.
26. Kreiss J, Ngugi E, Holmes K, Ndinya-Achola J, Waiyaki P, Roberts PL, Ruminjo I, Sajabi R, Kimata J, Fleming TR, et al. 1992. Efficacy of nonoxynol-9 contraceptive sponge use in preventing heterosexual acquisition of HIV in Nairobi prostitutes. JAMA 268: 477-482.
27. Leopold IH. 1945. Local toxic effect of detergents on ocular structures. Arch. Ophthalmol. 34: 99-102.
28. Malkovsky M, Newell A, Dalgleish AG. 1988. Inactivation of HIV by nonoxynol-9. Lancet 1: 645.
29. Namiki N, Takagi N, Yuasa H, Kanaya Y. 1998. Studies on development of dosage forms for pediatric use (V) oral mucosal irritation study of gummi drugs in hamster cheek pouch. Biol. Pharm. Bull. 21: 87-89.
30. Niruthisard S, Roddy RE, Chutivongse S. 1991. The effect of frequent nonoxynol-9 use on the vaginal and cervical mucosa. Sex. Transm. Dis. 18: 176-179.
31. Nixon GA, Tyson CA, Wertz WC. 1975. Interspecies comparisons of skin irritancy. Toxicol. Appl. Pharmacol. 31: 481-490.
32. Olson KJ, Dupree RW, Plomer ET, Rowe VK. 1962. Toxicological properties of several commercially available surfactants. J. Soc. Cosmet. Chem. 13: 469-476.
33. Phillips L, Steinberg M, Maibach HI, Akers WA. 1972. A comparison of rabbit and human skin response to certain irritants. Toxicol. Appl. Pharmacol. 21: 369-382.
34. Piret J, Désormeaux A, Bergeron MG. 2002a. Sodium lauryl sulfate, a microbicide effective against enveloped and nonenveloped viruses. Curr. Drug Targets 3: 17-30.
35. Piret J, Gagné N, Perron S, Désormeaux A, Tremblay MJ, Gourde P, Omar RF, Bergeron MG. 2001. Thermoreversible gel as a candidate barrier to prevent the transmission of HIV-I and herpes simplex virus type 2. Sex. Transm. Dis. 28: 484-491.
36. Piret J, Roy S, Gagnon M, Landry S, Désormeaux A, Omar RF, Bergeron MG. 2002b. Comparative study of mechanisms of herpes simplex virus inactivation by sodium lauryl sulfate and n-lauroylsarcosine. Antimicrob. Agents Chemother. 46: 2933-2942.
37. Roddy RE, Cordero M, Cordero C, Fortney JA. 1993. A dosing study of nonoxynol-9 and genital irritation. Int. J. STD AIDS 4: 165-170.
38. Roddy RE, Zekeng L, Ryan KA, Tamoufé U, Weir SS, Wong EL. 1998. A controlled trial of nonoxynol-9 film to reduce male-to-female transmission of sexually transmitted diseases. N. Engl. J. Med. 339: 504-510.
39. Rowe RC, Sheskey PJ, Weiler PJ. 2006. Handbook of Pharmaceutical Excipients, 5th ed. Pharmaceutical Press: UK; American Pharmaceutical Association: Washington, D.C.; 928.
40. Roy S, Gourde P, Piret J, Désormeaux A, Lamontagne J, Haineault C, Omar RF, Bergeron MG. 2001. Thermoreversible gel formulations containing sodium lauryl sulfate or n-lauroylsarcosine as potential topical microbicides against sexually transmitted diseases. Antimicrob. Agents Chemother. 45: 1671-1681.
41. Stafford MK, Ward H, Flanagan A, Rosenstein IJ, Taylor-Robinson D, Smith JR, Weber J, Kitchen VS. 1998. Safety study of nonoxynol-9 as a vaginal microbicide: evidence of adverse effects. J. Acquir. Immune Defic. Syndr. Hum. Retrovirol. 17: 327-331.
42. Van Damme L, Ramjee G, Alary M, Vuylsteke B, Chandeying V, Rees H, Sirivongrangson P, Mukenge-Tshibaka L, Ettiegne-Traore V, Uaheowitchai C, Karim SS, Masse B, Perriens J, Laga M, COL-1492 Study Group. 2002. Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-I transmission in female sex workers: a randomised controlled trial. Lancet 360: 971-977.
43. Wilkinson D, Tholandi M, Ramjee G, Rutherford GW. 2002, Nonoxynol-9 spermicide for prevention of vaginally acquired HIV and other sexually transmitted infections: systematic review and meta-analysis of randomised controlled trials including more than 5000 women. Lancet Infect. Dis. 2: 613-617.
44. Wingerd BD. 1984. Human Anatomy and Rabbit Dissection (Illustrations by G. Stein). John Hopkins University Press: Baltimore, MD; 121-123.
45. Zaneveld LJ, Waller DP, Anderson RA, Chany C, Rencher WF, Feathergill K, Diao XH, Doncel GF, Herold B, Cooper M. 2002. Efficacy and safety of a new vaginal contraceptive antimicrobial formulation containing high molecular weight poly(sodium 4-styrenesulfonate). Biol. Reprod. 66: 886-894.