Final Report on the Safety Assessment of Stearoxy Dimethicone, Dimethicone, Methicone, Amino Bispropyl Dimethicone, Aminopropyl Dimethicone, Amodimethicone, Amodimethicone Hydroxystearate, (see abstract)

International Journal of Toxicology

Volumn 22, Issue SUPPL. 2, 2003, Pages 11-35

  Andersen, F Alan ^a  

^a NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMINO BISPROPYL DIMETHICONE; AMINOPROPYL DIMETHICONE; AMODIMETHICONE; AMODIMETHICONE HYDROXYSTEARATE; BEHENOXY DIMETHICONE; CETYL DIMETHICONE; COSMETIC; DIMETHOXYSILYL ETHYLENEDIAMINOPROPYL DIMETHICONE; DIMETICONE; HEXYL METHICONE; HYDROXYPROPYLDIMETHICONE; INSULIN; METHICONE; POLYMER; SILOXANE; STEARAMIDOPROPYL DIMETHICONE; STEAROXY DIMETHICONE; STEARYL DIMETHICONE; STEARYL METHICONE; UNCLASSIFIED DRUG; VINYLDIMETHICONE;

ACUTE TOXICITY; AEROSOL; ANIMAL EXPERIMENT; ANIMAL MODEL; BODY WEIGHT; CARCINOGENICITY; CONCENTRATION RESPONSE; CONFERENCE PAPER; EXPOSURE; EYE IRRITATION; FEMALE; FETOTOXICITY; GUINEA PIG; LONG TERM EXPOSURE; MALE; MOLECULAR WEIGHT; MONKEY; MOUSE; NONHUMAN; PARTICLE SIZE; PATCH TEST; RABBIT; RAT; REPRODUCTIVE TOXICITY; SAFETY; SEMINAL VESICLE; SENSITIZATION; SKIN ABSORPTION; SKIN IRRITATION; TESTIS WEIGHT; TOXICITY TESTING;

ANIMALIA; CAVIA; CAVIA PORCELLUS; ORYCTOLAGUS CUNICULUS; SUS SCROFA;

EID: 0242657389     PISSN: 10915818     EISSN: None     Source Type: Journal    
DOI: 10.1080/747398362     Document Type: Conference Paper

References (114)

1. Atlas Chemical Industries. 1969. DC Medical Antifoam 351 compound: A thirteen-week feeding study in dogs with cover letter dated 04/20/94. National Technical Information Service (NTIS) report no. OTS0590154.
2. Atlas Chemical Industries. 1970. Dow Corning Antifoam A (medical grade): A teratogenic potential study in rats with cover letter dated 04/20/94. NTIS report no. OTS0556591.
3. Bio-Research Labs. 1985a. Study of the tolerance to a Dow Corning food additive additive and its effects upon nutrient absorption, with cover letter dated 05/09/94. NTIS report no. OTS0557411.
4. Bio-Research Labs. 1985b. The study of the tolerance to a Dow Corning food additive (increase dose and bolus phase), with cover letter dated 05/09/94. NTIS report no. OTS0557412.
5. Bushy Run Research Center. 1984. Initial submission: silicone emulsion ALE-56: acute toxicity and primary irritancy studies (final report) with cover letter dated 04/03/92. NTIS report no. OTS0535978.
6. Carson, S., M. S. Weinberg, and B. L. Oser. 1966. Safety evaluation of Dow Corning 360 Fluid and Antifoam A. Proc. Sci. Sect. Toilet Goods Assoc. 45:8-19.
7. Child, G. P., H. O. Paquin Jr., and W. B. Deichmann. 1951. Chronic toxicity of the methylpolysiloxane "DC antifoam A" in dogs. A. M. A. Archs. Ind. Hyg. 3:479-3482.
8. Committee of Revision of the United States Pharmacopeial Convention. 1995. The National Formulary, 18th ed. Rockville: United States Pharmacopeial Convention, Inc. 2242-2243.
9. 2
10. 2
11. 2
12. 2
13. 2
14. Cutler, M. G., A. J. Collings, I. S. Kiss, and M. Sharratt. 1974. A lifespan study of a polydimethylsiloxane in the mouse. Food Cosmet. Toxicol. 12:443-450.
15. 2
16. Dow Corning Corp. 1949. Results of acute oral and skin irritation tests conducted upon: DC mold release emulsion type P, and DC mold release emulsion type XE-18 with cover letter dated 04/20/94. NTIS report no. OTS0556484.
17. Dow Corning Corp. 1950. Results of range finding toxicological studies on DC 35A and DC 35B with cover letter dated 04/20/94. NTIS report no. OTS0590148.
18. Dow Corning Corp. 1953. DC XF-409 results of skin and eye irritation studies with cover letter dated 04/20/94. NTIS report no. OTS0556486.
19. Dow Corning Corp. 1954a. Explanation of significance of toxicological and clinical data submitted for Antifoam A relative to Dow Corning 151 emulsion with cover letter dated 04/20/94. NTIS report no. OTS0590150.
20. Dow Corning Corp. 1954b. The results of range finding toxicological tests on Dow Corning 710, 555, and 200 fluids, PA-type fluid, Dow Corning 133-1-12A and light mineral oil with cover letter dated 04/20/94. NTIS report no. OTS0556487.
21. Dow Corning Corp. 1956. The physiological assimilation of Dow Corning 200 Fluid with cover letter dated 04/20/94. NTIS report no. OTS0556488.
22. Dow Corning Corp. 1957a. Comparison of 200 fluid, treated and untreated, insofar as eye contact irritation is concerned with attachments and cover letter dated 04/20/94. NTIS report no. OTS0556492.
23. Dow Corning Corp. 1957b. Results of comparative tests on 200 fluid lot no. AA2921 (electrical grade), treated and untreated (3-14-57) with cover letter dated 04/20/94. NTIS report no. OTS0556491.
24. Dow Corning Corp. 1959. Comparative eye irritation of specially prepared Dow Corning 200 fluid with cover letter dated 04/20/94. NTIS report no. OTS0556495.
25. Dow Corning Corp. 1968. Eye irritation potential of several Dow Corning emulsions with cover letter dated 04/20/94. NTIS report no. OTS0556579.
26. Dow Corning Corp. 1969. Seven day subacute dermal toxicity study on three foot protector formulations with cover letter dated 04/20/94. NTIS report no. OTS0556588.
27. Dow Corning Corp. 1970. Range finding toxicity studies on Dow Corning XF-1-3753 with cover letter dated 04/20/94. NTIS report no. OTS0556594.
28. Dow Corning Corp. 1972a. Analysis of excreted Dow Corning 360 fluid from oral dosing of rhesus monkey with cover letter dated 04/20/94. NTIS report no. OTS0572183.
29. Dow Corning Corp. 1972b. Acute toxicological properties and industrial handling hazards of Dow Corning XEF-4-3561 emulsion with cover letter dated 04/20/94. NTIS report no. OTS0572181.
30. Dow Corning Corp. 1972c. The select effects of 20 cs DC-360 fluid and related linear/cyclic dimethylpolysiloxanes administered orally and dermally for 4 weeks to rats with cover letter dated 04/20/94. NTIS report no. OTS0590155.
31. Dow Corning Corp. 1974. Pharmacokinetic and metabolic studies on Dow Corning Antifoams A and M in mice, monkeys, and humans with cover letter dated 4/10/94. NTIS report no. OTS0572209.
32. Dow Corning Corp. 1975. Acute toxicological properties and industrial handling hazards of Dow Corning XF 2-107, an experimental hydraulic fluid with cover letter dated 04/20/94. NTIS report no. OTS0572227.
33. Dow Corning Corp. 1977. Acute toxicological properties of Dow Corning X2-1133 heat transfer fluid when tested according to the regulations of FHSA with cover letter dated 04/20/94. NTIS report no. OTS0572261.
34. Dow Corning Corp. 1978a. Acute toxicologic properties of Dow Corning X2-1162 heat transfer fluid when tested according to the regulations of FHSA with cover letter dated 04/20/94. NTIS report no. OTS0572281 or OTS0572278.
35. Dow Corning Corp. 1978b. Acute toxicologic properties of syltherm 444 heat transfer fluid when tested according to the FHSA regulations with cover letter dated 04/20/94. NTIS report no. OTS0572282.
36. Dow Corning Corp. 1978c. Mutagenicity evaluation of Dow Corning 200 Fluid in the Ames bacterial assay system with cover letter dated 04/20/94. NTIS report no. OTS0572280.
37. Dow Corning Corp. 1985. Skin sensitization study of Dow Corning Z7-2167/ 8 in Hartley albino guinea pigs with cover letter dated 04/20/94. NTIS report no. OTS0590134.
38. Dow Corning Corp. 1986a. Genetic evaluation of Dow Corning X2-5169 surfactant in bacterial reverse mutation assays with cover letter dated 04/20/94. NTIS report no. OTS090142.
39. Dow Corning Corp. 1986b. Genetic evaluation of Dow Corning X3-9626 in bacterial reverse mutation assays with cover letter dated 04/20/94. NTIS report no. OTS090137.
40. Dow Corning Corp. 1986c. Genetic evaluation of Dow Corning Q7-2159A medical gel extract in bacterial reverse mutation assays with cover letter dated 04/20/94. NTIS report no. OTS0590136.
41. Dow Corning Corp. 1986d. Genetic evaluation of Dow Corning Q7-2159A in the in vitro mammalian cell transformation assay with cover letter dated 04/20/94. NTIS report no. OTS0590144.
42. Dow Corning Corp. 1986e. Genetic evaluation of Dow Corning Q7-2159A in the CHO/HGPRT forward mutation assay with cover letter dated 04/20/94. NTIS report no. OTS0590140.
43. Dow Corning Corp. 1986f. Genetic evaluation of Dow Corning Q7-2159A medical gel extract in the rodent micronucleus assay with cover letter dated 04/20/94. NTIS report no. OTS0590143.
44. Dow Corning Corp. 1989a. Single and repeated dose pharmacokinetic studies of polydimethylsiloxanes in the rat with cover letter dated 04/20/94. NTIS report no. OTS0590100.
45. Dow Corning Corp. 1989b. 90-Day subchronic oral toxicity study with polydimethylsiloxane fluid in the mouse with cover letter dated 04/20/94. NTIS report no. OTS0590096.
46. Dow Corning Corp. 1989c. 90-Day sub-chronic oral toxicity study with polydimethylsiloxane fluids in the rat with cover letter dated 04/20/94. NTIS report no. OTS0590098.
47. Dow Corning Corp. 1989d. 90-Day sub-chronic oral toxicity study with polydimethylsiloxane fluids in male rats with cover letter dated 04/20/94. NTIS report no. OTS0590099.
48. Dow Corning Corp. 1989e. Genetic evaluation of Dow Corning CU-7439 in bacterial reverse mutation assay with cover letter dated 04/20/94. NTIS report no. OTS0590092.
49. Dow Corning Corp. 1989f. Genetic evaluation of Dow Corning Q7-2167/68 in the in vitro mammalian cell transformation assay with cover letter dated 04/20/94. NTIS report no. OTS0590090.
50. Dow Corning Corp. 1989g. Genetic evaluation of Dow Corning Q7-2167/68 in the CHO chromosome aberration assay with cover letter dated 04/20/94. NTIS report no. OTS0590091.
51. Dow Corning Corp. 1989h. Genetic evaluation of Dow Corning Q7-2167/68 in the CHO/HGPRT forward mutation assay with cover letter dated 04/20/94. NTIS report no. OTS0590089.
52. Dow Corning Corp. 1989i. Genetic evaluation of Dow Corning Q7-2167/68 in the rodent micronucleus assay with cover letter dated 04/20/94. NTIS report no. OTS0590094.
53. Dow Corning Corp. 1990a. Genetic evaluation of Dow Corning X2-3379 in bacterial reverse mutation assays with cover letter dated 04/20/94. NTIS report no. OTS0590110.
54. Dow Corning Corp. 1990b. Genetic evaluation of Dow Corning X2-3320 in bacterial reverse mutation assays with cover letter dated 04/20/94. NTIS report no. OTS0590111.
55. Dow Corning Corp. 1990c. Genetic evaluation of silastic Q7-2867 (polydimethyl siloxane) in bacterial reverse mutation assays with cover letter dated 04/20/94. NTIS report no. OTS0590116.
56. Dow Corning Corp. 1991. Guinea pig skin sensitization study of silastic Q7-1867 keratosis implant with cover letter dated 04/20/94. NTIS report no. OTS0572313.
57. Dupont De Nemours & Co. 1966. Toxicity studies on polydimethylsiloxane, methylpolysiloxane and [2,2-bis(chloromethyl)-1,3-propanediyltetrakis(2-chloroethyl)phosphate] with cover letter dated 07/30/93. NTIS report no. OTS0537788.
58. European Commission. 2003. Cosmetics Directive 76/768/EEC, as amended. http://pharmacos.eudra.org/F3/home.html
59. Federation of American Societies for Experimental Biology (FASEB). 1981. Evaluation of the health aspects of methylpolysilicones as food ingredients. NTIS report no. PB81-229239.
60. Food and Agriculture Organization of the United Nations/World Health Organization (FAO/WHO). 1994. Summary of evaluations performed by the joint FAO/WHO Expert Committee on Food Additives (JECFA). United States: International Life Sciences Institute.
61. Food and Drug Administration (FDA). 1978. Skin protectant drug products for over-the-counter human use. Establishment of a monograph; notice of proposed rulemaking Fed. Register 43:34628-34648.
62. FDA. 1984. Cosmetic product formulation and frequency of use data. FDA database. Washington, DC: FDA.
63. FDA. 1990. Skin protectant drug products for over-the-counter human use; proposed rulemaking for diaper rash drug products. Fed. Register 55:25204-25232.
64. FDA. 1998. Cosmetic product formulation data. FDA database. Washington, DC: FDA.
65. Food and Drug Research Labs. 1966. Rat biological assay of polysiloxanes with cover letter dated 04/20/94. NTIS report no. OTS0556519.
66. Food and Drug Research Labs. 1977a. Acute oral toxicity in rats of a white emulsion (35.5% dimethylpolysiloxane). One of various acute studies on silicones submitted by General Electric. NTIS report no. OTS0539961.
67. Food and Drug Research Labs. 1977b. Acute oral toxicity in rats of a white emulsion (38.0% dimethylpolysiloxane). One of various acute studies on silicones submitted by General Electric. NTIS report no. OTS0539961.
68. Food and Drug Research Labs. 1977c. Acute oral toxicity in rats of a rose colored paste (81.8% dimethylpolysiloxane). One of various acute studies on silicones submitted by General Electric. NTIS report no. OTS0539961.
69. Food and Drug Research Labs. 1977d. Acute oral toxicity in rats of a salmon colored putty (85.8% dimethylpolysiloxane). One of various acute studies on silicones submitted by General Electric. NTIS report no. OTS053996.
70. Food and Drug Research Labs. 1977e. Acute oral toxicity in rats of a rose colored paste (85.5% dimethylpolysiloxane). One of various acute studies on silicones submitted by General Electric. NTIS report no. OTS0539961.
71. Food and Drug Research Labs. 1978. Acute oral toxicity in rats of a caulking material (3.26% dimethylpolysiloxane). One of various acute studies on silicones submitted by General Electric. NTIS report no. OTS0539961.
72. Food and Drug Research Labs. 1979a. Acute oral toxicity in rats of a caulking compound-Uncured (3.26% dimethylpolysiloxane). One of various acute studies on silicones submitted by General Electric. NTIS report no. OTS0539961.
73. Food and Drug Research Labs. 1979b. Acute oral toxicity in rats of an adhesive sealant-Uncured (6.9% dimethylpolysiloxane). One of various acute studies on silicones submitted by General Electric. NTIS report no. OTS0539961.
74. Food and Drug Research Labs. 1980. Acute oral toxicity in rats of a white opaque semi-solid material (15.7% dimethylpolysiloxane). One of various acute studies on silicones submitted by General Electric. NTIS report no. OTS0539961.
75. Food and Drug Research Labs. 1981. Acute oral toxicity in rats of a white caulking (15.7% dimethylpolysiloxane). One of various acute studies on silicones submitted by General Electric. NTIS report no. OTS0539961.
76. Gloxhuber, C., and G. Hecht. 1955. Pharmacological examinations of silicones. Arzneimittel-Forschung 5:10-12.
77. 2
78. Harvey, S. C. 1990. Topical drugs. In Remington's pharmaceutical sciences, 18th ed., ed. A. R. Gennaro, 758-759. Easton, PA: Mack Publishing.
79. Hazleton France. 1988a. Test to evaluate the acute toxicity of AK 350 containing siloxanes and silicones, Di-Me following a single cutaneous application (limit test) in the rat, with cover letter dated 6/17/94. NTIS report no. OTS0557443.
80. Hazleton France. 1988b. Salmonella typhimurium mammalian microsome plate incorporation assay of silicone 81 AK 350 containing siloxanes and silicones, Di-Me with cover letter dated 6/17/94. NTIS report no. OTS0557442.
81. Hazleton France. 1989. Letter from Wacker Silicones Corp to US EPA regarding toxicological studies with AK 350 containing silicones and siloxanes, Di-Me with attachments dated 6/17/94. NTIS report no. OTS0557444.
82. Hazelton Labs. 1953. Acute inhalation toxicity masonry water repellents and constituents with cover letter dated 04/20/94. NTIS report no. OTS0556485.
83. Hazleton Labs. 1975. Initial submission: Letter concerning several enclosed acute toxicity tests on several chemicals with attachments. NTIS report no. OTS0534570.
84. Hill Top Research. 1967. Range-finding acute toxicity and irritation studies on DC 36 emulsion, lot 696, with cover letter dated 04/20/94. NTIS report no. OTS0556542.
85. Hill Top Research. 1984. Repeated insult patch test with 5% dimethyl silicones and siloxanes in decamethylcyclopentasiloxane with cover letter dated 04/28/94. NTIS report no. OTS0572502.
86. Hobbs, E. J., O. E. Fancher, and J. C. Calandra. 1972. Effect of selected organopolysiloxanes on male rat and rabbit reproductive organs. Toxicol. Appl. Pharmacol. 21:45-54.
87. IIT Research Institute. 1994. An acute inhalation toxicity study of Dow Corning X2-1731 volatile fluid in albino rats with cover letter dated 4/10/95. NTIS report no. OTS0554062-1.
88. Johnson, A. 1976. Nonsteroid skin cream in traumatic dermatoses; a clinical open evaluation. Med. J. Aust. 1:111-113.
89. Kennedy, G. L., Jr., M. L. Keplinger, J. C. Calandra, and E. J. Hobbs. 1976. Reproductive, teratologic and mutagenic studies with some polydimethylsiloxanes. J. Toxicol. Environ. Health 1:909-920.
90. Leopold, C. S., and B. C. Lippold. 1995. Enhancing effects of lipophilic vehicles on skin penetration of methyl nicotinate in vivo. J. Pharm. Sci. 84:195-198.
91. Leopold, C. S., and H. I. Maibach. 1996. Effect of lipophilic vehicles on in vivo skin penetration of methyl nicotinate in different races. Int. J. Pharm. 139:161-167.
92. Locock, R. A. 1971. Review of the antacids. Can. Pharm. J. 104:86-89.
93. MacDonald, W. E., G. E. Lanier, and W. B. Deichmann. 1960. The subacute oral toxicity to the rat of certain polydimethylsiloxanes. Arch. Ind. Health 21:514-518.
94. Mahmoud, G., J. M. Lachapelle, and D. van Neste. 1984. Histological assessment of skin damage by irritants: Its possible use in the evaluation of a 'barrier cream'. Contact Dermatitis 11:179-185.
95. Microbiological Associates. 1994. Salmonella/Escherichia coli preincubation mutagenicity assay: a confirmatory assay of Dabco Dow Corning 5143 surfactant, with cover letter dated 4/26/95. NTIS Report no. OTS0557689.
96. Mellon Institute. 1993. Letter from Union Carbide to EPA submitting multiple toxicity studies on siloxanes and silicones. NTIS repot no. OTS0537811.
97. Ministry of Health, Labor and Welfare (MHLW). 2001. Unofficial translation of MHLW ordinance no. 331, including attached tables. Ministry of Health, Labor and Welfare, Pharmaceutical and Medical Safety Bureau, Inspection and Guidance Division, 2-2, 1-chome, Kasumigaseki, Chiyoda-ku, Tokyo 100-8045, Japan.
98. Myers, R. C., and B. Ballantyne. 1993. Acute toxicologic evaluation of vinyl dimethylsiloxy-terminated polydimethylsiloxane. J. Am. Coll. Toxicol. 12:591.
99. National Institute of Environmental Health Sciences. 1990. Assessment of contact hypersensitivity to polydimethylsiloxane fluid in female B6C3F1 mice. Report to the National Toxicology Program. NTIS report no. PB94-121449.
100. National Technical Information Service (NTIS). 1987a. Two generation reproduction toxicity study of experimental motor oil in rats with cover letter dated 07/30/93. NTIS report no. OTS0537799.
101. NTIS. 1987b. Teratologic evaluation of dermally administered experimental motor oil in rats with cover letter dated 07/30/93. NTIS report no. OTS0537798.
102. NTIS. 1987c. Lifetime dermal tumorigenesis study in mice with cover letter dated 07/30/93 [sanitized]. NTIS report no. OTS0537797.
103. NTIS. 1988. Assessment of mutagenic potential in histidine auxotrophs of salmonella typhimurium with cover letter dated 7/27/93. NTIS report no. OTS0537780.
104. Nikitakis, J. M., and G. N. McEwen Jr. 1990. CTFA compendium of cosmetic ingredient composition. Washington, DC: CTFA.
105. Registry of Toxic Effects of Chemical Substances (RTECS). 1998. Vinyldimethicone. RTECS database. Bethesda, MD: National Library of Medicine.
106. Rowe, V. K., H. C. Spencer, and S. L. Bass. 1950. Toxicologic studies on certain commercial silicones. Arch. of Ind. Hyg. Med. 1:539-544.
107. Siddiqui, W. H. 1994. Developmental toxicity evaluation of Dow Corning® Antifoam A compound, food grade in rabbits. Teratology 49:397.
108. Springborn Labs. 1991. Acute toxicity studies with syltherm XLT in rats and rabbits with cover letter dated 06/04/93. NTIS report no. OTS0534570.
109. SRI International. 1980. Microbial mutagenesis testing of substances; compound report F76-060, dimethylpolysiloxane. NTIS report no. PB89-178644.
110. Toxikon Corp. 1991. Primary vaginal irritation study of Dow Corning X7-0008 mucoadhesive paste with cover letter dated 04/20/94. NTIS report no. OTS0572308.
111. University of Birmingham. 1967a. Studies on silicone antifoam compound, MS Antifoam M (formerly F 9816), acute feeding study with cover letter dated 04/20/94. NTIS report no. OTS0556571.
112. University of Birmingham. 1967b. Studies on silicone antifoam compound F 9816 with cover letter dated 04/20/94. NTIS report no. OTS0556572.
113. University of Birmingham. 1968. Studies on silicone antifoam compound, MS Antifoam M (formerly F 9816). 120-Day feeding test in dogs with cover letter dated 04/20/94. NTIS report no. OTS0556581.
114. Wenninger, J. A., R. C. Canterbery, and G. H. McEwen Jr. 2000. International cosmetic ingredient dictionary and handbook, 8th ed., vol. I & II. Washington, DC: CTFA.