Environmental Project No. 1031 – Siloxanes - Consumption, Toxicity and Alternatives

Siloxanes - Consumption, Toxicity and Alternatives

References

Allan, R.B., Kochs, P. & Chandra, G. 1997 Industrial organosilicon materials, their environmental entry and predicted fate. In: Chandra, H.G (Ed.). The handbook of environmental chemistry. Vol 3. part: Organosilicon Materials. Springer-Verlag, Berlin.

Andersen M.E., Sarangapani, R., Reitz, R.H., Gallavan, R. H., Dobrev, I.D. & Plotzke, K.P. 2001. Physiological Modeling Reveals Novel Pharmacokinetic Behavior For Inhaled Octamethylcyclotetrasiloxane in Rats. Toxicological Sciences, 60, 214-231.

Bek. 439. BEK nr 439 af 03/06/2002: Bekendtgørelse om listen over farlige stoffer [Statutory order on the list of dangerous substances]

Berthiaume, M.D. 1995. Silicones in hair fixatives & finishing products. A brief review. GE Silicones, Waterford, N.Y http://www.gesilicones.com/silicones/americas/business/
industries/personalcare/workshop/Article3.shtml

Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA). 2001. AGS Begründungen zur Bewertung von Stoffen als krebserzeugend, erbgutverändernd oder fortpflanzungsgefährdend.
http://www.baua.de/prax/ags/begr_9 05.htm

Burns, L.A., Mast, R.W., Meeks, R.G., Mann, P.C. & Thevenaz, P. 1998. Inhalation Toxicology of Decamethylcyclopentasiloxane (D5) Following a 3-Month Nose-Only Exposure in Fischer 344 Rats. Toxicological Sciences 43:230-240.

Cassidy, S.L., Dotti, A., Kolesar, G. B., Dochterman, L. W., Meeks, R. G., Chevalier, H. J. (in print). Hexamethyldisiloxane: A 13-Week Subchronic Whole-Body Vapor Inhalation Toxicity Study in F344 Rats. International Journal of Tox.

Centre Europeen des Silicones, 1999). (Comments to Swedish classification proposal for D4). http://ecb.jrc.it/classlab/3798a8.doc

DEPA (Miljøstyrelsen). 2003. Liste over potentielle PBT og vPvB stoffer (List of potential PBT and vPvB substances).

EPA DCN 84000000002. 1999. D4 Rat Uterotrophic Assay. Siloxane Research Program, Reston.

EPA DCN 86010000003. 2000. Percutaneous Absorption Studies of Neat and Formulated Octamethylcyclotetrasiloxane (D4) in Human Skin/Nude Mouse Model. Siloxane Research Program, Reston.

EPA DCN 86010000004. 2000. In-Vitro Evaluation of Estrogencity of Octamethylcyclotetrasiloxane (D4) Using the Human MCF-7 Cell Line. Siloxane Research Program, Reston.

EPA DCN 86010000007. 2000. Absorption, Distribution and Elimination of 13C D4 in Humans after Dermal Administration. Siloxane Research Program, Reston.

EPA DCN 86010000008. 2000. Evaluation of Decamethylcyclopentasiloxane (D5) as an Inhibitor of Human and Rat Cytochrome P450 Enzymes. Siloxane Research Program, Reston.

EPA DCN 86010000009. 2000. In Vivo Dermal ADME of C14-D4 in Fischer 344 Rats (to clarify expired air values). Siloxane Research Program, Reston.

EPA DCN 86010000010. 2000. Determination of both Parent Octamethylcyclotetrasiloxane (D4) and 14C-D4 in Female Sprague Dawley and Fischer 344 Rats Following a Single Nose-Only Vapor Inhalation Exposure to 700 ppm D4. Siloxane Research Program, Reston.

EPA DCN 86950000153. 1995. Three-Month Repeated Dose Inhalation Toxicity Study with Octamethylcyclotetrasiloxane in Rats. Siloxane Research Program, Reston.

EPA DCN 86950000154. 1995. Three-Month Repeated Dose Inhalation Toxicity Study with Decamethylcyclopentasiloxane in Rats. Siloxane Research Program, Reston.

EPA DCN 86950000155. 1995. One-Month Repeated Dose Inhalation Toxicity Study with Octamethylcyclotetrasiloxane in Rats. Siloxane Research Program, Reston.

EPA DCN 86950000174. 1995. One-Month Repeated Dose Inhalation Toxicity Study with Decamethylcyclopentasiloxane in Rats. Siloxane Research Program, Reston.

EPA DCN 86960000398. 1996. An Inhalation Range-Finding Reproductive Toxicity Study of Octamethylcyclotetrasiloxane (D4) in Rats. Siloxane Research Program, Reston.

EPA DCN 86960000517. 1996. A Pilot Study for the Determination of 14C-Octamethylcyclotetrasiloxane (D4) Pharmacokinetics in Fischer 344 Rats Following a single Nose-Only Vapor Inhalation Exposure to 700 PPM 14C-D4. Siloxane Research Program, Reston.

EPA DCN 86960000593. 1996. In Vitro Percutaneous Absorption of 14C-D5 in Rat Skin. Siloxane Research Program, Reston.

EPA DCN 86970000006. 1996. An Inhalation Range-Finding Reproductive Toxicity Study of Decamethylcyclopentasiloxane (D5) in the Rat. Siloxane Research Program, Reston.

EPA DCN 86970000009. 1996. In Vivo Percutaneous Absorption of 14C-Decamethylcyclopentasiloxane (D5) in Rat Skin. Siloxane Research Program, Reston.

EPA DCN 86970000023. 1996. An Inhalation Range-Finding Reproductive Toxicity Study of Octamethylcyclotetrasiloxane (D4) in Rats. Siloxane Research Program, Reston.

EPA DCN 86970000024. 1996. Pharmacokinetics of 14C-Octamethylcyclotetrasiloxane (D4) in the Rat Following Single Nose-Only Vapor Inhalation Exposure. Siloxane Research Program, Reston.

EPA DCN 86970000385. 1996. A 28-Day Inhalation Toxicity and Splenic Antibody Formation Study of Decamethylcyclopentasiloxane (D5) in Rats. Siloxane Research Program, Reston.

EPA DCN 86970000723. 1996. Effects of Octamethylcyclotetrasiloxane on liver size and enzyme induction: A Pilot Feasibility Study. Siloxane Research Program, Reston.

EPA DCN 86970000724. 1997. An Acute Whole Body Inhalation Study of Hexamethyldisiloxane in Albino Rats. Siloxane Research Program, Reston.

EPA DCN 86970000725. 1997. Effects of D4 on Liver Enlargement and Enzyme Induction: A Pilot Feasibility Study II. Siloxane Research Program, Reston.

EPA DCN 86970000847. 1997. Female Rat Inhalation Reproductive Study of Octamethylcyclotetrasiloxane (D4). Siloxane Research Program, Reston.

EPA DCN 86970000875. 1997. Pharmacokinetics of 14C-Octamethylcyclotetrasiloxane in the Rat Following 14 Repeat Daily Nose-Only Vapor Inhalation Exposures to Unlabelled D4 and a Single (Day 15) Exposure to 14C-D4 at Two Dose Levels. Siloxane Research Program, Reston.

EPA DCN 86980000017. 1997. Clinical Studies on the Respiratory Effects of Octamethylcyclotetrasiloxane (D4): Mouthpiece and Nasal Exposures. Siloxane Research Program, Reston.

EPA DCN 86980000020. 1997. Effects of Decamethylcyclopentasiloxane on Hepatic Cytochrom P450 in the Female Fischer 344 Rat. Siloxane Research Program, Reston.

EPA DCN 86980000032. 1997. Non-Regulated Study: Identification of Major Metabolites of Octamethylcyclotetrasiloxane (D4) in Rat Urine. Siloxane Research Program, Reston.

EPA DCN 86980000037. 1997. A Pilot Study to Determine if Classical Inducing Agents Alter the Metabolic Profile of a Single Dose of 14C-Octamethylcyclotetrasiloxane (D4) in Rats. Siloxane Research Program, Reston.

EPA DCN 86980000040. 1997. A Subchronic Toxicological Evaluation and Splenic Antibody Forming Cell Response in Sheep Erthrocytes Following a 28-day whole body inhalation Exposure with D4 in the Rat. Siloxane Research Program, Reston.

EPA DCN 86980000041. 1997. One-Month Repeated Dose Inhalation Toxicity Study with Hexamethyldisiloxane in Rats. Siloxane Research Program, Reston.

EPA DCN 86980000048. 1997. Three-Month Repeated Dose Inhalation Toxicity Study with Hexamethyldisiloxane in Rats. Siloxane Research Program, Reston.

EPA DCN 86980000049. 1997. An Inhalation Range-Finding Reproductive Toxicity Study of Octamethylcyclotetrasiloxane (D4) in Male Rats. Siloxane Research Program, Reston.

EPA DCN 86980000061. 1997. An Inhalation Range-Finding Reproductive Toxicity Study of Octamethylcyclotetrasiloxane (D4) in Male Rats. Siloxane Research Program, Reston.

EPA DCN 86980000072. 1997. Immunological Evaluation of D4 Using 28-Day Exposure in Male and Female Rats. Siloxane Research Program, Reston.

EPA DCN 86980000153. 1998. An Inhalation Reproductive Toxicity Study of Octamethylcyclotetrasiloxane (D4) in Female Rats Using Multiple Exposure Regimems. Siloxane Research Program, Reston.

EPA DCN 86980000163. 1998. Absorption of C14-Octamethylcyclotetrasiloxane Using the Flow-Through Diffusion Cell System for In-vitro Dermal Absorption in Human Skin. Siloxane Research Program, Reston.

EPA DCN 86980000182. 1998. Three-Month Repeated Dose Whole Body Inhalation Toxicity Study with Hexamethyldisiloxane in Rats. Siloxane Research Program, Reston.

EPA DCN 86980000184. 1998. An Oral Gavage Study to Compare the Absorption Potential of 14C-Octamethylcyclotetrasiloxane (D4) in Fischer 344 Rats When Delivered in Various Carriers. Siloxane Research Program, Reston.

EPA DCN 86990000015. 1998. Clinical Studies on the Immune Effects of Gastrointestinal Exposure to Octamethylcyclotetrasiloxane (D4). Siloxane Research Program, Reston.

EPA DCN 86990000017. 1998. Evaluation of Octamethylcyclotetrasiloxane (D4) as an Inhibitor of Human Cytochrome P450 Enzymes. Siloxane Research Program, Reston.

EPA DCN 86990000029. 1999. Effects of Repeated Whole Body Inhalation Exposure to Octamethylcyclotetrasiloxane (D4) Vapors on Hepatic Microsomal CYP2B1/2 Induction in Female Fischer 344 Rats: A Dose-Response Study. Siloxane Research Program, Reston.

EPA DCN 86990000032. 1999. A Two-Generation Inhalation reproductive Toxicity and Developmental Neurotoxicity Study of Decamethylcyclopentasiloxane (D5) in Rats. Siloxane Research Program, Reston.

EPA DCN 86990000058. 1999. An Inhalation Reproductive Toxicity Study of Octamethylcyclotetrasiloxane (D4) in Female Rats Using Multiple and Single-Day Exposure Regimens. Siloxane Research Program, Reston.

EPA DCN 86990000059. 1999. Interim Risk Assessment of D4 Reproductive Effects. Siloxane Research Program, Reston.

EPA, August 2003. Siloxane D5 in Drycleaning Applications. Fact Sheet. EPA/744-F-03-004.

European Commission, Joint Research Centre (2000): International Uniform Chemical Information Database. IUCLID CD-ROM, Existing Chemicals – Year 2000 edition. http://ecb.jrc.it/IUCLID-Data-Sheet/556672.pdf

Fendinger, N.J., R.G. Lehmann & Mihaich. E.M. 1997. Polydimethylsiloxane. In: Chandra, H.G (Ed.). The handbook of environmental chemistry. Vol 3. part: Organosilicon Materials. Springer-Verlag, Berlin.

Hobson, J.F., Atkinson, R and Carter, W.P.L. 1997. Volatile methylsiloxanes. In: Chandra, H.G (Ed.). The handbook of environmental chemistry. Vol 3. part: Organosilicon Materials. Springer-Verlag, Berlin.

Huppmann, R., Lohoff, H.W. & Schröder, H. Fr. 1996. Cyclic siloxanes in the biological wastewater treatment process - determination, quantification and possibilities of elimination. Fresenius' J. Anal. Chem. 354: 66-71.

IARC, 1999. Surgical implants and other foreign bodies. Internationl Agency for Research on Cancer (IARC) – Summaries & Evaluation. Vol: 74

INCI. 2000. Inventory of ingredients used in cosmetic products, published in Section I of the Annex to Commission Decision 96/335/EC. 1st Update EU Inventory 09/06/2000. The International Nomenclature of Cosmetic Ingredients. http://europa.eu.int/comm/food/fs/sc/sccp/out123cm_en.pdf

IRG. 1998. Silicone gel breast implants. The report of the independent review group. http://www.silicone-review.gov.

Kala S.V., Lykissa, E.D., Neely M.W. & Lieberman M.W. 1998. Low Molecular Weight Silicones are Widely Distributed after a Single Subcutaneous Injection in Mice. Short Communication. American J of Pathology 152:645-649. http://womnhlth.home.mindspring.com/studies/american_j_of_pathology.htm

Kirk Othmer. 1997. Kirk Othmer Encyclopedia of Industrial Chemistry. 4th edition. Wiley Interscience.

Krogh, H. 1999. Problematiske stoffer i byggevarer. SBI-Meddelelse 122. Statens Byggeforskningsinstitut, Hørsholm.

Looney,R.J., Frampton, M.W., Byam, J., Kenaga,C., Speers, D.M., Cox, C., Mast, R.W., Klykken, P.C., Morrow, P.E., & Utell, M.J. 1998. Acute respiratory exposure of human volunteers to octamethylcyclotetrasiloxane (D4): absence of immunological effects. Toxicological Sciences 44: 214-220.

Mathisen, A., D. 2003: Telephone communication with Anne Dorthe Mathisen, SPT, the 2. of September 2003.

McKim, J.M., Jr., Wilga, P.C., Kolesar, G.B., Choudhuri, S., Madan, A., Dochterman, L.W., Breen,J.G., Parkinson, A., Mast, R.W. & Meeks, R.G. 1998. Evaluation of Octamethylcyclotetrasiloxane (D4) as an Inducer of Rat Hepatic Microsomal Cytochrome P450, UDP-glucuronyl transferase, and Epoxide Hydrolase: A 28-Day Inhalation Study. Toxicological Sciences 41: 29-41.

Meeks R. G. 1999. The Dow Corning Siloxane Research Program: An Overview and Update. Medical Device &Diagnostic Industry Magazine, May 1999 Column, http://www.devicelink.com/mddi/archive/99/05/007.html

Pedersen H. 2004. Kortlægningen af forekomsten af nogle potentielle eller mistænkte PBT/vPvB-stoffer i forbrugerprodukter. Praktikrapport, Roskilde Universitetscenter.

Poulsen, P., A. A. Jensen & L. Hoffmann. 2002. Kortlægning af kemiske stoffer i hårstylingsprodukter. Kortlægning no. 18/2002. Danish EPA, Copenhagen. http://www.mst.dk/kemi/02052600.htm

Sarangapani, R. , Teeeguarden, J., Andersen, M.E., Reitz, R.H.& Plotzke, K.P. 2003. Route-specific differences in distribution characteristics of octamethylcyclotetrasiloxane in rats: analysis using PBPK models. Toxicological Sciences 71: 41-52.

Statistics Denmark. 1998-2001. 'Varestatistik for Industrien' and 'Udenrigshandelen Fordelt på Varer og Lande' for 1998, 1999, 2000, 2001. Statistics Denmark, Copenhagen.

Thomas, D.E., (Centre Europeen des Silicones) 1999. Re : Swedish comments to the proposed classification and labelling of octamethylcyclotetrasiloxane (D4) (Y009; CAS no: 556-67-2). http://ecb.jrc.it/classlab/3798a8.doc

U.S. EPA. 2003. PBT Profiler. Office of Pollution Prevention and Toxics, U.S. Environmental Protection Agency. May 2003. http://www.pbtprofiler.net/default.asp

Ullmann. 2003. Ullmann's Encyclopedia of Industrial Chemistry. Release 2003, 7th Edition. Wiley Interscience.

Utell, M.J., Gelein, R., Yu, C.P., Kenaga, C., Torres, A. Chalupa, D., Gibb, F.R., Speer, D.M., Mast, R.W. & Morrow, P.E. 1998. Quantitative exposure of humans to octamethylcyclotetrasiloxane (D4) vapor. Toxicological Sciences 44: 206-213.

Varaprath, S., McMahon, J.M. & Plotzke, K.P. 2003. Metabolites of hexamethyldisiloxane and decamethylpentasiloxane in Fisher 344 rate urine - a comparison of a linear and a cyclic siloxane. Drug metabolism and disposition: The biological effect of chemicals 31:206-14.

Vergnes J.S., Jung, R., Thakur, A.K., Barfknecht, T.R. & Reynolds, V.L. 2000. Genetic Toxicity Evaluation of Octamethylcyclotetrasiloxane. Environmental and Molecular Mutagenesis 36:13-21.

Will, R; Schlag, S. & Yoneyama, M. 2003. Silicones. CEH Marketing Research Report, SRI International.