A Compilation of Safety Impact Information for Extractables Associated with Materials Used in Pharmaceutical Packaging, Delivery, Administration, and Manufacturing Systems

Dennis Jenke; Tage Carlson

doi:10.5731/pdajpst.2014.00995

References

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24.
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25.
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34.
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42.
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43.
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49.
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50.
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51.
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52.
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56.
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57.
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58.
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59.
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60.
RTECS. 3-Cyclohexene-1-carbonitrile. CAS Registry No. 100-45-8. RTECS No. GW2625000. June 1998.
61.
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62.
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64.
RTECS. Isocyanic acid, methylenedi-phenylene ester. CAS Registry No. 101-68-8. RTECS No. NQ9350000. August, 2009.
65.
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67.
RTECS. Acrylic acid, 2-ethylehexyl ester. CAS Registry No. 103-11-7. RTECS No. AT0855000. April 2012.
68.
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69.
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70.
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71.
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72.
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75.
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76.
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77.
RTECS. 2H-Azepin-2-one, hexahydro. CAS Registry No. 105-60-2. RTECS No. CM3675000. July 2011.
78.
RTECS. 3-Heptanone. CAS Registry No. 106-35-4. RTECS No. MJ5250000. August 2009.
79.
RTECS. p-Xylene. CAS Registry No. 106-42-3. RTECS No. ZE2625000. August 2009.
80.
Acrylonitrile (CAS Registry No. 107-13-1). Integrated Risk Information System, U.S. EPA. Last revised on July 30, 2003. http:/www.epa.gov/iris/subst/0206.htm.
81.
ICH Harmonized Tripartite Guideline, Impurities: Guideline for Residual Solvents Q3C (R5). Current Step 4 version dated 4 February 2011. Parent Guideline dated 17 July 1997.
82.
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83.
RTECS. Butyric acid. CAS Registry No. 107-92-6. RTECS No. ES5425000. July 2011.
84.
RTECS. 3,5-Xylenol. CAS Registry No. 108-68-9. RTECS No. ZE6475000. January 2010.
85.
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86.
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87.
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RTECS. Phenol. CAS Registry No. 108-95-2. RTECS No. SJ3325000. July 2010.
89.
Phenol (CAS Registry No. 108-95-2). Integrated Risk Information System, National Center for Environmental Assessment, U.S. EPA. Last updated September 30, 2002. http://www.epa.gov/iris/subst/0088.htm.
90.
RTECS. 3-Pyridinol. CAS Registry No. 109-00-2. RTECS No. UU7701400. May 2003.
91.
RTECS. Butyric acid, butyl ester. CAS Registry No. 109-21-7. RTECS No. ES8120000. February 2006.
92.
RTECS. Valeric acid. CAS Registry No. 109-52-4. RTECS No. YV6100000. February 2006.
93.
ICH Harmonized Tripartite Guideline, Impurities: Guideline for Residual Solvents Q3C. Current Step 4 version dated 17 July 1997.
94.
RTECS. Succinic acid. CAS Registry No. 110-15-6. RTECS No. WM4900000. January 2010.
95.
RTECS. Valeraldehyde. CAS Registry No. 110-62-3. RTECS No. YV3600000. August 2009.
96.
RTECS. 1,4-Butabediol. CAS Registry No. 110-63-4. RTECS No. EKo525000. July 2011.
97.
RTECS. Ethanol, 2-ethoxy. CAS Registry No. 110-80-5. RTECS No. KK8050000. August 2009.
98.
Pyridine (CAS Registry No. 110-86-1). Integrated Risk Information System, National Center for Environmental Assessment, U.S. EPA. Last updated June 1, 1989. http://www.epa.gov/iris/subst/0261.htm.
99.
RTECS. Piperidine. CAS Registry No. 110-89-4. RTECS No. TM3500000. March 2011.
100.
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101.
RTECS. 2,6,10,14,18,22-Tetracosahexane, 2,6,10,15,19,223-hexamethyl. CAS Registry No. 111-02-4. RTECS No. XB6010000. May 2009.
102.
RTECS. 2-Octanone. CAS Registry No. 111-13-7. RTECS No. RH1484000. February 2006.
103.
RTECS. Heptanoic acid. CAS Registry No. 111-14-8. RTECS No. MJ15750000. October 1997.
104.
RTECS. Sebacic acid. CAS Registry No. 111-20-6. RTECS No. VS0875000. February 2006.
105.
RTECS. Hexyl alcohol. CAS Registry No. 111-27-3. RTECS No. MQ4025000. July 2011.
106.
RTECS. Diethylene glycol. CAS Registry No. 111-46-6. RTECS No. ID5950000. July 2010.
107.
RTECS. Stearic acid, 2-hydroxyethyl ester. CAS Registry No. 111-60-4. RTECS No. WI4100000. August 2009.
108.
RTECS. Stearic acid, ethyl ester. CAS Registry No. 111-61-5. RTECS No. WI3600000. September 1997.
109.
RTECS. 9-Octadecenoic acid (Z)- ethyl ester. CAS Registry No. 111-62-6. RTECS No. RG3715000. January 1997.
110.
RTECS. Heptyl alcohol. CAS Registry No. 111-70-6. RTECS No. MK0350000. February 2008.
111.
RTECS. Ethanol, 2-butoxy. CAS Registry No. 111-76-2. RTECS No. KJ8575000. July 2011.
112.
RTECS. Octyl alcohol. CAS Registry No. 111-87-5. RTECS No. RH6550000. August 2009.
113.
RTECS. Ethanol, 2-(2-ethoxyethoxy). CAS Registry No. 111-90-0. RTECS No. KK8750000. May 2008.
114.
European Commission, Scientific Committee on Consumer Safety (SCCS). Opinion on diethylene glycol monoethyl ether. SCCS/1316/10. September 21, 2010.
115.
RTECS. Dibutyl amine. CAS Registry No. 111-92-2. RTECS No. HR7780000. May 2008.
116.
RTECS. Nonanoic acid. CAS Registry No. 112-05-0. RTECS No. RA6650000. August 2009.
117.
Hazardous Substance Data Bank (HSDB). 2-(2-ethoxyethoxy) ethyl acetate. CAS Registry No. 112-15-2. HSDB No. 5555. Dec. 18, 2009.
118.
RTECS. Triethylene glycol. CAS Registry No. 112-27-6. RTECS No. YE4550000. August 2008.
119.
RTECS. Ethanol, 2-(2-butoxyethoxy). CAS Registry No. 112-34-5. RTECS No. KJ9100000. February 2009.
120.
RTECS. Undecanoic acid. CAS Registry No. 112-37-8. RTECS No. YQ2275000. October 1997.
121.
HSDB. Methyl palmitate. CAS Registry No. 112-39-0. HSDB No. 5570. February 14, 2003.
122.
RTECS. 1-Dodecene. CAS Registry No. 112-41-4. RTECS No. JR5120000. October 2002.
123.
RTECS. Dodecyl alcohol. CAS Registry No. 112-53-8. RTECS No. JR5775000. August 2009.
124.
IUCLID Dataset. Dodecan-1-ol. CAS Registry No. 112-53-8. EINECS No. 203-982-0. European Commission—European Chemicals Bureau. February 18, 2000.
125.
RTECS. 1-Dodecanal. CAS Registry No. 112-54-9. RTECS No. JR9100000. October 1997.
126.
RTECS. Tetraethylene glycol. CAS Registry No. 112-60-7. RTECS No. XC2100000. August 2006.
127.
IUCLID Dataset. Methyl oleate. CAS Registry No. 112-62-9. EINECS No. 203-992-5. European Commission—European Chemicals Bureau. 18 Feb 2000.
128.
RTECS. 1-Tetradecanol. CAS Registry No. 112-72-1. RTECS No. XB8655000. April 2010.
129.
RTECS. 9-Octadecanoic acid, (Z)-. CAS Registry No. 112-80-1. RTECS No. RG2275000. April 2010.
130.
IUCLID Dataset. (Z)-docos-13-enamide. CAS Registry No. 112-84-5. EINECS No. 204-009-2. European Commission—European Chemicals Bureau. 18 Feb 2000.
131.
RTECS. 9-Octadecenenitrile, (Z)-. CAS Registry No. 112-91-4. RTECS No. RG2265000. January 2010.
132.
RTECS. 1-Octadecanol, (Z)-. CAS Registry No. 112-92-5. RTECS No. RG2010000. August 2009.
133.
RTECS. Phosphoric acid, triphenyl ester. CAS Registry No. 115-86-6. RTECS No. TC8400000. August 2009.
134.
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135.
RTECS. Phthalic acid, decyloctyl ester. CAS Registry No. 119-07-3. RTECS No. TI0550000. October 1997.
136.
IUCLID Dataset. Benzophenone. CAS Registry No. 119-61-9. EINECS No. 204-337-6. European Commission—European Chemicals Bureau. 18 Feb 2000.
137.
Opinion of the Scientific Panel on Food Additives, Flavorings, Processing Aids and Materials in Contact with Food (AFC) on the Request to a 13^th List of Substances for Food Contact Materials. EFSA J. 418/427: 1 of 25. Adopted on November 29, 2006.
138.
RTECS. Vanillic acid. CAS Registry No. 121-34-6. RTECS No. YW5300000. April 2010.
139.
RTECS. Isophthalic acid. CAS Registry No. 121-91-5. RTECS No. NT2007000. January 2010.
140.
RTECS. 2-propanol, 1,1',1”-nitrilotri-. CAS Registry No. 122-20-3. RTECS No. UB8750000. April 2010.
141.
HPV Challenge Program Test Plan for 1,1'-Iminodipropan-2-ol and 1,1',1”-Nitrilotripropan-2-ol. CAS Registry No. 110-97-4 and 122-20-3. Submitted for The Dow Chemical Company on December 2, 2004. U.S. HPV Tracking No. 201-15719.
142.
RTECS. Hexanal, 2-ethyl-. CAS Registry No. 123-05-7. RTECS No. MN7525000. February 2006.
143.
RTECS. Nonanoic acid, ethyl ester. CAS Registry No. 123-29-5. RTECS No. RA6845000. January 1997.
144.
RTECS. Azelaic acid. CAS Registry No. 123-99-9. RTECS No. CM1980000. November 2004.
145.
RTECS. Adipic acid. CAS Registry No. 124-04-9. RTECS No. AU8400000. January 2010.
146.
RTECS. Octanoic acid. CAS Registry No. 124-07-2. RTECS No. RH0175000. November 2008.
147.
IUCLID Dataset. Methyl myristate. CAS Registry No. 124-10-7. European Commission—European Chemicals Bureau. 18 Feb 2000. http://ecb.jrc.c.europa.eu/iuclid-datasheet/124107pdf.
148.
RTECS. 1-Octanal. CAS Registry No. 124-13-0. RTECS No. RG7780000. August 2008.
149.
RTECS. 1-Nonanal. CAS Registry No. 124-19-6. RTECS No. RA5700000. August 2008.
150.
Octadecanamide (CAS Registry No. 124-26-5). HPV Information System, Office of Pollution Prevention and Toxics. U.S. EPA. http://www.epa.cov/hpvis.
151.
U.S. Environmental Ptoection Agency Hazard Characterization Document. Screening-Level Hazard Characterization, Fatty Nitrogen Derived Amines Category. November 2006.
152.
RTECS. 1,3-Propanediol, 2,2-dimethyl-. CAS Registry No. 126-30-7. RTECS No. TY5775000. April 2010.
153.
RTECS. Phosphoric acid, tributyl ester. CAS Registry No. 126-73-8. RTECS No. TC7700000. April 2010.
154.
RTECS. 5-Decyne-4,7-diol, 2,4,7,9-tetramethyl-. CAS Registry No. 126-86-3. RTECS No. HE5581000. August 2009.
155.
RTECS. Phenyl sulfone. CAS Registry No. 127-63-9. RTECS No. SX2400000. March 2000.
156.
RTECS. p-Cresol, 2,6-di-tert-butyl-. CAS Registry No. 128-37-0. RTECS No. GO7875000. July 2010.
157.
National Institute of Occupational Safety and Health, U.S. Department of Health, Education and Welfare. Reports and Memoranda. DHHS #92-100. 1992.
158.
Organization for Economic Cooperation and Development Screening Information Dataset (OECD/SIDS): 2,6-di-tert-butyl-p-cresol (BHT). CAS Registry No. 128-37-0. SIDS Initial Assessment Report for SIDS Initial Assssment Meeting (SIAM) 14. Paris, France. 26–28 March 2002.
159.
RTECS. Phenol, 2,6-di-tert-butyl. CAS Registry No. 128-39-2. RTECS No. SK8265000. August 2009.
160.
RTECS. Phthalic acid, monobutyl ester. CAS Registry No. 131-70-4. RTECS No. TI0550000. October 1997.
161.
RTECS. Tetramethylbutylphenol. CAS Registry No. 140-66-9. RTECS No. SM9625000. October 2011.
162.
RTECS. Fumaric acid, bis(2-ethylhexyl) ester. CAS Registry No. 141-02-6. RTECS No. LT0525000. June 1998.
163.
National Industrial Chemicals Notifciation and Assessment Scheme. Full Public report. KG16470. File No. N/A/749. Section 9.3 (page 13 of 20). October 29, 2000.
164.
Decamethyltetrasiloxane. CAS Registry No. 141-62-8. Letter to Toxic Substance Control Act (TSCA) Section 8(a). Notification of Substantial Risk: Amendment to the Letter Submitted on August 27, 2009, Correction to CAS Number for Decamethyltetrasiloxane CAS Registry No. 141-62-8. Dow Corning Corporation, 2200 W. Salzburg Rd., P.O. Box 994, #CO3101, Midland, MI. September 1, 2009.
165.
ChemIDplus, 2011. Dodecamethylpentasiloxane on line record. CAS Registry No. 141-63-9. U.S. Library of Medicine. Available at http://chem.sis.nlm.nih.gov/chemidplus/.
166.
RTECS. Acetic acid, ethyl ester. CAS Registry No. 141-78-6. RTECS No. AH5425000. July 2011.
167.
RTECS. Hexanoic acid. CAS Registry No. 142-62-1. RTECS No. MO5250000. October 1997.
168.
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[1] 1.↵
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