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PART 3 MATERIAL SAFETY DATA SHEETS
DRAFT ENVIRONMENTAL IMPACT ASSESSMENT REPORT
PROPOSED EXPANSION PROJECT FOR MANUFACTURING OF SYNTHETIC ORGANIC CHEMICALS
(PHARMACEUTICAL BULK DRUGS & INTERMEDIATES) [CAPACITY: 287.77 TPM]
[SCHEDULE 5(f) - CATEGORY A]
SURVEY NO: 44/B, VILLAGE: NALDHARI SILUDI-VALIA ROAD, NEAR ANKLESHWAR,
TAL.: VALIA, DIST.: BHARUCH, STATE: GUJARAT
[TOR LETTER NO.: IA-J-11011/583/2017-IA-II(I) Dated 10/02/2018]
[STUDY PERIOD: MARCH 2017 – MAY 2017]
PREPARED BY:
(QCI-NABET ACCREDITED EIA CONSULTANT)
CERTIFICATE NO.: NABET/EIA/1619/SA 053 VALID UPTO 22/05/2019
3RD FLOOR, AKASHGANGA COMPLEX, B/S. SUVIDHA SHOPPING CENTRE, NR. PARIMAL UNDERPASS, PALDI, AHMEDABAD-380 007, GUJARAT
TELEFAX: (079) 2665 0878; E-MAIL: [email protected]
MAY, 2018
Doc. No.: EEC/A-188/16-17/EIA-21/Rev. 01
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Intas Pharmaceuticals Ltd., Valia-Bharuch Environmental Impact Assessment Report Proposed Expansion Project for Manufacturing of Synthetic Organic Chemicals
MSDS of Products & Raw Materials
SR. NO. NAME OF PRODUCTS & RAW MATERIALS PAGE NO.
PRODUCTS
P1. Dabigatran Etexilate Mesylate M1
P2. Lurasidone HCl M4
P3. Lacosamide M8
P4. Bendamustine HCl M10
P5. Trazodone HCl M14
P6. Gemcitabine HCl M16
P7. Capecitabine M21
P8. Erlotinib HCl M23
P9. Imatinib Mesylate Alpha M25
P10. Nilotinib M27
P11. Dasatinib M30
P12. Pazopanib HCl M33
P13. Sorafenib M36
RAW MATERIALS
1. (1R,2R)-Cyclohexane-1,2-dicarboxilic acid M39
2. [1,2,4]Triazolo[4,3-a]pyridin-3(2H)-one M43
3. 1-(3-Chlorophenyl)-piperazine M46
4. 1,1’-Carbonyldiimidazole M49
5. 10% Palladium Carbon M52
6. 2-((4-cyanophenyl) amino) Acetic Acid M55
7. Piperazine ethanol M58
8. 2,3-dimethyl-2H-indazol-6-amine hydrochloride M61
9. 2,4-dichloropyrimidine M67
10. 2-amino-N-(2-chloro-6-methylphenyl)thiazole-5-carboxamide M71
11. 2 chloroethanol M72
12. 3-(1-Piperazinyl)-1,2-benzisothiazole M75
13. 3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)aniline M79
14. 3-(dimethylamino)-1-(pyridin-3-yl) prop-2-en-1-one M83
15. 3-Chloro propanol M86
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Intas Pharmaceuticals Ltd., Valia-Bharuch Environmental Impact Assessment Report
Proposed Expansion Project for Manufacturing of Synthetic Organic Chemicals
MSDS of Products & Raw Materials
SR. NO. NAME OF PRODUCTS & RAW MATERIALS PAGE NO.
16. 3-Ethynyl benzamine M89
17. 4-(1(4-methylpiperaziynl) methyl) benzoic acid M92
18. 4,6-dichloro-2-methylpyrimidine M96
19. 4-chloro-3-(trifluoromethyl) phenyl isocyanate M99
20. 4-chloro-pyridine-2-carboxylic acid methyl amide hydrochloride M102
21. 4-Di methyl amino pyridine M105
22. 4-methyl benzene sulfonic acid monohydrate M108
23. 5-fluorocytosine M108
24. 5-amino-2-methylbenzenesulfonamide M110
25. 5 Deoxy compounds M114
26. Acetic acid M117
27. Acetic Anhydride M120
28. Acetone M123
29. Acetonitrile M126
30. Activated Charcoal M129
31. Aluminum carbonate M132
32. NH3 Gas M134
33. Ammonia solution M137
34. Ammonium carbonate M140
35. Ammonium format M142
36. Benzoyl Chloride M145
37. Benzylamine M148
38. Benzyl chloroformate M150
39. Calcium chloride dihydrate M154
40. Caustic Flakes M157
41. Cesium carbonate M160
42. Cyclohexane M162
43. Dibenzoyl lactum M165
44. Diethyl acetamido malonate M168
45. Diethyl ether M171
46. Dihydro-2H-pyran-2,6(3H)-dione M174
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Intas Pharmaceuticals Ltd., Valia-Bharuch Environmental Impact Assessment Report Proposed Expansion Project for Manufacturing of Synthetic Organic Chemicals
MSDS of Products & Raw Materials
SR. NO. NAME OF PRODUCTS & RAW MATERIALS PAGE NO.
47. Dimethyl carbonate M177
48. Dimethyl Formamide M180
49. Dimethyl Sulphate M183
50. Dimethyl Sulphoxide M186
51. Ditert-butyl dicarbonate M189
52. D-serine M192
53. Ethanol M194
54. Ethyl 3-(3-amino-4-(methylamino)-N-(pyridin-2-yl)benzamido) propanoate M198
55. Ethyl 3-guanidino-4-methylbenzoate nitrate [NIL KSM-I] M201
56. Ethyl- 4,5-bis-(2-methoxyethoxy)-2-amino benzoate hydrochloride M203
57. Ethyl 5-(4-(4-(5-cyano-1H-indol-3-yl)butyl)piperazin-1-yl) benzofuran-2-carboxylate hydrochloride M205
58. Ethyl acetate M206
59. Exo-cis-5-norbornene-2,3-dicaroxylic anhydride M209
60. Formamide M213
61. Fumaric Acid M216
62. Hexa Methyl Di Silazane (HMDS) M218
63. Hexane M221
64. Hydrochloric Acid M224
65. Hydrogen Gas M228
66. Hyflow M232
67. Isobutyl chloroformate M236
68. Isopropyl acetate M239
69. Isopropyl Alcohol M242
70. Iso Propyl Alcohol- HCL (IPA HCL) M245
71. Maleic acid M247
72. Methane sulfonic acid M250
73. Methane sulfonyl chloride M254
74. Methanol M256
75. Methyl isobutyl ketone M259
76. Methyl tertiary butyl ether M262
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Intas Pharmaceuticals Ltd., Valia-Bharuch Environmental Impact Assessment Report
Proposed Expansion Project for Manufacturing of Synthetic Organic Chemicals
MSDS of Products & Raw Materials
SR. NO. NAME OF PRODUCTS & RAW MATERIALS PAGE NO.
77. Methylene chloride M264
78. N-(2-methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidine amine M267
79. N,N-Diisopropylethylamine M270
80. N N Dimethyl Formamide M273
81. N1-Methyl-4-nitrobenzene-1,2-diamine M276
82. N4 Acetyl cytosine M279
83. n-butanol M281
84. n-Heptane M286
85. n-Hexane M289
86. n-hexyl chloroformate M292
87. N-Methyl morpholine M295
88. n-Phenyl Chloroformate M298
89. Oxalyl chloride M300
90. Palladium Carbon M302
91. Paracetamol M306
92. Phenethyl bromide M308
93. Potassium carbonate M311
94. Potassium hydroxide M314
95. Pyridine M317
96. Silica gel M320
97. Sodium bicarbonate M322
98. Sodium bicarbonate M325
99. Sodium borohydride M327
100. Sodium carbonate M330
101. Sodium chloride M333
102. Sodium hydroxide M336
103. Sodium iodide M339
104. Sodium metabisulphite anhydrous M342
105. Sodium sulphate M345
106. Sodium tertiary butoxide solution M347
107. Stannic chloride M351
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Intas Pharmaceuticals Ltd., Valia-Bharuch Environmental Impact Assessment Report Proposed Expansion Project for Manufacturing of Synthetic Organic Chemicals
MSDS of Products & Raw Materials
SR. NO. NAME OF PRODUCTS & RAW MATERIALS PAGE NO.
108. Sulfuric acid M353
109. Tetra Butyl Ammonium Bromide M357
110. Tetrahydrofuran M360
111. Thionyl chloride M363
112. Toluene M367
113. Trimethyl Silyl Chloride M370
114. Triethyl amine M372
115. Trimethyl Silyl Triflate M375
116. Urea M379
117. Vitride M382
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MSDS
PRODUCTS
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CAT# 25260Date Updated: Feb. 05, 2016
MATERIAL SAFETY DATA SHEETwww.capotchem.com [email protected]
SECTION 1: Identification of the substance/mixture and of the company/undertaking
1.1 Product identifiers
Product name : Dabigatran etexilate mesylateProduct Number : 25260CAS-No. : 872728-81-9
1.2 Relevant identified uses of the substance or mixture and uses advised againstIdentified uses : Laboratory chemicals, Manufacture of substances
1.3 Details of the supplier of the safety data sheet
Company : Capot Chemical Co.,Ltd.Joinhands Science Park, No.4028 Nanhuan RoadHangzhou, Zhejiang, China 310053
Telephone : 0086-571-85586718Fax : 0086-571-85864795E-mail address : [email protected]
1.4 Emergency telephone numberEmergency Phone # : 0086-571-85586718
SECTION 2: Hazards identification
2.1 Classification of the substance or mixtureClassification according to Regulation (EC) No 1272/2008
For the full text of the H-Statements mentioned in this Section, see Section 16.Classification according to EU Directives 67/548/EEC or 1999/45/EC
For the full text of the R-phrases mentioned in this Section, see Section 16.
2.2 Label elements Labelling according Regulation (EC) No 1272/2008
Hazard statement(s)Precautionary statement(s)Supplemental Hazard Statements None
2.3 Other hazards
None
SECTION 3: Composition/information on ingredients
3.1 Substances
Synonyms : N-[[2-[[[4-[[[(Hexyloxy)carbonyl]aMino]iMinoMethyl]phenyl]aMino]Methyl]-1-Methyl-1H-benziMidazol-5-yFormula : C35H45N7O8SMolecular Weight : 723.84 g/molCAS-No. : 872728-81-9EC-No. : Not available
Hazardous ingredients according to Regulation (EC) No 1272/2008
Component Classification Concentration
Dabigatran etexilate mesylate
CAS-No. 872728-81-9EC-No. Not available
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carbon dioxide,nitrogen oxides (NOx),Hydrogen chloride gas5.3 Advice for firefighters
Wear self contained breathing apparatus for fire fighting if necessary.5.4 Further information
no data available
SECTION 6: Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures
Use personal protective equipment. Avoid dust formation. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Avoid breathing dust.For personal protection see section 8.
6.2 Environmental precautions Do not let product enter drains.
6.3 Methods and materials for containment and cleaning up Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed containers for disposal.
6.4 Reference to other sections For disposal see section 13.
SECTION 7: Handling and storage
7.1 Precautions for safe handling
Avoid contact with skin and eyes. Avoid formation of dust and aerosols.Provide appropriate exhaust ventilation at places where dust is formed.For precautions see section 2.2.
7.2 Conditions for safe storage, including any incompatibilities
Store in cool place. Keep container tightly closed in a dry and well-ventilated place.Store under inert gas. Hygroscopic.
7.3 Specific end use(s)Apart from the uses mentioned in section 1.2 no other specific uses are stipulated
SECTION 8: Exposure controls/personal protection
8.1 Control parameters Components with workplace control parameters
8.2 Exposure controls Appropriate engineering controls
Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday.Personal protective equipment
Eye/face protectionSafety glasses with side-shields conforming to EN166 Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).Skin protection
Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product.
q ( g g ) pDispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands.The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.Body Protection
impervious clothing, The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.Respiratory protection
For nuisance exposures use type P95 (US) or type P1 (EU EN 143) particle respirator.For higher level protection use type OV/AG/P99 (US) or type ABEK-P2 (EU EN 143) respirator cartridges.Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).Control of environmental exposureDo not let product enter drains.
SECTION 9: Physical and chemical properties
9.1 Information on basic physical and chemical properties
Appearance Not availablepH Not availableMelting point Not availableBoiling point Not availableAutoignition Temperature Not availableFlash Point Not availableExplosion Limits: Lower Not availableExplosion Limits: Upper Not availableDecomposition Temperature Not availableSolubility in water Not availableSpecific Gravity/Density Not available
9.2 Other safety information no data available
SECTION 10: Stability and reactivity
10.1 Reactivityno data available
10.2 Chemical stability Stable under recommended storage conditions.
10.3 Possibility of hazardous reactions no data available
10.4 Conditions to avoid Avoid moisture.
10.5 Incompatible materials acids, Acid chlorides, Acid anhydrides, Oxidizing agents
10.6 Hazardous decomposition products
Other decomposition products - no data availableIn the event of fire: see section 5
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SECTION 11: Toxicological information
11.1 Information on toxicological effects Acute toxicityno data availableSkin corrosion/irritationno data availableSerious eye damage/eye irritationno data availableRespiratory or skin sensitisationProlonged or repeated exposure may cause allergic reactions in certain sensitive individuals. The preceding data, or interpretation of data, was determined using Quantitative Structure Activity Relationship (QSAR) modeling.Germ cell mutagenicityno data availableCarcinogenicity
IARC : No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC.Reproductive toxicityno data availableSpecific target organ toxicity - single exposureInhalation - May cause respiratory irritation.Specific target organ toxicity - repeated exposureno data availableAspiration hazardno data availableAdditional InformationRTECS: Not availableTo the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated.
SECTION 12: Ecological information
12.1 Toxicity no data available
12.2 Persistence and degradability no data available
12.3 Bioaccumulative potential no data available
12.4 Mobility in soil no data available
12.5 Results of PBT and vPvB assessment PBT/vPvB assessment not available as chemical safety assessment not required/not conducted
12.6 Other adverse effects no data available
SECTION 13: Disposal considerations
13.1 Waste treatment methods
ProductBurn in a chemical incinerator equipped with an afterburner and scrubber but exert extra care in igniting as this material is highly flammable. Offer surplus and nonrecyclable solutions to a licensed disposal company. Contact a licensed professional waste disposal service to dispose of this material.Contaminated packagingDispose of as unused product.
SECTION 14: Transport informationDOT (US) Not dangerous goodsIMDGNot dangerous goodsIATANot dangerous goods
SECTION 15: Regulatory informationThis safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006.
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture no data available
15.2 Chemical Safety Assessment For this product a chemical safety assessment was not carried out
SECTION 16: Other informationFull text of H-Statements referred to under sections 2 and 3.
Full text of R-phrases referred to under sections 2 and 3.
Further information
The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. Capot Chemical Co., Ltd. shall not be held liable for any damage resulting from handling or from contact with the above product. See reverse side of invoice or packing slip for additional terms and conditions of sale.Copyright © 2012-2016 Capot Chemical Co., Ltd. License granted to make unlimited paper copies for internal use only. If you have any comments and suggestions, please contact us by [email protected].
Dabigatran etexilate mesylate SAFETY DATA SHEET
CAPOT CHEMICAL COMPANY LIMITEDJoinhands Science Park, No.4028 Nanhuan Road, Hangzhou, Zhejiang, P.R.China, 310053
Tel:+86-571-85586718 Fax:+86-571-85864795 [email protected] www.capotchem.comCopyright © 2012-2017 Capot Chemical Co., Ltd.
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Cerilliant - L-035 Page 1 of 9
SAFETY DATA SHEET Version 5.1
Revision Date 11/26/2014 Print Date 10/13/2016
1. PRODUCT AND COMPANY IDENTIFICATION 1.1 Product identifiers
Product name : Lurasidone-D8 HCl
Product Number : L-035 Brand : Cerilliant Index-No. : 608-001-00-3
1.2 Relevant identified uses of the substance or mixture and uses advised against Identified uses : Laboratory chemicals, Manufacture of substances
1.3 Details of the supplier of the safety data sheet Company : Sigma-Aldrich
3050 Spruce Street SAINT LOUIS MO 63103 USA
Telephone : +1 800-325-5832 Fax : +1 800-325-5052
1.4 Emergency telephone number Emergency Phone # : +1-703-527-3887 (CHEMTREC)
2. HAZARDS IDENTIFICATION 2.1 Classification of the substance or mixture
GHS Classification in accordance with 29 CFR 1910 (OSHA HCS) Flammable liquids (Category 2), H225 Acute toxicity, Oral (Category 4), H302 Acute toxicity, Inhalation (Category 4), H332 Acute toxicity, Dermal (Category 4), H312 Eye irritation (Category 2A), H319
For the full text of the H-Statements mentioned in this Section, see Section 16.
2.2 GHS Label elements, including precautionary statements Pictogram
Signal word Danger Hazard statement(s) H225 Highly flammable liquid and vapour. H302 + H312 + H332 Harmful if swallowed, in contact with skin or if inhaled H319 Causes serious eye irritation. Precautionary statement(s) P210 Keep away from heat/sparks/open flames/hot surfaces. - No smoking. P233 Keep container tightly closed. P240 Ground/bond container and receiving equipment. P241 Use explosion-proof electrical/ ventilating/ lighting/ equipment. P242 Use only non-sparking tools. P243 Take precautionary measures against static discharge.
Cerilliant - L-035 Page 2 of 9
P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray. P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P271 Use only outdoors or in a well-ventilated area. P280 Wear protective gloves/ eye protection/ face protection. P301 + P312 + P330 IF SWALLOWED: Call a POISON CENTER or doctor/ physician if you
feel unwell. Rinse mouth. P303 + P361 + P353 IF ON SKIN (or hair): Remove/ Take off immediately all contaminated
clothing. Rinse skin with water/ shower. P304 + P340 + P312 IF INHALED: Remove victim to fresh air and keep at rest in a position
comfortable for breathing. Call a POISON CENTER or doctor/ physician if you feel unwell.
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337 + P313 If eye irritation persists: Get medical advice/ attention. P363 Wash contaminated clothing before reuse. P370 + P378 In case of fire: Use dry sand, dry chemical or alcohol-resistant foam for
extinction. P403 + P235 Store in a well-ventilated place. Keep cool. P501 Dispose of contents/ container to an approved waste disposal plant.
2.3 Hazards not otherwise classified (HNOC) or not covered by GHS - none 3. COMPOSITION/INFORMATION ON INGREDIENTS 3.1 Substances
Molecular weight : 41.05 g/mol EC-No. : 200-835-2 Index-No. : 608-001-00-3 Hazardous components Component Classification Concentration
Acetonitrile Flam. Liq. 2; Acute Tox. 4; Eye
Irrit. 2A; H225, H302 + H312 + H332, H319
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Cerilliant - L-035 Page 3 of 9
5. FIREFIGHTING MEASURES 5.1 Extinguishing media
Suitable extinguishing media Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
5.2 Special hazards arising from the substance or mixture No data available
5.3 Advice for firefighters Wear self-contained breathing apparatus for firefighting if necessary.
5.4 Further information Use water spray to cool unopened containers.
6. ACCIDENTAL RELEASE MEASURES 6.1 Personal precautions, protective equipment and emergency procedures
Use personal protective equipment. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Remove all sources of ignition. Evacuate personnel to safe areas. Beware of vapours accumulating to form explosive concentrations. Vapours can accumulate in low areas. For personal protection see section 8.
6.2 Environmental precautions Prevent further leakage or spillage if safe to do so. Do not let product enter drains.
6.3 Methods and materials for containment and cleaning up Contain spillage, and then collect with an electrically protected vacuum cleaner or by wet-brushing and place in container for disposal according to local regulations (see section 13).
6.4 Reference to other sections For disposal see section 13.
7. HANDLING AND STORAGE 7.1 Precautions for safe handling
Avoid contact with skin and eyes. Avoid inhalation of vapour or mist. Use explosion-proof equipment.Keep away from sources of ignition - No smoking.Take measures to prevent the build up of electrostatic charge. For precautions see section 2.2.
7.2 Conditions for safe storage, including any incompatibilities Keep container tightly closed in a dry and well-ventilated place. Containers which are opened must be carefully resealed and kept upright to prevent leakage.
Recommended storage temperature -20 °C Storage class (TRGS 510): Flammable liquids
7.3 Specific end use(s) Apart from the uses mentioned in section 1.2 no other specific uses are stipulated
8. EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1 Control parameters
Components with workplace control parameters Component CAS-No. Value Control
parameters Basis
Acetonitrile 75-05-8 TWA 20.000000 ppm
USA. ACGIH Threshold Limit Values (TLV)
Remarks Lower Respiratory Tract irritation Not classifiable as a human carcinogen Danger of cutaneous absorption
Cerilliant - L-035 Page 4 of 9
TWA 20.000000 ppm 34.000000 mg/m3
USA. NIOSH Recommended Exposure Limits
Forms cyanide in the body. TWA 40.000000 ppm
70.000000 mg/m3
USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants
The value in mg/m3 is approximate.
8.2 Exposure controls Appropriate engineering controls Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday.
Personal protective equipment Eye/face protection Face shield and safety glasses Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).
Skin protection Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands. Body Protection Complete suit protecting against chemicals, Flame retardant antistatic protective clothing., The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.
Respiratory protection Where risk assessment shows air-purifying respirators are appropriate use a full-face respirator with multi-purpose combination (US) or type ABEK (EN 14387) respirator cartridges as a backup to engineering controls. If the respirator is the sole means of protection, use a full-face supplied air respirator. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).
Control of environmental exposure Prevent further leakage or spillage if safe to do so. Do not let product enter drains.
9. PHYSICAL AND CHEMICAL PROPERTIES 9.1 Information on basic physical and chemical properties
a) Appearance Form: clear, liquid Colour: colourless
b) Odour ether-like c) Odour Threshold No data available d) pH No data available e) Melting point/freezing
point Melting point/range: -47.99 °C (-54.38 °F)
f) Initial boiling point and boiling range
81.0 - 82.0 °C (177.8 - 179.6 °F) at 1,013.3 hPa (760.0 mmHg)
g) Flash point 2.0 °C (35.6 °F) - closed cup h) Evaporation rate 5.8 i) Flammability (solid, gas) No data available j) Upper/lower
flammability or explosive limits
Upper explosion limit: 16 %(V) Lower explosion limit: 3 %(V)
k) Vapour pressure 73.18 hPa (54.89 mmHg) at 15 °C (59 °F) 121.44 hPa (91.09 mmHg) at 25 °C (77 °F)
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Cerilliant - L-035 Page 5 of 9
413.23 hPa (309.95 mmHg) at 55 °C (131 °F) 98.64 hPa (73.99 mmHg) at 20 °C (68 °F)
l) Vapour density 1.42 - (Air = 1.0) m) Relative density 0.78 g/cm3 at 20 °C (68 °F) n) Water solubility completely soluble o) Partition coefficient: n-
octanol/water log Pow: -0.539 at 25 °C (77 °F)
p) Auto-ignition temperature
524.0 °C (975.2 °F)
q) Decomposition temperature
No data available
r) Viscosity No data available s) Explosive properties Not explosive t) Oxidizing properties The substance or mixture is not classified as oxidizing.
9.2 Other safety information Surface tension 29.0 mN/m at 20.0 °C (68.0 °F)
Relative vapour density 1.42 - (Air = 1.0) 10. STABILITY AND REACTIVITY 10.1 Reactivity
No data available
10.2 Chemical stability Stable under recommended storage conditions.
10.3 Possibility of hazardous reactions Vapours may form explosive mixture with air.
10.4 Conditions to avoid Heat, flames and sparks.
10.5 Incompatible materials acids, Bases, Oxidizing agents, Reducing agents, Alkali metals
10.6 Hazardous decomposition products Other decomposition products - No data available In the event of fire: see section 5
11. TOXICOLOGICAL INFORMATION 11.1 Information on toxicological effects
Acute toxicity No data available
LD50 Oral - Rat - male - 1,320 - 6,690 mg/kg Inhalation: No data available
LC50 Inhalation - Mouse - 4 h - 3587 ppm (OECD Test Guideline 403) LC50 Inhalation - Rat - 4 h - 26.8 mg/l Dermal: No data available
LD50 Dermal - Rabbit - male and female - > 2,000 mg/kg (OECD Test Guideline 402) No data available
Cerilliant - L-035 Page 6 of 9
No data available
Skin corrosion/irritation No data available
Skin - Rabbit Result: No skin irritation (OECD Test Guideline 404) Serious eye damage/eye irritation No data available
Eyes - Rabbit Result: Irritating to eyes. (OECD Test Guideline 405) Respiratory or skin sensitisation No data available
Buehler Test - Guinea pig Did not cause sensitisation on laboratory animals. (OECD Test Guideline 406) Germ cell mutagenicity No data available Hamster ovary Result: negative Mutation in mammalian somatic cells. Ames test S. typhimurium Result: Not mutagenic in Ames Test. Hamster ovary Result: Equivocal evidence. Sister chromatid exchange Mutagenicity (micronucleus test) Mouse Result: Positive results were obtained in some in vivo tests. Carcinogenicity No evidence of carcinogenicity in animal studies.
IARC: No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC.
NTP: No component of this product present at levels greater than or equal to 0.1% is identified as a known or anticipated carcinogen by NTP.
OSHA: No component of this product present at levels greater than or equal to 0.1% is identified as a carcinogen or potential carcinogen by OSHA.
Reproductive toxicity No data available No data available No data available
Animal testing did not show any effects on fertility.
Specific target organ toxicity - single exposure No data available
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Cerilliant - L-035 Page 7 of 9
Specific target organ toxicity - repeated exposure No data available
Aspiration hazard No data available
Additional Information RTECS: Not available To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated. Treat as cyanide poisoning., Always have on hand a cyanide first-aid kit, together with proper instructions., The onset of symptoms is generally delayed pending conversion to cyanide., Nausea, Vomiting, Diarrhoea, Headache, Dizziness, Rash, Cyanosis, excitement, depression, Drowsiness, impaired judgment, Lack of coordination, stupor, death
12. ECOLOGICAL INFORMATION 12.1 Toxicity
No data available Toxicity to fish LC50 - Pimephales promelas (fathead minnow) - 1,640.00 mg/l - 96 h NOEC - Oryzias latipes - 102 mg/l - 21 d Toxicity to daphnia and other aquatic invertebrates
EC50 - Daphnia magna (Water flea) - 3,600 mg/l - 48 h (OECD Test Guideline 202)
NOEC - Daphnia magna (Water flea) - 160 mg/l - 21 d
12.2 Persistence and degradability No data available
12.3 Bioaccumulative potential No data available
12.4 Mobility in soil No data available
12.5 Results of PBT and vPvB assessment PBT/vPvB assessment not available as chemical safety assessment not required/not conducted
12.6 Other adverse effects No data available Avoid release to the environment. Stability in water
Remarks: Hydrolyses slowly.
13. DISPOSAL CONSIDERATIONS 13.1 Waste treatment methods
Product Burn in a chemical incinerator equipped with an afterburner and scrubber but exert extra care in igniting as this material is highly flammable. Offer surplus and non-recyclable solutions to a licensed disposal company. Contact a licensed professional waste disposal service to dispose of this material.
Contaminated packaging Dispose of as unused product.
14. TRANSPORT INFORMATION
DOT (US) UN number: 1648 Class: 3 Packing group: II Proper shipping name: Acetonitrile, solution Reportable Quantity (RQ):
Cerilliant - L-035 Page 8 of 9
Poison Inhalation Hazard: No IMDG UN number: 1648 Class: 3 Packing group: II EMS-No: F-E, S-D Proper shipping name: ACETONITRILE, SOLUTION IATA UN number: 1648 Class: 3 Packing group: II Proper shipping name: Acetonitrile, solution
15. REGULATORY INFORMATION
SARA 302 Components No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
SARA 313 Components The following components are subject to reporting levels established by SARA Title III, Section 313: Acetonitrile
CAS-No. 75-05-8
Revision Date 2007-07-01
SARA 311/312 Hazards Fire Hazard, Acute Health Hazard
Massachusetts Right To Know Components Acetonitrile
CAS-No. 75-05-8
Revision Date 2007-07-01
Pennsylvania Right To Know Components Acetonitrile
CAS-No. 75-05-8
Revision Date 2007-07-01
New Jersey Right To Know Components Acetonitrile
CAS-No. 75-05-8
Revision Date 2007-07-01
California Prop. 65 Components This product does not contain any chemicals known to State of California to cause cancer, birth defects, or any other reproductive harm.
16. OTHER INFORMATION
Full text of H-Statements referred to under sections 2 and 3. Acute Tox. Acute toxicity Eye Irrit. Eye irritation Flam. Liq. Flammable liquids H225 Highly flammable liquid and vapour. H302 Harmful if swallowed. H302 + H312 + H332
Harmful if swallowed, in contact with skin or if inhaled
H312 Harmful in contact with skin. H319 Causes serious eye irritation. H332 Harmful if inhaled.
HMIS Rating Health hazard: 2 Chronic Health Hazard: Flammability: 3 Physical Hazard 0
NFPA Rating Health hazard: 2 Fire Hazard: 3
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Cerilliant - L-035 Page 9 of 9
Reactivity Hazard: 0
Further information Copyright 2014 Sigma-Aldrich Co. LLC. License granted to make unlimited paper copies for internal use only. The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. Sigma-Aldrich Corporation and its Affiliates shall not be held liable for any damage resulting from handling or from contact with the above product. See www.sigma-aldrich.com and/or the reverse side of invoice or packing slip for additional terms and conditions of sale.
Preparation Information Sigma-Aldrich Corporation Product Safety – Americas Region 1-800-521-8956 Version: 5.1 Revision Date: 11/26/2014 Print Date: 10/13/2016
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1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKINGProduct Identifier
Material Name: Bendamustine for Injection (Hospira, Inc.)
Trade Name: Not establishedChemical Family: Cytotoxic and Antineoplastic
Relevant Identified Uses of the Substance or Mixture and Uses Advised AgainstIntended Use: Pharmaceutical product for the treatment of cancer
Details of the Supplier of the Safety Data Sheet
2. HAZARDS IDENTIFICATION
Classification of the Substance or MixtureGHS - Classification
Acute Oral Toxicity: Category 3Germ Cell Mutagenicity: Category 2Reproductive Toxicity: Category 2Carcinogenicity: Category 2
US OSHA Specific - ClassificationPhysical Hazard: Combustible Dust
Label ElementsSignal Word: DangerHazard Statements: H301 - Toxic if swallowed
H341 - Suspected of causing genetic defectsH361fd - Suspected of damaging fertility. Suspected of damaging the unborn child.H351 - Suspected of causing cancerMay form combustible dust concentrations in air
_______________________________________________________________________________________________________PZ02748
Revision date: 07-Nov-2016
Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300
Emergency telephone number:International CHEMTREC (24 hours): +1-703-527-3887
Version: 1.1
Contact E-Mail: [email protected]
SAFETY DATA SHEET
Page 1 of 8
Hospira, A Pfizer Company275 North Field DriveLake Forest, Illinois 600451-800-879-3477
Hospira UK LimitedHorizonHoney LaneHurleyMaidenhead, SL6 6RJUnited Kingdom
SAFETY DATA SHEET
_______________________________________________________________________________________________________
Precautionary Statements: P201 - Obtain special instructions before useP202 - Do not handle until all safety precautions have been read and understoodP264 - Wash hands thoroughly after handlingP270 - Do not eat, drink or smoke when using this productP301+ P310 - IF SWALLOWED: Immediately call a POISON CENTRE or doctor/physicianP308 + P313 - IF exposed or concerned: Get medical attention/adviceP330 - Rinse mouthP405 - Store locked upP501 - Dispose of contents/container in accordance with all local and national regulations
Other Hazards An Occupational Exposure Value has been established for one or more of the ingredients (seeSection 8).
Note: This document has been prepared in accordance with standards for workplace safety, whichrequires the inclusion of all known hazards of the product or its ingredients regardless of thepotential risk. The precautionary statements and warning included may not apply in all cases.Your needs may vary depending upon the potential for exposure in your workplace.
3. COMPOSITION / INFORMATION ON INGREDIENTS
HazardousIngredient CAS Number EU
EINECS/ELINCSList
GHS Classification %
Bendamustine hydrochloridemonohydrate
1374784-02-7 Not Listed Acute Tox.3 (H301)Muta.2(H341)
Repr.2(H361fd)Carc.2(H351)
5-10
Ingredient CAS Number EUEINECS/ELINCS
List
GHS Classification %
Mannitol 69-65-8 200-711-8 Not Listed *Water for Injection 7732-18-5 231-791-2 Not Listed *
Additional Information: * ProprietaryIngredient(s) indicated as hazardous have been assessed under standards for workplacesafety. In accordance with 29 CFR 1910.1200, the exact percentage composition of thismixture has been withheld as a trade secret.
For the full text of the CLP/GHS abbreviations mentioned in this Section, see Section 16
4. FIRST AID MEASURES
Description of First Aid Measures
_______________________________________________________________________________________________________PZ02748
Material Name: Bendamustine for Injection (Hospira, Inc.)Version: 1.1Page 2 of 8
Revision date: 07-Nov-2016
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SAFETY DATA SHEET
_______________________________________________________________________________________________________
4. FIRST AID MEASURESEye Contact: Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention
immediately.
Skin Contact: Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seekmedical attention.
Ingestion: Never give anything by mouth to an unconscious person. Wash out mouth with water. Do notinduce vomiting unless directed by medical personnel. Seek medical attention immediately.
Inhalation: Remove to fresh air and keep patient at rest. Seek medical attention immediately.
Most Important Symptoms and Effects, Both Acute and DelayedSymptoms and Effects ofExposure:
For information on potential signs and symptoms of exposure, See Section 2 - HazardsIdentification and/or Section 11 - Toxicological Information.
Medical ConditionsAggravated by Exposure:
None known
Indication of the Immediate Medical Attention and Special Treatment NeededNotes to Physician: None
5. FIRE FIGHTING MEASURES
Extinguishing Media: Extinguish fires with CO2, extinguishing powder, foam, or water.
Special Hazards Arising from the Substance or MixtureHazardous CombustionProducts:
Formation of toxic gases is possible during heating or fire.
Fire / Explosion Hazards: Fine particles (such as dust and mists) may fuel fires/explosions.
Advice for Fire-FightersDuring all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus.
6. ACCIDENTAL RELEASE MEASURES
Personal Precautions, Protective Equipment and Emergency ProceduresPersonnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure.
Environmental PrecautionsPlace waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release.
Methods and Material for Containment and Cleaning UpMeasures for Cleaning /Collecting:
Contain the source of spill if it is safe to do so. Collect spilled material by a method thatcontrols dust generation. A damp cloth or a filtered vacuum should be used to clean spills ofdry solids. Clean spill area thoroughly.
Additional Consideration forLarge Spills:
Non-essential personnel should be evacuated from affected area. Report emergencysituations immediately. Clean up operations should only be undertaken by trained personnel.
7. HANDLING AND STORAGE
Precautions for Safe Handling
_______________________________________________________________________________________________________PZ02748
Version: 1.1Page 3 of 8
Revision date: 07-Nov-2016Material Name: Bendamustine for Injection (Hospira, Inc.)
SAFETY DATA SHEET
_______________________________________________________________________________________________________
7. HANDLING AND STORAGERestrict access to work area. Avoid open handling. Ground and bond all bulk transfer equipment. Minimize dust generation.Use process containment, local exhaust ventilation or perform work under fume hood/fume cupboard. Avoid inhalation andcontact with skin, eyes, and clothing. When handling, use appropriate personal protective equipment (see Section 8). Washhands and any exposed skin after removal of PPE. Releases to the environment should be avoided. Review and implementappropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure orenvironmental releases. Potential points of process emissions of this material to the atmosphere should be controlled with dustcollectors, HEPA filtration systems or other equivalent controls.
Conditions for Safe Storage, Including any IncompatibilitiesStorage Conditions: Store as directed by product packaging.
Specific end use(s): Pharmaceutical drug product Antineoplastic
8. EXPOSURE CONTROLS / PERSONAL PROTECTIONControl Parameters
The purpose of the Occupational Exposure Band (OEB) classification system is to separate substances into different Hazard categorieswhen the available data are sufficient to do so, but inadequate to establish an Occupational Exposure Limit (OEL). The OEB given isbased upon an analysis of all currently available data; as such, this value may be subject to revision when new information becomesavailable.
Exposure ControlsEngineering Controls: Engineering controls should be used as the primary means to control exposures. General
room ventilation is adequate unless the process generates dust, mist or fumes. Keep airbornecontamination levels below the exposure limits listed above in this section.
Personal ProtectiveEquipment:
Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE). Contact your safety and health professional or safety equipmentsupplier for assistance in selecting the correct protective clothing/equipment based on anassessment of the workplace conditions, other chemicals used or present in the workplace andspecific operational processes.
Hands: Impervious disposable gloves (e.g. Nitrile, etc.) (double recommended) if skin contact with drugproduct is possible and for bulk processing operations. (Protective gloves must meet thestandards in accordance with EN374, ASTM F1001 or international equivalent.)
Eyes: Wear safety glasses or goggles if eye contact is possible. (Eye protection must meet thestandards in accordance with EN166, ANSI Z87.1 or international equivalent.)
Skin: Impervious disposable protective clothing is recommended if skin contact with drug product ispossible and for bulk processing operations. (Protective clothing must meet the standards inaccordance with EN13982, ANSI 103 or international equivalent.)
Respiratory protection: Under normal conditions of use, if the applicable Occupational Exposure Band (OEB) isexceeded, wear an appropriate respirator with a protection factor sufficient to control exposuresto below the OEB (e.g. particulate respirator with a half mask, P3 filter). (Respirators mustmeet the standards in accordance with EN140, EN143, ASTM F2704-10 or internationalequivalent.)
_______________________________________________________________________________________________________PZ02748
Pfizer Occupational ExposureBand (OEB):
OEB 4 (control exposure to the range of 1ug/m3 to
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SAFETY DATA SHEET
_______________________________________________________________________________________________________
9. PHYSICAL AND CHEMICAL PROPERTIES
Solvent Solubility: No data availableWater Solubility: No data availablepH: No data available.Melting/Freezing Point (°C): No data availableBoiling Point (°C): No data available.Partition Coefficient: (Method, pH, Endpoint, Value)
Decomposition Temperature (°C): No data available.
Evaporation Rate (Gram/s): No data availableVapor Pressure (kPa): No data availableVapor Density (g/ml): No data availableRelative Density: No data availableViscosity: No data available
Flammablity:Autoignition Temperature (Solid) (°C): No data availableFlammability (Solids): No data availableFlash Point (Liquid) (°C): No data availableUpper Explosive Limits (Liquid) (% by Vol.): No data availableLower Explosive Limits (Liquid) (% by Vol.): No data available
10. STABILITY AND REACTIVITY
Reactivity: No data availableChemical Stability: Stable under normal conditions of use.Possibility of Hazardous Reactions
Oxidizing Properties: No data availableConditions to Avoid: Fine particles (such as dust and mists) may fuel fires/explosions.Incompatible Materials: As a precautionary measure, keep away from strong oxidizersHazardous DecompositionProducts:
No data available
11. TOXICOLOGICAL INFORMATION
Information on Toxicological Effects
_______________________________________________________________________________________________________PZ02748
No data available.
Bendamustine hydrochloride
Version: 1.1
No data available
Odor Threshold: No data available.
Page 5 of 8
Molecular Formula: Mixture
Bendamustine hydrochloride monohydrateNo data available
Molecular Weight: Mixture
MannitolNo data available
Physical State: Lyophilized powder
Water for Injection
Revision date: 07-Nov-2016
No data available
Color: White to off-white
Bendamustine
Material Name: Bendamustine for Injection (Hospira, Inc.)
No data available
Odor:
SAFETY DATA SHEET
_______________________________________________________________________________________________________
11. TOXICOLOGICAL INFORMATIONKnown Clinical Effects: Based on clinical trials in humans, possible adverse effects following exposure to this
compound may include: fever, nausea, vomiting, fatigue, malaise, weakness, dry mouth,sleepiness (somnolence), cough, constipation, headache, immunosuppression, low plateletcount, and inflammation of the mouth (stomatitis).
Acute Toxicity: (Species, Route, End Point, Dose)
Genetic Toxicity: (Study Type, Cell Type/Organism, Result)
Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))
Carcinogen Status: Not listed as a carcinogen by IARC, NTP or US OSHA.
12. ECOLOGICAL INFORMATION
Environmental Overview: Environmental properties have not been investigated.
Toxicity: No data available
Persistence and Degradability: No data available
Bio-accumulative Potential: No data available
Mobility in Soil: No data available
_______________________________________________________________________________________________________PZ02748
Material Name: Bendamustine for Injection (Hospira, Inc.)
In Vitro Sister Chromatid Exchange Not specified Positive
Bendamustine hydrochloride
Version: 1.1
Bendamustine hydrochloride
Rat Oral LD 50 200 - 300 mg/kg
4 Day(s) Mouse Intraperitoneal 12.5 mg/kg/day LOAEL Tumors
Mannitol
Page 6 of 8
4 Day(s) Mouse Oral 62.5 mg/kg/day LOAEL Tumors, Lungs
Rat Oral LD 50 13500 mg/kg
Bendamustine hydrochloride
Revision date: 07-Nov-2016
Bacterial Mutagenicity (Ames) Salmonella , E. coli Positive
Mouse Oral LD 50 22 g/kg
In Vivo Micronucleus Rat Bone Marrow Positive
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SAFETY DATA SHEET
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13. DISPOSAL CONSIDERATIONS
Waste Treatment Methods: Dispose of waste in accordance with all applicable laws and regulations. Member Statespecific and Community specific provisions must be considered. Considering the relevantknown environmental and human health hazards of the material, review and implementappropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure and environmental release. It is recommended that waste minimizationbe practiced. The best available technology should be utilized to prevent environmentalreleases. This may include destructive techniques for waste and wastewater.
14. TRANSPORT INFORMATIONThe following refers to all modes of transportation unless specified below.
Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.
15. REGULATORY INFORMATION
Safety, Health and Environmental Regulations/Legislation Specific for the Substance or Mixture
_______________________________________________________________________________________________________PZ02748
Present
Not Listed
Australia (AICS): Present
Version: 1.1
REACH - Annex IV - Exemptions from theobligations of Register:
Present
California Proposition 65 Not Listed
EU EINECS/ELINCS List 200-711-8
Page 7 of 8
Water for InjectionCERCLA/SARA 313 Emission reporting Not Listed
EU EINECS/ELINCS List Not Listed
California Proposition 65 Not Listed
Revision date: 07-Nov-2016
Inventory - United States TSCA - Sect. 8(b) Present
Mannitol
Australia (AICS): Present
Bendamustine hydrochloride monohydrate
REACH - Annex IV - Exemptions from theobligations of Register:
Present
CERCLA/SARA 313 Emission reporting
EU EINECS/ELINCS List 231-791-2
Not Listed
Material Name: Bendamustine for Injection (Hospira, Inc.)
California Proposition 65 Not Listed
CERCLA/SARA 313 Emission reporting
Inventory - United States TSCA - Sect. 8(b)
SAFETY DATA SHEET
_______________________________________________________________________________________________________
16. OTHER INFORMATION
Text of CLP/GHS Classification abbreviations mentioned in Section 3
Acute toxicity, oral-Cat.3; H301 - Toxic if swallowedGerm cell mutagenicity-Cat.2; H341 - Suspected of causing genetic defectsReproductive toxicity-Cat.2; H361fd - Suspected of damaging fertility. Suspected of damaging the unborn child.Carcinogenicity-Cat.2; H351 - Suspected of causing cancer
Data Sources: Publicly available toxicity information. Commercial vendor MSDS.
Reasons for Revision: Updated Section 2 - Hazard Identification. Updated Section 1 - Identification of theSubstance/Preparation and the Company/Undertaking. Updated Section 8 - Exposure Controls/ Personal Protection. Updated Section 7 - Handling and Storage.
Revision date: 07-Nov-2016
Prepared by:Product Stewardship Hazard Communication
Pfizer Global Environment, Health, and Safety Operations
Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, itis without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no knowninformation at this time.
End of Safety Data Sheet
_______________________________________________________________________________________________________PZ02748
Revision date: 07-Nov-2016Material Name: Bendamustine for Injection (Hospira, Inc.)
Version: 1.1Page 8 of 8
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Material Safety Data SheetTrazodone hydrochloride MSDS
Section 1: Chemical Product and Company Identification
Product Name: Trazodone hydrochloride
Catalog Codes: SLT1585
CAS#: 25332-39-2
RTECS: XZ5650000
TSCA: TSCA 8(b) inventory: No products were found.
CI#: Not available.
Synonym: 2-[3-[4-(3-Chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-alpha]pyridin-3(2H)-one monohydrochloride
Chemical Name: Not available.
Chemical Formula: C19H22ClN5O.HCl
Contact Information:
Sciencelab.com, Inc.14025 Smith Rd.Houston, Texas 77396
US Sales: 1-800-901-7247International Sales: 1-281-441-4400
Order Online: ScienceLab.com
CHEMTREC (24HR Emergency Telephone), call:1-800-424-9300
International CHEMTREC, call: 1-703-527-3887
For non-emergency assistance, call: 1-281-441-4400
Section 2: Composition and Information on Ingredients
Composition:
Name CAS # % by Weight
Trazodone hydrochloride 25332-39-2 100
Toxicological Data on Ingredients: Trazodone hydrochloride: ORAL (LD50): Acute: 690 mg/kg [Rat]. 584 mg/kg [Mouse].
Section 3: Hazards Identification
Potential Acute Health Effects:Very hazardous in case of skin contact (irritant). Hazardous in case of eye contact (irritant), of ingestion, of inhalation (lungirritant). Slightly hazardous in case of skin contact (permeator).
Potential Chronic Health Effects:CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available.DEVELOPMENTAL TOXICITY: Not available. Repeated or prolonged exposure is not known to aggravate medical condition.
Section 4: First Aid Measures
Eye Contact:
p. 2
Check for and remove any contact lenses. Immediately flush eyes with running water for at least 15 minutes, keeping eyelidsopen. Cold water may be used. Do not use an eye ointment. Seek medical attention.
Skin Contact:After contact with skin, wash immediately with plenty of water. Gently and thoroughly wash the contaminated skin with runningwater and non-abrasive soap. Be particularly careful to clean folds, crevices, creases and groin. Cold water may be used.Cover the irritated skin with an emollient. If irritation persists, seek medical attention. Wash contaminated clothing beforereusing.
Serious Skin Contact:Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek immediate medicalattention.
Inhalation: Allow the victim to rest in a well ventilated area. Seek immediate medical attention.
Serious Inhalation: Not available.
Ingestion:Do not induce vomiting. Examine the lips and mouth to ascertain whether the tissues are damaged, a possible indication thatthe toxic material was ingested; the absence of such signs, however, is not conclusive. Loosen tight clothing such as a collar,tie, belt or waistband. If the victim is not breathing, perform mouth-to-mouth resuscitation. Seek immediate medical attention.
Serious Ingestion: Not available.
Section 5: Fire and Explosion Data
Flammability of the Product: May be combustible at high temperature.
Auto-Ignition Temperature: Not available.
Flash Points: Not available.
Flammable Limits: Not available.
Products of Combustion: These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...), halogenatedcompounds.
Fire Hazards in Presence of Various Substances: Not available.
Explosion Hazards in Presence of Various Substances:Risks of explosion of the product in presence of mechanical impact: Not available. Risks of explosion of the product inpresence of static discharge: Not available.
Fire Fighting Media and Instructions:SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray, fog or foam. Do not use water jet.
Special Remarks on Fire Hazards: Not available.
Special Remarks on Explosion Hazards: Not available.
Section 6: Accidental Release Measures
Small Spill:Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water onthe contaminated surface and dispose of according to local and regional authority requirements.
Large Spill:Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on thecontaminated surface and allow to evacuate through the sanitary system.
Section 7: Handling and Storage
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p. 3
Precautions:Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate the residue under afume hood. Ground all equipment containing material. Do not ingest. Do not breathe dust. Wear suitable protective clothing Incase of insufficient ventilation, wear suitable respiratory equipment If ingested, seek medical advice immediately and show thecontainer or the label. Avoid contact with skin and eyes
Storage:Keep container dry. Keep in a cool place. Ground all equipment containing material. Keep container tightly closed. Keep in acool, well-ventilated place. Combustible materials should be stored away from extreme heat and away from strong oxidizingagents.
Section 8: Exposure Controls/Personal Protection
Engineering Controls:Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommendedexposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminantsbelow the exposure limit.
Personal Protection:Splash goggles. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.
Personal Protection in Case of a Large Spill:Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoidinhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling thisproduct.
Exposure Limits: Not available.
Section 9: Physical and Chemical Properties
Physical state and appearance: Solid. (Solid crystalline powder.)
Odor: Not available.
Taste: Not available.
Molecular Weight: 408.33 g/mole
Color: White. Off-white.
pH (1% soln/water): Not available.
Boiling Point: Not available.
Melting Point: 231°C (447.8°F)
Critical Temperature: Not available.
Specific Gravity: Not available.
Vapor Pressure: Not applicable.
Vapor Density: Not available.
Volatility: Not available.
Odor Threshold: Not available.
Water/Oil Dist. Coeff.: Not available.
Ionicity (in Water): Not available.
Dispersion Properties: See solubility in water.
p. 4
Solubility: Partially soluble in cold water.
Section 10: Stability and Reactivity Data
Stability: The product is stable.
Instability Temperature: Not available.
Conditions of Instability: Not available.
Incompatibility with various substances: Not available.
Corrosivity: Non-corrosive in presence of glass.
Special Remarks on Reactivity: Not available.
Special Remarks on Corrosivity: Not available.
Polymerization: No.
Section 11: Toxicological Information
Routes of Entry: Eye contact. Inhalation. Ingestion.
Toxicity to Animals: Acute oral toxicity (LD50): 584 mg/kg [Mouse].
Chronic Effects on Humans: Not available.
Other Toxic Effects on Humans:Very hazardous in case of skin contact (irritant). Hazardous in case of ingestion, of inhalation (lung irritant). Slightly hazardousin case of skin contact (permeator).
Special Remarks on Toxicity to Animals: Not available.
Special Remarks on Chronic Effects on Humans: Not available.
Special Remarks on other Toxic Effects on Humans: Not available.
Section 12: Ecological Information
Ecotoxicity: Not available.
BOD5 and COD: Not available.
Products of Biodegradation:Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.
Toxicity of the Products of Biodegradation: The products of degradation are more toxic.
Special Remarks on the Products of Biodegradation: Not available.
Section 13: Disposal Considerations
Waste Disposal:
Section 14: Transport Information
DOT Classification: Not a DOT controlled material (United States).
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p. 5
Identification: Not applicable.
Special Provisions for Transport: Not applicable.
Section 15: Other Regulatory Information
Federal and State Regulations: TSCA 8(b) inventory: No products were found.
Other Regulations:OSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200). EINECS: This product is on theEuropean Inventory of Existing Commercial Chemical Substances.
Other Classifications:
WHMIS (Canada): CLASS D-2B: Material causing other toxic effects (TOXIC).
DSCL (EEC):R22- Harmful if swallowed. R36/37/38- Irritating to eyes, respiratory system and skin.
HMIS (U.S.A.):
Health Hazard: 2
Fire Hazard: 1
Reactivity: 0
Personal Protection: E
National Fire Protection Association (U.S.A.):
Health: 2
Flammability: 1
Reactivity: 0
Specific hazard:
Protective Equipment:Gloves. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Wear appropriate respiratorwhen ventilation is inadequate. Splash goggles.
Section 16: Other Information
References: Not available.
Other Special Considerations: Not available.
Created: 10/10/2005 12:07 AM
Last Updated: 05/21/2013 12:00 PM
The information above is believed to be accurate and represents the best information currently available to us. However, wemake no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assumeno liability resulting from its use. Users should make their own investigations to determine the suitability of the information fortheir particular purposes. In no event shall ScienceLab.com be liable for any claims, losses, or damages of any third party or forlost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if ScienceLab.comhas been advised of the possibility of such damages.
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Material Name: Gemcitabine Hydrochloride for InjectionTrade Name: Not applicableChemical Family: MixtureIntended Use: Pharmaceutical product used as Antineoplastic
2. HAZARDS IDENTIFICATION
Appearance: White to off-white Lyophilized powderSignal Word: DANGER
Statement of Hazard: May be harmful if swallowed.Causes eye irritation.Causes skin irritation.May cause genetic defects.May damage fertility or the unborn child.
Additional Hazard Information:Short Term: May be absorbed through the skin and cause systemic effects.Long Term: Repeat-dose studies in animals have shown a potential to cause adverse effects on
reproductive system and blood and blood forming organs. Animal studies have shown apotential to cause adverse effects on the fetus.
Known Clinical Effects: Adverse effects associated with therapeutic use include decreased blood cell count, nausea,vomiting, swelling, skin rash, liver enzyme changes, flu-like syndrome
EU Indication of danger: HarmfulIrritantToxic to Reproduction: Category 2Mutagenic: Category 2
EU Hazard Symbols:
EU Risk Phrases:
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MATERIAL SAFETY DATA SHEET
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Pfizer IncPfizer Pharmaceuticals Group 235 East 42nd StreetNew York, New York 100171-212-573-2222
Pfizer LtdRamsgate RoadSandwich, KentCT13 9NJUnited Kingdom+00 44 (0)1304 616161
Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300
Revision date: 20-Jun-2011
Emergency telephone number:ChemSafe (24 hours): +44 (0)208 762 8322
Contact E-Mail: [email protected]
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_______________________________________________________________________________________________________
2. HAZARDS IDENTIFICATIONR22 - Harmful if swallowed.R46 - May cause heritable genetic damage.R60 - May impair fertility.R61 - May cause harm to the unborn child.R36/38 - Irritating to eyes and skin.
Australian Hazard Classification(NOHSC):
Hazardous Substance. Non-Dangerous Goods.
Note: This document has been prepared in accordance with standards for workplace safety, whichrequire the inclusion of all known hazards of the active substance or its intermediatesregardless of the potential risk. The precautionary statements and warnings included may notapply in all cases. Your needs may vary depending upon the potential for exposure in yourworkplace.
3. COMPOSITION/INFORMATION ON INGREDIENTS
HazardousIngredient CAS Number EU EINECS/ELINCS List EU Classification %
Gemcitabine hydrochloride 122111-03-9 Not Listed Xn,R22; Xi, R36/38;Repr. Cat. 2,R60-
61; Mut. Cat. 2,R46
51-53
Sodium hydroxide 1310-73-2 215-185-5 C;R35 **
Hydrochloric Acid 7647-01-0 231-595-7 C;R35T;R23
**
Ingredient CAS Number EU EINECS/ELINCS List EU Classification %Mannitol 69-65-8 200-711-8 Not Listed *Sodium acetate 127-09-3 204-823-8 Not Listed *
Additional Information: * Proprietary** to adjust pHIngredient(s) indicated as hazardous have been assessed under standards for workplacesafety.
For the full text of the R phrases mentioned in this Section, see Section 16
4. FIRST AID MEASURES
Eye Contact: Flush with water while holding eyelids open for at least 15 minutes. Seek medical attentionimmediately.
Skin Contact: Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seekmedical attention.
Ingestion: Never give anything by mouth to an unconscious person. Wash out mouth with water. Do notinduce vomiting unless directed by medical personnel. Seek medical attention immediately.
Inhalation: Remove to fresh air and keep patient at rest. Seek medical attention immediately.
Symptoms and Effects of Exposure: For information on potential signs and symptoms of exposure, See Section 2 - HazardsIdentification and/or Section 11 - Toxicological Information.
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5. FIRE FIGHTING MEASURES
Extinguishing Media: Use carbon dioxide, dry chemical, or water spray.
Hazardous Combustion Products: Formation of toxic gases is possible during heating or fire.
Fire Fighting Procedures: During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus.
Fire / Explosion Hazards: Fine particles (such as dust and mists) may fuel fires/explosions.
6. ACCIDENTAL RELEASE MEASURES
Health and Safety Precautions: Personnel involved in clean-up should wear appropriate personal protective equipment (seeSection 8). Minimize exposure.
Measures for Cleaning / Collecting: Contain the source of spill if it is safe to do so. Collect spill with absorbent material. Clean spillarea thoroughly.
Measures for EnvironmentalProtections:
Place waste in an appropriately labeled, sealed container for disposal. Care should be taken toavoid environmental release.
Additional Consideration for LargeSpills:
Non-essential personnel should be evacuated from affected area. Report emergencysituations immediately. Clean up operations should only be undertaken by trained personnel.
7. HANDLING AND STORAGE
General Handling: Restrict access to work area. Avoid breathing vapor or mist. Avoid contact with eyes, skin andclothing. When handling, use appropriate personal protective equipment (see Section 8).Wash thoroughly after handling. Releases to the environment should be avoided. Review andimplement appropriate technical and procedural waste water and waste disposal measures toprevent occupational exposure or environmental releases. Potential points of processemissions of this material to the atmosphere should be controlled with dust collectors, HEPAfiltration systems or other equivalent controls.
Storage Conditions: Store as directed by product packaging.
8. EXPOSURE CONTROLS / PERSONAL PROTECTIONRefer to available public information for specific member state Occupational Exposure Limits.
_______________________________________________________________________________________________________PZ01520
Czech Republic OEL - TWA Listed
Material Name: Gemcitabine Hydrochloride for Injection
Estonia OEL - TWA Listed
ACGIH Ceiling Threshold Limit:
France OEL - TWA Listed
2 mg/m3
Greece OEL - TWA Listed
Version: 1.0
Hungary OEL - TWA Listed
Australia PEAK 2 mg/m3
Japan - OELs - Ceilings 2 mg/m3
Page 3 of 9
Latvia OEL - TWA ListedOSHA - Final PELS - TWAs: 2 mg/m³
Austria OEL - MAKs Listed
Poland OEL - TWA Listed
Revision date: 20-Jun-2011
Bulgaria OEL - TWA Listed
Sodium hydroxide
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8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Engineering Controls: Engineering controls should be used as the primary means to control exposures. Generalroom ventilation is adequate unless the process generates dust, mist or fumes. Keep airbornecontamination levels below the exposure limits listed above in this section.
Environmental Exposure Controls: Refer to specific Member State legislation for requirements under Community environmentallegislation.
Personal Protective Equipment: Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE).
Hands: Impervious, disposable gloves (double suggested) are recommended if skin contact with drugproduct is possible and for bulk processing operations.
Eyes: Wear safety glasses or goggles if eye contact is possible.Skin: Impervious disposable protective clothing is recommended if skin contact with drug product is
possible and for bulk processing operations.Respiratory protection: If airborne exposures are within or exceed the Occupational Exposure Band (OEB) range, wear
an appropriate respirator with a protection factor sufficient to control exposures to the bottom ofthe OEB range.
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Italy OEL - TWA Listed
Slovenia OEL - TWA
Japan - OELs - Ceilings 5 ppm7.5 mg/m3
Austria OEL - MAKs Listed
Latvia OEL - TWA Listed
Listed
Lithuania OEL - TWA ListedLuxembourg OEL - TWA Listed
Belgium OEL - TWA Listed
Malta OEL - TWA ListedNetherlands OEL - TWA Listed
Bulgaria OEL - TWA
Poland OEL - TWA Listed
Listed
Romania OEL - TWA Listed
Sweden OEL - TWAs Listed
Slovenia OEL - TWA Listed
Cyprus OEL - TWA Listed
Spain OEL - TWA Listed
Gemcitabine hydrochloride
Revision date: 20-Jun-2011
Pfizer Occupational ExposureBand (OEB):
OEB 5 - Skin (control exposure to ) indicates that the toxicity endpoint being tested was not achievableat the highest dose used in the test.
Irritation / Sensitization: (Study Type, Species, Severity)
Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)
_______________________________________________________________________________________________________PZ01520
Molecular Weight: Mixture
Rabbit Dermal LD50 > 1000 mg/kg
Page 5 of 9
Mannitol
Sodium hydroxide
Rat Oral LD 50 13500 mg/kg
Eye Irritation Rabbit Severe
Physical State: Lyophilized powder
Skin Irritation Rabbit Severe
Mouse Oral LD 50 22 g/kg
Gemcitabine hydrochloride
Revision date: 20-Jun-2011
Skin Irritation Rabbit Irritant
Sodium hydroxide
Eye Irritation Rabbit Irritant
Color: White to off-white
Mouse IP LD50 40 mg/kg
Gemcitabine hydrochloride
Material Name: Gemcitabine Hydrochloride for Injection
6 Month(s) Dog No route specified 0.04 mg/kg/day NOAEL Blood, Erythroid cells, Lymphoid tissue, Immune system
Gemcitabine hydrochloride
6 Month(s) Mouse No route specified 0.006 mg/kg/day LOAEL Erythroid cells, Male reproductive system, Spleen
Molecular Formula: Mixture
Mouse Oral Minimum Lethal Dose 333 mg/kg
Version: 1.0
Rat Oral LD50 > 500 mg/kg
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11. TOXICOLOGICAL INFORMATION
Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))
Genetic Toxicity: (Study Type, Cell Type/Organism, Result)
Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.
12. ECOLOGICAL INFORMATIONEnvironmental Overview: Environmental properties have not been thoroughly investigated. Releases to the environment
should be avoided.Partition Coefficient(Calculated - Log Pow/Log Kow):
1.27 (gemcitabine)
Aquatic Toxicity: (Species, Method, End Point, Duration, Result)
Bacterial Inhibition: (Inoculum, Method, End Point, Result)
13. DISPOSAL CONSIDERATIONS
Waste Treatment Methods: Dispose of waste in accordance with all applicable laws and regulations. Member Statespecific and Community specific provisions must be considered. Considering the relevantknown environmental and human health hazards of the material, review and implementappropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure and environmental release. It is recommended that waste minimizationbe practiced. The best available technology should be utilized to prevent environmentalreleases. This may include destructive techniques for waste and wastewater.
_______________________________________________________________________________________________________PZ01520
Gemcitabine hydrochloride
In Vitro Chromosome Aberration Negative
Version: 1.0
Oncorhynchus mykiss (Rainbow Trout) LC50 96 Hours > 1043 mg/L
Page 6 of 9
Pimephales promelas (Fathead Minnow) LC50 96 Hours > 1014 mg/LDaphnia Magna (Water Flea) EC50 48 Hours > 999 mg/L
Gemcitabine hydrochloride
Selenastrum capricornutum (Green Alga) EC50 5.4 mg/L
Gemcitabine hydrochloride
Hydrochloric Acid
Gemcitabine hydrochloride
In Vivo Micronucleus Mouse Positive
Nostoc sp. (Freshwater Cyanobacteria) MIC 800 mg/L
IARC: Group 3
Aspergillus niger (Fungus) MIC > 1000 mg/L
Revision date: 20-Jun-2011
In Vitro Mammalian Cell Mutagenicity Mouse Lymphoma Positive
Reproductive & Fertility Mouse Intraperitoneal 0.05 mg/kg/day NOAEL Fertility
Bacterial Mutagenicity (Ames) Salmonella , E. coli Negative
Material Name: Gemcitabine Hydrochloride for Injection
In Vivo Sister Chromatid Exchange Negative
Fertility and Embryonic Development Mouse Intravenous 0.25 mg/kg/day LOAEL Fetotoxicity, Embryotoxicity, MaternalToxicity
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
14. TRANSPORT INFORMATIONThe following refers to all modes of transportation unless specified below.
Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.
15. REGULATORY INFORMATION
EU Symbol: TEU Indication of danger: Harmful
IrritantToxic to Reproduction: Category 2Mutagenic: Category 2
EU Risk Phrases:R22 - Harmful if swallowed.R46 - May cause heritable genetic damage.R60 - May impair fertility.R61 - May cause harm to the unborn child.R36/38 - Irritating to eyes and skin.
EU Safety Phrases:S22 - Do not breathe dust.S53 - Avoid exposure - obtain special instructions before use.S36/37 - Wear suitable protective clothing and gloves.
OSHA Label:DANGERMay be harmful if swallowed.Causes eye irritation.Causes skin irritation.May cause genetic defects.May damage fertility or the unborn child.
Canada - WHMIS: ClassificationsWHMIS hazard class:Class D, Division 2, Subdivision A
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Sodium hydroxide
Revision date: 20-Jun-2011Material Name: Gemcitabine Hydrochloride for Injection
Version: 1.0Page 7 of 9
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15. REGULATORY INFORMATION
16. OTHER INFORMATION
Text of R phrases mentioned in Section 3
R22 - Harmful if swallowed.R23 - Toxic by inhalation.R35 - Causes severe burns.R46 - May cause heritable genetic damage.R60 - May impair fertility.R61 - May cause harm to the unborn child.R36/38 - Irritating to eyes and skin.
Data Sources: Publicly available toxicity information. Safety data sheets for individual ingredients.
Prepared by: Product Stewardship Hazard CommunicationsPfizer Global Environment, Health, and Safety Operations
_______________________________________________________________________________________________________PZ01520
Standard for the Uniform Schedulingfor Drugs and Poisons:
EU EINECS/ELINCS List 231-595-7
Schedule 5Schedule 6
Version: 1.0
Mannitol
Page 8 of 9
Inventory - United States TSCA - Sect. 8(b) Listed
EU EINECS/ELINCS List 215-185-5
Australia (AICS): ListedREACH - Annex IV - Exemptions from theobligations of Register:
Present
CERCLA/SARA Hazardous Substancesand their Reportable Quantities:
Hydrochloric Acid
EU EINECS/ELINCS List 200-711-8
1000 lb final RQ454 kg final RQ
Sodium acetateInventory - United States TSCA - Sect. 8(b) Listed
CERCLA/SARA 313 Emission reporting 1.0% de minimis concentration acid aerosols including mists,vapors, gas, fog, and other airborne forms of any particle size
Australia (AICS): ListedEU EINECS/ELINCS List 204-823-8
CERCLA/SARA Hazardous Substancesand their Reportable Quantities:
2270 kg final RQ5000 lb final RQ
Inventory - United States TSCA - Sect. 8(b) Listed
CERCLA/SARA - Section 302 Extremely HazardousTPQs
500 lb TPQ gas only
Revision date: 20-Jun-2011
CERCLA/SARA - Section 302 Extremely HazardousSubstances EPCRA RQs
5000 lb
Inventory - United States TSCA - Sect. 8(b) Listed
Australia (AICS): Listed
Australia (AICS): Listed
Material Name: Gemcitabine Hydrochloride for Injection
Standard for the Uniform Schedulingfor Drugs and Poisons:
Schedule 5Schedule 6
MATERIAL SAFETY DATA SHEET
_______________________________________________________________________________________________________
Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, itis without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no knowninformation at this time.
End of Safety Data Sheet
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Revision date: 20-Jun-2011
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