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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

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

Intas Pharmaceuticals Ltd., Valia-Bharuch Environmental Impact Assessment Report

Proposed Expansion Project for Manufacturing of Synthetic Organic Chemicals



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




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

Intas Pharmaceuticals Ltd., Valia-Bharuch Environmental Impact Assessment Report

Proposed Expansion Project for Manufacturing of Synthetic Organic Chemicals



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




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

MSDS

PRODUCTS

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

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

M-2

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.

M-3

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.


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


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


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)

M-5


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


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

M-6


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):


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


Pennsylvania Right To Know Components Acetonitrile

CAS-No. 75-05-8


New Jersey Right To Know Components Acetonitrile

CAS-No. 75-05-8


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

M-7


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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M-9

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


M-10

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

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


No data available

Color: White to off-white

Bendamustine


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


In Vitro Sister Chromatid Exchange Not specified Positive


Version: 1.1


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



Bacterial Mutagenicity (Ames) Salmonella , E. coli Positive

Mouse Oral LD 50 22 g/kg

In Vivo Micronucleus Rat Bone Marrow Positive

M-12

SAFETY DATA SHEET

_______________________________________________________________________________________________________

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.


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



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


Not Listed



CERCLA/SARA 313 Emission reporting

Inventory - United States TSCA - Sect. 8(b)

SAFETY DATA SHEET

_______________________________________________________________________________________________________


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.


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.)


M-13

p. 1

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Fire

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1

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E

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

M-14

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).

M-15

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:

_______________________________________________________________________________________________________PZ01520

Version: 1.0

MATERIAL SAFETY DATA SHEET

Page 1 of 9

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]

M-16


_______________________________________________________________________________________________________

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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Material Name: Gemcitabine Hydrochloride for InjectionVersion: 1.0Page 2 of 9



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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


Bulgaria OEL - TWA Listed

Sodium hydroxide

M-17


_______________________________________________________________________________________________________

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.

_______________________________________________________________________________________________________PZ01520

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


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



Skin Irritation Rabbit Irritant

Sodium hydroxide

Eye Irritation Rabbit Irritant

Color: White to off-white

Mouse IP LD50 40 mg/kg



6 Month(s) Dog No route specified 0.04 mg/kg/day NOAEL Blood, Erythroid cells, Lymphoid tissue, Immune system


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

M-18


_______________________________________________________________________________________________________

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


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


Selenastrum capricornutum (Green Alga) EC50 5.4 mg/L


Hydrochloric Acid


In Vivo Micronucleus Mouse Positive

Nostoc sp. (Freshwater Cyanobacteria) MIC 800 mg/L

IARC: Group 3

Aspergillus niger (Fungus) MIC > 1000 mg/L


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


In Vivo Sister Chromatid Exchange Negative

Fertility and Embryonic Development Mouse Intravenous 0.25 mg/kg/day LOAEL Fetotoxicity, Embryotoxicity, MaternalToxicity


_______________________________________________________________________________________________________

14. TRANSPORT INFORMATIONThe following refers to all modes of transportation unless specified below.

Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.


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

_______________________________________________________________________________________________________PZ01520

Sodium hydroxide

Revision date: 20-Jun-2011Material Name: Gemcitabine Hydrochloride for Injection


M-19


_______________________________________________________________________________________________________



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:


Schedule 5Schedule 6

Version: 1.0

Mannitol

Page 8 of 9

Inventory - United States TSCA - Sect. 8(b) Listed


Australia (AICS): ListedREACH - Annex IV - Exemptions from theobligations of Register:

Present

CERCLA/SARA Hazardous Substancesand their Reportable Quantities:

Hydrochloric Acid


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


CERCLA/SARA - Section 302 Extremely HazardousTPQs

500 lb TPQ gas only


CERCLA/SARA - Section 302 Extremely HazardousSubstances EPCRA RQs

5000 lb


Australia (AICS): Listed

Australia (AICS): Listed


Standard for the Uniform Schedulingfor Drugs and Poisons:

Schedule 5Schedule 6


_______________________________________________________________________________________________________

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

_______________________________________________________________________________________________________PZ01520

Material Name: Gemcitabine Hydrochloride for InjectionVersion: 1.0Page 9 of 9


M-20

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