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ENCAPSULA NANOSCIENCES LLC
                           MATERIAL SAFETY DATA SHEET

                                                        Date Printed: 12/18/2011
                                                        Date Updated: 02/04/2006
                                                        Version 1.4

Section 1 - Product and Company Information

Product Name:     LIPOSOME ENCAPSULATED CLODRONATE
Product Number:   CLDN-2
Brand:            CLODROSOMEĀ®

Company Address: ENCAPSULA NANOSCIENCES LLC
                 441 DONELSON PIKE, SUITE 345
                 NASHVILLE, TN 37214, USA

Technical Phone: 615-884-4442
Fax:             615-250-8747
Emergency Phone: 615-438-8553

Section 2 - Composition/Information on Ingredient

Substance Name                              CAS#                        SARA313

CLODRONATE ENCAPSULATED LIPOSOMES           NONE                        No

Ingredient Name                             CAS #          Percent      SARA313

WATER                                       7732-18-5      >90          No
SODIUM CHLORIDE                             7647-14-5      <5           No
POTASSIUM CHLORIDE                          7447-40-7      <5           No
DISODIUM PHOSPHATE                          7558-79-4      <5           No
POTASSIUM PHOSPHATE                         7758-11-4      <5           No
L-Ī±-PHOSPHATIDYLCHOLINE                     8002-43-5      <5           No
CHOLESTEROL                                 57-88-5        <5           No
CLODRONATE DISODIUM                         22560-50-5     <5           No

Section 3- Hazards Identification

EMERGENCY OVERVIEW
OSHA HAZARDS
TARGET ORGAN EFFECT

TARGET ORGANS
BONE, KIDNEY

HMIS RATING
HEALTH: 0
CHRONIC HEALTH HAZARD: *
FLAMMABILITY: 0
REACTIVITY: 0

NFPA RATING
                                                                                   1




HEALTH: 0
                                                                                   Page




FLAMMABILITY: 0


CLODROSOMEĀ®                   WWW.CLODROSOME.COM
ENCAPSULA NANOSCIENCES LLC
                        MATERIAL SAFETY DATA SHEET
REACTIVITY: 0
Potential Health Effects



Inhalation May be harmful if inhaled. May cause respiratory tract
irritation.

Skin May be harmful if absorbed through skin. May cause skin irritation.

Eyes May cause eye irritation.

Ingestion May be harmful if swallowed.

For additional information on toxicity, please refer to Section 11.

Section 4 - First Aid Measures

ORAL EXPOSURE
   If swallowed, wash out mouth with water provided person is
   conscious. Call a physician.

INHALATION EXPOSURE
   If inhaled, remove to fresh air. If not breathing give
   artificial respiration. If breathing is difficult, give oxygen.

DERMAL EXPOSURE
   In case of contact, immediately wash skin with soap and copious amounts
of water.

EYE EXPOSURE
   In case of contact, immediately flush eyes with copious amounts
   of water for at least 15 minutes.

Section 5 - Fire Fighting Measures

FLASH POINT
   N/A

AUTOIGNITION TEMP
   N/A

FLAMMABILITY
   N/A

EXTINGUISHING MEDIA
   Suitable: Water spray. Carbon dioxide, dry chemical powder, or
   appropriate foam.

FIREFIGHTING
   Protective Equipment: Wear self-contained breathing apparatus
                                                                             2



   and protective clothing to prevent contact with skin and eyes.
                                                                             Page




   Specific Hazard(s): Emits toxic fumes under fire conditions.



CLODROSOMEĀ®                WWW.CLODROSOME.COM
ENCAPSULA NANOSCIENCES LLC
                         MATERIAL SAFETY DATA SHEET
Section 6 - Accidental Release Measures

METHODS FOR CLEANING UP
   Absorb on sand or vermiculite and place in closed containers for
   disposal. Ventilate area and wash spill site after material


      pickup is complete.

Section 7 - Handling and Storage

HANDLING
   User Exposure: Do not breathe vapor. Do not get in eyes, on
   skin, on clothing.

STORAGE
   Suitable: Keep tightly closed under an inert gas. Store in refrigerator
at 4 Ā°C.

Section 8 - Exposure Controls / Personal Protection

ENGINEERING CONTROLS
   Safety shower and eye bath. Mechanical exhaust required.

PERSONAL PROTECTIVE EQUIPMENT
   Respiratory: Use respirators and components tested and approved
   under appropriate government standards such as NIOSH (US) or CEN
   (EU). Respiratory protection is not required. Where protection is
   desired, use multi-purpose combination (US) or type ABEK (EN
   14387) respirator cartridges.

      Hand: Compatible chemical-resistant gloves.

      Eye: Chemical safety goggles.

GENERAL HYGIENE MEASURES
   Wash thoroughly after handling. Wash contaminated clothing before
   reuse.


Section 9 - PHYSICAL AND CHEMICAL PROPERTIES

Appearance
White liquid dispersion

Safety data

pH
7.4

Melting point
                                                                             3



N/A
                                                                             Page




Boiling point


CLODROSOMEĀ®                   WWW.CLODROSOME.COM
ENCAPSULA NANOSCIENCES LLC
                         MATERIAL SAFETY DATA SHEET
N/A

Flash point
N/A

Ignition temperature


N/A

Lower explosion limit
N/A

Upper explosion limit
N/A

Water solubility
N/A

Section 10 - STABILITY AND REACTIVITY

Storage stability
Can be stored for one month under nitrogen or argon at 4 Ā°C.

Materials to avoid
Strong acids, Strong bases

Hazardous decomposition products
Hazardous decomposition products formed under fire conditions. - Carbon
oxides, Oxides of phosphorus, Hydrogen chloride gas, Sodium oxides

Section 11 - TOXICOLOGICAL INFORMATION
Acute toxicity
N/A

Skin Contact: May cause skin irritation.

Skin Absorption: May be harmful if absorbed through the skin.
Eye Contact: May cause eye irritation.

Inhalation: Material may be irritating to mucous membranes and
upper respiratory tract. May be harmful if inhaled.

Ingestion: May be harmful if swallowed.

Chronic exposure
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.
                                                                             4
                                                                             Page




CLODROSOMEĀ®                  WWW.CLODROSOME.COM
ENCAPSULA NANOSCIENCES LLC
                         MATERIAL SAFETY DATA SHEET
ACGIH: No component of this product present at levels greater than or
equal to 0.1% is identified as a carcinogen or potential carcinogen by
ACGIH.

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.



Signs and Symptoms of Exposure
Nausea, Vomiting, Diarrhoea, Rash

Potential Health Effects
Inhalation May be harmful if inhaled. May cause respiratory tract
irritation.

Skin May be harmful if absorbed through skin. May cause skin irritation.

Eyes May cause eye irritation.

Ingestion May be harmful if swallowed.

Target Organs Bone, Kidney,


Additional Information
RTECS: SZ7640700

Section 12 - ECOLOGICAL INFORMATION
Elimination information (persistence and degradability)
N/A

Ecotoxicity effects
N/A

Further information on ecology
N/A
Section 13 - DISPOSAL CONSIDERATIONS

Product
Observe all federal, state, and local environmental regulations.

Contaminated packaging
Dispose of as unused product.

Section 14- TRANSPORT INFORMATION
                                                                             5



DOT (US)
                                                                             Page




Not dangerous goods



CLODROSOMEĀ®                   WWW.CLODROSOME.COM
ENCAPSULA NANOSCIENCES LLC
                         MATERIAL SAFETY DATA SHEET
IMDG
Not dangerous goods

IATA
Not dangerous goods

Section 15 - REGULATORY INFORMATION

OSHA Hazards
Target Organ Effect

DSL Status
This product contains the following components that are not on the
Canadian DSL nor NDSL lists.

Disodium dihydrogen (dichloromethylene)diphosphonate
CAS-No.
22560-50-5

SARA 302 Components

SARA 302: No chemicals in this material are subject to the reporting
requirements of SARA Title III, Section 302.

SARA 313 Components

SARA 313: This material does not contain any chemical components with
known CAS numbers that exceed the threshold (De Minimis) reporting levels
established by SARA Title III, Section 313.

SARA 311/312 Hazards
Chronic Health Hazard

Massachusetts Right To Know Components
No components are subject to the Massachusetts Right to Know Act.

Pennsylvania Right To Know Components
Disodium dihydrogen (dichloromethylene)diphosphonate AKA Clodronate
CAS-No. 22560-50-5
Revision Date:

Lecithin AKA L-Ī±-Phosphatidylcholine
CAS-No. 8002-43-5
Revision Date:

Cholesterol
CAS-No. 55-88-5
Revision Date:

New Jersey Right To Know Components
                                                                            6



Disodium dihydrogen (dichloromethylene)diphosphonate AKA Clodronate
                                                                            Page




CAS-No. 22560-50-5
Revision Date:


CLODROSOMEĀ®                 WWW.CLODROSOME.COM
ENCAPSULA NANOSCIENCES LLC
                        MATERIAL SAFETY DATA SHEET

Lecithin AKA L-Ī±-Phosphatidylcholine
CAS-No. 8002-43-5

Cholesterol
CAS-No. 55-88-5
Revision Date:

California Prop. 65 Components


This product does not contain any chemicals known to State of California
to cause cancer, birth, or any other reproductive defects.

Section 16- OTHER INFORMATION

Further information
Copyright 2009 Encapsula NanoSciences 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. Encapsula
NanoSciences LLC shall not be held liable for any damage resulting from
handling or from contact with the above product.




                                                                             7
                                                                             Page




CLODROSOMEĀ®                WWW.CLODROSOME.COM

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  • 1. ENCAPSULA NANOSCIENCES LLC MATERIAL SAFETY DATA SHEET Date Printed: 12/18/2011 Date Updated: 02/04/2006 Version 1.4 Section 1 - Product and Company Information Product Name: LIPOSOME ENCAPSULATED CLODRONATE Product Number: CLDN-2 Brand: CLODROSOMEĀ® Company Address: ENCAPSULA NANOSCIENCES LLC 441 DONELSON PIKE, SUITE 345 NASHVILLE, TN 37214, USA Technical Phone: 615-884-4442 Fax: 615-250-8747 Emergency Phone: 615-438-8553 Section 2 - Composition/Information on Ingredient Substance Name CAS# SARA313 CLODRONATE ENCAPSULATED LIPOSOMES NONE No Ingredient Name CAS # Percent SARA313 WATER 7732-18-5 >90 No SODIUM CHLORIDE 7647-14-5 <5 No POTASSIUM CHLORIDE 7447-40-7 <5 No DISODIUM PHOSPHATE 7558-79-4 <5 No POTASSIUM PHOSPHATE 7758-11-4 <5 No L-Ī±-PHOSPHATIDYLCHOLINE 8002-43-5 <5 No CHOLESTEROL 57-88-5 <5 No CLODRONATE DISODIUM 22560-50-5 <5 No Section 3- Hazards Identification EMERGENCY OVERVIEW OSHA HAZARDS TARGET ORGAN EFFECT TARGET ORGANS BONE, KIDNEY HMIS RATING HEALTH: 0 CHRONIC HEALTH HAZARD: * FLAMMABILITY: 0 REACTIVITY: 0 NFPA RATING 1 HEALTH: 0 Page FLAMMABILITY: 0 CLODROSOMEĀ® WWW.CLODROSOME.COM
  • 2. ENCAPSULA NANOSCIENCES LLC MATERIAL SAFETY DATA SHEET REACTIVITY: 0 Potential Health Effects Inhalation May be harmful if inhaled. May cause respiratory tract irritation. Skin May be harmful if absorbed through skin. May cause skin irritation. Eyes May cause eye irritation. Ingestion May be harmful if swallowed. For additional information on toxicity, please refer to Section 11. Section 4 - First Aid Measures ORAL EXPOSURE If swallowed, wash out mouth with water provided person is conscious. Call a physician. INHALATION EXPOSURE If inhaled, remove to fresh air. If not breathing give artificial respiration. If breathing is difficult, give oxygen. DERMAL EXPOSURE In case of contact, immediately wash skin with soap and copious amounts of water. EYE EXPOSURE In case of contact, immediately flush eyes with copious amounts of water for at least 15 minutes. Section 5 - Fire Fighting Measures FLASH POINT N/A AUTOIGNITION TEMP N/A FLAMMABILITY N/A EXTINGUISHING MEDIA Suitable: Water spray. Carbon dioxide, dry chemical powder, or appropriate foam. FIREFIGHTING Protective Equipment: Wear self-contained breathing apparatus 2 and protective clothing to prevent contact with skin and eyes. Page Specific Hazard(s): Emits toxic fumes under fire conditions. CLODROSOMEĀ® WWW.CLODROSOME.COM
  • 3. ENCAPSULA NANOSCIENCES LLC MATERIAL SAFETY DATA SHEET Section 6 - Accidental Release Measures METHODS FOR CLEANING UP Absorb on sand or vermiculite and place in closed containers for disposal. Ventilate area and wash spill site after material pickup is complete. Section 7 - Handling and Storage HANDLING User Exposure: Do not breathe vapor. Do not get in eyes, on skin, on clothing. STORAGE Suitable: Keep tightly closed under an inert gas. Store in refrigerator at 4 Ā°C. Section 8 - Exposure Controls / Personal Protection ENGINEERING CONTROLS Safety shower and eye bath. Mechanical exhaust required. PERSONAL PROTECTIVE EQUIPMENT Respiratory: Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Respiratory protection is not required. Where protection is desired, use multi-purpose combination (US) or type ABEK (EN 14387) respirator cartridges. Hand: Compatible chemical-resistant gloves. Eye: Chemical safety goggles. GENERAL HYGIENE MEASURES Wash thoroughly after handling. Wash contaminated clothing before reuse. Section 9 - PHYSICAL AND CHEMICAL PROPERTIES Appearance White liquid dispersion Safety data pH 7.4 Melting point 3 N/A Page Boiling point CLODROSOMEĀ® WWW.CLODROSOME.COM
  • 4. ENCAPSULA NANOSCIENCES LLC MATERIAL SAFETY DATA SHEET N/A Flash point N/A Ignition temperature N/A Lower explosion limit N/A Upper explosion limit N/A Water solubility N/A Section 10 - STABILITY AND REACTIVITY Storage stability Can be stored for one month under nitrogen or argon at 4 Ā°C. Materials to avoid Strong acids, Strong bases Hazardous decomposition products Hazardous decomposition products formed under fire conditions. - Carbon oxides, Oxides of phosphorus, Hydrogen chloride gas, Sodium oxides Section 11 - TOXICOLOGICAL INFORMATION Acute toxicity N/A Skin Contact: May cause skin irritation. Skin Absorption: May be harmful if absorbed through the skin. Eye Contact: May cause eye irritation. Inhalation: Material may be irritating to mucous membranes and upper respiratory tract. May be harmful if inhaled. Ingestion: May be harmful if swallowed. Chronic exposure 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. 4 Page CLODROSOMEĀ® WWW.CLODROSOME.COM
  • 5. ENCAPSULA NANOSCIENCES LLC MATERIAL SAFETY DATA SHEET ACGIH: No component of this product present at levels greater than or equal to 0.1% is identified as a carcinogen or potential carcinogen by ACGIH. 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. Signs and Symptoms of Exposure Nausea, Vomiting, Diarrhoea, Rash Potential Health Effects Inhalation May be harmful if inhaled. May cause respiratory tract irritation. Skin May be harmful if absorbed through skin. May cause skin irritation. Eyes May cause eye irritation. Ingestion May be harmful if swallowed. Target Organs Bone, Kidney, Additional Information RTECS: SZ7640700 Section 12 - ECOLOGICAL INFORMATION Elimination information (persistence and degradability) N/A Ecotoxicity effects N/A Further information on ecology N/A Section 13 - DISPOSAL CONSIDERATIONS Product Observe all federal, state, and local environmental regulations. Contaminated packaging Dispose of as unused product. Section 14- TRANSPORT INFORMATION 5 DOT (US) Page Not dangerous goods CLODROSOMEĀ® WWW.CLODROSOME.COM
  • 6. ENCAPSULA NANOSCIENCES LLC MATERIAL SAFETY DATA SHEET IMDG Not dangerous goods IATA Not dangerous goods Section 15 - REGULATORY INFORMATION OSHA Hazards Target Organ Effect DSL Status This product contains the following components that are not on the Canadian DSL nor NDSL lists. Disodium dihydrogen (dichloromethylene)diphosphonate CAS-No. 22560-50-5 SARA 302 Components SARA 302: No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302. SARA 313 Components SARA 313: This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313. SARA 311/312 Hazards Chronic Health Hazard Massachusetts Right To Know Components No components are subject to the Massachusetts Right to Know Act. Pennsylvania Right To Know Components Disodium dihydrogen (dichloromethylene)diphosphonate AKA Clodronate CAS-No. 22560-50-5 Revision Date: Lecithin AKA L-Ī±-Phosphatidylcholine CAS-No. 8002-43-5 Revision Date: Cholesterol CAS-No. 55-88-5 Revision Date: New Jersey Right To Know Components 6 Disodium dihydrogen (dichloromethylene)diphosphonate AKA Clodronate Page CAS-No. 22560-50-5 Revision Date: CLODROSOMEĀ® WWW.CLODROSOME.COM
  • 7. ENCAPSULA NANOSCIENCES LLC MATERIAL SAFETY DATA SHEET Lecithin AKA L-Ī±-Phosphatidylcholine CAS-No. 8002-43-5 Cholesterol CAS-No. 55-88-5 Revision Date: California Prop. 65 Components This product does not contain any chemicals known to State of California to cause cancer, birth, or any other reproductive defects. Section 16- OTHER INFORMATION Further information Copyright 2009 Encapsula NanoSciences 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. Encapsula NanoSciences LLC shall not be held liable for any damage resulting from handling or from contact with the above product. 7 Page CLODROSOMEĀ® WWW.CLODROSOME.COM