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9001-12-1 7365-45-9 10035-04-8 9073-78-3 7647-14-5

File Name: 9001-12-1_7365-45-9_10035-04-8_9073-78-3_7647-14-5.asp

                                        Material Safety Data Sheet
Revision date:
Print Date: 01/21/2009
Version: 0

1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING

Liberase MTF C/T (2:3) GMP Grade
Product name:
05339880001
Product number:
Roche Applied Sciences
Business area:
None Identified
Product line:
Supplier: Emergency telephone number:
Roche Diagnostics Corporation CHEMTREC:
9115 Hague Road 1-800-424-9300 (U.S. or Canada)
Indianapolis, IN 46250 1-703-527-3887 (International)
Site Phone Number: 1-800-428-5074


2. COMPOSITION/INFORMATION ON INGREDIENTS

Description 1: Bottle 1
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
Collagenase 9001-12-1 95-100 NA NA NA NA
HEPES 7365-45-9 1-5 NA NA NA NA
Calcium chloride 10035-04-8 0.1-<1 NA NA NA NA


Description 2: Bottle 2
Components CAS Number Weight % OSHA PEL: OSHA STEL: ACGIH TLV: ACGIH STEL:
HEPES 7365-45-9 20-30 NA NA NA NA
Calcium chloride 10035-04-8 1-5 NA NA NA NA
Thermolysin 9073-78-3 10 - 20 NA NA NA NA
Sodium chloride 7647-14-5 50 - 60 NA NA NA NA



3. HAZARDS IDENTIFICATION

Emergency Overview

NFPA Ratings: Health= 2 Flammability= 0 Reactivity= 0 Special= S, H
Special Definitions: A=Allergen CA=Carcinogen CO=Corrosive F=Flammable H=Harmful I=Irritant Ox=Oxidizer PB=Potential Biohazard
R=Reproductive S=Sensitizer T=Toxic T+=Highly Toxic W=Water Reactive

Ingestion, inhalation, skin and/or eye contact.
Principle routes of exposure:

May cause sensitization by inhalation. Harmful by inhalation.
Inhalation:

Ingestion may cause gastrointestinal irritation, nausea, vomiting and diarrhea
Ingestion:

May cause sensitization by skin contact. Harmful in contact with skin.
Skin contact:

Avoid contact with skin and eyes. Contact with eyes may cause irritation.
Eye contact:

May cause sensitisation of susceptible persons by skin contact or by inhalation of aerosol or dust.
Sensitization or Odor threshold:

Persons with pre-existing skin disorders, eye problems, impaired liver, kidney, or respiratory function may
Medical conditions aggravated by
be more susceptible to the effects of the substance.
exposure:

None
Additional information:

4. FIRST AID MEASURES

Consult a physician. Move to fresh air. If not breathing, give artificial respiration. If breathing is difficult,
Inhalation:
give oxygen

Rinse with plenty of water. If skin irritation persists, call a physician. Remove and wash contaminated
Skin contact:
clothing before re-use

Consult a physician. Do not induce vomiting without medical advice
Ingestion:

In the case of contact with eyes, rinse immediately with plenty of water and seek medical advice
Eye contact:
None determined
Notes to physician:

5. FIRE-FIGHTING MEASURES

Use dry chemical, CO2, water spray or `alcohol` foam
Suitable extinguishing media:

None known
Unusual hazards:

Wear self contained breathing apparatus for fire fighting if necessary
Special protective equipment for
firefighters:

6. ACCIDENTAL RELEASE MEASURES

Use personal protective equipment. Evacuate personnel to safe areas
Personal precautions:
Prevent further leakage or spillage if safe to do so. Prevent product from entering drains.
Environmental precautions:
Never return spills in original containers for re-use. Sweep up or vacuum (if powder) or soak up with inert
Methods for cleaning up:
absorbent material (if liquid), then place into a suitable clean, dry, closed container, and label for disposal

7. HANDLING AND STORAGE

Protect from contamination. Wear personal protective equipment
Handling:
No special precautions required
Storage:

8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Use only in area provided with appropriate exhaust ventilation. In case of insufficient ventilation, wear
Engineering measures:
suitable respiratory equipment.

Personal Protective Equipment

Respiratory protection is not required under normal use of this product. If respiratory protection is needed,
Respiratory protection:
follow the OSHA regulation, 29CFR1910.134. Always use a NIOSH approved respirator when necessary

Wear appropriate protective gloves to prevent skin contact. Replace torn or punctured gloves promptly
Hand protection:

Wear appropriate body protection to prevent skin contact
Skin and body protection:

Wear appropriate eye protection to prevent eye contact
Eye protection:

Avoid contact with skin, eyes and clothing
Hygiene measures:

9. PHYSICAL AND CHEMICAL PROPERTIES

Powder. (lyophilised).
Appearance:
White.
Color:
7.5
pH:
Solid.
Physical state:

10. STABILITY AND REACTIVITY

Stable under recommended storage conditions
Stability:
Not applicable
Polymerization:
Carbon oxides
Hazardous decomposition products:
Strong acids and strong bases. Strong oxidising agents
Materials to avoid:

11. TOXICOLOGICAL INFORMATION

Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Sodium chloride =3 g/kg Oral LD50 Rat
>10 g/kg Dermal LD50 Rabbit
>42 g/m3 Inhalation LC50 Rat 1h


No additional data available
Inhalation:
No additional data available
Skin:
No additional data available
Oral:
Product number: 05339880001 Page 2 of 4
Product name: Liberase MTF C/T (2:3) GMP Grade
No data is available on the product itself
Mutagenic effects:
No data is available on the product itself
Reproductive toxicity:
Carcinogenic effects:


12. ECOLOGICAL INFORMATION

Not determined
Bioaccumulation:

No data is available on the product itself
Aquatic toxicity:

No data is available on the product itself
Ecotoxicity effects:

U.S. EPA, RCRA, CERCLA, SARA, or DGC information on persistent, bioaccumulative, and toxic chemicals (PBTs):
The following chemicals are listed under the U.S. EPA regulations of RCRA, CERCLA, SARA, or DGC:

13. DISPOSAL CONSIDERATIONS

Waste disposal must be in accordance with appropriate Federal, State, and local regulations. This product,
Waste from residues / unused products:
if unaltered by use, may be disposed of by treatment at a permitted facility or as advised by your local
hazardous waste regulatory authority. Residue from fires extinguished with this material may be
hazardous

14. TRANSPORT INFORMATION

No
Is product hazardous to ship?
DOT

Proper shipping name: None
UN Number: Not applicable Hazard class: Not applicable Subsidiary risk: Not applicable Packing group: Not applicable

ICAO/IATA

Proper shipping name: None
UN Number: Not applicable Hazard class: Not applicable Subsidiary risk: Not applicable Packing group: Not applicable

15. REGULATORY INFORMATION

U.S. Regulations:

U.S. CERCLA/SARA/TSCA Regulatory Information: The following chemicals are listed under the following TSCA/SARA/CERCLA lists. Refer to
TSCA regulation if you need a definition for acronyms that may be shown in the TSCA Inventory field in the table below


Components CERCLA/SARA 302 CERCLA/SARA 304 SARA 313 TSCA Inventory
RQ and TPQ RQ Emission reporting
(40 CFR 355, App.A) (40 CFR Table 302.4)
Collagenase Listed
HEPES Listed


Components CERCLA/SARA 302 CERCLA/SARA 304 SARA 313 TSCA Inventory
RQ and TPQ RQ Emission reporting
(40 CFR 355, App.A) (40 CFR Table 302.4)
HEPES Listed
Sodium chloride Listed


The following chemicals are listed under the CWA and/or California Proposition 65:
U.S. Clean Water Act (CWA)/ California
Proposition 65:


Canadian Regulations:

This product does not comply with DSL
Canada DSL Inventory List -
This product does not comply with NDSL
Canada NDSL Inventory List -

Components Canada - WHMIS: Classifications of Substances:
Calcium chloride D2B


Product number: 05339880001 Page 3 of 4
Product name: Liberase MTF C/T (2:3) GMP Grade
Components Canada - WHMIS: Classifications of Substances:
Calcium chloride D2B
Sodium chloride Uncontrolled product according to WHMIS classification criteria



16. OTHER INFORMATION

Not applicable
Reason for revision:
None
References:
None
Additional advice:
Roche Diagnostics, Health & Safety Department, MSDS Contact: 317-521-7425 or 317-521-7505
Prepared by:

The information, data and recommendations contained herein are based upon information believed by Roche Diagnostics Corporation, after reasonable investigation and
research, to be accurate; however, Roche Diagnostics Corporation does not warrant the accuracy of this information. All materials and mixtures may present unknown
hazards and should be used with caution. When necessary or appropriate, independent opinions regarding the risk of handling or exposure should be obtained from trained
professionals. Roche Diagnostics Corporation disclaims any warranty against patent infringement and the implied warranties of merchantability and fitness for a particular
purpose. Customer's sole and exclusive remedy shall be replacement of the product or return of the product and refund of the purchase price, at Roche Diagnostics
Corporation's option. In no case shall Roche Diagnostics Corporation be liable for incidental or consequential damages, including lost profits.

End of Safety Data Sheet




Product number: 05339880001 Page 4 of 4
Product name: Liberase MTF C/T (2:3) GMP Grade

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