Material Safety Data Sheet
Authorization date: 06/14/1999
Revision date: 08/22/2006
Print Date: 08/24/2006
Version: 0
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Product name: Gentamicin
Product number: 1059467
Global material number: 11059467001
Business area: Roche Applied Sciences
Product line: Not applicable
Instrument type: Not applicable
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:
Gentamicin Sulfate 1405-41-0 5 - 10 NA NA NA NA
3. HAZARDS IDENTIFICATION
Emergency Overview
NFPA Ratings: Health= 1 Flammability= 0 Reactivity= 0 Special= S
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
Principle routes of exposure: Ingestion, inhalation, skin and/or eye contact.
Inhalation: May cause irritation of respiratory tract.
Ingestion: May cause gastrointestinal irritation with nausea, vomiting and diarrhea. May cause kidney damage. May
cause auditory damage with possible loss of hearing. May cause neuromuscular paralysis.
Skin contact: Causes skin burns. May cause allergic skin reaction.
Eye contact: May cause irritation.
Sensitization or Odor threshold: Inhalation of aerosol or skin contact may cause sensitisation of susceptible persons.
Medical conditions aggravated by None known
exposure:
Additional information: None
4. FIRST AID MEASURES
Inhalation: Consult a physician. Move to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give
oxygen.
Skin contact: Wash off immediately with plenty of water for at least 15 minutes. If skin irritation persists, call a physician.
Ingestion: Call a physician immediately. Do not induce vomiting without medical advice.
Eye contact: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes.
Notes to physician: None determined
5. FIRE-FIGHTING MEASURES
5. FIRE-FIGHTING MEASURES
Suitable extinguishing media: Use dry chemical, CO2, water spray or "alcohol" foam.
Unusual hazards: None known.
Special protective equipment for In the event of fire, wear self-contained breathing apparatus.
firefighters:
6. ACCIDENTAL RELEASE MEASURES
Personal precautions: Use personal protective equipment. Evacuate personnel to safe areas. Remove all sources of ignition.
Environmental precautions: Prevent further leakage or spillage if safe to do so. Prevent product from entering drains. Do not flush into
surface water or sanitary sewer system. Do not let product enter drains.
Methods for cleaning up: Never return spills in original containers for re-use. Soak up with oil absorbent material. Sweep up or
vacuum (if powder) or soak up with inert absorbent material (if liquid), then place into a suitable clean, dry,
closed container, and label for disposal.
7. HANDLING AND STORAGE
Handling: Protect from contamination. Wear personal protective equipment.
Storage: No special precautions required.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Engineering measures: Not applicable.
Personal Protective Equipment
Respiratory protection: Respiratory protection is not required under normal use of this product. If respiratory protection is needed,
follow the OSHA regulation, 29CFR1910.134. Always use a NIOSH approved respirator when necessary.
Hand protection: Wear appropriate protective gloves to prevent skin contact. Replace torn or punctured gloves promptly.
Skin and body protection: Wear appropriate body protection to prevent skin contact.
Eye protection: Wear appropriate eye protection to prevent eye contact.
Hygiene measures: When using, do not eat, drink or smoke. Keep away from food and drink. Keep away from tobacco
products. Wash hands before breaks and immediately after handling the product. Handle in accordance
with good industrial hygiene and safety practice for diagnostics.
9. PHYSICAL AND CHEMICAL PROPERTIES
Boiling point/range: No information available
Melting point/range: Not determined
pH: ~5-7
Physical state: Not determined.
Flash point: No information available.
LEL (%): Not determined
UEL (%): Not determined
10. STABILITY AND REACTIVITY
Stability: Stable under recommended storage conditions.
Polymerization: None under normal processing.
Hazardous decomposition products: Thermal decomposition can lead to release of irritating gases and vapours. Carbon monoxide. Nitrogen
oxides (nox). Sodium oxides.
Materials to avoid: Incompatible with strong acids and bases. Oxidising agents (strong).
11. TOXICOLOGICAL INFORMATION
Description 1: Bottle 1
Components NIOSH - NIOSH Pocket Guide -
Selected LD50s and LC50s: Target Organs:
Gentamicin Sulfate > 11269 mg/kg Oral LD50 Mouse
> 5 g/kg Oral LD50 Rat
Inhalation: No additional data available
Product number: 1059467 Page 2 of 4
Product name: Gentamicin
Skin: No additional data available
Oral: No additional data available
Mutagenic effects: No data is available on the product itself
Reproductive toxicity: No data is available on the product itself
Carcinogenic effects:
12. ECOLOGICAL INFORMATION
Bioaccumulation: No data available
Aquatic toxicity: Not applicable
Ecotoxicity effects: No data is available on the product itself
13. DISPOSAL CONSIDERATIONS
Waste from residues / unused products: Waste disposal must be in accordance with appropriate Federal, State, and local regulations. This product,
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
Is product hazardous to ship? No
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
U.S. Clean Water Act (CWA)/ California The following chemicals are listed under the CWA and/or California Proposition 65:
Proposition 65:
Canadian Regulations:
Canada DSL Inventory List - This product does not comply with DSL
Canada NDSL Inventory List - This product does not comply with NDSL
Components Canada - WHMIS: Classifications of Substances:
Gentamicin Sulfate D2B
16. OTHER INFORMATION
Reason for revision: Not applicable
References: (1) Yoshioka H et al: Placental transfer of gentamicin. J Pediatr 80:121-3, 1972. (2) Kauffman R et al:
Placental transfer and fetal urinary excretion of gentamicin during constant rate maternal infusion. Pediatr
Res 9:104-7, 1975.
Additional advice: None
Prepared by: Roche Diagnostics, Health & Safety Department, MSDS Contact: 317-521-7425 or 317-521-7505
Product number: 1059467 Page 3 of 4
Product name: Gentamicin
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: 1059467 Page 4 of 4
Product name: Gentamicin
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