Docstoc

3806061pdf

Document Sample
3806061pdf Powered By Docstoc
					Material Safety Data Sheet
MSDS Number: Revision date: Print date: 1087925 06/23/2003 06/23/2003

1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
MSDS Number: Product name: Product code: Synonyms: Chemical Family: Product Type: Container Information: Product Use: 1087925 Enlon (Edrophonium Chloride Injection, USP) NDC 10019-873-15 Edrophonium Chloride Anticholinesterase agent Regulated Prescription Drug 15 ml vials Pharmaceutical

Supplier: BAXTER HEALTHCARE CORPORATION DEERFIELD, ILLINOIS 60015 (800) 422-9837 or (847) 948-4770 Emergency telephone number: PROSAR: USA (888) 990-0996 OUTSIDE USA (615)917-6114 CHEMTREC: USA (800) 424-9300 OUTSIDE USA (743)741-6089

2. COMPOSITION/INFORMATION ON INGREDIENTS
Component Edrophonium Chloride 116-38-1 Phenol 108-95-2 Sodium Sulfite Anhydrous 7757-83-7 Water 7732-18-5 Weight % 1 <0.5 UN Number: None UN2821 Classification: None C;R34 T;R24/25 None None

<0.5 >98

None None

3. HAZARDS IDENTIFICATION
Emergency overview: May be harmful if swallowed. Cardiovascular effects. Respiratory effects. Neurologic effects. Gastrointestinal effects. Musculoskeletal effects. Absorbed through skin. Eye contact. Ingestion. Inhalation not likely under normal use conditions. May be harmful if swallowed. May cause irritation and/or allergic reactions. May cause irritation and/or allergic reactions.

Principle routes of exposure: Inhalation: Ingestion: Skin contact: Eye contact:

______________________________________________________________ Product id: 1087925 Product name: Enlon (Edrophonium Chloride Injection, USP)

4. FIRST AID MEASURES
Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention if symptoms appear. In case of contact, immediately flush skin with plenty of water. Remove contaminated clothing and shoes. Wash clothing before reuse. Get medical attention if irritation develops. Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. If large quantities of this material are swallowed, call a physician immediately. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Get medical attention if irritation develops. See patient package insert in shipping carton for complete information.

Skin contact:

Ingestion:

Eye contact:

Notes to physician:

5. FIRE FIGHTING MEASURES
Suitable extinguishing media: Special protective equipment for firefighters: Specific methods: Flash point: Autoignition temperature: Flammable limits in air-lower (%): Flammable limits in air-upper (%): Use foam or all purpose dry chemicals to extinguish. Fire fighters should wear positive pressure self-contained breathing apparatus (SCBA) and full turnout gear. No information available. Not determined Not applicable Not applicable Not applicable

6. ACCIDENTAL RELEASE MEASURES
Personal precautions: Keep unnecessary personnel away. Use suitable protective equipment (Section 8). Follow all fire fighting procedures (Section 5). No information available. For small spills add absorbent (soil may be used in the absence of other suitable materials) scoop up material and place in a sealed, liquid-proof container for disposal. For large spills dike spilled material or otherwise contain material to ensure runoff does not reach a waterway. Place spilled material in an appropriate container for disposal.

Environmental precautions: Methods for cleaning up:

7. HANDLING AND STORAGE
Handling: Technical measures/precautions: Storage: Technical measures/storage conditions: Incompatible products: Wash thoroughly after handling.

Keep containers tightly closed in a cool, well-ventilated place. Store between 1530°C (59 to 86°F). No special restrictions on storage with other products.

______________________________________________________________ Product id: 1087925 Product name: Enlon (Edrophonium Chloride Injection, USP)

8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Occupational Exposure Limits
Component OSHA- Time Weighted Average: None = 19 mg/m³ TWA = 5 ppm TWA None None OSHA- Short OSHA- Ceiling ACGIH- Time ACGIH- Short Term Limits Weighted Term Exposure Average: Exposure Limit: Limit: None None None None None None = 5 ppm TWA None ACGIH- Ceiling Limit Value:

Edrophonium Chloride 116-38-1 Phenol 108-95-2 Sodium Sulfite Anhydrous 7757-83-7 Water 7732-18-5

None None

None None

None None

None None

None None

None None

Engineering measures:

No special containment is required. Good general ventilation should be sufficient to control airborne levels.

Personal protective equipment: Respiratory protection: Perform exposure monitoring for this product and its components to ensure that employees are not exposed to levels greater than applicable regulatory limits. If exposure levels exceed regulatory limits, implement a respiratory protection program including respiratory protection that is in compliance with OSHA 29 CFR1910.134 (in the US) or equivalent regulation in other regions. Fire fighting requires the use of a self-contained breathing apparatus with full face piece and positive pressure mode. Hand protection: Skin and body protection: Use chemical resistant, impervious gloves. Work uniform or laboratory coat. Additional body garments should be used based upon the task being performed (e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces. Safety glasses. Goggles, face shield, or other full-face protection if potential exists for direct exposure to aerosols or splashes.

Eye protection:

9. PHYSICAL AND CHEMICAL PROPERTIES
Physical state: Appearance: Color: Odor: pH: Molecular weight: Boiling point/range: Melting point/range: Density: Vapor pressure: Evaporation rate: Solubility: Liquid Aqueous solution Not available. Not available. 5.4 Not available. Not available. Not available. Not available. Not available. Not available. Soluble in water.

______________________________________________________________ Product id: 1087925 Product name: Enlon (Edrophonium Chloride Injection, USP)

Partition coefficient (noctanol/water): Viscosity: % Volatile by Volume:

Not available. Not available. Not available.

10. STABILITY AND REACTIVITY
Stability: Polymerization: Hazardous decomposition products: Materials to avoid: Stable under recommended storage conditions. Not applicable Not available.

Not available.

11. TOXICOLOGICAL INFORMATION
Component Edrophonium Chloride 116-38-1 Phenol 108-95-2

LD50s and LC50s Intravenous LD50 Mouse = 8.5 mg/kg Inhalation LC50 Mouse = 177 mg/m³ Oral LD50 Mouse = 270 mg/kg Inhalation LC50 Rat = 316 mg/m³ Oral LD50 Rat = 317 mg/kg Dermal LD50 Rabbit = 630 mg/kg Oral LD50 Mouse = 820 mg/kg Oral LD50 Rat: >50000 mg/kg

Sodium Sulfite Anhydrous 7757-83-7 Water 7732-18-5

Acute toxicity:

Gastrointestinal effects (may include nausea/vomiting, abdominal pain, diarrhea, dry mouth, colic). Cardiovascular effects (may include fluctuations in heart rate, changes in blood pressure, chest pain). Respiratory effects (may include shortness of breath, bronchospasms, laryngospasms). Target Organs: Muscle. Nervous System. Not classified or listed by IARC, NTP, OSHA, EU and ACGIH. No data is available on the product itself. No data is available on the product itself. No data is available on the product itself. Not available.

Chronic toxicity: Carcinogenic effects:

Mutagenic effects: Reproductive toxicity: FDA Pregnancy Catagory

12. ECOLOGICAL INFORMATION
______________________________________________________________ Product id: 1087925 Product name: Enlon (Edrophonium Chloride Injection, USP)

Environmental properties:
Component

Ecotoxicity - Water Fish Species Flea Data Ecotoxicity

Ecotoxicity Freshwater Algae Data None.

Microtox Etoxicity Data

Edrophonium Chloride 116-38-1 Phenol 108-95-2

None. = 23.0 mg/L 48 Hr LC50 water flea

None.

None. = 28.8 mg/L 5 min EC50 Photobacterium phosphoreum = 31.6 mg/L 15 min EC50 Photobacterium phosphoreum

Sodium Sulfite Anhydrous 7757-83-7 Water 7732-18-5

None. None.

LC50 (96 hr) fathead None. minnow:24 mg/L:;LC50 (96 hr) rainbow trout:8.9 mg/L:Flow-through, 13-15 °C, pH 7.78.1, 565-700 mg/L CaCO3.;LC50 (96 hr) bluegill:23.88 mg/L:Static, 25 °C, pH 7.5, 20.0 mg/L CaCO3. None. None. None. None.

None. None.

Ecotoxicity effects: Bioaccumulation:

No data available No data available

13. DISPOSAL CONSIDERATIONS
Waste Classification: Waste from residues / unused products: Not regulated. Waste disposal must be in accordance with appropriate Federal, State, and local regulations.

14. TRANSPORT INFORMATION
DOT: DOT shipping name: UN Number: DOT Packing Group: DOT Hazard class: TDG (Canada): TDG Proper shipping name: TDG UN/NA Number: TDG Packing Group: TDG Hazard class: None None None None

None None None None

ADR/RID: ADR Official Transport Name: None ADR Proper shipping name: None ADR UN/NA number: None ADR Hazard Class: None ______________________________________________________________ Product id: 1087925 Product name: Enlon (Edrophonium Chloride Injection, USP)

ICAO / IATA: IATA Proper shipping name: IATA UN NUMBER IATA Primary Hazard IATA Packing group: ICAO ERG Code: IMO / IMDG: IMDG Hazard Class and Division: IMDG Proper Shipping Name: IMDG Packing Group: IMDG Subsidiary Risks:

None None None None None

None None None None

15. REGULATORY INFORMATION
U.S. Regulations: TSCA Inventory List OTHER REGULATIONS: Japanese Inventory (ENCS) The product is exempt from TSCA, it is FDA Regulated This product complies with JPENCS

Component

Weight %

RCRA Status:

Edrophonium Chloride Phenol

1 <0.5

Not Listed waste number U188

Sodium Sulfite Anhydrous Water

<0.5 >98

Not Listed Not Listed

CERCLA CERCLA/SARA - Listed as Sara Reportable 302 Ext. haz. 313 title III: Quantity: substances: Not Listed Not Listed Not Listed = 1000 lb final RQ = 10,000 lb TPQ form R reporting = 454 kg final RQ (upper threshold) required for 1.0% = 1000 lb EPCRA de minimis RQ concentration = 500 lb TPQ (lower threshold) Not Listed Not Listed Not Listed Not Listed Not Listed Not Listed

STATE REGULATIONS:
Component California Prop 65: Minnesota Right-To Know: Florida Right- Rhode Island Massachusetts Pennsylvania New Jersey Right-toto-Know Right-to-Know Right-to-Know Right-to-Know: Know: Reporting List: List: List:

Edrophonium Chloride Phenol Sodium Sulfite Anhydrous Water

Not Listed Not Listed Not Listed Not Listed

Not Listed Skin Not Listed Not Listed

Not Listed [present] Not Listed Not Listed

Not Listed Not Listed Not Listed Toxic, extraordinarily environmental Flammable hazardous hazard Not Listed Not Listed Not Listed Not Listed Not Listed Not Listed

Not Listed sn 1487 Not Listed Not Listed

CANADIAN REGULATIONS: Canada DSL Inventory List This product does not comply with DSL

EU EINECS List -

This product complies with EINECS

Risk Phrases: NONE ______________________________________________________________ Product id: 1087925 Product name: Enlon (Edrophonium Chloride Injection, USP)

Safety Phrases: NONE

16. OTHER INFORMATION
This data sheet contains changes from the previous version in section(s)?: New MSDS format. Additional information: Not Available. Prepared by: Technology Resources, Baxter Healthcare Corporation

To the best of our knowledge, the information contained herein is accurate. However, neither the above named supplier nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the information contained herein. Final determination of suitability of any material is the sole responsibility of the user. All materials may present unknown hazards and should be used with caution. Although certain hazards are described herein, we cannot guarantee that these are the only hazards that exist. End of safety data sheet:

______________________________________________________________ Product id: 1087925 Product name: Enlon (Edrophonium Chloride Injection, USP)


				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:3
posted:8/21/2009
language:English
pages:7