MSDS Number: LEVTR Effective Date: 9/16/2003 Supercedes: 10/23/2001
Eye Contact:
Mild irritant, but will also have a strong narcotic effect (pupil contraction) and the eye may serve as an
absorption route into the body in general.
Chronic Exposure:
Caution, may be habit forming.
Aggravation of Pre-existing Conditions:
Some individuals may become sensitized from exposure and develop skin rashes, coughs, stuffy nose,
asthma, and other allergic complaints. Sensitivity may develop soon after immediate contact or after years of
exposure.
4. First Aid Measures
Inhalation:
Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a
physician.
Ingestion:
Induce vomiting immediately as directed by medical personnel. Never give anything by mouth to an
unconscious person.
Skin Contact:
Immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and
shoes. Call a physician, immediately. Wash clothing before reuse.
Eye Contact:
Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper eyelids
occasionally. Get medical attention immediately.
5. Fire Fighting Measures
Fire:
As with most organic solids, fire is possible at elevated temperatures or by contact with an ignition source.
Explosion:
Fine dust dispersed in air in sufficient concentrations, and in the presence of an ignition source is a potential
dust explosion hazard.
Fire Extinguishing Media:
Water spray, dry chemical, alcohol foam, or carbon dioxide.
Special Information:
In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus
with full facepiece operated in the pressure demand or other positive pressure mode. Follow handling
guidance appropriate for OEB-3 potent compounds, (see Section 7).
6. Accidental Release Measures
Ventilate area of leak or spill. Remove all sources of ignition. Wear appropriate personal protective equipment
as specified in Section 8, and follow handling guidance appropriate for OEB-3 potent compounds, (see
Section 7). Isolate hazard area. Keep unnecessary and unprotected personnel from entering. All clean-up
operations should be witnessed by more than one individual.
Spills: Carefully sweep up material into an appropriate container and save for reclamation or disposal. Use
non-sparking tools and equipment. Do not flush to sewer! The amount of material collected should be
assessed and documented.
7. Handling and Storage
Keep in a tightly closed container, stored in a cool, dry, ventilated area. Protect from physical damage and
direct sunlight. CONTROLLED SUBSTANCE. Location of storage area must comply with all Drug
Enforcement Agency regulations.
Page 2 of 6
MSDS Number: LEVTR Effective Date: 9/16/2003 Supercedes: 10/23/2001
Levorphanol Tartrate has potent pharmacological activity and is classified as an OEB-3* material. Handling
practices for OEB-3 substances are described below Laboratory
* Wear appropriate gloves, lab coat, and safety glasses. Use good lab practices.
* A designated area is required for handling compounds.
* Work surfaces are to be cleaned daily. If lab bench absorbent paper is used, it is to be changed at least
daily.
* High-energy operations such as milling, particle sizing, spraying or fluidizing should be done within an
approved emission control or containment system.
* Develop cleaning procedures and techniques that limit potential exposure.
* Powders Handling:
To prevent contamination and overexposure, no open handling of powder should be allowed. Powder
handling operations are to be done in a powders weighing hood, a glove box, or other equivalent ventilated
containment system. In situations where these ventilated containment hoods have not been installed, a non-
ventilated enclosed containment hood should be used. Pending changes resulting from additional air
monitoring data, up to 300 mg can be handled outside of an enclosure provided that no grinding, crushing or
other dust-generating process occurs. An air-purifying respirator (P95 or other type providing a higher level of
protection) should be worn by all personnel in the immediate area in cases where non-ventilated containment
is used, where significant amounts of material (e.g., more than 2 grams) are used, or where the material may
become airborne (as through grinding, etc.). Powder should be put into solution or a closed or covered
container after handling. If using a ventilated enclosure that has not been validated, wear a half-mask
respirator equipped with HEPA cartridges until the enclosure is validated for use.
* Solutions Handling:
- Solutions can be handled outside a containment system or without local exhaust ventilation during
procedures with no potential for aerosolization. If the procedures have a potential for aerosolization, an air-
purifying respirator (P95 or other type providing a higher level of protection) is to be worn by all personnel in
the immediate area.
- Solutions used for procedures where aerosolization may occur (e.g., vortexing, pumping) are to be handled
within a containment system or with local exhaust ventilation. In situations where this is not feasible (may
include animal dosing), an air-purifying respirator (P95 or other type providing a higher level of protection) is to
be worn by all personnel in the immediate area.
- If using a ventilated enclosure that has not been validated, wear a half-mask respirator equipped with HEPA
cartridges until the enclosure is validated for use.
-Ensure gloves are protective against solvents in use.
Pilot Plant and Production
* Wear appropriate gloves; lab coat, nylon coveralls or disposable Tyvek suit; safety glasses, safety shoes,
and disposable booties. Use good manufacturing practices (i.e., cGMPs).
* Protective garment (coveralls, Tyvek, lab coat) is not to be worn outside the work area.
* Clean/dirty/decontamination areas are to be established.
* Negative/positive air pressure relationships and buffer zones required (i.e., ante-room/degowning
room/airlock).
* Area access is to be restricted.
* High-energy operations such as milling, particle sizing, spraying or fluidizing should be done within an
approved emission control or containment system.
* Develop cleaning procedures and techniques that limit potential exposure.
* Powders Handling
- Emphasis is to be placed on closed material transfer systems and process containment, with no open
handling of powders. Use enclosures and containment measures to reduce potential exposures.
- Use a powered, air-purifying respirator (PAPR) with HEPA cartridges or a supplied-air respirator (SAR) until
processes have been monitored to show that respiratory protection is not required.
* Solutions Handling
- Enclose systems where possible. Processing tanks are to be kept covered. Process samples should be
taken from sample ports if feasible.
Page 3 of 6
MSDS Number: LEVTR Effective Date: 9/16/2003 Supercedes: 10/23/2001
Hazardous Decomposition Products:
Burning may produce carbon monoxide, carbon dioxide, nitrogen oxides.
Hazardous Polymerization:
Will not occur.
Incompatabilities:
Alkalis, tannin, strong oxidizing agents, borax, ferric chloride, iodides, lead acetate, mercuric chloride, gold
salts.
Conditions to Avoid:
No information found.
11. Toxicological Information
Levorphanol Tartrate (Anhydrous): oral rat LD50: 150 mg/kg; investigated as a mutagen, reproductive effector.
Cancer Lists
---NTP Carcinogen---
Ingredient Known Anticipated IARC Category
Levorphanol tartrate (125-72-4) No No None
12. Ecological Information
Environmental Fate:
No information found.
Environmental Toxicity:
No information found.
13. Disposal Considerations
Notify site Drug Enforcement Agency compliance officer and local DEA office for appropriate disposal
procedures. Processing, use or contamination of this product may change the waste management options.
State and local disposal regulations may differ from federal disposal regulations.
Follow handling guidance appropriate for OEB-3 potent compounds, (see Section 7).
Dispose of container and unused contents in accordance with federal, state and local requirements.
14. Transport Information
Not regulated.
15. Regulatory Information
Chemical Inventory Status
---Canada---
Ingredient TSCA EC Japan Australia Korea DSL NDSL Phil.
Levorphanol tartrate (125-72-4) Exempt Yes No No No No No No
Federal, State & International Regulations
---SARA 302--- -----------SARA 313----------- -RCRA- -TSCA-
Ingredient RQ TPQ List Chemical Catg. CERCLA 261.33 8(d)
Levorphanol tartrate (125-72-4) No No No No No No No
Chemical Weapons Convention: No TSCA 12(b): No CDTA: No
SARA 311/312: Acute: Yes Chronic: No Fire: No Pressure: No Reactivity: No (Mixture / Solid)
Australian Hazchem Code: None allocated. Australian Poison Schedule: S8
Page 5 of 6
MSDS Number: LEVTR Effective Date: 9/16/2003 Supercedes: 10/23/2001
WHMIS: This MSDS has been prepared according to the hazard criteria of the Controlled Products
Regulations (CPR) and the MSDS contains all of the information required by the CPR.
16. Other Information
NFPA Ratings:
Health: 3 Flammability: 1 Reactivity: 1
Label Hazard Warning:
DANGER! MAY BE FATAL IF SWALLOWED. HARMFUL IF INHALED OR ABSORBED THROUGH SKIN.
ALLERGEN. EXPOSURE MAY PRODUCE ALLERGIC RESPONSE. POTENT NARCOTIC.
Label Precautions:
Do not breathe dust.
Do not get in eyes, on skin, or on clothing.
Keep container closed.
Wash thoroughly after handling.
Use only with adequate ventilation.
Label First Aid:
In all cases call a physician immediately. If swallowed, induce vomiting immediately as directed by medical
personnel. Never give anything by mouth to an unconscious person. If inhaled, remove to fresh air. If not
breathing, give artificial respiration. If breathing is difficult, give oxygen. In case of contact, immediately flush
eyes or skin with plenty of water for at least 15 minutes.
Product Use:
Medication: anesthetic
Revision Information:
MSDS Section(s) changed since last revision of document include: 3, 5, 6, 7, 8, 13, 16.
Disclaimer:
Mallinckrodt provides the information contained herein in good faith but makes no representation as to its
comprehensiveness or accuracy. This document is intended only as a guide to the appropriate precautionary
handling of the material by a properly trained person using this product. Individuals receiving the information
must exercise their independent judgment in determining its appropriateness for a particular purpose.
MALLINCKRODT MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE WITH RESPECT TO THE INFORMATION SET FORTH HEREIN OR THE
PRODUCT TO WHICH THE INFORMATION REFERS. ACCORDINGLY, MALLINCKRODT WILL NOT BE
RESPONSIBLE FOR DAMAGES RESULTING FROM USE OF OR RELIANCE UPON THIS INFORMATION.
Prepared By: Environmental Health & Safety
Phone Number: (314) 654-1600 (U.S.A.)
Page 6 of 6
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