Synonyms: d-Propoxyphene hydrochloride; alpha-[2-(dimethylamino)-1-methylethyl]-alpha-phenyl-, propanoate (ester) hydrochloride, [S-(R*, S*))]-benzene ethanol; Propoxyphene Hydrochloride ARS; dextropropoxyphene hydrochloride; Propoxyphene related coumpound, ARS
CAS No.: 1639-60-7
Molecular Weight: 375.94
Chemical Formula: C22H29NO2.HCl
Product Codes: 0914, 0933, 0934, 0962, 1273, 1523
Ingredient CAS No Percent Hazardous --------------------------------------- ------------ ------------ --------- d-Propoxyphene hydrochloride 1639-60-7 100% Yes
Emergency Overview
--------------------------
WARNING! HARMFUL IF SWALLOWED OR INHALED. AFFECTS CENTRAL NERVOUS SYSTEM. ALLERGEN. EXPOSURE MAY PRODUCE ALLERGIC RESPONSE. CAUSES IRRITATION TO EYES AND RESPIRATORY TRACT.
Potential Health Effects
----------------------------------
Inhalation:
May be irritating to the respiratory tract. May produce an allergic response in sensitized individuals. Symptoms may include rash, wheezing, and other symptoms paralleling ingestion.
Ingestion:
Toxic. Doses of 32-65 mg, 3-4 times daily are well tolerated in adults. Doses above 800 mg have produced severe intoxications and even death. Symptoms include incoordination, coma, convulsions, cyanosis, and death from respiratory arrest.
The most frequently reported side effects from therapeutic doses include dizziness, sedation, nausea, vomiting constipation, abdominal pain, skin rashes, lightheadedness, headache, weakness, hallucinations, and minor visual disturbances.
Skin Contact:
May produce allergic responses paralleling inhalation.
Eye Contact:
May cause eye irritation. Propoxyphene napsylate may cause burns or permanent tissue damage to the eyes.
Chronic Exposure:
Abuse may lead to habituation or addiction.
Dependence has occurred when patients have taken propoxyphene for a long period of time at doses greater than recommended.
Aggravation of Pre-existing Conditions:
The CNS-depressant effect of propoxyphene is additive with that of other CNS depressants, including alcohol. Persons who have had a prior allergic reaction to propoxyphene should not be exposed to propoxyphene products.
Inhalation:
Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.
Ingestion:
Induce vomiting immediately as directed by medical personnel. Never give anything by mouth to an unconscious person.
Skin Contact:
Wash exposed area with soap and water. Get medical advice if irritation develops.
Eye Contact:
Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper eyelids occasionally. Get medical attention immediately.
Fire:
As with most organic solids, fire is possible at elevated temperatures or by contact with an ignition source.
Explosion:
Not an explosion hazard under normal conditions of storage and use, but 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-2 potent compounds, (see Section 7).
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-2 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.
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. Containers of this material may be hazardous when empty since they retain product residues (dust, solids); observe all warnings and precautions listed for the product. Propoxyphene has potent pharmacological activity and is classified as an OEB-2* material. Handling practices for OEB-2 substances are described below:
Laboratory
*Wear appropriate gloves, lab coat, and safety glasses. Use good lab practices.
*No local exhaust ventilation required for transfer/handling of quantities of powder less than 100 g (total weight transferred or handled). However, if the source container contains 2 kg or more, pilot plant practices apply.
*No local exhaust ventilation required for solutions of these compounds.
*Quantities of solid above 100 g require use of a powders weighing hood or other approved containment/ventilation system.
*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.
Pilot Plant and Production
*Wear appropriate gloves; lab coat, nylon coveralls or disposable Tyvek suit; safety glasses and safety shoes. Use good manufacturing practices (i.e., cGMPs).
*Use local exhaust and/or enclosure at dust-generating points. Emphasis is to be placed on closed material transfer systems and process containment, with limited open handling of powders.
*Where open handling of powders occurs, use a powered, air-purifying respirator (PAPR) with HEPA cartridges or a supplied-air respirator (SAR), unless air-monitoring data has shown that a lower level of respiratory protection is adequate.
*Protective garments (coveralls, Tyveks, lab coat) are not to be worn in common areas (e.g., cafeterias) or out-of-doors.
*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.
*OEB - Mallinckrodt's Occupational Exposure Band: The classification of a compound or pharmaceutical ingredient into one of four ordinal categories of increasing potency and toxicity. This rating assigns a set of pre-determined handling and containment practices to a compound until a quantitative OEL is established.
Airborne Exposure Limits:
Propoxyphene HCl:
Occupational Exposure Guideline (OEG):160 ug/m3 (8-hour time-weighted average)
Ventilation System:
A system of local and/or general exhaust is recommended to keep employee exposures below the Occupational Exposure Guidelines. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area. Please refer to the ACGIH document, Industrial Ventilation, A Manual of Recommended Practices, most recent edition, for details. See Section 7 for additional information on proper handling and venting requirements for potent compounds.
Personal Respirators (NIOSH Approved):
Where open handling of powders occurs, use a powered, air-purifying respirator (PAPR) with HEPA cartridges or a supplied-air respirator (SAR), unless air-monitoring data has shown that a lower level of respiratory protection is adequate.
Skin Protection:
Wear appropriate gloves; lab coat, nylon coveralls or disposable Tyvek suit; safety glasses, safety shoes, and disposable booties.
Eye Protection:
Use chemical safety goggles and/or a full face shield where splashing is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures:
Because this is a controlled substance, special handling and storage requirements must be observed to assure compliance with Drug Enforcement Administration regulations. See Section 7 for additional information on occupational control measures appropriate for OEB-2 potent compounds.
Appearance:
Fine, white powder.
Odor:
Odorless.
Solubility:
Soluble in water.
Density:
No information found.
pH:
No information found.
% Volatiles by volume @ 21C (70F):
No information found.
Boiling Point:
No information found.
Melting Point:
No information found.
Vapor Density (Air=1):
No information found.
Vapor Pressure (mm Hg):
No information found.
Evaporation Rate (BuAc=1):
No information found.
Stability:
Stable under ordinary conditions of use and storage.
Hazardous Decomposition Products:
Carbon dioxide, carbon monoxide, and hydrogen chloride may form when heated to decomposition.
Hazardous Polymerization:
Will not occur.
Incompatibilities:
No information found.
Conditions to Avoid:
No information found.
Oral rat LD50: 84 mg/kg; investigated as a reproductive effector.
--------\Cancer Lists\------------------------------------------------------
---NTP Carcinogen---
Ingredient Known Anticipated IARC Category
------------------------------------ ----- ----------- -------------
d-Propoxyphene hydrochloride No No None
(1639-60-7)
Environmental Fate:
No information found.
Environmental Toxicity:
No information found.
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-2 potent compounds, (see Section 7). Dispose of container and unused contents in accordance with federal, state and local requirements.
Domestic (Land, D.O.T.)
-----------------------
Proper Shipping Name: Toxic Solid, Organic NOS (2-Butanol, 4-(dimethylamino)-3-methyl-1,2-diphenyl-, propionate (ester), hydrochloride)
Hazard Class: 6.1
UN/NA: UN2811
Packing Group: III
Information reported for product/size: all sizes
--------\Chemical Inventory Status - Part 1\---------------------------------
Ingredient TSCA EC Japan Australia
----------------------------------------------- ---- --- ----- ---------
d-Propoxyphene hydrochloride (1639-60-7) Yes Yes No Yes
--------\Chemical Inventory Status - Part 2\---------------------------------
--Canada--
Ingredient Korea DSL NDSL Phil.
----------------------------------------------- ----- --- ---- -----
d-Propoxyphene hydrochloride (1639-60-7) No Yes No No
--------\Federal, State & International Regulations - Part 1\----------------
-SARA 302- ------SARA 313------
Ingredient RQ TPQ List Chemical Catg.
----------------------------------------- --- ----- ---- --------------
d-Propoxyphene hydrochloride (1639-60-7) No No No No
--------\Federal, State & International Regulations - Part 2\----------------
-RCRA- -TSCA-
Ingredient CERCLA 261.33 8(d)
----------------------------------------- ------ ------ ------
d-Propoxyphene hydrochloride No No No
(1639-60-7)
Chemical Weapons Convention: No TSCA 12(b): No CDTA: No
SARA 311/312: Acute: Yes Chronic: Yes Fire: No Pressure: No
Reactivity: No (Pure / Solid)
Australian Hazchem Code: None allocated.
Poison Schedule: S8
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.
NFPA Ratings: Health: 3 Flammability: 1 Reactivity: 0
Label Hazard Warning:
WARNING! HARMFUL IF SWALLOWED OR INHALED. AFFECTS CENTRAL NERVOUS SYSTEM. ALLERGEN. EXPOSURE MAY PRODUCE ALLERGIC RESPONSE. CAUSES IRRITATION TO EYES AND RESPIRATORY TRACT.
Label Precautions:
Avoid breathing dust.
Keep container closed.
Use with adequate ventilation.
Wash thoroughly after handling.
Label First Aid:
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 all cases call a physician.
Product Use:
Medication: Analgesic agent
Revision Information:
MSDS Section(s) changed since last revision of document include: 14.
Disclaimer:
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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.
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Prepared by: Environmental Health & Safety
Phone Number: (314) 654-1600 (U.S.A.)