MSDS Number: CODEI * * * * * Effective Date: 08/28/06 * * * * * Supercedes: 08/30/02 CODEINE SULFATE


CODEINE SULFATE


1. Product Identification

Synonyms: Methylmorphine sulfate trihydrate; Morphian-6-a-ol, 7,8-didehydro-4,5a-epoxy-3-methoxy-17-methyl-, sulfate (2:1) salt, trihydrate; Codeine Sulfate ARS-(For R&D Use Only)
CAS No.: 1420-53-7
Molecular Weight: 750.86
Chemical Formula: (C18H21NO3)2. H2SO4. 3H2O
Product Codes: 1322, 1566, 1580

2. Composition/Information on Ingredients


  Ingredient                                CAS No         Percent        Hazardous                                  
  ---------------------------------------   ------------   ------------   ---------   
 
  Codeine sulfate                           1420-53-7          100%          Yes                                                                 
 

3. Hazards Identification

Emergency Overview
--------------------------
DANGER! MAY BE FATAL IF SWALLOWED. HARMFUL IF INHALED OR ABSORBED THROUGH SKIN. ALLERGEN. EXPOSURE MAY PRODUCE ALLERGIC RESPONSE. NARCOTIC.

Potential Health Effects
----------------------------------

Inhalation:
Narcotic. Can irritate the nasal and respiratory surfaces. Sneezing and breathing difficulty can result. Inhalation of appreciable quantities may produce lung edema and typical symptoms of narcosis. See Ingestion, below.
Ingestion:
Narcotic, extremely toxic. Lethal dose for non-addicted human, 0.5-1 g. Can cause nausea, vomiting, constipation, dizziness, and central nervous system depression. Pin-point pupils, drop in blood pressure and possible convulsions may also be observed.
Skin Contact:
Mild irritant on prolonged contact or with moist or sensitive areas. Absorption through the skin with narcotic symptoms is possible.
Eye Contact:
Irritant and may cause narcotic effects, particularly pupil contraction, if absorbed.
Chronic Exposure:
May lead to habituation or addiction.
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:
No information found.
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.

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. 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. 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. CONTROLLED SUBSTANCE. Location of storage area must comply with all Drug Enforcement Agency regulations.

8. Exposure Controls/Personal Protection

Airborne Exposure Limits:
None established.
Ventilation System:
A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. 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.
Personal Respirators (NIOSH Approved):
For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator (NIOSH type N95 or better filters) may be worn. If oil particles (e.g. lubricants, cutting fluids, glycerine, etc.) are present, use a NIOSH type R or P filter. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator. WARNING: Air-purifying respirators do not protect workers in oxygen-deficient atmospheres.
Skin Protection:
Wear protective gloves and clean body-covering clothing.
Eye Protection:
Use chemical safety goggles. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures:
Allergic responses in sensitive individuals will disappear if removed from exposure.

9. Physical and Chemical Properties

Appearance:
White powder.
Odor:
Odorless.
Solubility:
3 g in 100 g of water.
Density:
1.35-1.4
pH:
No information found.
% Volatiles by volume @ 21C (70F):
No information found.
Boiling Point:
Not applicable.
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.

10. Stability and Reactivity

Stability:
Stable under ordinary conditions of use and storage. Darkens on exposure to air or light.
Hazardous Decomposition Products:
Toxic gases and vapors may be released if involved in a fire.
Hazardous Polymerization:
Will not occur.
Incompatibilities:
Alkalis, copper, iron or lead salts, alkaloid precipitants, ammonium chloride or bromide.
Conditions to Avoid:
No information found.

11. Toxicological Information


Codeine sulfate anhydrous: oral rat LD50: 430 mg/kg; oral mouse LD50: 395 mg/kg; investigated as a mutagen, reproductive effector.
  --------\Cancer Lists\------------------------------------------------------
                                         ---NTP Carcinogen---
  Ingredient                             Known    Anticipated    IARC Category
  ------------------------------------   -----    -----------    -------------
  Codeine sulfate (1420-53-7)             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. 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 - Part 1\---------------------------------
  Ingredient                                       TSCA  EC   Japan  Australia
  -----------------------------------------------  ----  ---  -----  ---------
  Codeine sulfate (1420-53-7)                     Exempt Yes   No       Yes                                       
 
  --------\Chemical Inventory Status - Part 2\---------------------------------
                                                          --Canada--
  Ingredient                                       Korea  DSL   NDSL  Phil.
  -----------------------------------------------  -----  ---   ----  -----
  Codeine sulfate (1420-53-7)                       No    No    No     No         
 
  --------\Federal, State & International Regulations - Part 1\----------------
                                             -SARA 302-    ------SARA 313------
  Ingredient                                 RQ    TPQ     List  Chemical Catg.
  -----------------------------------------  ---   -----   ----  --------------
  Codeine sulfate (1420-53-7)                No    No      No         No
 
  --------\Federal, State & International Regulations - Part 2\----------------
                                                        -RCRA-    -TSCA-
  Ingredient                                 CERCLA     261.33     8(d) 
  -----------------------------------------  ------     ------    ------
  Codeine sulfate (1420-53-7)                No         No         No      
 
 
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.

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. NARCOTIC.
Label Precautions:
Avoid breathing dust.
Avoid contact with eyes, skin and clothing.
Keep container closed.
Use with adequate ventilation.
Wash thoroughly after handling.
Label First Aid:
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. In all cases call a physician.
Product Use:
For FDA Regulated Use.
Revision Information:
MSDS Section(s) changed since last revision of document include: 5, 15. Removed "Not considered to be an explosion hazard" from section 5 because we don't have testing data to validate this statement - 08/28/2006 [CR].
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.)