DOXYLAMINE SUCCINATE

MSDS Number: D8882 --- Effective Date: 12/08/96


1. Product Identification

Synonyms: 2-[alpha-(2-dimethylaminoethoxy)-alpha-methylbenzyl] pyridine, succinate
CAS No.: 562-10-7
Molecular Weight: 388.51
Chemical Formula: C17H22N2O.C4H6O4
Product Codes: 6907, 7079

2. Composition/Information on Ingredients


  Ingredient                                CAS No         Percent   Hazardous                                       
  ---------------------------------------   ------------   -------   ---------        
 
  Doxylamine Succinate                      562-10-7         100%       Yes                                                               
 

3. Hazards Identification

Emergency Overview
--------------------------
WARNING! HARMFUL IF SWALLOWED OR INHALED. MAY CAUSE IRRITATION TO SKIN, EYES, AND RESPIRATORY TRACT. AFFECTS THE LIVER. MAY FORM COMBUSTIBLE DUST CONCENTRATIONS IN AIR.

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

Inhalation:
Inhalation of dust may produce drowsiness. Other symptoms paralleling ingestion are expected.
Ingestion:
Toxic. Symptoms may include headache, nausea, drowsiness, dryness of the mouth and nervousness. Symptoms from larger doses vary and may include disorientation, staggering, tremors, convulsions and coma. Estimated fatal dose: 50-500 mg/kg in humans.
Skin Contact:
May cause irritation.
Eye Contact:
May cause irritation.
Chronic Exposure:
Overexposure has shown degradation of the liver and tumors.
Aggravation of Pre-existing Conditions:
No information found.

4. First Aid Measures

Inhalation:
Remove to fresh air. Get medical attention for any breathing difficulty.
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:
Wash thoroughly with running water. Get medical advice if irritation develops.

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. Minimum explosive concentration: 0.09 oz/ft3. Minimum ignition temperature: 310C (590F).
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

Remove all sources of ignition. Ventilate area of leak or spill. Wear appropriate personal protective equipment as specified in Section 8. Spills: Clean up spills in a manner that does not disperse dust into the air. Use non-sparking tools and equipment. Reduce airborne dust and prevent scattering by moistening with water. Pick up spill for recovery or disposal and place in a closed container.

7. Handling and Storage

Store in a tightly closed container. Avoid dust formation and control ignition sources. Employ grounding, venting and explosion relief provisions in accord with accepted engineering practices in any process capable of generating dust and/or static electricity. Empty only into inert or non-flammable atmosphere. Emptying contents into a non-inert atmosphere where flammable vapors may be present could cause a flash fire or explosion due to electrostatic discharge. 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.

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 the dust or mist is apparent, a half-face dust/mist respirator may be worn. 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:
Safety glasses. Maintain eye wash fountain and quick-drench facilities in work area.

9. Physical and Chemical Properties

Appearance:
White to off-white powder.
Odor:
Characteristics.
Solubility:
1g/1ml (water)
Specific Gravity:
No information found.
pH:
4.9 - 5.1 (1% aqueous solution)
% Volatiles by volume @ 21C (70F):
0
Boiling Point:
No information found.
Melting Point:
103 - 108C (217 - 226F)
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.
Hazardous Decomposition Products:
Burning may produce carbon monoxide, carbon dioxide, nitrogen oxides.
Hazardous Polymerization:
Will not occur.
Incompatibilities:
Strong oxidizers.
Conditions to Avoid:
Heat, dusting and incompatibles.

11. Toxicological Information


Oral mouse LD50: 470 mg/kg; Investigated as a tumorigen, mutagen, reproductive effector.
  --------\Cancer Lists\------------------------------------------------------
                                         ---NTP Carcinogen---
  Ingredient                             Known    Anticipated    IARC Category
  ------------------------------------   -----    -----------    -------------
  Doxylamine Succinate (562-10-7)         No          No            None

12. Ecological Information

Environmental Fate:
No information found.
Environmental Toxicity:
No information found.

13. Disposal Considerations

Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. 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
  -----------------------------------------------  ----  ---  -----  ---------
  Doxylamine Succinate (562-10-7)                 Exempt Yes   No       Yes                                       
 
  --------\Chemical Inventory Status - Part 2\---------------------------------
                                                          --Canada--
  Ingredient                                       Korea  DSL   NDSL  Phil.
  -----------------------------------------------  -----  ---   ----  -----
  Doxylamine Succinate (562-10-7)                   Yes   No    No     No                              
 
  --------\Federal, State & International Regulations - Part 1\----------------
                                             -SARA 302-    ------SARA 313------
  Ingredient                                 RQ    TPQ     List  Chemical Catg.
  -----------------------------------------  ---   -----   ----  --------------
  Doxylamine Succinate (562-10-7)            No    No      No         No
 
  --------\Federal, State & International Regulations - Part 2\----------------
                                                        -RCRA-    -TSCA-
  Ingredient                                 CERCLA     261.33     8(d) 
  -----------------------------------------  ------     ------    ------
  Doxylamine Succinate (562-10-7)            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: No information found.
Poison Schedule: No information found.
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: 1 Flammability: 1 Reactivity: 0
Label Hazard Warning:
WARNING! HARMFUL IF SWALLOWED OR INHALED. MAY CAUSE IRRITATION TO SKIN, EYES, AND RESPIRATORY TRACT. AFFECTS THE LIVER. MAY FORM COMBUSTIBLE DUST CONCENTRATIONS IN AIR.
Label Precautions:
Avoid breathing dust.
Wash thoroughly after handling.
Keep container closed.
Avoid dust cloud in presence of an ignition source.
Use with adequate ventilation.
INTENDED FOR FDA APPROVED USE ONLY.
NOT ON THE TSCA INVENTORY.
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. Get medical attention for any breathing difficulty. 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:
Medication: Antihistaminic For Food and Drug or Research and Development use
Revision Information:
New 16 section MSDS format, all sections have been revised.
Disclaimer:
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Mallinckrodt Baker, Inc. 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 BAKER, INC. 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 BAKER, INC. WILL NOT BE RESPONSIBLE FOR DAMAGES RESULTING FROM USE OF OR RELIANCE UPON THIS INFORMATION.
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Prepared by: Strategic Services Division
Phone Number: (314) 539-1600 (U.S.A.)