Celupan
MSDS Number: NALID * * * * * Effective Date: 09/16/04 * * * * * Supercedes: 08/30/02
NALTREXONE HYDROCHLORIDE
1. Product Identification
Synonyms: 17-(cyclopropylmethyl)-4,5-epoxy-3, 14 dihydroxy-morphinan-6-one hydrochloride; narcotic antagonist; Naltrexone Hydrochloride ARS-(FOR R&D USE ONLY)
CAS No.: 16676-29-2
Molecular Weight: 377.46
Chemical Formula: C20H23NO4.HCl
Product Codes: 1170, 1477, 1479
2. Composition/Information on Ingredients
Ingredient CAS No Percent Hazardous --------------------------------------- ------------ ------------ --------- Naltrexone hydrochloride 16676-29-2 100% Yes
3. Hazards Identification
Emergency Overview
--------------------------
WARNING! HARMFUL IF SWALLOWED OR INHALED. CAUSES RESPIRATORY TRACT IRRITATION. CHRONIC EXPOSURE MAY AFFECT LIVER.
Potential Health Effects
----------------------------------
Inhalation:
Inhalation of dust can irritate the respiratory tract. Other symptoms may parallel those from ingestion.
Ingestion:
At therapeutic doses, may cause drowsiness, dizziness, cognitive impairment, anxiety, mood alteration, gastrointestinal pain, and nausea. At higher than therapeutic doses, may cause liver toxicity.
Skin Contact:
Not expected to cause any adverse health effects.
Eye Contact:
No adverse effects expected but dust may cause mechanical irritation.
Chronic Exposure:
Repeated ingestion may cause liver damage.
Aggravation of Pre-existing Conditions:
Produces acute withdrawal symptoms in individuals physically dependent on opiods. Persons with impaired kidney or liver function may be more susceptible to the effects of the substance.
4. First Aid Measures
Inhalation:
Remove to fresh air. Get medical attention for any breathing difficulty.
Ingestion:
If large amounts were swallowed, give water to drink and get medical advice.
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.
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. Follow handling guidance appropriate for OEB-2 potent compounds, (see Section 7).
6. Accidental Release Measures
Ventilate area of leak or spill. 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.
Spills: Carefully sweep up material into an appropriate container and save for reclamation or disposal. Do not flush to sewer!
7. Handling and Storage
Store at controlled room temperature 15-30C (59-86F). 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.
Naltrexone Hydrochloride 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.
8. Exposure Controls/Personal Protection
Airborne Exposure Limits:
Naltrexone hydrochloride:
Occupational Exposure Guidelines (OEG): 50ug/m3, as 8-hour time-weighted average
Short-term Exposure Guidelines (STEG): 500ug/m3, as 15-minute average.
Ventilation System:
A system of local and/or general exhaust is recommended to keep employee exposures below the Airborne Exposure Limits. 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):
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 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:
See Section 7 for additional information on occupational control measures appropriate for OEB-2 potent compounds.
9. Physical and Chemical Properties
Appearance:
White to slightly off-white powder or tablets.
Odor:
Odorless.
Solubility:
Soluble in water.
Specific Gravity:
ca. 1.3
pH:
No information found.
% Volatiles by volume @ 21C (70F):
No information found.
Boiling Point:
No information found.
Melting Point:
274 - 276C (525 - 529F)
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:
Nitrogen oxides, oxides of carbon as well as ionic or oxidized halogen.
Hazardous Polymerization:
Will not occur.
Incompatibilities:
Strong oxidizers.
Conditions to Avoid:
No information found.
11. Toxicological Information
Oral rat LD50:1450 mg/kg; oral mouse LD50: 1100 mg/kg; Investigated as a mutagen; Information in drug literature indicates this substance has been shown to have embryocidal effects in experimental animals at large doses.
Reproductive toxicity is not expected to occur under occupational conditions. Positive results in laboratory studies are not considered to be biologically relevant to humans.
--------\Cancer Lists\------------------------------------------------------
---NTP Carcinogen---
Ingredient Known Anticipated IARC Category
------------------------------------ ----- ----------- -------------
Naltrexone hydrochloride No No None
(16676-29-2)
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. 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.
14. Transport Information
Not regulated.
15. Regulatory Information
--------\Chemical Inventory Status - Part 1\---------------------------------
Ingredient TSCA EC Japan Australia
----------------------------------------------- ---- --- ----- ---------
Naltrexone hydrochloride (16676-29-2) Exempt Yes No No
--------\Chemical Inventory Status - Part 2\---------------------------------
--Canada--
Ingredient Korea DSL NDSL Phil.
----------------------------------------------- ----- --- ---- -----
Naltrexone hydrochloride (16676-29-2) No No No No
--------\Federal, State & International Regulations - Part 1\----------------
-SARA 302- ------SARA 313------
Ingredient RQ TPQ List Chemical Catg.
----------------------------------------- --- ----- ---- --------------
Naltrexone hydrochloride (16676-29-2) No No No No
--------\Federal, State & International Regulations - Part 2\----------------
-RCRA- -TSCA-
Ingredient CERCLA 261.33 8(d)
----------------------------------------- ------ ------ ------
Naltrexone hydrochloride (16676-29-2) 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 (Pure / Solid)
Australian Hazchem Code: None allocated.
Poison Schedule: S4
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. CAUSES RESPIRATORY TRACT IRRITATION. CHRONIC EXPOSURE MAY AFFECT LIVER.
Label Precautions:
Avoid breathing dust.
Keep container closed.
Use with adequate ventilation.
Wash thoroughly after handling.
Label First Aid:
If large amounts were swallowed, give water to drink and get medical advice. If inhaled, remove to fresh air. Get medical attention for any breathing difficulty.
Product Use:
Medication: Antagonist to Narcotics.
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.)