Synonyms: Alfentanil Hydrochloride monohydrate; Propanamide, N-(1-(2-(4-ethyl-4,5-dihydro-5-oxo-1H-tetrazol-1-yl)ethyl)- 4-methoxymethyl)4-piperidinyl)-n-phenyl-, hydrochloride monohydrate; Alfentanil Hydrochloride ARS; Hydroxymethylpiperidine Alfentanil ARS; N-Acetyl Alfentanil ARS; Methoxymethylpiperidine Alfentanil ARS; Dipropionyl Alfentanil ARS
CAS No.: 70879-28-6
Molecular Weight: 471.07
Chemical Formula: C21H33ClN6O3.H20
Product Codes: 0620, 0622, 0625, 0626, 0628, 0682
Ingredient CAS No Percent Hazardous --------------------------------------- ------------ ------------ --------- Alfentanil hydrochloride 70879-28-6 100% Yes
Emergency Overview
--------------------------
DANGER! MAY BE FATAL IF SWALLOWED, INHALED OR ABSORBED THROUGH SKIN. POTENT NARCOTIC.
Potential Health Effects
----------------------------------
Described as being 20 to 30 times as potent as morphine, the human health effects associated with occupational exposure to Alfentanil hydrochloride are not well documented.
Inhalation:
Narcotic. Can irritate the respiratory passages and cause sneezing or coughing but will also have an anesthetic effect. Inhalation of appreciable quantities may produce lung edema, dizziness, and respiratory difficulties; large dose inhalation may result in respiratory arrest. See also Ingestion, below.
Ingestion:
Toxic! Narcotic. Human lethal dose probably 120-250 mg. In addition to its analgesic action, morphine may cause gastric disturbance with nausea, vomiting and constipation. Large amounts may cause central nervous system depression, respiratory or cardiac collapse, coma and death.
Skin Contact:
Absorption through intact skin may occur. Symptoms may parallel ingestion.
Eye Contact:
Mild irritant but will also have a strong narcotic effect (pupil constriction) and the eye may serve as an absorption route to the body in general.
Chronic Exposure:
Caution, may be habit forming.
Aggravation of Pre-existing Conditions:
Rare individuals may have prior hypersensitivity from clinical administration of fentanyl; such individuals should obtain competent medical advice regarding handling of fentanyl products.
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.
Note to Physician:
The principal sign of serious overdose to fentanyl include stupor and respiratory depression. Treatment for these effects due to fentanyl is the same as for overdose by other opioids: airway maintenance, ventilation support, and administration of a narcotic antagonist such as naloxone (NarcanŽ) beginning with 0.4 to 2 mg intravenously and repeating every three minutes as clinically indicated. Intramuscular or subcutaneous administration may be necessary if the intravenous route is not available.
Fire:
As with most organic solids, fire is possible at elevated temperatures or by contact with an ignition source.
Explosion:
Not considered to be an 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).
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.
Keep in a tightly closed container, stored in a cool, dry, ventilated area. Protect against physical damage. 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.
Alfentanil 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.
- Wear a P95 Dust/Mist respirator or a respirator supplying a higher level of protection until processes have been monitored to show that respiratory protection is not required.
- Ensure gloves are protective against solvents in use.
*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:
Alfentanil:
Occupational Exposure Guideline (OEG): 3ug/m3, as 8-hour time-weighted average
STEL: 9 ug/m3, as 15-minute average, Notation: Skin
Ventilation System:
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. See Section 7 for additional information on proper handling and venting requirements for potent compounds.
Personal Respirators (NIOSH Approved):
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.). 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. See Section 7 for additional information on proper handling and respirator recommendations for potent compounds.
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. See Section 7 for additional information on occupational control measures appropriate for OEB-3 potent compounds.
Appearance:
White granules or 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:
140.8C (286F)
Vapor Density (Air=1):
No information found.
Vapor Pressure (mm Hg):
No information found.
Evaporation Rate (BuAc=1):
No information found.
Stability:
Discolors on exposure to light.
Hazardous Decomposition Products:
Burning may produce carbon monoxide, carbon dioxide, nitrogen oxides.
Hazardous Polymerization:
Will not occur.
Incompatibilities:
No information found.
Conditions to Avoid:
No information found.
Intravenous rat LD50:47.5 mg/kg (Merck Index)
--------\Cancer Lists\------------------------------------------------------
---NTP Carcinogen---
Ingredient Known Anticipated IARC Category
------------------------------------ ----- ----------- -------------
Alfentanil hydrochloride No No None
(70879-28-6)
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-3 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, N.O.S.(Propanamide, N-[1-[2-(4-ethyl-4,5-dihydro-5-oxo-1H-tetrazol -1-yl)ethyl]-4-(methoxymethyl)-4-piperidinyl]- N-phenyl-, HCL
Hazard Class: 6.1
UN/NA: UN2811
Packing Group: II
Information reported for product/size: all sizes
--------\Chemical Inventory Status - Part 1\---------------------------------
Ingredient TSCA EC Japan Australia
----------------------------------------------- ---- --- ----- ---------
Alfentanil hydrochloride (70879-28-6) Exempt No No No
--------\Chemical Inventory Status - Part 2\---------------------------------
--Canada--
Ingredient Korea DSL NDSL Phil.
----------------------------------------------- ----- --- ---- -----
Alfentanil hydrochloride (70879-28-6) No No No No
--------\Federal, State & International Regulations - Part 1\----------------
-SARA 302- ------SARA 313------
Ingredient RQ TPQ List Chemical Catg.
----------------------------------------- --- ----- ---- --------------
Alfentanil hydrochloride (70879-28-6) No No No No
--------\Federal, State & International Regulations - Part 2\----------------
-RCRA- -TSCA-
Ingredient CERCLA 261.33 8(d)
----------------------------------------- ------ ------ ------
Alfentanil hydrochloride (70879-28-6) 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: 2XE
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: 4 Flammability: 1 Reactivity: 1
Label Hazard Warning:
DANGER! MAY BE FATAL IF SWALLOWED, INHALED OR ABSORBED THROUGH SKIN. POTENT NARCOTIC.
Label Precautions:
Do not breathe dust.
Do not get in eyes, on skin, or on clothing.
Keep container closed.
Use with adequate ventilation.
Wash thoroughly after handling.
Wear gloves and protective clothing.
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.
Revision Information:
MSDS Section(s) changed since last revision of document include: 8, 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.)