Acepromazine Maleate 2006-July-05
Injection
MATERIAL SAFETY DATA SHEET
1 PRODUCT AND COMPANY IDENTIFICATION
Product Name: Acepromazine Maleate Injection
Product No.: NADA 117-531
GHS Product Identifier: Not applicable
Synonyms: Not available
Molecular Formula: Mixture, not applicable
Molecular Weight: Not applicable
CAS Number: Mixture, not applicable
Chemical Family: Phenothiazine Tranquilizer/Sedative
Manufacturer: Emergency Telephone:
Boehringer Ingelheim Vetmedica, Inc. Transportation Emergency: (800) 424-9300
2621 North Belt Hwy
St. Joseph, MO 64506-2002 Medical Emergency (24HR): (800)530-5432
Non-emergency Telephone: (800) 821-7467
Intended Use:
Tranquilization aid and preanesthetic agent in
dogs, cats and horses
2 HAZARDS IDENTIFICATION
Emergency Overview
Physical State: 50mL multidose vial of 10mg/mL sterile liquid
Color: Yellow
Odor: Odorless
WARNING!
Harmful if swallowed-For dog, cat and horse injection only.
Not for human use.
May cause drowsiness or dizziness.
Causes eye irritation.
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Precautionary Statements:
Accidental human injection can cause serious local reactions or anaphylactic reaction and
systemic effects.
Not for use in animals intended for food.
Keep only in original container.
Keep at a temperature not exceeding 30掳 C.
Fire-fighting: Use foam, carbon dioxide, dry powder and water fog or material appropriate for
surrounding fire.
Avoid contact with eyes, skin and clothing.
Wash thoroughly with soap and water after handling.
Wear suitable gloves and eye/face protection.
Spills: Cover with absorbent or contain. Collect and dispose.
In case of accident or if you feel unwell, seek medical advice immediately (show the label where
possible).
Have the product container or label with you when calling a poison control center or doctor, or
going for treatment.
If swallowed, seek medical advice immediately and show this container or label.
In case of contact with eyes, rinse immediately with plenty of water for at least 15 minutes. Get
medical attention.
This material and its container must be disposed of in a safe way.
Keep out of reach of children.
Keep away from food, drink, and animal feedstuffs.
Acute effect:
Hypotension can occur after rapid intravenous injection causing cardiovascular collapse.
Tranquilizers are potent central nervous system depressants and they can cause marked sedation
with suppression of the sympathetic nervous system.
May produce an additive action when given in conjunction with other depressants.
Will potentiate general anesthesia.
In horses, paralysis of the retractor penis muscle has been associated with the use of
phenothiazine derivative tranquilizers. The risk should be duly considered prior to administration
to male horses (castrated and uncastrated).
Accidental Intracarotid injection in horses can produce clinical signs ranging from disorientation
to seizures to death.
Precautions/Contraindications:
Should be avoided in pregnant or lactating animals. Should be used with caution in older animals,
animals with liver disease, heart disease, injury or debilitation. Should not be used in animals
with a history of epilepsy, those prone to seizures or those receiving a myelogram (lowers the
seizure threshold). Should not be used in animals with tetanus or strychnine poisoning. Use with
caution in giant dog breeds and greyhounds due to their increased sensitivity to acepromazine.
Overdosage:
Overdose can cause excessive sedation, slow respiratory and heart rate, pale gums, unsteady gait,
poor coordination, and inability to stand. May cause sudden collapse, unconsciousness, seizures
and death. Phenylephrine and norepinephrine are the drugs of choice to treat acepropmazine-
induced hypotension. Barbiturates or diazepam may be used for the treatment of seizures
associated with overdose.
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ADVERSE REACTIONS TO PRODUCT: May cause marked sedation with suppression of the
sympathetic nervous system. Can produce prolonged depression or motor restlessness when given
in excessive amounts or when given to sensitive animals. Idiosyncratic reactions may occur in
dogs following oral or parenteral administration. Symptoms include potentially serious adverse
reactions including behavioral disorders such as aggression, biting, chewing, and nervousness.
Penile paralysis is a recognized side effect of acepromazine in the horse. Should be avoided in
breeding stallions.
Potential Health Effects
Inhalation: Not expected to be an inhalation hazard.
Eye Contact: Not expected to be a hazard to the eye with prescribed use. Exposure to liquid in
eye may cause eye irritation.
Skin Contact: Can cause hypersensitive reactions.
Ingestion: Not expected to be an ingestion hazard with prescribed use. Harmful. Ingestion may
cause vomiting, nausea, dizziness, drowsiness or other systemic effects.
Injection: May cause drowsiness or dizziness.
Chronic Health Effects: Possible hypersensitization (development of abnormal sensitivity).
Target Organ(s): Central Nervous System
Potential Physical Effects: Decreases anxiety causes central nervous system depression, a drop
in blood pressure and heart rate.
OSHA Regulatory Status: Nonhazardous, exempt
Environment: No data available
3 COMPOSITION / INFORMATION ON INGREDIENTS
Chemical Name EC No. CAS- No. Concentration Classificatio Notes
n
Acepromazine maleate 2227489 3598-37-6 10mg/mL Xn; R22; ----
R36
Benzyl alcohol 2028599 100-51-6 1% Xn; R20/22 Norway
Sodium citrate,
dihydrate 2006753 6132-04-3 proprietary ---- ----
Citric acid,
monohydrate 2010691 5949-29-1 proprietary ---- ----
Water 2317912 7732-18-5 proprietary ---- ----
The full texts for all R-Phrases are displayed in Section 16.
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4 FIRST AID MEASURES
General: Animals or persons developing anaphylactic (life-threatening) reactions, such as
difficulty in breathing or unconsciousness, must receive immediate medical attention.
Inhalation: Move to fresh air. Treat symptomatically. Get medical attention if symptoms persist.
Eye Contact: Immediately flush with plenty of water for at least 15 minutes. If easy to do,
remove contact lenses. Get medical attention.
Skin Contact: Wash with soap and water. Get medical attention if symptoms occur.
Ingestion: Call a physician or poison control center immediately. Only induce vomiting at the
instruction of medical personnel. Never give anything by mouth to an unconscious person.
Injection: In case of accidental injection, wash the site thoroughly. Seek medical attention
immediately.
Note to Physician: For animal injection only. Not for human use. Epinephrine is contraindicated
for treatment of acute hypotension caused by phenothiazine derivative tranquilizers since further
depression of blood pressure can occur. Other pressor amines, such as norepinephrine or
phenylephrine are the drugs of choice. Barbiturates or diazepam may be used for the treatment of
seizures associated with overdose.
5 FIRE-FIGHTING MEASURES
Extinguishing Media: Extinguish with foam, carbon dioxide, dry powder and water fog or
material appropriate for surrounding fire.
Unsuitable Extinguishing Media: None known
Special Fire Fighting Procedures: Wear self-contained breathing apparatus and protective
clothing.
Unusual Fire & Explosion Hazards: None known
Hazardous Combustion Products: Carbon monoxide, carbon dioxide.
Flammability Class: 0
6 ACCIDENTAL RELEASE MEASURES
Personal Precautions: Wear appropriate personal protective equipment. (See Section 8).
Spill Cleanup Methods: STEPS TO BE TAKEN IF SIGNIFICANT QUANTITIES OF LIQUID
IS SPILLED: Eliminate all ignition sources. Wear an approved respirator, eye protection,
personal protective coverings and gloves. Use HEPA filtered vacuum or wet sweeping to clean
up spillage. Place spillage in appropriate container for waste disposal. Wash contaminated
clothing before use.
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Environmental Precautions: Prevent runoff from entering drains, sewers or streams. Dike for
later disposal.
7 HANDLING AND STORAGE
Handling: Avoid contact with eyes. Avoid accidental injection. Do not taste or swallow. Wash
thoroughly with soap and water after handling.
Storage: Keep only in the original container. Store at 15掳-30掳 C (59掳-86掳 F). Store away from
foodstuffs.
8 EXPOSURE CONTROLS / PERSONAL PROTECTION
Exposure Limits:
Chemical Name Source Type Exposure Limits Notes
Acepromazine ----- ---- N/A ----
maleate
Benzyl alcohol AIHA 8-HR TWA 10 ppm ----
5.0 mg/m3
Benzyl alcohol Bulgaria OELs ----
Regulation No.
13
Citric acid, ---- ---- N/A ----
monohydrate
Sodium citrate, ---- ---- N/A ----
dihydrate
Water ---- ---- N/A ----
Engineering Controls: Not generally required when handling containers or liquid. (See exposure
limits). Good general ventilation (typically 10 air changes per hour) should be used. Ventilation
rates should be matched to conditions.
Respiratory Protection: Not generally required when handling containers or liquid. If
engineering controls do not maintain airborne concentrations below recommended exposure
limits (where applicable) or to an acceptable level (in countries where exposure limits have not
been established), an approved respirator must be worn. In the United States of America, if
respirators are used, a program should be instituted to assure compliance with OSHA standard 63
FR 1152, January 8, 1998. Respirator type: NIOSH approved air-purifying respirator with an
appropriate, government approved (where applicable), air-purifying filter, cartridge, or canister.
PERSONAL PROTECTIVE EQUIPMENT: Not generally required when handling containers.
If containers are compromised or exposure to the active ingredient or mixture is likely wear:
Eye Protection: Wear safety glasses with side shields (or goggles).
Hand Protection: Wear suitable gloves.
Skin Protection: It is a good industrial hygiene practice to minimize skin contact.
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Hygiene Measures: Eye bath, washing facilities
9 PHYSICAL AND CHEMICAL PROPERTIES
Color: Yellow
Odor: Odorless
Odor Threshold: No data available
Physical State: 50mg 鈥? Multidose vial of 10mg/ml liquid
pH: ~ 5.3
Melting Point: No data available
Freezing Point: No data available
Boiling Point: 110掳 C (212掳F)
Flash Point: > 93掳C (200掳F)
Flammability Limit 鈥? Upper (%): No data available
Flammability Limit 鈥? Lower (%): No data available
Evaporation rate: No data available
Vapor Pressure: No data available
Vapor Density (Air=1): No data available
Specific Gravity: No data available
Solubility: Miscible
Partition Coefficient (n-Octanol/water): No data available
Autoignition Temperature: Not applicable
Decomposition Temperature: No data available
10 STABILITY AND REACTIVITY
Stability: Stable
Conditions to Avoid: None known
Incompatible Materials: Strong oxidizing agents
Hazardous Decomposition Products: None known
Possibility of Hazardous Reactions: Hazardous polymerization will not occur.
11 TOXICOLOGICAL INFORMATION
Specified Substances
Acute Toxicity
Chemical Name Test Results
Acepromazine maleate Oral LD50 (rat): 400 mg/kg
Intravenous LD50 (rat): 65 mg/kg
Oral LD50 (mouse): 270 mg/kg
Subcutaneous LD50 (mouse): 175 mg/kg
Benzyl alcohol Oral LD50 (rat): 1230 mg/kg
Oral LD50 (rat): 3100 mg/kg
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Oral LD50 (mouse): 1580 mg/kg
Listed Carcinogens: None
12 ECOLOGICAL INFORMATION
Ectotoxicity: No data available
Persistence and degradability: No data available
Mobility in soil: No data available
Other adverse effects: No data available
Germany WGK: Benzyl alcohol: ID No: 216; Class: 1: slightly water-endangering; Benzyl
alcohol: ID No: 216: Class 1: slightly water-endangering; Citric acid: ID 57: Class 1: slightly
water-endangering; Sodium citrate dihydrate: ID No: 2203; Class 1: slightly water-endangering;
13 DISPOSAL CONSIDERATIONS
General Information: Dispose of in accordance with local, state and federal regulations.
Disposal Methods: No specific disposal method required. Do not empty into drains; dispose of
this material and its container in a safe way. Do not contaminate water, food, or feed by storage
disposal.
Container: Since emptied containers retain product residue, follow label warnings even after
container is emptied.
14 TRANSPORT INFORMATION
DOT: Not regulated
TDG: Not regulated
ADR/RID: Not regulated
IATA: Not regulated
IMDG: Not regulated
15 REGULATORY INFORMATION
Canadian Controlled Products Regulations: This product has been classified according to the
hazard criteria of the Canadian Controlled Products Regulations, Section 33, and the MSDS
contains all required information.
WHMIS Classification: Noncontrolled, exempt
Inventory Status
This material is not listed on the US TSCA Inventory. Therefore, it can only be used for TSCA exempt
purposes such as R&D or veterinary use.
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This material is not listed on the DSL Inventory.
US Regulations
FEDERAL LAW RESTRICTS THIS DRUG TO LICENSED VETERINARIANS.
FDA Status: Benzyl alcohol GRAS
State Regulations
California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): None
Massachusetts Right-To-Know List: Benzyl alcohol
Minnesota Hazardous Substances List: Benzyl alcohol
New Jersey Right-To-Know List: None
Pennsylvania Right-To-Know List: Benzyl alcohol
European Regulations
Switzerland Toxins List 1: alpha-Hydroxytoluol: Toxicity Category: 4; Sodium citrate
dihydrate: Toxicity Category: None: possible sensitizer, carcinogenic potential.
16 OTHER INFORMATION
Hazard Ratings
Health Hazard Fire Hazard Reactivity Hazard
2 0 0
HMIS
Health Hazard Fire Hazard Reactivity Hazard Special Hazard
2 0 0 N/A
NFPA
*- Chronic health effect; 0 鈥? Minimal; 1 鈥? Slight; 2 鈥? Moderate; 3 鈥? Serious; 4 鈥? Severe
Xn - Harmful
R20 -Harmful by inhalation.
R22 - Harmful if swallowed.
R36 - Irritating to eyes.
S25 - Avoid contact with eyes.
S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical
advice.
S46 - In case of accident or if you feel unwell, seek medical advice immediately (show the label
where possible).
ABBREVIATIONS:
BIV - Boehringer Ingelheim Vetmedica, Inc.
AIHA- American Industrial Hygiene Association
mppcf 鈥? million particles/cubic foot
N/A - Not applicable.
N/E - Not established.
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References:
1. Freedom of Information Summary. ANADA 200-361. Acepromazine Maleate
Injection, Tranquilizer. Boehringer Ingelheim Vetmedica, Inc. April 2004.
www.fda.gov
2. Freedom of Information Summary. ANADA 200-319. Acepropmazine Maleate
Injection 10mg/mlPhoenix Scientific, Inc., St. Joseph, MO. March 25, 2003.
www.fda.gov
3. Acepromazine Maleate Injection and Tablets. Product Reference Information.
Boehringer Ingelheim Vetmedica, Inc. www.bi-vetmedica.com
4. Acepromazine Maleate Injection. Product Label. Boehringer Ingelheim Vetmedica,
Inc. www.bi-vetmedica.com
5. Ariel WebInsight Regulatory Database. Regulatory Summary for North America,
Western Europe, and Global Inventories Database. Benzyl Alcohol, Acepromazine
Maleate.
6. RTECS 鈥? Benzyl Alcohol. RTECS No. DN3150000
7. GHS Manual
Revision Information: Updated all sections of the MSDS for ANSI, GHS and OSHA
Compliance.
Prepared by: Boehringer Ingelheim Vetmedica, Inc.
Issue Date: 07/05/06
Supercedes Date: 3/15/05
Disclaimer: The information provided herein is offered by Boehringer Ingelheim Vetmedica,
Inc. (鈥淏IV鈥?) in good faith as accurate as of the date hereof, but without guarantee. This
information includes information which has been generated by other parties and provided to BIV,
and which BIV has not independently verified. The information provided herein relates only to
the specific product designated, and may not be valid where such product is used in combination
with any other materials or in any process. The information provided herein is offered solely for
your consideration, investigation and verification, and Boehringer Ingelheim Vetmedica, Inc.
(鈥淏IV鈥?) expressly disclaims all liability for reliance thereon. BIV EXPRESSLY DISCLAIMS
ALL WARRANTIES OF EVERY KIND AND NATURE (INCLUDING WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE) WITH RESPECT
TO THE USE OR SUITABILITY OF THE PRODUCT. In addition, since the conditions of use
and suitability of the product for particular uses are beyond BIV鈥檚 control, ALL RISKS OF USE
OF THE PRODUCT ARE THEREFORE ASSUMED BY THE USER, AND BIV EXPRESSLY
DISCLAIMS ANY AND ALL LIABILITY AS TO ANY RESULTS OBTAINED OR
ARISING FROM ANY USE OF THE PRODUCT. Use or transmission of the information
contained herein in any other format than the format as presented is strictly prohibited. Nothing
herein shall be construed as permission or recommendation for the use of the product in a manner
that might infringe an existing patent. BIV neither represents nor warrants that the format, content
or product formulas contained in this document comply with the laws of any other country except
the United States of America.
漏 Copyright 2001 Boehringer Ingelheim Vetmedica, Inc. All rights reserved.
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