Acepromazine Maleate Tablets 2006-June-30
MATERIAL SAFETY DATA SHEET
1 PRODUCT AND COMPANY IDENTIFICATION
Product Name: Acepromazine Maleate Tablets
Product No.: NADA 117-532
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 and cats
2 HAZARDS IDENTIFICATION
Emergency Overview
Physical State: Solid, quarter scored tablets (0220 embossed on 10mg tablets and 0221
embossed on 25mg tablets)
Color: Pink -10mg; Yellow 鈥? 25mg
Odor: Odorless
WARNING!
Harmful if swallowed-For dog and cat oral use only.
Not for human use.
May cause drowsiness or dizziness.
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Precautionary Statements:
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: Sweep spilled substance into appropriate waste containers.
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.
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.
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:
A safety study using elevated dosages of Acepromazine Maleate Tablets demonstrated no adverse
reactions even when administered at three times the upper limit of the recommended daily dosage
(3.0 mg/lb body weight). The clinical observation for this high dose was mild depression which
disappeared in most dogs 24 hours after termination of dosing.
Overdose can cause 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.
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.
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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.
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. Contact with eye may
cause irritation.
Skin Contact: Can cause hypersensitive reactions.
Ingestion: Harmful. Ingestion may cause vomiting, nausea, dizziness, drowsiness or other
systemic effects.
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 Classification Notes
Acepromazine maleate 2227489 3598-37-6 10 mg tablet Xn; R22; R36 ----
25 mg tablet
Microcrystalline 2326749 9004-34-6 proprietary N/A ----
cellulose
Dextrose, 200075 50-99-7 proprietary N/A 25 mg
monohydrate, U.S.P. (glucose) tablets
only
Starch, pregelatinized 2326796 9005-25-8 proprietary N/A ----
(starch)
Magnesium stearate, 89040* 557-04-0 proprietary N/A ----
N.F
Dibasic calcium 2318261 7757-93-9 proprietary N/A 10 mg
phosphate dihydrate tablets
only
D & C Red Lake N/A mixture proprietary N/A 10 mg
Blend tablets
only
*EC Reference No.
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: Any material that contacts the eye should be washed out immediately with water.
If easy to do, remove contact lenses. Get medical attention if symptoms persist.
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.
Note to Physician: For animal use 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
TABLETS ARE BROKEN: Wear an approved respirator, eye protection, personal protective
coverings and gloves. Use HEPA filtered vacuum or wet sweeping to clean up spillage. Avoid
dust. Place spillage in appropriate container for waste disposal. Wash contaminated clothing
before use.
Environmental Precautions: Prevent runoff from entering drains, sewers or streams. Dike for
later disposal.
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7 HANDLING AND STORAGE
Handling: HANDLING SIGNIFICANT QUANTITIES OF BROKEN TABLETS: Avoid contact
with eyes, skin or clothing. Do not taste or swallow. Avoid generating dust. Wash hand
thoroughly after handling.
Storage: Keep only in the original container. Store at 15掳-30掳 C (59掳-86掳 F). Keep from light.
Store away from foodstuffs.
8 EXPOSURE CONTROLS / PERSONAL PROTECTION
Exposure Limits:
Chemical Name Source Type Exposure Notes
Limits
Acepromazine ----- ---- N/A ----
maleate
10 mg/m3
Cellulose, respirable OSHA Z-1 8-HR TWA Irritation
fraction
5 mg/m3
Cellulose, total dust OSHA Z-1 8-HR TWA Irritation
10 mg/m3
Cellulose Alberta 8-HR TWA Irritation
3 mg/m3
Cellulose, respirable British 8-HR TWA ----
fraction Columbia
10 mg/m3
Cellulose, total dust British 8-HR TWA ----
Columbia
10 mg/m3
Cellulose (paper Quebec 8-HR TWA ----
fibres), total dust
10 mg/m3
Cellulose Belgium 8-HR TWA ----
10 mg/m3
Cellulose France 8-HR TWA ----
4 mg/m3
Cellulose, respirable Ireland 8-HR TWA ----
dust
10 mg/m3
Cellulose, total Ireland 8-HR TWA ----
inhalable dust
10 mg/m3
Cellulose Italy 8-HR TWA ----
10 mg/m3
Cellulose Portugal 8-HR TWA ----
10 mg/m3
Cellulosa Spain 8-HR Daily ----
exposure limit
3 mg/m3
Cellulose, Switzerland TWA ----
poussi猫res
alv猫olaires
10 mg/m3
Cellulose, inhalable United TWA ----
dust Kingdom
10 mg/m3
Cellulose, respirable United TWA ----
dust Kingdom
Dextrose, ---- ---- N/A ----
monohydrate, U.S.P.
Dibasic calcium ---- ---- N/A ----
phosphate dihydrate
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D & C Red Lake
Blend ---- ---- N/A ----
10 mg/m3
Starch ACGIH 8-HR TWA Dermatitis, lung
5 mg/m3
Starch, respirable OSHA Z-1 PEL ----
fraction
15 mg/m3
Starch, total dust OSHA Z-1 PEL ----
10 mg/m3
Starch Alberta 8-HR TWA ----
3 mg/m3
Starch, (respirable British 8-HR TWA ----
fraction) Columbia
3 mg/m3
Starch, (total dust) British 8-HR TWA ----
Columbia
10 mg/m3
Starch (total dust) Ontario 8-HR TWA ----
10 mg/m3
Starch (total dust) Quebec 8-HR TWA ----
10 mg/m3
Starch Belgium 8-HR TWA ----
10 mg/m3
Starch (inhalable) Greece 8-HR TWA ----
5 mg/m3
Starch (respirable) Greece 8-HR TWA ----
4 mg/m3
Starch, respirable Ireland 8-hour OEL ----
dust (TWA)
10 mg/m3
Starch, total Ireland 8-hour OEL ----
inhalable dust (TWA)
10 mg/m3
Starch Italy 8-HR TWA ----
10 mg/m3
Starch Portugal 8-HR TWA ----
10 mg/m3
Starch Spain 8-hour Daily ----
Exposure Limit
3 mg/m3
Starch Switzerland TWA ----
4 mg/m3
Starch, respirable United TWA ----
Kingdom
10 mg/m3
Starch, total Untied TWA ----
inhalable Kingdom
3 mg/m3
Starch, (respirable British 8-HR TWA ----
fraction) Columbia
Starch, (total dust) British
10 mg/m3
Columbia 8-HR TWA ----
10 mg/m3
Starch (total dust) Ontario 8-HR TWA ----
10 mg/m3
Starch Quebec 8-HR TWA ---
10 mg/m3
Magnesium Stearate ACGIH 8-HR TWA Irritation
(generic group
name: stearates;
except stearates of
toxic metals)
10 mg/m3
Stearates (excluding Alberta 8-HR TWA ----
stearates of toxic
metal)
10 mg/m3
Stearates Belgium 8-HR TWA ----
10 mg/m3
Stearates Ireland 8-HR TWA ----
5 mg/m3
Stearates Italy 8-HR TWA ----
5 mg/m3
Stearates Netherlands 8-HR TWA ----
10 mg/m3
Stearates Portugal 8-HR TWA ----
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10 mg/m3
Stearates Spain 8-HR TWA ----
5 mg/m3
Stearates Sweden 8-HR TWA ----
Engineering Controls: Not generally required when handling containers or tablets. Good general
ventilation (typically 10 air changes per hour) should be used. Ventilation rates should be
matched to conditions. If operations involve crushing or other processes that may release powder,
use process enclosures, local exhaust ventilation, or other engineering controls to maintain
airborne levels below recommended exposure limits.
Respiratory Protection: Not generally required when handling containers or tablets. If
containers or tablets are broken and 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: Dust
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.
Hygiene Measures: Eye bath, washing facilities
9 PHYSICAL AND CHEMICAL PROPERTIES
Color: Pink: 10 mg tablet; Yellow: 25 mg tablet
Odor: Odorless
Odor Threshold: No data available
Physical State: Solid, quarter scored tablets (0220 embossed on 10mg tablets and 0221 on
25 mg tablets).
pH: No data available
Melting Point: No data available
Freezing Point: No data available
Boiling Point: No data available
Flash Point: No data available
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: Slight
Partition Coefficient (n-Octanol/water): No data available
Autoignition Temperature: Not applicable
Decomposition Temperature: No data available
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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
Listed Carcinogens: None
12 ECOLOGICAL INFORMATION
Ecotoxicity: No data available
Persistence and degradability: No data available
Mobility in soil: No data available
Other adverse effects: No data available
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
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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.
This material is not listed on the DSL Inventory.
US Regulations
FEDERAL LAW RESTRICTS THIS DRUG TO LICENSED VETERINARIANS.
State Regulations
California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): None
Massachusetts Right-To-Know List: Cellulose, Starch Dust
Minnesota Hazardous Substances List: Cellulose, Starch
New Jersey Right-To-Know List: None
Pennsylvania Right-To-Know List: Cellulose, Starch
European Regulations
Switzerland Toxins List 1: alpha-Hydroxytoluol: Toxicity Category: 4; Starch: Toxicity
Category: Not Categorized: G-8447; Calcium-Hydrogenphosphat: Toxicity Category: Not
Categorized: G-7156
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
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Xn - Harmful
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
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 Tablets. 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: 06/30/06
Supercedes Date: 3/29/05
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
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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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