Alpha-7鈩? (7410.01) 2006-July-07
MATERIAL SAFETY DATA SHEET
1 PRODUCT AND COMPANY IDENTIFICATION
Product Name: Alpha-7鈩? Injection
Product No. : 7410.01
GHS Product Identifier: Not applicable
Synonyms: Clostridium Chauvoei-Septicum-Novyi-Sordellii-Perfringens Types C & D
Bacterin-Toxoid Vaccine
Molecular Formula: Mixture, not applicable
Molecular Weight: Not applicable
CAS Number: Mixture, not applicable
Chemical Family: Vaccine
Emergency Telephone:
Manufacturer: Transportation Emergency: (800) 424-9300
Boehringer Ingelheim Vetmedica, Inc.
2621 North Belt Hwy Medical Emergency (24HR): (800)530-5432
St. Joseph, MO 64506-2002
Non-emergency Telephone: (800) 821-7467
Intended Use:
Seven-way Clostridia Vaccine for healthy,
susceptible cattle, including bred heifers,
lactating beef and dairy cattle, against disease
caused by Clostiridium chauvoei, CI septicum,
CI novyi, CI sordellii, and CI perfringens
Types C and D.
2 HAZARDS IDENTIFICATION
Emergency Overview
Physical State: Liquid; Multi-dose vials: 20 mL (10 doses); 100 mL (50 doses); 500mL (250
doses)
Color: White
Odor: No data available
WARNING!
1/11
Alpha-7鈩? (7410.01) 2006-July-07
For cattle injection only.
Not for human use.
May cause allergic skin reaction.
Precautionary Statements:
Accidental human injection can cause serious local reactions or anaphylactic reaction and
systemic effects.
Keep only in original container.
Keep at a temperature not exceeding 7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.
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:
Swelling at injection site may occur.
Precautions/Contraindications:
Use entire contents when first opened. Do not vaccinate within 60 days of slaughter.
Overdosage: None known.
ADVERSE REACTIONS TO PRODUCT: Anaphylactoid reactions may occur.
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. May cause skin sensitization by contact.
Ingestion: Not expected to be an ingestion hazard with prescribed use. Ingestion may cause
vomiting, nausea or other systemic effects.
Injection: Swelling at injection site may occur.
Chronic Health Effects: Possible hypersensitization (development of abnormal sensitivity).
2/11
Alpha-7鈩? (7410.01) 2006-July-07
Target Organ(s): Immune System
Potential Physical Effects: Can cause skin sensitization.
OSHA Regulatory Status: Nonhazardous, exempt
Environment: No data available
3 COMPOSITION / INFORMATION ON INGREDIENTS
Chemical Name EC No. CAS- No. Concentration Classification Notes
Mineral oil 2323842 8012-95-1 55 ---- ----
Formaldehyde 2000018 50-00-0 .5 Xi, R43 ----
Gentamicin sulfate 2157789 1405-41-0 30 mcg/mL ---- ----
---- N/A proprietary ---- ----
Clostridium
chauvoei
---- N/A proprietary ---- ----
Clostridium
septicum
---- N/A proprietary ---- ----
Clostridium novyi
Clostridium
---- 68583-13-1 proprietary ---- ----
perfringens,
Type C
Clostridium
---- 68583-14-2 proprietary ---- ----
perfringens,
Type D
Deionized water 2317912 7732-18-5 proprietary ---- ----
Montanide 888 ---- mixture proprietary ---- ----
The full texts for all R-Phrases are displayed in Section 16.
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: In case of contact, immediately flush skin with plenty of water for at least 15
minutes while removing contaminated clothing and shoes. 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.
3/11
Alpha-7鈩? (7410.01) 2006-July-07
Injection: In case of accidental injection, wash the site thoroughly. Contact a physician
immediately.
Note to Physician: For animal injection only. Not for human use.
Antidote: Epinephrine is indicated for anaphylactoid reactions.
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.
Spill Cleanup Methods: Small liquid spill: Use a non-combustible material like vermiculite,
earth or sand to soak up the product and place into container for later disposal. For large liquid
spill: Absorb or cover with dry earth, sand or other non-combustible material and transfer to
containers.
Environmental Precautions: Prevent runoff from entering drains, sewers or streams. Dike for
later disposal.
7 HANDLING AND STORAGE
Handling: Avoid contact with eyes, skin and clothing. Avoid accidental injection. Wash
thoroughly with soap and water after handling. Use only with adequate ventilation.
Storage: Keep only in the original container. Store at 2掳-7掳 C (35掳-45掳 F). Avoid freezing. Keep
out of reach of children. Keep away from food, drink, and animal feedstuffs.
8 EXPOSURE CONTROLS / PERSONAL PROTECTION
For Exposures:
Exposure Limits:
4/11
Alpha-7鈩? (7410.01) 2006-July-07
Chemical Name Source Type Exposure Limits Notes
---- ---- N/A ----
Clostridium
chauvoei
---- ---- N/A ----
Clostridium
septicum
---- ---- N/A ----
Clostridium novyi
---- ---- N/A
Clostridium ----
perfringens,
Type C
---- ---- N/A ----
Clostridium
perfringens,
Type D
Formaldehyde ACGIH 8-HR TWA 0.3 ppm Irritation, cancer
Formaldehyde OSHA Action .75 ppm Cancer-suspect
Level agent
Formaldehyde Alberta 8-HR TWA .75 ppm Irritation
Formaldehyde British Columbia 8-HR TWA 0.3 ppm Capable of
causing
respiratory,
dermal or
conjunctival
sensitization.
Formaldehyde Ontario 8-HR TWA 1 ppm ----
Formaldehyde Quebec Ceiling 2 ppm ----
Exposure
Value
.06 mg/m3
Formaldehyde Austria MAK TWA Justifiably
List (Annex I) suspected of
carcinogenic
potential. Skin
absorption.
Sensitizer
0.38 mg/m3
Formaldehyde Belgium 15-minute Irritant
STEL
0.4 mg/ m3
Formaldehyde Denmark Ceiling ----
.37 mg/m3
Formaldehyde Finland 8-HR Limit ----
Formaldehyde France Short Term 1 ppm ----
Limit
(VLE)
2.5 mg/m3
Formaldehyde Greece 8-HR TWA ----
0.4 mg/ m3
Formaldehyde Iceland 8-HR TWA Allergenic
substance
2.5 mg/m3
Formaldehyde Ireland 8-HR TWA ----
Formaldehyde Italy Ceiling .3 ppm ---
limit
1.5 mg/m3
Formaldehyde Netherlands MAC TWA ----
0.6 mg/m3
Formaldehyde Norway TLV Allergenic
substance
Formaldehyde Portugal OELs 3 ppm Sensitizer,
5/11
Alpha-7鈩? (7410.01) 2006-July-07
suspected
human
carcinogen
.37 mg/m3
Formaldehyde Spain 15-minute ----
STEL
0.6 mg/m3
Formaldehyde Sweden Level Limit ----
Value
.37 mg/m3
Formaldehyde Switzerland TWA ----
2.5 mg/m3
Formaldehyde United Kingdom TWA ----
Montanide 888 ---- ---- N/A ----
5.0 mg/m3
Oil mist, mineral ACGIH 8-HR TWA Lung
5.0 mg/m3
Oil mist (mineral) OSHA PEL ----
5.0 mg/m3
Oil mist (mineral) Belgium 8-HR TWA ----
1 mg/ m3
Oil mist (mineral) Denmark 8-HR TWA ----
5.0 mg/m3
Oil mist (mineral) Finland 8-HR limit ----
Engineering Controls: Not generally required when handling vials or containers. Good
ventilation (typically 10 air changes per hour) should be used. Ventilation rates should be
matched to conditions. If applicable, use process enclosures, local exhaust ventilation, or other
engineering controls to maintain airborne levels below recommended exposure limits. If exposure
limits have not been established, maintain airborne levels to an acceptable level.
Respiratory Protection: Not generally required when handling vials or containers. 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 organic vapor respirator.
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: Wear protective clothing appropriate for the risk of exposure.
Hygiene Measures: Eye bath, washing facilities, shower
9 PHYSICAL AND CHEMICAL PROPERTIES
Color: White
Odor: Odorless
Odor Threshold: No data available
Physical State: Liquid; Multi-dose vials: 20 mL (10 doses); 100 mL (50); 500mL (250) doses
pH: No data available
Melting Point: No data available
Freezing Point: No data available
6/11
Alpha-7鈩? (7410.01) 2006-July-07
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: No data available
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
Formaldehyde Oral LD50 (rat): 100 mg/kg
Oral LD50 (rat): 500 mg/kg
Dermal LD50 (rabbit): 270 mg/kg
Inhalation TCLo (rat) : 40 ppm (effects on embryo or fetus:
fetotoxicity (except death, e.g., stunted fetus)
Oral LD50 (mouse): 500 mg/kg
Subcutaneous LD50 (mouse): 300 mg/kg
Eye irritation (rabbit): 10 mg: severe irritation
Eye irritation (human): 1ppm/6M rinse : mild irritation
Skin irritation (human): 150碌g/3D-I : mild irritation
Skin irritation (rabbit) 2mg/24hr: severe irritation
Gentamicin Sulfate Oral LD50 (rat): > 5,000 mg/kg
Oral LD50 (mouse): > 11,269 mg/kg
Intramuscular LD50 (rat): 245 mg/kg
Mineral Oil Oral LD50 (rat): 22 gm/kg
Eye Irritation (rabbit) : 500mg, moderate irritation
Skin Irritation (guinea pig) : 100mg/24hr, mild irritation
7/11
Alpha-7鈩? (7410.01) 2006-July-07
Listed Carcinogens
Chemical Name IARC NTP OSHA ACGIH
Formaldehyde 1 Anticipated Cancer-Suspect A2 鈥揝uspected
carcinogen Agent human carcinogen
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
Germany WGK: Formaldehyde: ID No: 112; Class: 2: 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.
RCRA Information: EPA Hazardous U-number Formaldehyde: U122, D001.
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
8/11
Alpha-7鈩? (7410.01) 2006-July-07
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.
Canada CEPA Schedule 1 - Formaldehyde
US Regulations
CERCLA Hazardous Substance List (40 CFR 302.4):
Component Reportable
Quantity
Formaldehyde 100 lbs
SARA Title III
Section 302Extremely Hazardous Substance (40 CFR 355, Appendix A):
Component Reportable Threshold
Quantity Planning
Quantity
Formaldehyde 100 lbs 500 lbs
Clean Water Act Section 311 Hazardous Substances (40 CFR 117.3): Formaldehyde
State Regulations
California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65):
Formaldehyde (gas)
Massachusetts Right-To-Know List: Oil mist, (mineral), Formaldehyde, Formalin
Minnesota Hazardous Substances List: Oil mist, (mineral), Formaldehyde
New Jersey Right-To-Know List: Mineral oil, Formaldehyde
Pennsylvania Right-To-Know List: Mineral oil mist, Formaldehyde
Rhode Island Right-To-Know List: Mineral oil, Formaldehyde
European Regulations
Austria MAK List (Annex I): Formaldehyde: Carcinogens Group IIIB (Justifiably suspected of
carcinogenic potential-Special danger of skin absorption).
Denmark (Annex 3.6, April 2005): Carcinogens: Formaldehyde
Germany (Dangerous Substances Ordinance 2004, Annex III): Formaldehyde
Norway (List of Dangerous Substance): Formaldehyde
Sweden (Sensitizers- Annex 3): Formaldehyde
Switzerland (Toxins List 1): Formaldehyde: Toxicity Category 3
16 OTHER INFORMATION
Hazard Ratings
Health Hazard Fire Hazard Reactivity Hazard
1* 0 0
HMIS
9/11
Alpha-7鈩? (7410.01) 2006-July-07
Health Hazard Fire Hazard Reactivity Hazard Special Hazard
1 0 0 N/A
NFPA
*- Chronic health effect; 0 鈥? Minimal; 1 鈥? Slight; 2 鈥? Moderate; 3 鈥? Serious; 4 鈥? Severe
Xi - Irritant
R43 - May cause sensitization by skin contact.
S24 - Avoid contact with skin.
S37 鈥? Wear suitable gloves.
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. Ariel WebInsight Regulatory Database. Regulatory Summary for North America,
Western Europe, and Global Inventories Database. Formaldehyde, Gentamycin and
Mineral Oil.
2. Alpha-7鈩? Product Label, Boehringer Ingelheim Vetmedica, Inc.
3. Alpha-7鈩? Clostridia Vaccine, Product Information.
www.bi-vetmedica.com/product_sites/Alpha7/reference.html
4. RTECS 鈥? Formaldehyde. RTECS No. LP8925000
5. RTECS - Gentamycin, sulfate. RTECS No. LY26225000
6. RTECS 鈥? Mineral Oil. RTECS No. PY8030000
7. Food & Drug Administration. www.fda.gov
8. GHS Manual
Revision Information: Updated all sections of the MSDS for ANSI, GHS and OSHA
Compliance.
Prepared by: Boehringer Ingelheim Vetmedica, Inc.
Issue Date: 07/07/06
Supercedes Date: 3/21/05
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
10/11
Alpha-7鈩? (7410.01) 2006-July-07
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.
11/11
|