Solo-Jec庐 7 Plus 2007-April-04
MATERIAL SAFETY DATA SHEET
1 PRODUCT AND COMPANY IDENTIFICATION
Product Name: Solo-Jec庐 7 Plus
Product No. : Not applicable
MSDS ID# : Not applicable
GHS Product Identifier: Not applicable
Synonyms: ImmunoVax 7; Univac 7; Companion Vac 7; Spectra 7
Molecular Formula: Mixture, not applicable
Molecular Weight: Not applicable
CAS Number: Mixture, not applicable
Chemical Family: Vaccine
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:
For the vaccination of healthy, susceptible dogs
as an aid in the reduction of diseases caused by
Canine Distemper, Canine Adenovirus Type 1
and Type 2, Parainfluenza, Parvovirus,
Leptospira canicola, and L.
icterohaemorrhagiae.
2 HAZARDS IDENTIFICATION
Emergency Overview
Physical State: 1 dose vial of desiccated vaccine cake and 1 mL vial of vaccine diluent;
Packages: Individual bag with syringe 25 bags (doses) per display; Plastic tray with 25 doses-no
syringes
Color: No data available
Odor: No data available
WARNING!
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For use in dogs only.
Not for human use.
Severe allergic reactions can occur.
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 between 2 - 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: Vaccine may be given subcutaneously or intramuscular.
Contains attenuated strains of Canine Distemper, Canine Adenovirus Type 2 (CAV-2), Canine
Parainfluenza, and Canine Parvovirus Type 2b, propagated in cell line tissue cultures. The diluent
is Canine Parvovirus Vaccine-Leptospira Canicola-Iceterohaemorrhagiae Bacterin.
The CAV-2 fraction cross-protects against respiratory infection caused by infectious canine
hepatitis (CAV-1).
Do not vaccinate pregnant animals. Do not use in ferrets or mink. Protective immunity may not
be completely established in all puppies vaccinated at less than 16 weeks of age because of
maternal antibody interference. Only vaccinate healthy animals. Animals incubating any disease
or stressed due to shipping, malnutrition, or parasitism may not achieve or maintain an adequate
immune response. Use entire contents when first opened.
Overdosage: None known.
ADVERSE REACTIONS TO PRODUCT: Anaphylactoid reactions may occur but are rare.
Potential Health Effects
Inhalation: Not expected to be an inhalation hazard with prescribed use.
Eye Contact: Not expected to be a hazard to the eye with prescribed use. Exposure to liquid in
eye may cause mild eye irritation.
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Skin Contact: Not expected to be a hazard to the skin. Can cause hypersensitive reactions. May
cause skin sensitization by contact.
Ingestion: Not expected to be an ingestion hazard with prescribed use. Ingestion may cause
nausea and systemic effects.
Injection: Swelling at injection site may occur.
Chronic Health Effects: Possible hypersensitization (development of abnormal sensitivity).
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
---- ---- proprietary ----
Desiccated Vaccine ---
Cake:
Canine Distemper, Canine
Adenovirus Type 2 (CAV-
2), Canine Parainfluenza,
and Canine Parvovirus
Type 2b, propagated in
cell line tissue cultures
---- ---- proprietary ----
Diluent: ---
Canine Parvovirus
Vaccine-Leptospira
Canicola-
Icterohaemorrhagiae
Bacterin
Gentamicin sulfate 2157789 1405-41-0 proprietary ---- *
Amphotericin B 2157422 1397-89-3 proprietary ---- *
The full texts for all R-Phrases are displayed in Section 16, if applicable.
*Preservative
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.
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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.
Injection: In case of accidental injection, wash the site thoroughly. Contact a physician
immediately.
Note to Physician: For use in dogs only.
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. (See Section 8)
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: Store at 2掳-7掳 C (35掳-45掳 F). Avoid freezing. Store out of direct sunlight to protect
product integrity.
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8 EXPOSURE CONTROLS / PERSONAL PROTECTION
For Industrial Exposures:
Exposure Limits: None
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.
Europe: Wear appropriate personal protective equipment according to the Council
Directive 89/686/EEC (4) and the appropriate CEN standards.
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: No data available
Odor: No data available
Odor Threshold: No data available
Physical State: Liquid; 1 dose vial of desiccated vaccine cake and 1 mL vial of vaccine diluent;
Packages: Individual bag with syringe 25 bags (doses) per display; Plastic tray with 25 doses- no
syringes
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
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Vapor Density (Air=1): No data available
Specific Gravity: No data available
Solubility: Soluble in water
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: Temperatures below 2掳 C (35掳 F), direct sunlight
Incompatible Materials: Strong oxidizing agents
Hazardous Decomposition Products: None known
Possibility of Hazardous Reactions: Will not occur.
11 TOXICOLOGICAL INFORMATION
Specified Substances
Acute Toxicity: Product contains a modified live virus.
Gentamicin Sulfate Oral LD50 (rat): > 5,000 mg/kg
Oral LD50 (mouse): > 11,269 mg/kg
Intramuscular LD50 (rat): 245 mg/kg
Amphotericin B Oral LD50 (rat): > 5,000 mg/kg
Oral LD50 (mouse): 280 mg/kg
Intramuscular LD50 (rat): > 5,000 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
Germany WGK: Amphotericin B: Class 3: severely water-endangering
13 DISPOSAL CONSIDERATIONS
General Information: Dispose of in accordance with local, state and federal regulations.
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Disposal Methods: Incinerate containers and unused contents. Do not empty into drains; dispose
of this material and its container in a safe way. Do not contaminate water, food, or feed by
disposal.
RCRA Information: Not applicable
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.
This material is not listed on the DSL or European Inventory.
Canada CEPA Schedule 1 - None
US Regulations
CERCLA Hazardous Substance List (40 CFR 302.4): None
SARA Title III
Section 302Extremely Hazardous Substance (40 CFR 355, Appendix A): None
Clean Water Act Section 311 Hazardous Substances (40 CFR 117.3): None
State Regulations
California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): None
Massachusetts Right-To-Know List: None
Minnesota Hazardous Substances List: None
New Jersey Right-To-Know List: None
Pennsylvania Right-To-Know List: None
Rhode Island Right-To-Know List: None
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European Regulations
Austria MAK List (Annex I): None
Denmark (Annex 3.6, April 2005): None
Germany (Dangerous Substances Ordinance 2004, Annex III): None
Norway (List of Dangerous Substance): None
Sweden (Sensitizers- Annex 3): None
Switzerland (Toxins List 1): None
16 OTHER INFORMATION
Hazard Ratings
Health Hazard Fire Hazard Reactivity Hazard
1 0 0
HMIS
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.
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.
2. Product Label, Solo-Jec庐 7 Plus, Pharma International Inc.,Boehringer Ingelheim
Vetmedica, Inc.
3. Solo-Jec庐 7 Vaccine, Product Information. http://www.bi-
vetmedica.com/product_sites/SoloJec/documents/SoloJec7_rp.pdf
4. RTECS 鈥? Amphotericin B., BU2625000 Review Date, RTECS No. 200608
5. RTECS 鈥? Gentamycin sulfate, LY2625000 Review Date, RTECS No. 200611.
6. GHS Manual
Prepared by: Boehringer Ingelheim Vetmedica, Inc.
Issue Date: 04/04/07
Supercedes Date: New MSDS
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
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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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