Ingelvac 庐 2006-October-23
CircoFLEX鈩?
MATERIAL SAFETY DATA SHEET
1 PRODUCT AND COMPANY IDENTIFICATION
Product Name: Ingelvac庐 CircoFLEX鈩?
Product No. : N/A
MSDS ID# : N/A
GHS Product Identifier: Not applicable
Synonyms: Not applicable
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:
Vaccination of healthy, susceptible pigs 3
weeks of age or older as an aid in the reduction
of lymphoid depletion, inflammation and
colonization of lymphoid tissue, viremia, nasal
shedding of virus associated with Porcine
Circovirus Type 2 (PCV2).
2 HAZARDS IDENTIFICATION
Emergency Overview
Physical State: Liquid; Multi-dose vials: 10, 50, 100, 250, and 500 mL bottles. 1 mL per dose
Color: Clear-yellowish
Odor: None
WARNING!
For swine injection only.
Not for human use.
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.
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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 21 days before slaughter.
Overdosage: None known
ADVERSE REACTIONS TO PRODUCT: Anaphylactoid reactions may occur.
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 may
cause mild transient eye irritation.
Skin Contact: Not expected to be a hazard to the skin with prescribed use. Exposure to liquid
may cause mild transient skin irritation.
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).
Target Organ(s): Immune System
Potential Physical Effects: None known. This is an inactivated vaccine and there should be no
danger of reversion to virulence or potential for it to combine with field strains.
OSHA Regulatory Status: Non-hazardous, exempt
Environment: No data available
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3 COMPOSITION / INFORMATION ON INGREDIENTS
Chemical Name EC No. CAS- No. Concentration Classification Notes
Inactivated ---- ---- proprietary ---- ----
baculo-expressed
PCV2 ORf2
Additives ---- proprietary proprietary ---- ----
The components not listed are non-hazardous or below required disclosure limits.
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. 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 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
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6 ACCIDENTAL RELEASE MEASURES
Personal Precautions: Wear appropriate personal protective equipment.
Spill Cleanup Methods: Small liquid spill: Wipe up or 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 container closed. Store at 2掳-7掳 C (35掳-45掳 F). Do not freeze. Use entire contents
when first opened.
8 EXPOSURE CONTROLS / PERSONAL PROTECTION
For Industrial Exposures:
Exposure Limits:
Chemical Name Source Type Exposure Limits Notes
Inactivated ---- ---- N/A ----
baculo-expressed
PCV2 ORf2
Additives ---- ---- N/A ----
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:
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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
9 PHYSICAL AND CHEMICAL PROPERTIES
Color: Clear-yellowish
Odor: None
Odor Threshold: No data available
Physical State: Multi-dose vials: 10, 50, 100, 250, and 500 mL bottles. 1 mL per dose.
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: 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
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Chemical Name Test Results
Inactivated baculo- None available
expressed PCV2 ORf2
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: Proprietary Additive: 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.
RCRA Information: Not applicable
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
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Inventory Status
Inactivated baculo-expressed PCV2 ORf2 is not is listed on the following inventories: AICS
(Australia), TSCA (United States), DSL (Canada), IECSC (China), EINECS (Europe), ENCS
(Japan), KECI (Korea), ERMA (New Zealand), and PICCS (Philippines).
Proprietary additives are listed on the following inventories: AICS (Australia), IECSC (China),
KECI (Korea), ERMA (New Zealand), and PICCS (Philippines). One additive is not listed on
EINECS (Europe) but is listed as a common nomenclature of ingredients employed in cosmetic
products (INCI) as amended by Decision 2006/257/EC (OJ (L97)1, 5 Apr 2006). One additive is
not listed on TSCA, but it is classified under the TSCA polymer exemption. It is not listed on the
DSL (Canada) but is regulated under the Food & Drugs Act. One additive is not listed on ENCS
(Japan).
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
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
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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
This product has been reviewed and is classified and labeled as follows in full accord with EC
Directive 67/548 and all other current applicable amending Directives, including, but not limited
to, 91/155/EC, 1999/45/EC, 2001/58/EC and 2001/59/EC.
Not classified as hazardous
Handle in accordance with good industrial hygiene and safety practice.
References:
1. Ariel WebInsight Regulatory Database. Regulatory Summary for North America,
Western Europe, and Global Inventories Database.
2. Control of Porcine Circovirus Diseases (PCVDS) towards improved Food Quality
and Safety, www.pcvd.org.
3. GHS Manual
4. Ingelvac庐, CircoFLEX鈩? Product Label, Boehringer Ingelheim Vetmedica, Inc.
5. Launch of Joint PCVD Discussion Forum; www.thepigsite.com.
6. RTECS
7. Swine Health Fact Sheet, Circovirus Infection in Swine; October 2002.
Prepared by: Boehringer Ingelheim Vetmedica, Inc.
Issue Date: 10/23/06
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
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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