MATERIAL SAFETY DATA SHEET
CompCore AF Stack & Flow Cartridge & SyringeMix; Base
Revision D EU acc. To ISO 11014
Last Revised: 12-March-2007
Approved for Use: 13-March-2007
1. Chemical Product and Company Identification
Product Name: CompCore AF Stack & Flow Cartridge & SyringeMix Nanofill Composite Dual-Cured
Core Build-up Material; Base
Manufacturer:
Premier Dental Products Company
1710 Romano Drive
Plymouth Meeting, PA 19462
Phone: 610-239-6000 Fax: 610-239-6171
2. Composition / Information on Hazardous Ingredients
Hazardous Ingredients CAS# Hazard Identification & Risk Phases
Bis-GMA 1565-94-2 N/E
Triethylenglycoldimethacrylate 109-16-0 Xi
Co-initiator 10287-53-3 Xi, R36/37/38
Photoinitiator 10373-78-1 Xi, R36/37/38
Dendritic Polymer 362603-93-8 N/E
Barium aluminoborosilicate glass 65997-17-3 N/E
Fumed Silica 7631-86-9 R36/37/38
Additional information: For the wording of the listed risk phrases refer to section 16.
3. Hazards Identification
Acute Health Hazards: May cause eye, respiratory and skin irritation in high concentration.
Chronic Health Hazards: Material is not known to cause significant health problems
Signs and Symptoms of Exposure: High concentrations can cause eye and respiratory irritation. Prolonged skin exposure
can cause dryness
Primary routes of exposure: Inhalation, skin contact, eye contact.
Carcinogenicity: NTP - no, OSHA - no, IARC 鈥? no.
4. First Aid Measures
In case of inhalation: If irritation occurs, take victim to open air. If breathing difficulty persists, consult a physician.
In case of skin contact: Wash with soap and water.
In case of eye contact: Flush with large quantities of water for 15 minutes. Consult a physician.
In case of ingestion: Consult a physician.
Page 1 of 4
5. Fire-Fighting Measures
Flash point: N/A
Extinguishing Media: Carbon dioxide, water spray, dry chemical
Special Fire Fighting Procedures: Avoid a direct jet of water.
Unusual Fire and Explosion Hazards: None.
6. Accidental Release Measures
Environmental Precautions: Avoid seepage into sewers and water supplies.
Clean-Up Procedure: Contain spill and pick up material with a suitable absorbent material. Place
absorbent into a container
for later disposal.
7. Handling and Storage
Handling: No special measures necessary if handled according to instruction
Storage: Keep container tightly closed when not in use. Store in a cool, dry location. Keep material in original packaging.
Storage away from light, open flames, contamination and prolonged storage above 24掳C (75掳F).
8. Exposure Controls / Personal Protection
Exposure Controls: Use only in well-ventilated areas
Respiratory Protection: Avoid inhalation of vapors. No special protection under normal use.
Hand and Skin Protection: Avoid unnecessary skin contact. Wear latex gloves when handling
Eye Protection: Wear safety goggles or safety glasses with side shields when handling,
Hygiene Measures: Remove spilled material from skin and clothing. Do not eat or drink when handling this material
9. Physical and Chemical Properties
Appearance: White paste / Gold-Yellow paste/ Blue paste.
Odor: Specific odor
Boiling Point: N/A
Evaporation Rate (Water = 1): N/A
Vapor Density (Air = 1): N/A
Solubility in Water: Insoluble
10. Stability and Reactivity
Stability: This material is stable.
Hazardous Reactions: None if handled according to directions
Hazardous Polymerization: May occur.
Conditions to Avoid: Heat, UV light
Incompatibility: Free radicals, reducing agents, heavy metal ions
Hazardous Decomposition Products: Carbon dioxide, water, carbon monoxide, acrylic decomposition products, depending
on conditions of heating and burning.
11. Toxicological Information
Acute oral toxicity: LD50 (rat) > 5000mg/KG
Irritation of Skin: Dryness and irritation possible upon prolonged exposure
Allergic Effects: Methacrylate sensitive individuals may exhibit an allergic reaction.
Page 2 of 4
12. Ecological Information
Do not discharge into sewers or water supplies
Environmental persistence and degradability: no data available
Ecotoxicity: no data available
13. Disposal Considerations
May be disposed of in landfill or Incinerator In accordance with local, state and federal regulations
14. Transport Information
14.1 Transport at land ADR RID
UN Number Kemler Number
Packing Group
Proper shipping name
14.2 Transport at sea ADNR IMDG
UN Number
EMS MFAG
Packing Group
Proper shipping name
14.3 Air transport ICAO / IATA-DGR
UN Number
Proper shipping name
Subsidiary Risk
Labels
Packing Group
U.S. DOT Shipping Name: Not Regulated
U.S. DOT Hazard Class: None
U.N./N.A. Number None
U.S. DOT Packing Group: None
Other: Not considered hazardous cargo
15. Regulatory Information
This product requires classification according to the criteria of EC.
The product is a medical device according to the EC-directive 93/42.
15.1 UN Number
15.2 National regulations
15.3 EU number
15.4 Hazard symbols
15.5 Hazard designation
15.6 Risk phrases
15.7 Safety phrases
U.S.-O.S.H.A. Status: This material is not hazardous under the criteria of the U.S Federal Hazard Communication Standard.
Page 3 of 4
16. Other Information
These data are based on our present knowledge. However, they shall not constitute a guarantee for any specific product
features and shall establish a legally valid contractual relationship.
Relevant R-phrases
22 Harmful if swallowed.
36/37/38 Irritating to eyes, respiratory system, and skin
Xi Irritant
Material should be maintained in original containers. Empty containers should not be re-used.
ANSI/NFPA 704 Data
Fire = 1
Health = 0
Reactivity = 0
Specific Hazard = None
This information is based on data considered accurate. However, no warranty is expressed or implied regarding the
accuracy of these data, or the results to be obtained from use thereof. In no event will the manufacturer or distributor be
responsible for damages of any nature whatsoever resulting from the use of, or reliance upon this information. General
properties described herein are to be regarded as guides and are not guaranteed for all samples.
030719 Rev2
Page 4 of 4
|