DiaDent Group International
Material Safety Data Sheet
DiaRoot庐 BioAggregate
January 1, 2007
1 - Identification
DiaRoot庐 BioAggregate
Trade Name
BioAggregate Root Canal Repair Filling Material
Synonyms
Root Canal Repair Material
Product Use
Manufacturer Distributor
Innovative BioCeramix Inc. DiaDent Group International
3650 Wesbrook Mall 11-3871 North Fraser Way
Vancouver, BC V6S 2L2 Canada Burnaby, BC V5J 5G6 Canada
Tel: 604-221-6800 Fax: 604-677-6129 Tel: 604-451-8851
604-221-6800 Fax: 604-451-8865
Emergency Contact
2 - Composition
BioAggregate Powder
DiaRoot BioAggregate Root Canal Repair Material is a fine white hydraulic powder cement-like material
intended for dental applications. This material is essentially hydraulic calcium silicates, calcium phosphate,
Description
amorphous silicon oxide and tantalum oxide, contained in a crystalline mass, not separable into individual
components.
Approximate Concentration (%)
Chemical Formula Major Compounds CAS #
3CaO路SiO2 Tricalcium silicate 12168-85-3 41
2CaO路SiO2 Dicalcium silicate 10034-77-2 24
Ta2O5 Tantalum pentoxide 1314-61-0 25
Ca(H2PO4)2 Calcium phosphate monobasic 7758-23-8 6
SiO2 Amorphous silicon oxide 7631-86-9 4
BioA Liquid
Chemical Formula Major Compounds CAS # Approximate Concentration (%)
H 2O Deionized water 7732-18-5 100%
Hazardous Ingredients
ACGIH TLV-TWA OSHA PEL OSHA PEL
(1995-1996) (8-hour TWA) (8-hour TWA)
Chemicals CSA #
Tricalcium silicate 12168-85-3
10mg/m3 total dust 10mg/m3 total dust 5 mg/m3 respirable dust
Dicalcium silicate 10034-77-2
10mg/m3 total dust 6mg/m3 6 mg/m3 respirable dust
Amorphous silicon oxide 7631-86-9 total dust
5mg/m3 total dust 5mg/m3 5mg/m3 total dust
Tantalum pentoxide 1314-61-0 total dust
Calcium phosphate
7758-23-8 Not listed Not listed Not listed
monobasic
Trace Ingredients
Trace amounts of naturally occurring potentially harmful constituents may be detected during chemical analysis.
Trade Name: DiaRoot BioAggregate MSDS DiaDent Group International
3 鈥? Health Hazards Identification 4 - First Aid Measures
Routes of Routes of
Effects First Aid Treatment
Entry Entry
Immediately flush eyes thoroughly with
Exposure to airborne dry powder or splashes of moist
running water for at least 15 minutes,
DiaRoot BioAggregate material may cause immediate or
Eyes Eyes including under the upper and lower
delayed effects ranging from eye irritation or inflammation to
eyelids to remove all particles. Seek
chemical burns and in severe instances, blindness.
medical aid.
鈥? Exposure to the dry powder and /or moist DiaRoot Flush skin thoroughly with running water
BioAggregate material may cause discomfort or pain and and pH-neutral skin soap or a mild
may cause a delayed response, and therefore cannot be detergent for at least 15 minutes. Remove
relied upon to alert a person to a hazardous skin exposure. any contaminated clothes and shoes. Seek
Skin Skin
medical aid if irritation or inflammation
鈥? Exposure may cause irritation, drying, cracking or
develops or persists. Seek immediate
fissuring of the skin. Prolonged exposure can cause severe
medical aid in the event of burns.
skin damage in the form of chemical (caustic) burns.
Exposure may cause irritation to the moist mucus membranes Remove from exposure and move to fresh
of the nose, throat and upper respiratory system. air immediately. Immediately seek
Inhalation Inhalation
Pre-existing upper respiratory and lung diseases may be medical aid if breathing is difficult,
aggravated. The effects may cause delayed lung injury. coughing persists or not breathing.
Do not induce vomiting. If conscious,
Exposure may cause internal discomfort or irritation to the
have the victim drink plenty of water.
Ingestion Ingestion
digestive tract.
Immediately seek medical aid.
Emergency Information
DiaRoot BioAggregate Root Canal Repair Material is a white powder and when it is in contact with moisture in eyes or on skin, or when
mixed with water, DiaRoot BioAggregate becomes highly caustic (pH >12) and will damage or burn (as severely as third-degree) the eyes or
skin. Inhalation may cause irritation to the moist mucous membranes of the nose, throat and upper respiratory system or may cause or
aggravate certain lung diseases or conditions. Use personal protection methods described in Section 8.
Carcinogenic Potential
Although the components used to manufacture DiaRoot BioAggregate Root Canal Repair Material are not listed as carcinogens by NTP.
OSHA or IARC; it may, however contain trace amounts of substances recognized as carcinogens by these organizations.
5 - Fire Fighting Measures
None Not combustible.
Conditions of Flammability: Auto-ignition Temperature:
Use water spray, dry chemical,
None
Means of Extinction: Hazardous Combustion Products:
carbon dioxide, or chemical foam.
None None
Flash Point: Unusual Fire and Explosion Hazards:
None None
Upper Flammable Limit: Danger of Explosion:
None None
Lower Flammable Limit: Special Fire Fighting Procedures:
National Fire Protection Association (NFPA) Ratings
1
Health: 0
Reactivity:
Flammability: 0 B
Personal Protective Equipment:
6 - Accidental Release Measures
Not required.
Person-Related Safety Precautions
Measures for Environmental
No special measures required.
Protection
鈥? Wear appropriate person protective equipment (see Section 8).
鈥? Use dry clean-up methods that do not disperse the powder into the air or entry into surface water
Measures for Cleaning of
and dispose of in a suitable container. Avoid inhaling or contacting the powder.
Accidental Release and Spills
鈥? Wipe or scrape up moist material with a moist paper towel and dispose of in a suitable container.
鈥? Do Not wash large amounts of powder or moist material down drains.
No dangerous substances are released
Additional Information
DiaRoot MSDS 01/07 Page 2 of 4
Trade Name: DiaRoot BioAggregate MSDS DiaDent Group International
7 鈥? Handling and Storage
鈥? Wear appropriate gloves to prevent skin exposure (PVC, PE, Natural Rubber or Nitrile gloves).
Information for Safe
Handling 鈥? Avoid inhaling the powder.
Handling Information About
No special measures required.
Protection Against
Explosions and Fires
Keep dry until used.
鈥?
Store at room temperature in a dry area.
鈥?
Storage Requirements Store in a tightly closed container.
鈥?
Store away from food and drinks.
鈥?
Do Not store near ammonia, ammonia nitrate, chlorine or chlorine containing items.
鈥?
8 鈥? Exposure Controls and Personal Protection
鈥? Wear safety glasses with side shields or goggles.
Eye Protection 鈥? Contact lenses should not be worn when working with DiaRoot BioAggregate Root Canal
Personal Repair Material.
Protective Wear appropriate gloves to prevent skin exposure (PVC, PE, Natural Rubber or Nitrile gloves).
Protection of Hands
Equipment
Light-weight protective clothing.
Body Protection
Surgical masks are recommended.
Respirators
9 - Physical and Chemical Properties
Solid (powder) Not applicable.
Physical State: Vapor Pressure (at 20掳C) (68掳F):
White Not applicable.
Color: Vapor Density:
No distinct odor. Not applicable.
Odor: Evaporation Rate:
Specific Gravity (H2O = 1.0): 3 to 4 >1000潞C (1800潞F)
Boiling/Melting Point:
12 to 13 Slightly soluble
pH (in water): Solubility in / Miscibility with Water:
10 - Stability and Reactivity
Product is stable. Keep dry until used.
Chemical Stability
Moist DiaRoot BioAggregate Root Canal Repair Material is alkaline. It is incompatible with acids,
Incompatibility
ammonia, ammonia nitrate, ammonium salts, aluminum metal and chlorine.
No dangerous reactions known.
Reactivity Conditions
Decomposition will not spontaneously occur.
Hazardous Decomposition
Will not occur.
Hazardous Polymerization
Avoid unintentional contact with water to prevent premature setting. Contact with BioA Liquid (deionized
Conditions to Avoid
water) or water to the powder will result in hydration and produces (caustic) calcium hydroxide.
11 - Toxicological Information
Cytotoxicity, mutagenicity and skin sensitization tests have been performed to ensure that DiaRoot BioAggregate Root Canal Repair
Material is safe for the indications for use described on the instructions for use.
Skin contact, eye contact, ingestion and inhalation. Non-mutagenic
Route of Entry: Mutagenicity:
Non-cytotoxic No allergic potential after multiple uses.
Skin Sensitization:
Cytotoxicity:
12 - Ecological Information
No known toxicity to plants or animals.
13 - Waste Disposal
鈥? Dispose of waste material according to regional and federal regulations.
鈥? Dispose of packaging in an approved landfill or incinerator.
14 - Transportation Information
No special precautions required.
DiaRoot BioAggregate Root Canal Repair Material is not hazardous under the Canada or U.S. Department of Transportation regulations.
DiaRoot MSDS 01/07 Page 3 of 4
Trade Name: DiaRoot BioAggregate MSDS DiaDent Group International
15 鈥? Regulatory Information
Status under Canadian Environmental
Not listed.
Protection Act
The major compounds of DiaRoot BioAggregate Root Canal Repair Material are on the
Status under Canadian DSL List
Canadian DSL List.
DiaRoot BioAggregate Root Canal Repair Material (major compounds) is considered to
contain hazardous materials under the hazardous Products Act as defined by the
Status under WHMIS
Controlled Products Regulations (Class E 鈥? Corrosive Material) and subject to the
requirements of WHMIS.
DiaRoot BioAggregate Root Canal Repair Material (major compounds) is considered to
Status under US OSHA Hazard
be 鈥渉azardous chemicals鈥? under this regulation and should be included in the employer鈥檚
Communication
hazard communication program.
Rule 29 CFR 1910.1200
Status under US CERCLA/Superfund,
Not listed.
40 CFR 117 and 302
DiaRoot BioAggregate Root Canal Repair Material (major compounds) qualifies as a
Hazard Category under US SARA (Title III),
鈥渉azardous substances鈥? with delayed health effects.
Section 311 and 312
Status under US SARA (Title III),
Not subject to reporting requirements under Section 313.
Section 313
Some substances in DiaRoot BioAggregate Root Canal Repair Material are on the TSCA
Status under US TSCA (as of May 1997)
inventory list.
DiaRoot BioAggregate Root Canal Repair Material (major compounds) is considered a
Status under the US Federal Hazardous
hazardous substance subject to statutes promulgated under the subject act.
Substances Act
This product may contain chemicals and heavy metals (trace), a substance known to the
State of California to cause cancer, birth defects or other reproductive harm. California
Status under California Proposition 65
law requires the manufacturer to give the above warning in the absence of definitive
testing to prove that the defined risk does not exist.
16 - Miscellaneous Information
DiaDent Group International
Prepared By/Date
January 1, 2007
Not applicable
Date of Previous MSDS
DiaRoot BioAggregate Root Canal Repair Material should be used according to the manufacturer鈥檚 instructions. DiaRoot BioAggregate
Root Canal Repair Material reacts chemically with BioA Liquid or water, and that specific intermediate products of this reaction (i.e.
calcium hydroxide, a common material used in dental procedures) is present only while the product is setting or curing,) can produce a more
severe hazard than does the dry BioAggregate powder.
This MSDS provides a useful summary of the hazards of DiaRoot BioAggregate Root Canal Repair Material as it is to be used for the
indications for use described in the instructions for use. Health and safety precautions in this MSDS may not be adequate for all individuals
or situations. Inexperienced product users or handlers should obtain proper training before using or packaging this product. Users have the
responsibility to comply with all laws and procedures applicable to the products鈥? safe handling and use, determine the suitability of the
product for its intended use, and understand possible hazards associated with mixing DiaRoot BioAggregate Root Canal Repair Material
with other materials.
The information provided herein is, to the best of our knowledge, believed by DiaDent Group International. to be accurate at the time of
preparation. However, the data is provided without any warranty, expressed or implied, regarding its correctness or accuracy. In no event
will DiaDent Group International. be responsible for damages of any nature resulting from the use of or reliance upon the information
contained herein.
DiaRoot MSDS 01/07 Page 4 of 4
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