Pulpdent Corporation Revision Date: July 1, 2008
Safety Data Sheet
According to Regulation (EC) No. 1907/2006 (REACH)
Trade Name: Pulpdent Root Canal Sealer
1.0 Commercial Product Name and Supplier
1.1 Commercial product name / Pulpdent Root Canal Sealer Powder and Liquid
designation
1.2 Application / Use Dental material for use by dental professional only.
1.2.2 SIC 851 Human health activity
1.2.3 Use Category 55
1.3 Manufacturer, Importer
Pulpdent Corporation
1.3.1 Manufacturer
80 Oakland Street
P.O. Box 780
Watertown, MA 02472 USA
Telephone: 1 617 9266666
Fax: 1 617 9266262
Email: Pulpdent@pulpdent.com
1.4 Emergency Telephone Number 18005355053 (24 Hour / USA)
1.5 Authorized European Representative International Business Solutions Ltd.
54 Mayfield Ridge
Hatch Warren, Basingstoke, RG22 4RS UK
Tel: 07989 407479 / Fax: 01256 350330
Email: scwcqc@globalnet.co.uk
2.0 Hazards Identification
2.1 Classification Irritant.
2.2 Adverse human health effects May be irritating to eyes, respiratory system and skin. Do not inhale
powder or vapor. May cause sensitization by inhalation or skin contact.
Swallowing liquid may be harmful.
3.0 Composition
3.1 Chemical characterization of the preparation: Twopart, zinc oxide / eugenol dental cement. Powder and liquid are
mixed together to initiate setting.
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Pulpdent Corporation Revision Date: July 1, 2008
Safety Data Sheet
According to Regulation (EC) No. 1907/2006 (REACH)
Trade Name: Pulpdent Root Canal Sealer
3.2 Hazardous ingredients
CAS Number EC Number Name of the Ingredient Concentration Warning symbol, R phrases
Powder 4060% Xi (irritant) R36/37/38
1314132 2152225 Zinc oxide
Note: Zinc oxide which is not freshly
formed, as in this product, is irritating
but not harmful when inhaled
Liquid 8595% Xi (irritant)
97530 2025891 Eugenol
[2Methoxy4(2 R22, R36/37/38, R42/43
propenyl) phenol]
4.0 First Aid Measures
4.1 Special Instructions Show this safety data sheet to medical personnel. Get medical
attention in case of uncertainty.
4.2 Inhalation Move to fresh air. If necessary, administer artificial respiration and seek
medical attention.
4.3 Skin Contact Wash skin thoroughly with soap and water.
4.4 Eye Contact Keep eyelids apart and flush with running water for 15+ minutes. Get
medical attention if irritation persists.
4.5 Ingestion Rinse mouth with water. Do not induce vomiting except on the advice of
physician. Get immediate medical attention. May be irritating to mucous
membranes.
4.6 Further Information Never give anything by mouth to an unconscious person.
5.0 Fire Fighting Measures
5.1 Suitable extinguishing media Foam, carbon dioxide and dry chemical. Water spray may be used to
keep fire exposed containers cool.
5.2 Extinguishing media to avoid Do not use direct water stream
5.3 Special exposure hazards in a fire Burning liberates carbon monoxide, carbon dioxide and smoke. As with
all unsaturated fats and oils, some porous materials (rags, insulation,
clay) when wetted with eugenol may undergo spontaneous combustion.
5.4 Special protective equipment for firefighters A selfcontained breathing apparatus should be worn by fire fighting
personnel. Cool exposed containers with water spray.
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Pulpdent Corporation Revision Date: July 1, 2008
Safety Data Sheet
According to Regulation (EC) No. 1907/2006 (REACH)
Trade Name: Pulpdent Root Canal Sealer
6.0 Accidental Release Measures
6.1 Personal precautions. Ventilate area. Wear gloves, lab coat and safety glasses.
6.2 Environmental precautions Contain spilled material. Follow all government regulations.
6.3 Method for clean up Powder should be carefully swept into dry, covered container. Avoid
raising dust. Rinse area with water.
Absorb Liquid with inert absorbent material (paper towels, etc.). Collect
for disposal in a covered container kept in a cool place. Wash area of
spill with detergent/soap and hot water. Rinse with hot water. Spills of
Root Canal Liquid are very slippery.
7.0 Handling and Storage
7.1 Handling For use only by dental professionals trained in their use. Follow good
hygiene practices. Do not smoke, eat or drink while using. Cap product
immediately after use.
7.2 Storage Keep containers tightly closed. Store each part in original container at
cool room temperature (<25 C) and in a dry, well ventilated area. Avoid
O
direct, strong light, sources of ignition and extremes of temperature.
May darken with age. Shelf life of unopened liquid is three years from
date of manufacture. Shelf life of the powder is five years from date of
manufacture. Shelf life is dependent on proper storage conditions.
7.3 Specific uses Dental material for use in endodontic procedures.
8.0 Exposure Controls / Personal Protection
8.1 Exposure limit values Zinc oxide: PEL: 5 mg/m . TLV: 10 mg/m .
3 3
2Methoxy4(2propenyl) phenol: Not available
8.2 Exposure controls
8.2.1 Occupational exposure controls No special equipment required under normal conditions of use of this
product in the quantity provided.
8.2.1.1 Respiratory protection None required. Good general ventilation is sufficient to control any
nuisance dust or airborne vapors during normal conditions of use.
8.2.1.2 Hand protection No special requirements. The usual surgical gloves worn by dental staff
will limit contact with uncured material.
8.2.1.3 Eye protection No special requirements other than the usual safety glasses worn by
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Pulpdent Corporation Revision Date: July 1, 2008
Safety Data Sheet
According to Regulation (EC) No. 1907/2006 (REACH)
Trade Name: Pulpdent Root Canal Sealer
dental staff.
8.2.1.4 Skin protection No special requirements. Good personal hygiene and safety practices
and wearing a lab coat should protect dental staff from unnecessary
exposure.
8.2.1.5 Other controls Emergency eye wash fountain should be available. Wash hands after
use.
8.2.2 Environmental exposure controls Powder is inert. Liquid should not be discharged into environment.
9.0 Physical and Chemical Properties
9.1 Appearance / Color Powder Liquid
Fine powder Oily liquid
9.1.1 Color White Colorless to pale yellow
9.1.2 Odor None Cloves
9.2 Important health, safety and environmental information
9.2.1 pH Not applicable 7.0
9.2.2 Boiling point Not applicable 253 C
o
9.2.3 Flash point Not applicable 110 C
o
9.2.4 Flammability (solid, gas) Not determined Not applicable
9.2.5 Explosive properties Not applicable Not applicable
9.2.6 Oxidizing properties Not determined Not an oxygen donor
9.2.7 Vapor pressure < 1 mm Hg / 133 Pa 0.1 mm Hg
9.2.8 Specific gravity 5.650 1.064
9.2.9 Solubility in water Nil
i Slight
N
Partition coefficient Not determined Not determined
9.2.10
Viscosity Not determined Not determined
9.2.11
Vapor density Not determined Not determined
9.2.12
Evaporation rate Not determined Not determined
9.2.13
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Pulpdent Corporation Revision Date: July 1, 2008
Safety Data Sheet
According to Regulation (EC) No. 1907/2006 (REACH)
Trade Name: Pulpdent Root Canal Sealer
10.0 Stability and reactivity
10.1 Conditions to avoid Heat (> 38 C), light, air.
o
10.2 Materials to avoid Powder: Strong oxidizing agents.
Liquid: Ferric chloride, Potassium permanganate.
10.3 Hazardous decomposition products Carbon monoxide and carbon dioxide.
10.4 Further information Eugenol is not pyrophoric, does not react with water, is not an
oxygen donor and is shock stable.
11.0 Toxicological information
11.1 Acute toxicity Not toxic. Minimal health hazard in the quantities present in this
product and under normal conditions of use.
11.2 Irritation and corrosiveness Both powder and liquid may be irritating to eyes, respiratory
system or skin on contact or with prolonged exposure.
11.3 Sensitization Liquid may be sensitizing. Prolonged or frequent inhalation or
skin contact may cause allergic reactions in some susceptible
individuals.
11.4 Subacute, subchronic and prolonged toxicity Prolonged exposure to large amounts of zinc oxide may cause
dermatitis unless good personal hygiene is practiced. Prolonged
exposure to powder or liquid may cause eye and respiratory
irritation.
11.5 Empirical data Not available
11.6 Other information None
12.0 Ecological Information
Ecotoxicity To the best of our knowledge, Root Canal Sealer Powder is
12.1
inert. Root Canal Sealer Liquid should not be discharged into
the environment.
13.0 Disposal Considerations
Regulations Follow all local and national government regulations in disposing
13.1
material or contaminated packaging.
14.0 Transport Information
14.1 Restrictions None. Not regulated.
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Pulpdent Corporation Revision Date: July 1, 2008
Safety Data Sheet
According to Regulation (EC) No. 1907/2006 (REACH)
Trade Name: Pulpdent Root Canal Sealer
15.0 Regulatory Information
15.1 Information on the warning label
Hazard symbol Xi
15.1.1
Hazardous ingredient Zinc oxide
15.1.2
2Methoxy4(2propenyl) phenol [Eugenol]
15.1.3 Risk phrases R22, Harmful if swallowed
R36, Irritant to eyes.
R37, Irritant to respiratory system.
R38, Irritant to skin.
R42/43, Sensitizing by inhalation or skin contact.
15.1.4 Safety phrases S26: In case of contact with eyes, rinse immediately with plenty
of water and seek medical advice.
S36: Wear suitable protective clothing.
S3/9/49: Keep only in the original container in a cool, well
ventilated place.
16.0 Other information
16.1 List of relevant R phrases See above
16.2 Training advice Root Canal Sealer is for use only by dental professionals.
16.3 Restrictions on use Root Canal Sealer is for use only by dental professionals
16.4 Further information The information presented herein is believed to be factual as it
has been derived from the works of persons believed to be
qualified experts. However, nothing contained in this information
is to be taken as a warranty or representation for which Pulpdent
Corporation bears legal responsibility. The user should review
any recommendations in the specific context of the intended use
to determine whether they are appropriate.
16.5 Sources of key data National Institute for Occupational Safety (NIOSH)
Occupational Safety and Health Administration (OSHA)
EurLex European Union Law
16.6 Information which has been added, deleted or This Safety Data Sheet has been revised to meet the
revised. requirements of Commission Directive 2001/58/EC.
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