DENTSPLY/International
DENTSPLY/Caulk
Safety Data Sheet 526385
1. Identification
Product Name SDS Code Number
?br>
Reprosil Impression Material 526385
Substance Identity Date of Last Revision
?br>
Reprosil Vinyl Polysiloxane Impression Material 07/24/09
Manufacturer: Address
DENTSPLY Caulk 38 West Clarke Avenue
Milford DE 19963-1805
http://www.caulk.com
http://www.dentsply.com
Grades or Minor Variant Identities Information Telephone Number
(302) 422-4511 (8:00 AM ?4:30 PM Eastern Time)
Light Body, Regular Body, Heavy Body, Putty, Quixx
Putty
Product Use (for Canada) Emergency Telephone Number
(302) 422-4511 (8:00 AM ?4:30 PM Eastern Time)
Dental Bite Registration Material
2. Hazard(s) Identification
WARNING
MAY CAUSE AN ALLERGIC SKIN REACTION
3. Composition/Information on Ingredients
Hazardous Components C.A.S. Number Exposure Limits %
3
Silicon Dioxide - Amorphous 7631-86-9 0.05 mg/m < than 30
0.05 mg/m3
Silicon Dioxide -Crystalline 14464-46-1 < than 30
10 mg/m3
Calcium Sulfate 7778-18-9 < than 15
10 mg/m3
Hydrophobic Amorphous Fumed Silica 68909-20-6 < than 10
10 mg/m3
Titanium Dioxide 13463-67-7 < than 5
Colorant Information The base pastes may contain fluorescent organic dyes and/or ultramarine pigments.
The Chemical structure of all Ultramarine pigments, regardless of color, is Sodium Aluminosulfosilicate.
4. First Aid Measures
Routes of First Aid Instructions Immediate Delayed Effects
Exposure Medical Attention
Eye Rinse opened eye for several minutes under running water. If Not Applicable Not Applicable
symptoms persist consult physician
Skin Immediately wash with soap and water and rinse thoroughly Not Applicable Not Applicable
Inhalation Supply fresh air, consult physician if symptoms persist Not Applicable Not Applicable
Ingestion If symptoms persist consult physician Not Applicable Low order of toxicity is expected when large
amounts of material are ingested. Acute
toxicology study in rats LD50 >2,000mg/kg.
Other Not Applicable Not Applicable Not Applicable
Note to Physicians (Treating, Testing and Monitoring): Treat symptomatically.
5. Fire Fighting Measures
Flame Propagation or Burning Rate Properties Contributing to Fire Intensity: Flammability Classification: Not Applicable Other: Not Applicable
(for Solids): Not Applicable Not Applicable
Extinguishing Media: CO2, extinguishing powder, foam carbon dioxide or water Extinguishing Media to Avoid: Water with full jet.
spray. Fight larger fires with water spray or alcohol resistant foam.
Protection and Procedures for Firefighters: Firefighters should wear self-contained respiratory protective devices.
Unusual Fire and Explosion Hazards: No dangerous decomposition products known. - Product does not present an explosion hazard.
6. Accidental Release Measures
Containment Techniques: Material is a paste and as such will not flow.
Spill/Leak Clean-up Procedures and Equipment: Wear protective clothing and scoop up bulk material and place in a labeled plastic or metal container.
Avoid gross skin contact to minimize the possibility of contact dermatitis to susceptible persons. Ensure adequate ventilation.
Evacuation Procedures: Not Applicable Special Instructions: Not Applicable Reporting Requirements: Not Applicable
7. Handling and Storage
Handling Practices and Warnings: Product is intended for dental use only. Handling of this product should be by trained dental healthcare professionals only.
Observe normal care for working with chemicals.
Storage Practices and Warnings: Store only in the original package. Keep package tightly sealed. Store in a dry area. Protect from exposure to direct light. Store
away from food and beverages.
8. Exposure Control / Personal Protection
Individual Protection Personal Protective Equipment for Normal Use Personal Protective Equipment for
Measures Emergencies
Eye/Face Safety Glasses Not Applicable
Skin The glove material has to be impermeable and resistant to the product. Not Applicable
Inhalation Not Required Not Applicable
Body Protection Protective work clothing Not Applicable
Occupational Exposure Limits: Not Applicable Engineering Controls: Not Applicable
9. Physical and Chemical Characteristics
Appearance: Various colored pastes, may be high viscosity paste or runny. Catalyst is grey-colored. Odor: Characteristic sweet ester odor.
Normal Physical State: Material is available in several viscosities. It varies from a very high viscosity liquid Melting Point: Not Applicable
(Paste) to a more runny material.
Specific Gravity: Varies from 1.2 g/cm3 to 1.5 g/cm3 Solubility in Water: Not soluble pH: Not Applicable
Vapor Pressure (mm Hg): Not Applicable Vapor Density (AIR=1): Not Applicable Evaporation Rate (Butyl Acetate =1): N A
Flashpoint Method: Not Applicable Flammable (Explosive) Limits in Air Autoignition Temperature: Not Applicable,
LEL: Not Applicable UEL: Not Applicable Product will not autoignite.
Other: Not Applicable
10. Stability and Reactivity Data
Incompatibility (Materials to Avoid): Strong oxidizing materials.
Hazardous Products Produced During Decomposition: No dangerous decomposition products known if used according to Directions for Use.
Hazardous Polymerization: May Occur May Not Occur Conditions to Avoid: None known
Stability? Stable Unstable Conditions to Avoid: None known
11.Toxicological Information
Toxicity Data, Epidemiology Studies, Carcinogenicity, Neurological Effects, Genetic Effects, Reproductive Effects, or Structure Activity Data:
Product may irritate the skin and mucous membranes. The unpolymerized product may cause irritation to the skin in susceptible persons. On the eye the
product has an irritating effect. Sensitization: No sensitizing effects known.
Emergency Overview: Material may be mildly irritating to eyes.
Routes of Single, Repeated, or Severity (Mild, Acute and Chronic Health Effect(s)
Exposure Signs and Symptoms Lifetime Exposure Moderate, Severe) Target Organ(s)
Eye Material can cause irritation. Single Moderate Irritation and possible corneal damage Not Applicable
Skin Material may be an irritant Single & Repeated Moderate Irritation or possible allergic response. Not Applicable
Inhalation Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable
Ingestion Material is probably not Not Applicable Mild Low order of toxicity is expected when Not Applicable
harmful if swallowed large amounts of material are ingested.
Acute toxicology study in rats LD50
>2,000mg/kg.
Other Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable
Medical Conditions Aggravated by Exposure Open sores and wounds of the skin.
Carcinogenicity NTP?: Not listed IARC monographs?: Not listed OSHA regulated?: No All components of this product are in
compliance with the inventory listing Requirements of the U. S. Toxic Substances Control Act (TSCA) Chemical Substance Inventory.
Potential Environmental Effects Do not allow to enter sewers/ surface or ground water.
NFPA Hazard Classification Ratings (Scale 0-4), Health = 0, Fire = 1, Reactivity = 0
12.Ecological Information
Toxicity Data, Environmental Fate, Physical/Chemical Data, or other Data Supporting Environmental Hazard Statements: Water Hazard class1 (Self-
assessment): slightly hazardous for water. Do not allow undiluted product or large quantities of it to reach ground water, water streams or sewage system.
13.Disposal Considerations
Regulations: Must not be disposed of together with household garbage. Do not allow product to reach sewage system.
Dispose of material as solid waste in a closed container. Dispose of in accordance with Federal, State and Local regulations
Properties (Physical/Chemical) Affecting Disposal: Dispose of material as solid waste in a closed container.
14.Transport Information
Regulated for Shipping: No. Not Regulated DOT Shipping Name: Not Regulated Packing Group: Not Applicable
Do Changes in Quantities, packaging, or shipment DOT Hazard Class: Not Applicable UN Number: Not Applicable
method change product classification? No
15.Regulatory Information
This product has been classified in accordance with the hazard criteria of the Globally Harmonized System of Classification and
Labeling of Chemicals and the SDS contains all of the information required by the Canadian Controlled Products Regulations.
U.S. Federal Regulations: CERCLA 103 Reportable Quantity: This product is not subject to CERCLA reporting requirements.
Many states have more stringent release reporting requirements. Report spills required under federal, state and local
regulations
Section 313 Toxic Chemicals: This product contains the following chemicals subject to Annual Release Reporting
Requirements Under SARA Title III, Section 313 (40 CFR 372): None
Section 302 Extremely Hazardous Substances (TPQ): None
EPA Toxic Substances Control Act (TSCA) Status: All of the components of this product are listed on the TSCA inventory.
U.S. State Regulations California Proposition 65: This product does not contain any chemicals, which are on the California
Proposition 65 list.
International Regulations: Canadian Environmental Protection Act:
This product is a medical device and not subject to chemical notification requirements.
European Community Labeling: Not a dangerous preparation.
European Inventory of New and Existing Chemicals Substances (EINECS):
This product is a medical device and not subject to chemical notification requirements.
Other: Not Applicable
16.Other Information
To the best of our knowledge this product does not contain gluten, wheat grains, flaxseed, natural rubber, or natural latex.
All components are synthetically produced; none are derived from animal products.
This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific products
features and shall not establish a legally valid contractual relationship.
The attached safety data sheet covers the dangers and measures to be taken when large quantities of material are released, for
example due to accidents during transport or storage by the dealer. For quantities of material typically used in clinical practice,
information necessary for safe use and storage of the product is given in the DFU.
|