PENTRON Clinical Material Safety Data Sheet in accordance with Community Regulation 2006/1907/EC (R.E.A.Ch.) Revision Date: 15st June 2011 SECTION 1 Product & Company identification
1.1 Product name BOND-1®/Nano Bond - Dual Cure Activator
1.2 Uses/Application: Adhesive activator for dental bonding agents. 1.3 Company (Name, address and info phone number) PENTRON CLINICAL 1717 West Collins Avenue Orange, CA 92867 Free phone number: +1-800-5377-123 1.4 Emergency phone (according to communitarian directive 99/45/EC, article 17) +39-081-8508325 (08.00-17.00, European time, GMT+1) E-mail address: SECTION 2 Hazard identification
2.1 Hazard classification (according to communitarian directives 67/548/EEC & 99/45/EC) Highly Flammable; Sensitizing; Irritating. 2.2 Other hazard None. SECTION 3 Composition/Information on Ingredients (according to communitarian directives 67/548/EEC, 99/45/EC & 2001/58/EC) 3.1 Hazardous ingredients HAZARDOUS INGREDIENTS Benzoyl PerOxide (BPO)
3.2 Other non-hazardous ingredients None.
Material Safety Data Sheet for: BOND-1/Nano Bond D.C. ACTIVATOR SECTION 4 First aid measures
4.1 Treatment for eye contact: Rinse with plenty of water and then consult an ophtamologist. 4.2 Treatment for skin contact: Wash skin thoroughly with soap and water. Use hand cream. 4.3 Treatment for inhalation (breathing): Remove to fresh air. If irritation persists, seek medical attention. 4.4 Treatment for ingestion (swallowing): Do not give liquids if person is unconscious. Seek medical SECTION5 Fire-fighting Measures
5.1 Suitable extinguishing media: Carbon dioxide, water, dry chemical. 5.2 Forbidden extinguishing media: Unknown. 5.3 Special fire fighting measures: None. Wear self-contained breathing apparatus and full protective gear.
5.4 Unusual fire and explosion hazards: Unknown
5.5 Special protection equipment: Sealed overall against liquids and gases.
SECTION6 Accidental Release Measures
6.1 Personal Precautions: Adopt the same precautions listed in section 8. 6.2 Environmental Precautions: Keep spilled material out of sewers. 6.3 Reclaiming Methods: Absorb with inert material. Collect in closed containers and dispose of in SECTION7 Handling and Storage (according to article 5 of communitarian directive 98/24/EC) 7.1 Handling Precautions: Handle away from sources of ignition. Adopt precautions listed in section 8. 7.2 Precautions in case of Fire and Explosion: Extinguish all ignition sources. 7.3 Storage Conditions: Store in a cool, dry place, away from heat, light and ignition sources. 7.4 Suggested container(s): The original containers provided by manufacturer (or metal containers). 7.5 Indication for Combined Storage: Avoid contact with oxidizing and reducing agents. 7.6 Environmental precautions: Avoid contamination of sewers with product. 7.7 Other Precautions: Use according to directions and good personal hygiene and safety practices. Material Safety Data Sheet for: BOND-1/Nano Bond D.C. ACTIVATOR SECTION8 Exposure controls/personal protection
TWA/TLV : 500 ppm (Acetone);
(BPO): 0,5ppm (5 mg/m3); (HCl): 5ppm 8.2.1 Precautionary Measures: (according to communitarian directives 89/686/EEC & article 4 of 98/24/EC)
Local Exhaust Ventilation: Sufficient to keep vapours under exposure limits.
Special Ventilation: None required. Mechanical (General) Ventilation: Good general ventilation recommended. Other Ventilation: None required.
Avoid breathing of vapours of the material. In case of high vapours concentration,
use a mask with a filter against organic vapours.
Impervious gloves, Nitrile or Vinyl type, are recommended.
Handle in accordance with good personal hygiene and safety practices. These practices include avoiding unnecessary exposure to uncured material.
Measures listed in this paragraph are to be considered as indications and NOT prescriptions (89/656/EEC) 8.2.2 Environment exposure control measures Not Applicable.SECTION9 Physical and Chemical Properties
Appearance: Clear to slight yellow liquid.
9.2 Information related to health, safety and environment
Partition coefficient n-octanol/water: N/E
9.3 Other information (according to communitarian directive 94/9/EC):
Miscibility: Complete in water and many organic solvents.
Material Safety Data Sheet for: BOND-1/Nano Bond D.C. ACTIVATOR SECTION10 Stability and Reactivity
Stability: Stable if stored as directed. 10.1 Conditions to avoid: Heat, sparks and open flame. 10.2 Materials to avoid (incompatibility): Strong bases, oxidizing agents. 10.3 Hazardous decomposition products: Carbon Oxides.
Hazardous Polymerization Products: Not determined
Safety significance in case of change in physical appearance: Unknown
Stabilizers: The product is stabilized with non-hazardous polymerization inhibitors.
SECTION11 Toxicological Information
CMR effects (Carcinogenicity, Mutagenicity and toxicity for reproduction):
None. _____________________________________________________________________________ Effects and hazards of eye contact: May cause irritation.
Effects and hazards of skin contact: May cause skin defatting, dryness and cracking, edema, erythema and
itch; sensitization in sensitive individuals.
Effects and hazards of Inhalation (Breathing): Repeated exposure may cause drowsiness and dizziness. Effects and hazards of Ingestion (Swallowing): Large amounts of material may be harmful if swallowed. Effects for prolonged Exposure: Unknown. Toxic-kinetic effects: Unknown. Effects on metabolism: Unknown. ______________________________________________________________________________ Toxicological data for ingredients:
Hydrochloric Acid Material Safety Data Sheet for: BOND-1/Nano Bond D.C. ACTIVATOR SECTION12 Ecological Information This product has not known ecological hazardous effects. 12.1 Eco-toxicity: Not available 12.2 Mobility: Not available 12.3 Persistence and degradability: Not available 12.4 Bioaccumulative potential: Not available 12.5 Results of PBT (Persistent Bio-Toxicity) assessment: Not available 12.6 Other adverse effects: Not available Aquatic toxicity data for ingredients:
EC50 (Bacteria, breathing inhibition of active muds)
SECTION13 Disposal considerations Dispose of in accordance with local regulations. SECTION14 Transport information
14.1 Sea transportation (IMDG)
Proper shipping name: Acetone 14.2 Air transportation (ICAO/IATA)
Maximum quantities: 5 Lt (Passenger Aircraft);
14.3 Transportation by Road/Railway (RID/ADR)
Exempted Quantity: E2 (30ml for inner, 500ml for outer pack).
SECTION15 (Classification according to communitarian directives 67/548/EEC & 99/45/EC) Regulatory information
Hazard labelling not required. This product is an exempted medical device (directive 1999/45/EC, article 1, paragraph 5g). Material Safety Data Sheet for: BOND-1/Nano Bond D.C. ACTIVATOR SECTION 16 Other information 16.1 Risk phrases of all ingredients
Extreme risk of explosion by shock, friction, fire or other sources of ignition.
May cause sensitization by skin contact.
Repeated exposure may cause skin dryness or cracking
Vapours may cause drowsiness and dizziness
16.1.1 Safety phrases of all ingredients
Keep locked up and out of reach of children.
Keep away from sources of ignition - No Smoking!
In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
36/37/39 Wear suitable protective clothing, gloves and eye/face protection. 16.2 Sources of key data used to compile the Safety Data Sheet:
European Chemicals Bureau (ECB – European chemical Substances Information System (ESIS - A.C.G.I.H. N.I.OS.H. O.S.H.A. U.E. I.A.R.C. N.T.P. European Community Directives:
67/548/EEC: Classification, packaging and labelling of dangerous substances. 99/45/EC:
Directive concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations.
2001/58/EC: Second amendment of directive 91/155/EEC for the definition of a detailed arrangement of
specific information relating to dangerous preparations (art. 14 of 99/45/EC) and substances (art. 27 of 67/548/EEC).
89/656/EEC: Directive on the minimum health and safety requirements for the use by workers of
personal protective equipment at the workplace (third individual directive within the meaning of Article 16 (1) of Directive 89/391/EEC).
89/686/EEC: Approximation of the laws of the Member States relating to personal protective equipment. 94/9/EC:
Approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres
Protection of the health and safety of workers from the risks related to chemical agents at work.
Material Safety Data Sheet for: BOND-1/Nano Bond D.C. ACTIVATOR
Document modification history: First version in compliance of Community Regulation 2006/1907/EC
CAUTION: PRODUCT FOR PROFESSIONAL USE The information on this Safety Sheet is based on presently available data and to our best knowledge for the correct handling of the product under normal conditions. Any use of this product in any way not indicated on this Sheet or the use of this product together with any other process/procedure will be exclusively under the user’s responsibility. This document does not constitute explicit or implicit warranty of product quality or fitness for a particular purpose.
FIRST news A Publication of First Source Benefits Group, LLC February 2006 Volume III: Edition 7 Account Executive QUOTE OF THE MONTH Health Premiums Increase Due to More Utilization Don’t join an easy crowd; you won’t grow. Go where the A 13.6% increase in outpatient costs contributed to a large expectations and the demands to perform are high” portion of las
MAXIMUS FEDERAL SERVICES, INC. Notice of Independent Medical Review Determination Dated: 9/26/2013 1) MAXIMUS Federal Services, Inc. has determined the request for a 28 day functional restoration program is not medically necessary and appropriate. 2) MAXIMUS Federal Services, Inc. has determined the request for a 6 month follow-up aftercare program is not medically nec