Hazard Classification: Not classified as hazardous according to OSHA Hazard Communication Standard, 29 CFR

Transcription

1 Safety Data Sheet: Stance SnF2 Rinse Concentrate 0.63% SECTION 1: IDENTIFICATION Product Name: Stance - Stannous Fluoride Rinse Concentrate 0.63% Catalog Numbers: Mint & Tropical Fruit , Product Classification: OTC Monograph Rinse Concentrate Active Ingredient: Stannous Fluoride Manufactured By: Elevate Oral Care 346 Pike Rd, Suite 5 West Palm Beach, FL Issue Date: October 31, 2016 Supersedes Date: NEW Product Use: Anti-Caries, hypersensitivity relief and reduction of gingival inflammation. Dental Preventive, Fluoride Treatment Restrictions on Use: For use only under dental supervision SECTION 2: HAZARDS IDENTIFICATION Hazard Classification: Not classified as hazardous according to OSHA Hazard Communication Standard, 29 CFR Label Elements/Signal Word: Not applicable Symbols: Not applicable Pictograms: Not applicable Hazards not otherwise classified: None SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS Chemical % CAS # ID (By Weight) Glycerin >85 Xylitol 10 Flavor NA <2 SECTION 4: FIRST AID MEASURES The following first aid recommendations are based on an assumption that appropriate personal hygiene and industrial hygiene practices are followed. Eye Contact: Skin Contact: Inhalation: Ingestion: Flush with large amounts of waer. Remove contact lenses if easy to do. Continue rinsing. If signs/symptoms persist, get medical attention. Wash with soap and water. If signs/symptoms develop, get medical attention. No need for first aid is anticipated. Rinse mouth, if you feel unwell, get medical attention. Most Important symptoms and effects, both acute and delayed. See Section Information on toxicological effects. Indication of any immediate medical attention and special treatment required.

2 Not Applicable. SECTION 5: FIRE FIGHTING MEASURES Extinguishing Media: Special hazards arising from the substance or mixture. None inherent in this product. Hazardous Decomposition or By-Products Carbon monoxide and carbon dioxide during combustion. Special protective actions for fire fighters No special protective actions for fire-fighters are anticipated. In case of fire: Use a fire fighting agent suitable for ordinary combustible material such as water or foam to extinguish. SECTION 6: ACCIDENTAL RELEASE MEASURES Personal Precautions, protective equipment and emergency procedures. Ventilate the area with fresh air. For large spill, or spills in confined spaces, provide mechanical ventilation to disperse or exhaust vapors, in accordance with good industrial hygiene practice. Observe precautions from other sections. Environmental precautions Avoid release to the environment. Methods and material for containment and cleaning up No special storage requirements. SECTION 7: HANDLING AND STORAGE Handling: Storage: Avoid prolonged or repeated skin contact. Do not eat, drink, or smoke when using this product. Wash thoroughly after handling. No special storage conditions or requirements. SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION Occuption exposure limits: Glycerin, TWA (as total dust): 15 mg/m3; TWA (respirable fraction): 5 mg/m3 Engineering Controls: Eye/Face Protection: Skin Protection: Respiratory Protection: Use in a well-ventilated area. Select and use eye/face protection to prevent contact based on the results of an exposure assessment. The following eye/face protection(s) are recommended; Safety glasses with side shields. See section 7.1 for additional information on skin protection None required. SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES Appearance Odor & Odor Threshold ph Specific Gravity Viscosity % Volatile Clear to yellow Not Odor of Stated Flavor 1.27 No data N/A liquid applicable

3 Boiling Point / Freezing Point Decomposition Temperature Octanol/Water Partitioning Coefficient (Log Po/w) Vapor Pressure Vapor Density Evaporation Rate Ignition Solubility in Water (20 C) 554 F/ NA No Data N/DA N/A N/A N/A N/A N/A Flash Point ( F/ C) Flammable Limit Auto-Ignition Temperature (vol%) 390 F N/A N/A SECTION 10: STABILITY AND REACTIVITY Stability: Reactivity: Materials and Conditions to Avoid: Hazardous Decomposition Products: Hazardous Polymerization: Incompatible Materials: Stable. This material is considered to be non reactive under normal use conditions None known None known Hazardous polymerization will not occur. None Known SECTION 11: TOXICOLOGY INFORMATION The information below may not be consistent with the material classification in Section 2 if specific ingredient classifications are mandated by a competent authority. In addition, toxicological data on ingredients may not be reflected in the material classification and/or the signs and symptoms of exposure, because an ingredient may be present below the threshold for labeling, an ingredient may not be available for exposure, or the data may not be relevant to the material as a whole. This document has been prepared in accordance with the U.S. OSHA Hazard Communication Standard, which requires the inclusion of all known hazards of the product or ingredients regardless of the potential risk. The risks of the hazards communicated in this document may vary depending on the potential for exposure Information on Toxicological effects Signs and Symptoms of Exposure Based on test data and/or information on the components, this material may produce the following health effects: Inhalation: This product may have a characteristic odor; however, no adverse health effects are anticipated. Skin Contact: Contact with the skin during product use is not expected to result in significant irritation. Eye Contact: Contact with the eyes during product use is not expected to result in significant irritation. Ingestion: Gastrointestinal Irritation: Signs/symptoms may include abdominal pain, stomach upset, nausea, vomiting and diarrhea. Toxicological Data If a component is disclosed in section 3 but does not appear in a table below, either no data are available for that endpoint or the data are not sufficient for Acute Toxicity Name - Route - Species - Value Overall product - Ingestion - - No data available; calculated ATE > 5,000 mg/kg GLYCERIN - Dermal - Rabbit - LD50 estimated to be > 5,000 mg/kg

4 GLYCERIN - Ingestion - Rat - LD50 > 5,000 mg/kg ATE = acute toxicity estimate Skin Corrosion/Irritation Name - Species - Value GLYCERIN - Rabbit - No significant irritation Serious Eye Damage/Irritation Name - Species - Value GLYCERIN - Rabbit - No significant irritation Skin Sensitization Name - Species - Value GLYCERIN - Guinea pig - Not sensitizing Respiratory Sensitization Germ Cell Mutagenicity Carcinogenicity Name - Route - Species - Value GLYCERIN - Ingestion - Mouse - Some positive data exist, but the data are not sufficient for classification Reproductive Toxicity Reproductive and/or Developmental Effects Name - Route - Value - Species - Test Result - Exposure - Duration GLYCERIN - Ingestion - Not toxic to female or male reproduction or development - Rat - NOAEL 2,000 mg/kg/day - 2 generation Target Organ(s) Specific Target Organ Toxicity - single exposure Specific Target Organ Toxicity - repeated exposure Name Route Target Organ(s) Value Species Test Result Exposure Duration GLYCERIN Inhalation respiratory system Some positive data exist, but the data are not sufficient for Rat NOAEL 3.91 mg/l 14 days GLYCERIN Inhalation heart liver kidney and/or bladder All data are negative. Rat NOAEL 3.91 mg/l 14 days GLYCERIN Ingestion endocrine system hematopoietic system liver kidney and/or bladder All data are negative. Rat NOAEL 10,000 mg/kg/day 2 years Aspiration Hazard Please contact the address or phone number listed on the first page of the SDS for additional toxicological information on this material and/or its components. SECTION 12: ECOLOGICAL INFORMATION Ecotoxicological Information: Not determined.

5 Chemical Fate Information: Not determined. SECTION 13: DISPOSAL CONSIDERATION Dispose of in compliance with governmental regulations. Dispose of container and unused contents in accordance with local, state, and federal requirements. For EU Member States, please refer to any relevant Community provisions relating to waste. In their absence, it is useful to remind the user that national or regional provisions may be in force. SECTION 14: TRANSPORTATION INFORMATION UN Number UN Proper Shipping Name Hazard Class(s) Packing Group Environmental Hazards DOT None Not Regulated None None Not applicable ADR (road) None Not Regulated None None Not applicable RID (rail) None Not Regulated None None Not applicable IMDG (sea) None Not Regulated None None Not applicable IATA/ICAO (air) None Not Regulated None None Not applicable Other Information: SECTION 15: REGULATORY INFORMATION 311/312 Hazard Categories: Fire Hazard - No Pressure Hazard - No Reactivity Hazard - No Immediate Hazard - Yes Delayed Hazard - No State Regulations Contact Elevate Oral Care for more information Chemical Inventories This material contains one or more substances not listed on the TSCA Inventory. Commercial use of this material is regulated by the FDA. Contact Elevate Oral Care for more information International Regulations Contact Elevate Oral Care for more information. N/A SECTION 16: OTHER INFORMATION NFPA Hazard Classification Health: 0 Flammability: 1

6 Instability: 0 Special Hazards: None National Fire Protection Association (NFPA) hazard ratings are designed for use by emergency response personnel to address the hazards that are presented by short-term, acute exposure to a material under conditions of fire, spill, or similar emergencies. Hazard ratings are primarily based on the inherent physical and toxic properties of the material but also include the toxic properties of combustion or decomposition products that are known to be generated in significant quantities. The information presented herein was obtained from sources considered to be reliable. However, this information is provided without any warranty, expressed or implied, regarding its correctness or suitability for consumers intended use and/or application. For this and other reasons, EOC assumes no responsibility and expressly disclaims liability for loss, damage, or expense arising out of any way connected with the handling, storage, use, or disposal of this product. This SDS was expressly prepared for this product. Use the materials only as directed. If the product is used as a component in another product, the information contained within this SDS may not be applicable.