gengigel liquid/hydrogel

RICERFARMA srl
GENGIGEL LIQUID/HYDROGEL
SAFETY DATA SHEET V. 1.5 – May, 11, 2015
GENGIGEL LIQUID/HYDROGEL PRODUCT SAFETY DATA SHEET
1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING
Material Name: Trade Name: Chemical Family: Intended Use: Manufacturer Name: Address: Revision Date: Hyaluronic Acid oral solution GENGIGEL LIQUID GENGIGEL HYDROGEL Mixture MEDICAL DEVICE Oral product RICERFARMA s.r.l. Via Egadi 7 (20144 Milano ‐ Italy) e‐mail: [email protected] tel.: 0248010300 May/11/2015 2. COMPOSITION/INFORMATION ON INGREDIENTS
Ingredient CAS Number Hyaluronic Acid Sodium 9067‐32‐7 Water 7732‐18‐5 Cellulose gum 9004‐32‐4 Ethyl alcohol 64‐17‐5 Xylitol 87‐99‐0 PEG‐40 hydrogenated castor oil 61788‐85‐0 Polisorbate 20 9005‐64‐5 Polyacrylic acid crosslinked with divinyl glycol 9003‐01‐4 2,4 Dichlorobenzyl alcohol 1777‐82‐8 Aroma N.A. Color CI 42090 3844‐45‐9 Sodium hydroxide 1310‐73‐2 Citric Acid Monohydrate 5949‐29‐1 1/1
RICERFARMA srl
GENGIGEL LIQUID/HYDROGEL
SAFETY DATA SHEET V. 1.5 – May, 11, 2015
3. HAZARDS IDENTIFICATION
Physical State: Appearance: Color: Odor: Environment Hazards: slightly viscous solution homogeneous, trasparent blue Peculiar See Section 12 for additional Ecological Information Not a fire hazard The product(s) described in the Material Safety Data Sheet are regulated under the Federal Food, Drug and Cosmetics Act are safe to use as per directions on the container, box or accompaning literature. No significant health or environmental effects associated with this material Not a WHMIS controlled substance. This product is labeled in accordance with regulations administered by the Consumer Product Safety Commission (CPSC). However, the use pattern and exposure in the workplace are generally not consistent with those experienced by consumers. Therefore, the requirements of the Occupational Safety and Health Administration applicable to this MSDS differ from the labeling requirements of the CPSC, and this MSDS may contain additional health hazard information not pertinent to consumer use and not found on the product label. HMIS/NFPA: Health Hazard: Flammability: Reactivity: Applies to All Ingredients : Potential Health Effects: Eye Contact: Acute: Skin Contact: Acute: 0 0 0 Rinse opened eyes for several minutes under running water
The product is not skin irritating Rinse with warm water 2/2
RICERFARMA srl
GENGIGEL LIQUID/HYDROGEL
SAFETY DATA SHEET V. 1.5 – May, 11, 2015
Inhalation: Ingestion: Chronic Health Effects: Target Organs: Aggravation of Pre‐Existing Conditions: Physical form suggests that risk of inhalation exposure is negligible. Material is practically non‐toxic. May cause gastrointestinal discomfort if consumed in large amounts. Swallowing small amounts of this material during normal handling is not likely to cause harmful effects. No known effect based on information supplied None known. None known Emergency Overview: This product formulation contains no ingredients at their given percentages that are considered hazardous to your health. This material is not a controlled product under WHMIS. Properties affecting health: There are no known properties to affect one's health. 4. FIRST AID MEASURES
Eye Contact: Skin Contact: Inhalation: Note to Physicians: Ingestion: Immediately flush eyes with large amounts of clean, flowing water, occasionally lifting upper and lower eyelids. Get medical attention immediately if irritation persists. Wash skin with soap and water. Reaction not expected. Seek medical attention in the event of aspiration. Never give anything by mouth to an unconscious person. This product is safe for it intended use. If large amounts are ingested, it may cause nausea, vomiting or diarrhea. Get medical attention. Treat symptomatically 5. FIRE FIGHTING MEASURES
Fire: Flammable Properties: Flammability Limits in Air: Explosion: Explosion Limits: Flash Point: Auto Ignition Temperature: Extinguishing Media: Not flammable No information available No information available Not determined No information available No information available Suitable: Use extinguishing measures that are appropriate to local circumstances and the 3/3
RICERFARMA srl
GENGIGEL LIQUID/HYDROGEL
SAFETY DATA SHEET V. 1.5 – May, 11, 2015
Hazardous Combustion By products: Protective Equipment: Fire / Explosion Hazards: Sensitivity to Impact: Static Discharge Effects: surrounding environment. Use carbon dioxide, dry chemical, or water spray. Carbon oxides. Formation of toxic gases is possible during heating or fire. Protective Equipment and Precautions for Firefighters: As in any fire, wear self‐contained breathing apparatus pressure‐demand and full protective gear Not applicable Sensitivity to Mechanical Impact: Not sensitive Sensitivity to Static Discharge: Not sensitive 6. ACCIDENTAL RELEASE MEASURES
Spill Cleanup Measures: Wearing suitable protective clothing, wipe product up with appropriate absorbent material and place into a container for disposal. Impermeable gloves (latex or nitrile) and eye protection should be worn as a minimum precaution. Additional protective clothing/equipment may be needed depending on the extent of the spill. The spill area should be ventilated and decontaminated after spill has been picked up to remove slippery residue. SEE SECTION 8, EXPOSURE CONTROLS AND PERSONAL PROTECTION, FOR PROTECTIVE GEAR NEEDED FOR SPILL CLEAN‐UP. Small Spill: Absorb on vermiculite, floor absorbent or other absorbent material. Flush area with water. Large Spill: Prevent run‐off to sewers, streams or other bodies of water. If run‐off occurs, notify proper authorities as required, that a spill has occurred. Persons not wearing protective equipment should be excluded from area of spill until clean‐up has been completed. Stop spill at source, dike area of spill to prevent spreading, pump liquid to salvage tank. Remaining liquid may be taken up on sand, clay, earth, floor absorbent, or other absorbent material and shovelled into containers. Flush area with water. 4/4
RICERFARMA srl
GENGIGEL LIQUID/HYDROGEL
SAFETY DATA SHEET V. 1.5 – May, 11, 2015
7. HANDLING and STORAGE
Handling: Storage: Container Requirements: Hygiene Practices: Avoid extreme heat and open flames. Store product at room temperature. Avoid elevated temperatures. Avoid contact with: metals, reducing agents, strong oxidizing agents, sulfur components. Wash hands after handling material and before eating, smoking, using lavatory, and at the end of the day. Containers as described in Section 1. 8. EXPOSURE CONTROLS, PERSONAL PROTECTION
Ventilation System: Hand Protection Description: Eye/Face Protection: Protective Clothing/Body Protection: Respiratory Protection: Exposure Limits: Hygiene: None beyond good room ventilation normally required; special ventilation should not be needed when handling small quantities of product. Protective Gloves: Wear impervious (latex or nitrile) gloves if the potential exists for dermal contact. Wear safety glasses (ANSI Z87.1) during manufacture or spill response for the material. Use of eye protection is recommended for other handling of this material. Wear protective coveralls, whenever the potential for splashing or spraying with the product exists. A respirator should not be needed when handling the fluid in a clinical or manufacturing setting. Exposure Guideline Summary: An exposure guideline has not been established for this material. Wash hands after handling material and before eating, smoking, using lavatory, and at the end of the day. 9. PHYSICAL and CHEMICAL PROPERTIES
Physical State/Appearance: Color: Odor: pH: Density: Viscosity: Vapor Pressure: slightly viscous trasparent solution blue Peculiar 6,0 ± 0,5 (at 20°C) ≥ 1,020 ≤ 1,060 ( at 20°C) ≤ 100 cPs (at 20°C ) Not Determined. 5/5
RICERFARMA srl
Vapor Density: Flash Point: Boiling Point: Freezing Point: Melting Point: Solubility: Evaporation Point: Viscosity: Coefficient of Water/Oil Distribution: GENGIGEL LIQUID/HYDROGEL
SAFETY DATA SHEET V. 1.5 – May, 11, 2015
(Air = 1): Not Determined. Not available. Not available. Not available. Not available. In water: Stable dispersion. Not available. Greater than water, material is a viscous gel. Not available. 10. STABILITY and REACTIVITY
Chemical Stability: Incompatibilities with Other Materials: Reactivity: Hazardous Polymerization: Hazardous Decomposition Products: Explosion data (mechanical impact): Explosion data (static discharge): Self‐inflammability: Danger of explosion: This product is expected to be stable. None known. Conditions of Reactivity: None known. Will not occur. None known. No specific data. Not expected to be a hazard. No specific data. Not expected to be a hazard. Product is not selfigniting Product is not explosive 11. TOXICOLOGICAL INFORMATION
Applies to all ingredients: Acute Health Effects: Other Toxicological Information: Chronic Toxicity/Carcinogenicity: Product Information: Product does not present an acute toxicity hazard based on known or supplied information Target Organ Effects: None known. This product is not expected to cause long term adverse health effects. This product has not been tested as a whole. However, this formula was reviewed by expert toxicologists in the Product Safety Assurance Department of RICERFARMA and is determined to be safe for its intended use. This review has taken into consideration available safety‐related information including information on individual ingredients, similar ingredients, similar formulas and potential ingredient interactions. This review is a component of the hazard determination used to prepare the statements in Section 3 of the MSDS 6/6
RICERFARMA srl
GENGIGEL LIQUID/HYDROGEL
SAFETY DATA SHEET V. 1.5 – May, 11, 2015
12. ECOLOGICAL INFORMATION
Ecotoxicity: Environmental Fate: Not Determined. Chemical Fate Information: Not Determined. 13. DISPOSAL CONSIDERATIONS
Waste Disposal: Dispose of in accordance with National, State, Local and applicable country regulations. 14. TRANSPORT INFORMATION
DOT Shipping Information: DOT Shipping Name: DOT UN Number: DOT Hazard Class: DOT Packing Group: DOT Subpart E Labeling Requirement: IATA: Label requirements: Placard requirements: IATA Shipping Name: IATA Hazard Class: IATA UN Number: IATA Packing Group: IMO: Canadian TDG: Maritime Transportation CGVS/GGVE/IMDG: ICAO: DOMESTIC: Placard requirements: Not applicable. Not regulated. Not regulated. Not regulated . Not regulated. Not applicable. INTERNATIONAL Not regulated. Not regulated . Not regulated. Not regulated . Not regulated. Not regulated. Not regulated. Not regulated. Not regulated. Not regulated. 15. REGULATORY INFORMATION
Applies to all ingredients: US Federal: OSHA hazard warnings may include: None noted. International Chemical Inventory Lists: None noted. Designation according to EC guidelines: Risk phrases: None Safety phrases: None 7/7
RICERFARMA srl
Classification according to VbF: Water hazard class 0 (self‐assessment): GENGIGEL LIQUID/HYDROGEL
SAFETY DATA SHEET V. 1.5 – May, 11, 2015
Void generally not hazardous for water 16. ADDITIONAL INFORMATION
MSDS Revision Date: May, 11, 2015 MSDS Status: V. 1.5 Disclaimer: The information on this sheet is limited to the material identified and is believed by RUCERFARMA to be correct based on its knowledge and information as of the date noted. . However, they shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship. 8/8