Tech Star Medical, Inc. Safety Data Sheet SECTION 1- IDENTIFICATION Finished Product Trade Name: CAS Number: INCI Name: Uses of the Substance/ Mixture: Dura-Zyme XL Company Name: Tech Star Medical, Inc. Company Address: 4142 Mariner Blvd. #523 Spring Hill, FL 34609 Phone Number: 888-596-9802 Emergency Phone Number: Chemtrec: 800.424.9300 SECTION 2 HAZARDOUS IDENTIFICATION Classification: Serious eye damage/eye irritation Category 2A Acute Toxicity, Oral Category 4 Respiratory Sensitization Category 1 Label Elements: Hazard Symbol: Signal Word: Danger Hazard Statement: H319 Causes serious eye irritation H302 Harmful if swallowed H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled Precautionary Statement: Prevention: P264Wash thoroughlyafter handling. Wear eye/face protection. P261 Avoid breathing dust/fume/gas/mist/vapours/spray P270 Do not eat, drink, or smoke when using this product P285 In case of inadequate ventilation, wear respiratory p protection Response: P301 + P312+ 330: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. Rinse mouth P305 + P315: IF IN EYES: Rinse cautiously with water several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persist: Get medical advice/attention. P304 + P341: If INHALED: If breathing is difficult, remove victim to fresh air and keep at rest position comfortable for Page 1of 6 Issue Date: 6/1/15
Storage: Disposal: Other hazards which do not result In GHS classification P342 + P311: breathing If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician Store away from incompatible materials. Dispose of waste and residues in accordance with local authority requirements SECTION 3 COMPOSITION/ INFORMATION ON INGREDIENTS HAZARDOUS COMPONENTS CAS No. % GHS Classification Sodium Xylenesulphonate 1300-72-7 1-5 Serious eye damage/irritation: Category 2A Α-Amylase from AspergillusOryzae 9001-19-8 1-5 Acute Toxicity: Category 4 Respiratory Sensitization: Category 1 SECTION 4 FIRST AID MEASURES Description of Necessary First-Aid Measures Inhalation: Skin Contact: Eye Contact: Ingestion: Remove to fresh air. If breathing is irregular or stopped, administer artificial Respiration. In case of shortness of breath, give oxygen Wash off immediately with soap and water. If symptoms persist seek medical advice. Rinse thoroughly with water for at least 15 minutes and consult a physician Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persist: Get medical advice/attention. If swallowed, call a poison center or doctor immediately. Do not induce Vomiting without medical advice. Never give anything by mouth to an Unconscious person. SECTION 5 FIREFIGHTING MEASURES Extinguishing Media Suitable Extinguishing Media: Water spray, Carbon Dioxide, dry chemical, foam Special Hazards Arising from the Substance or Mixture Specific hazards during firefighting: During fire, gases hazardous to health may be formed Advice for Firefighters Special protective equipment: Wear self-contained breathing apparatus and protective suit Further Information Page 2 of 6 Issue Date: 6/1/15
SECTION 6 ACCIDENTAL RELEASE MEASURES Personal Precautions, Protective Equipment and Emergency Procedures Contain spillage, and then collect with absorbent material and place in container for disposal according to local/ national regulations (see section 13) SECTION 7 HANDLING AND STORAGE Handling&Storage Safe Handling Advice: Storage/Transport: Avoid contact with eyes. Avoid inhalation of vapour mist. Provide adequate ventilation. Wear appropriate personal protective equipment. Store away from incompatible materials SECTION 8 EXPOSURE CONTROLS/ PERSONAL PROTECTION Components with Workplace Control Parameters Components Value Type Value Update Basis Components with Workplace Foreign Control Parameters Components Value Type Value Update Basis Personal Protective Equipment Respiratory Protection: Eye Protection: Skin and Body Protection: Hygiene Measures: Respiratory protection is normally not required, except in emergencies or when Conditions cause excessive airborne levels of mists or vapors. Use NIOSH Approved respiratory protection Wear as appropriate: Goggles, faceshield Wear suitable protective clothing, gloves and eye/face protection Good personal practices should be used. Wash after any contact. Contaminated clothing and shoes should be cleaned before reuse. SECTION 9 PHYSICAL AND CHEMICAL PROPERTIES Appearance Form: Color: Odor: Odor Threshold: Liquid Orange Mild Scent Safety Data ph: 8.0-9.5 Melting Point/Range: Boiling Point/ Range: Flash Point (ASTM D56) >200 F (TCC) Flammability (solid, gas): Page 3 of 6 Issue Date: 6/1/15
Auto-ignition Temperature: Water Solubility: Solubility in other Solvents: Partition Coefficient: noctanol/water: Vapor Pressure: Soluble Evaporation rate: Relative Vapor Density: Specific Gravity @ 25 C: 1.05 Oxidation/ Reduction Potential: Viscosity, dynamic: Viscosity, kinematic: Explosive Properties: Thermal Decomposition: Lower Explosion Limit: Upper Explosion Limit: SECTION 10 STABILITY AND REACTIVITY Chemical Stability Hazardous Reactions Conditions to Avoid Materials to Avoid Hazardous Polymerization Hazardous Decomposition Stable at normal ambient temperature and pressure Contact with incompatible materials Oxidizing agents Will not occur Upon decomposition this product may yield sulfur dioxides and oxides of sulfur SECTION 11 TOXICOLOGICAL INFORMATION Acute Toxicity Acute Oral Toxicity: Acute Inhalation Toxicity: Acute Dermal Toxicity: Other Routes of Administration: Aspiration Toxicity: Skin Corrosion/ Irritation Skin Irritation: Serious Eye Damage/ Eye Irritation Eye Irritation: Respiratory or Skin Sensitization Sensitization: Repeated Dose Toxicity Repeated Dose Toxicity: STOT STOT single exposure: STOT repeated exposure: Carcinogenicity Carcinogenicity: Mutagenicity Page 4 of 6 Issue Date: 6/1/15
Genotoxicity in vitro: Genotoxicity in vivo: Reproductive Toxicity Reproductive Toxicity: SECTION 12 ECOLOGICAL INFORMATION Ecotoxicity Assessment: Ecotoxicity Assessment: Persistence and Degradability Biodegradability: Bioaccumulation Bioconcentration Factor (BCF): Other Adverse Effects Environment Assessment: SECTION 13 DISPOSAL CONSIDERATION Product Disposal Waste Code Disposal Method The waste code should be assigned in discussion with user, the producer and the waste disposal company Dispose of only in accordance with local, state, and federal regulations Empty Containers Dispose of only in accordance with local, state, and federal regulations SECTION 14 TRANSPORTATION INFORMATION ADR RID IMDG IATA Note: The above regulatory prescriptions are those valid on the date of publication of this sheet. Given the possible evolution of transport regulations for hazardous materials, it would be advisable to check their validity with your sales office. SECTION 15 REGULATORY INFORMATION OSHA Hazards (HCS 1994) Non-Hazardous TSCA Inventory Listing SARA 302 SARA 311/312 Classification SARA 313 Chemical All components listed No chemicals are subject to reporting requirements Immediate (acute) health hazard This material does not contain any chemical components with known CAS numbers That exceed the threshold reporting levels established by SARA Title III, Section 313 Page 5 of 6 Issue Date: 6/1/15
Prop 65 CERCLA WHMIS EU Aspiration hazard, Category 1 AICS ENCS NDSL EINECS Listed Listed Not Listed Not Listed SECTION 16 OTHER INFORMATION The information provided in this Safety Data Sheet is accurate to the best oftech Star Medical, Inc. s knowledge. No guarantees or liabilities are expressed or implied. Because users are most aware of the application of the product, they must ensure that the proper personal protective equipment (PPE) is provided consistent with the information contained in the product SDS. This information is intended solely for the use of individuals trained in the particular hazard rating system. It does not release users from ensuring they are in conformity with all regulations linked to its activity. Page 6 of 6 Issue Date: 6/1/15