Material Safety Data Sheet Revision date: 03-20-2014 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING Supplier: Janssen Diagnostics, LLC 700 US Highway Route 202 South Raritan, NJ 08869 E-mail address Janssen@its.jnj.com UK - ukhotline@its.jnj.com French - hotlinefrance@its.jnj.com German - ocdtechsupport-de@its.jnj.com Italian - italianhl@its.jnj.com Nordic - nordichotline@its.jnj.com Polish - polskahl@its.jnj.com Portuguese - Port_OCDhotline@its.jnj.com South Ireland - UKhotline@its.jnj.com Spanish - spanishhotline@its.jnj.com Customer service telephone: (800) 421-3311 Emergency telephone number: (800) 424-9300 ChemTrec (24 hours) Product name: CellSave Tube Synonyms None Identified use: The CellSave Preservative Tube is intended for the collection and preservation of circulating epithelial cells (tumor cells) in whole blood, to be used for enumeration and phenotyping. 2. HAZARDS IDENTIFICATION General hazard information: May cause sensitization by skin contact. Company: Janssen Diagnostics, LLC Product name: CellSave Tube Page 1 of 6
Indication of danger: i - Irritant. Most important hazards Risk Phrase R43 - May cause sensitization by skin contact. Carcinogenicity rating: Johnson & Johnson: European Union: 3. COMPOSITION/INFORMATION ON INGREDIENTS CAS Number Weight % Synonyms EINECS-No. Classification Imidazolidinyl Urea 39236-46-9 <50 2543726 Listed. i;r43 Sodium Hydroxide <0.5 215-185-5 C; R35 4. FIRST AID MEASURES Eye contact: Skin contact: Ingestion: Inhalation: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Keep eye wide open while rinsing. If symptoms persist, call a physician Wash off immediately with soap and plenty of water. In the case of skin irritation or allergic reactions see a physician. Do not induce vomiting. Clean mouth with water and drink afterwards plenty of water. Never give anything by mouth to an unconscious person. Call a physician immediately. Move to fresh air immediately. If experiencing difficulty breathing, seek medical attention. 5. FIRE-FIGHTING MEASURES Suitable extinguishing media: Use any extinguishing media which is suitable for the surrounding fire. Extinguishing media which must not be used for safety reasons: Special exposure hazards arising from the substance or preparation itself, combustion products, resulting gases: Special protective equipment for firefighters: Combustion products or resulting gases: None reasonably foreseeable. Wear self-contained breathing apparatus for fire fighting if necessary. 6. ACCIDENTAL RELEASE MEASURES Personal precautions: Environmental precautions: Methods for cleaning up: Ensure adequate ventilation. Use suitable protective equipment. Prevent further leakage or spillage if safe to do so. Keep in suitable, closed containers for disposal. Soak up with inert absorbent material. Company: Janssen Diagnostics, LLC Product name: CellSave Tube Page 2 of 6
7. HANDLING AND STORAGE Handling: Technical measures/precautions: Safe handling advice: Storage: Technical measures/storage conditions: Incompatible products: Specific use(s): No special technical protective measures required. Avoid contact with skin, eyes and clothing. Wash hands before breaks and immediately after handling the product. Keep containers tightly closed in a cool, well-ventilated place. No special restrictions on storage with other products. The CellSave Preservative Tube is intended for the collection and preservation of circulating epithelial cells (tumor cells) in whole blood, to be used for enumeration and phenotyping. 8. EPOSURE CONTROLS / PERSONAL PROTECTION Australia Hong Kong Japan India Korea Malaysia China Sodium Hydroxide (<0.5%) Ceiling 2 mg/m 3 Ceiling 2 mg/m 3 TWA 2 mg/m 3 Ceiling 2 mg/m 3 Ceiling 2 mg/m 3 Ceiling 2 mg/m 3 MAC 2 mg/m 3 New Zealand Philippines Singapore Taiwan Thailand ACGIH OEL Indonesia Sodium Hydroxide (<0.5%) Ceiling 2 mg/m 3 TWA 2 mg/m 3 STEL 2 mg/m 3 TWA 2 mg/m 3 STEL 4 mg/m 3 Ceiling 2 mg/m 3 KTD 2 mg/m 3 Engineering controls: Eye protection: Hand protection: Respiratory protection: Skin and body protection: Ensure adequate ventilation. Tightly fitting safety goggles. Wear protective gloves When workers are facing concentrations above the exposure limit they must use appropriate certified respirators. Wear suitable protective clothing. 9. PHYSICAL AND CHEMICAL PROPERTIES General Information Physical state: Color: Odor: Liquid White to Light yellow None Important Health Safety and Environmental Information Flash point: ph: Not determined. 7-8 Boiling point/range:. Other information Explosivity: 10. STABILITY AND REACTIVITY Chemical stability: Materials to avoid: Conditions to avoid: Hazardous polymerization: Possibility of hazardous reactions: Stable under recommended storage conditions. Extremes of temperature and direct sunlight. Hazardous polymerization does not occur. Company: Janssen Diagnostics, LLC Product name: CellSave Tube Page 3 of 6
11. TOICOLOGICAL INFORMATION Acute toxicity Eye contact Not expected to cause eye irritation. Skin contact May cause sensitization by skin contact. Ingestion Inhalation LD50 Oral LD50 Dermal LC50 (mg/m 3 ) Inhalation Imidazolidinyl Urea (<50%) 11300 mg/kg (rat) 39236-46-9 1350 mg/kg (rabbit) LC50 (ppm) Inhalation Sub-Chronic/Chronic Toxicity No repeat dose data available. Specific effects Target Organ(s) Reproductive effects Developmental effects Carcinogenic effects Genotoxic effects 12. ECOLOGICAL INFORMATION Ecotoxicity Ecotoxicity effects: Aquatic toxicity effects: Mobility: Persistence / degradability: Bioaccumulation: Degradation: This product has no known eco-toxicological effects. This product has no known aquatic toxicological effects.. 13. DISPOSAL CONSIDERATIONS Company: Janssen Diagnostics, LLC Product name: CellSave Tube Page 4 of 6
13. DISPOSAL CONSIDERATIONS Waste from residues / unused products: Contaminated packaging: Waste disposal must be in accordance with appropriate US, Federal, State and International regulations. This product, if unaltered by use, may be disposed of by treatment at a permitted facility or as advised by your local hazardous waste regulatory authority. Waste disposal must be in accordance with appropriate US, Federal, State and International regulations. 14. TRANSPORT INFORMATION Product not regulated by DOT, IATA/ICAO, IMO/IMDG, ADR/RID, or TDG. 15. REGULATORY INFORMATION Indication of danger: i - Irritant. R -phrase(s) R43 - May cause sensitization by skin contact. S -phrase(s) S24 - Avoid contact with skin. S37 - Wear suitable gloves. Imidazolidinyl Urea (<50%) 39236-46-9 Australia (AICS) List: New Zealand Japan Inventory of Existing & New Chemical Substances (ENCS) China Inventory List: Philippines (PICCS) List: Korea Inventory (KECL) List: KE-23828 (2)-1972 (1)-410 KE-31487 Japan Industrial Safety & Health Law (ISHL) Listing Japan Pharmacopoeia List: Japan class ii specified chemical substance -: Japan designated chemical substance -: Japan ISHL Prohibited Substances Data Japan Deleterious Substances - Main Law List Imidazolidinyl Urea (<50%) 39236-46-9 Australia Hazardous Substances List China Banned or Severely Restricted Toxic Chemicals List Korea Non-Toxic Chemicals List Korea Restricted Substances Data Phillipines Priority Chemical List (PCL) Thailand More Dangerous Chemicals List Thailand Hazardous Substances List Type 1 Thailand Dangerous Chemicals List 16. OTHER INFORMATION Company: Janssen Diagnostics, LLC Product name: CellSave Tube Page 5 of 6
16. OTHER INFORMATION This data sheet contains changes from the previous version in section(s): Additional advice: Literary reference: Australian Poisons Information Centre 24 Hour Service: - 13 11 26 Police or Fire Brigade: - 0000 (exchange): - 1100 The values set up in the table for Content % are derived from the 28th Adaption of Annex I and Chips III for calculating the formulation. C represents concentration. MSDS Format: Asian Pacific Format This Material Safety Data Sheet was prepared in accordance with Regulation JIS Z7250 of the Occupational Safety and Health Regulation. Disclaimer: The information and recommendations contained herein are based upon tests believed to be reliable. However, Johnson and Johnson does not guarantee their accuracy or completeness NOR SHALL ANY OF THIS INFORMATION CONSTITUTE A WARRANTY, WHETHER EPRESSED OR IMPLIED, AS TO THE SAFETY OF THE GOODS, THE MERCHANTABILITY OF THE GOODS, OR THE FITNESS OF THE GOODS FOR A PARTICULAR PURPOSE. Adjustment to conform to actual conditions of usage may be required. Johnson and Johnson assumes no responsibility for results obtained or for incidental or consequential damages, including lost profits arising from the use of these data. No warranty against infringement of any patent, copyright or trademark is made or implied. End of Safety Data Sheet Company: Janssen Diagnostics, LLC Product name: CellSave Tube Page 6 of 6