MATERIAL SAFETY DATA SHEET

Transcription

1 MATERIAL SAFETY DATA SHEET 1. IDENTIFICATION OF PRODUCT This Material Safety Data Sheet applies to: Product Name: Kit Configuration Part No.: GEM Premier 4000 Pak BG/HCT 75 Tests (21 days) Tests (21 days) Tests (21 days) Tests (21 days) GEM Premier 4000 Pak BG/HCT 75 Tests (30 days) Tests (30 days) Tests (30 days) Tests (30 days) GEM Premier 4000 Pak BG/HCT/CO-OX 75 Tests (21 days) Tests (21 days) Tests (21 days) Tests (21 days) Tests (21 days) GEM Premier 4000 Pak BG/HCT/CO-OX 75 Tests (30 days) Tests (30 days) Tests (30 days) Tests (30 days) GEM Premier 4000 Pak BG/HCT/LYTES 75 Tests (21 days) Tests (21 days) Tests (21 days) Tests (21 days) GEM Premier 4000 Pak BG/HCT/LYTES 75 Tests (30 days) Tests (30 days) Tests (30 days) Tests (30 days) CO # Sheet 1 of 13 Part No Rev 03

2 1. IDENTIFICATION OF PRODUCT (Continued) GEM Premier 4000 Pak BG/HCT/LYTES/CO-OX 75 Tests (21 days) Tests (21 days) Tests (21 days) Tests (21 days) Tests (21 days) GEM Premier 4000 Pak BG/HCT/LYTES/CO-OX 75 Tests (30 days) Tests (30 days) Tests (30 days) Tests (30 days) GEM Premier 4000 Pak BG/HCT/LYTES/GLU/LAC 75 Tests (21 days) Tests (21 days) Tests (21 days) Tests (21 days) GEM Premier 4000 Pak BG/HCT/LYTES/GLU/LAC 75 Tests (30 days) Tests (30 days) Tests (30 days) Tests (30 days) GEM Premier 4000 Pak BG/HCT/LYTES/GLU/LAC/CO-OX 75Tests (21 days) Tests (21 days) Tests (21 days) Tests (21 days) Tests (21 days) GEM Premier 4000 Pak BG/HCT/LYTES/GLU/LAC/CO-OX 75 Tests (30 days) Tests (30 days) Tests (30 days) Tests (30 days) CO # Sheet 2 of 13 Part No Rev 03

3 2. COMPOSITION INGREDIENT NAME Cal A CONCENTRATION PERCENT BY WEIGHT MOPS 3-(N-Morpholino) propane sulfonic acid 2.51 CAS No.: EINECS No.: Risk Code: R36/37/38 Sodium Hydroxide 0.2 CAS No.: EINECS No.: Hazard Classification: C (as raw material) Risk code: R35: causes severe burns. Choline Chloride 0.10 CAS No.: EINECS No.: Risk Code: R 36/37/38 Kathon 893 MW (preservative) (mixture of various ingredients) a) 2-octyl-2H-isothiazol-3-one CAS No.: EINECS No.: Hazard Classification T+ N (as raw material) Risk Code: R 22-23/ /53 R22: harmful if swallowed R23/24: Toxic by inhalation and contact with skin R34: causes burns R43: May cause sensitization by skin contact R50/53: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment b) Propylene Glycol CAS No.: EINECS No.: Hazard Classification: NO Hazardous (as raw material) Risk Code: Not Applicable CO # Sheet 3 of 13 Part No Rev 03

4 2. COMPOSITION (Continued) INGREDIENT NAME CONCENTRATION PERCENT BY WEIGHT Cal A (Continued) Amaranth (acid Red 27) 0.2 CAS No.: EINECS No.: Risk Code: R 36/37/38 Calcium Chloride CAS No.: EINECS No.: Risk Code: R36 R36: irritating to eyes Cal B MOPS 3-(N-Morpholino) propane sulfonic acid 2.09 CAS No.: EINECS No.: Risk Code: R36/37/38 Sodium Hydroxide 0.3 CAS No.: EINECS No.: Hazard Classification: C (as raw material) Risk code: R35: causes severe burns Choline Chloride 0.34 CAS No.: EINECS No.: Risk Code: R 36/37/38 CO # Sheet 4 of 13 Part No Rev 03

5 2. COMPOSITION (Continued) INGREDIENT NAME Cal B (Continued) CONCENTRATION PERCENT BY WEIGHT Calcium Chloride CAS No.: EINECS No.: Risk Code: R36 R36: irritating to eyes Gentamicin Sulfate CAS No.: EINECS No.: Hazard Classification: Xn (as raw material) Risk Code: R 42/43 R42/43: May cause sensitization by inhalation contact Isopropyl Alcohol CAS No.: EINECS No.: Hazard Classification: F, Xi (as raw material) Risk Code: F: R11 Xi: R36-67 R11: Highly flammable R36: Irritating to eyes R67: Vapors may cause drowsiness and dizziness Cal C Sodium Hydroxide CAS No.: EINECS No.: Hazard Classification: C (as raw material) Risk code: R35: causes severe burns 1-3-Phenylene Diamine CAS No.: EINECS No.: Hazard Classification: T (as raw material) Risk Code: R23/24/25-36/37/38-42/43-40 R23/24/25: toxic by inhalation, in contact with skin or if swallowed R42/43: may cause sensitization by inhalation contact R40: possible risk of irreversible effects CO # Sheet 5 of 13 Part No Rev 03

6 2. COMPOSITION (Continued) INGREDIENT NAME Cal D CONCENTRATION PERCENT BY WEIGHT MOPS 3-(N-Morpholino) propane sulfonic acid CAS No.: EINECS No.: Risk Code: R36/37/38 Sodium Hydroxide 0.14 CAS No.: EINECS No.: Hazard Classification: C (as raw material) Risk code: R35: causes severe burns Calcium Chloride CAS No.: EINECS No.: Risk Code: R36 R36: irritating to eyes Choline Chloride 0.34 CAS No.: EINECS No.: Risk Code: R 36/37/38 Gentamicin Sulfate CAS No.: EINECS No.: Hazard Classification: Xn (as raw material) Risk Code: R 42/43 R42/43: May cause sensitization by inhalation contact CO # Sheet 6 of 13 Part No Rev 03

7 2. COMPOSITION (Continued) INGREDIENT NAME Cal D (Continued) CONCENTRATION PERCENT BY WEIGHT Kathon 893 MW (preservative) (mixture of various ingredients) a) 2-octyl-2H-isothiazol-3-one CAS No.: EINECS No.: Hazard Classification T+ N (as raw material) Risk Code: R 22-23/ /53 R22: harmful if swallowed R23/24: toxic by inhalation and contact with skin R34: causes burns R43: may cause sensitization by skin contact R50/53: very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment b) Propylene Glycol CAS No.: EINECS No.: Hazard Classification: NO Hazardous (as raw material) Risk Code: Not Applicable Sulforhodamine B (acid Red 52) CAS No.: EINECS No.: Hazard Classification: None (as raw material) Risk Code: Not Applicable Lysing MOPS 3-(N-Morpholino) propane sulfonic acid 3.76 CAS No.: EINECS No.: Risk Code: R36/37/38 Sodium Hydroxide 0.45 CAS No.: EINECS No.: Hazard Classification: C (as raw material) Risk code: R35: causes severe burns CO # Sheet 7 of 13 Part No Rev 03

8 2. COMPOSITION (Continued) INGREDIENT NAME Lysing (continued) CONCENTRATION PERCENT BY WEIGHT Triton X CAS No.: EINECS No.: / Hazard Classification: Xn (as raw material) Risk code: R22-41 R22: harmful if swallowed R41: risk of serious damage to eye Reference Solution Potassium Nitrate 8.4 CAS No.: EINECS No.: Hazard Classification: O (as raw material) Risk Code: R /37/38 R8: contact with combustible material may cause fire R22: harmful is swallowed Brij (Ethozylated dodecyl alcohol) 3.4 CAS No.: EINECS No: / Risk Code: R36/37/38 Glycerol 52.9 CAS No.: EINECS No: Hazard Classification: None (as raw material) Risk Code: / 3. HAZARD IDENTIFICATION POTENTIAL HEALTH EFFECTS EYES Cal A / B / C / D / Reference Solution / Lysing Direct eye contact cause redness and irritation. Avoid contact with the eyes. SKIN Prolonged or repeated contact might cause skin irritation. Avoid contact with the skin. INGESTION Harmful if swallowed. INHALATION Inhalation of vapors or mists might irritate respiratory tract. CO # Sheet 8 of 13 Part No Rev 03

9 4. FIRST AID MEASURES EYES Wash eyes with plenty of water for at least 15 minutes. Ensure adequate flushing by separating the eyelids with fingers. Obtain medical attention if irritation persists. SKIN Wash exposed area with soap and water. Obtain medical advice if irritation develops. INGESTION Flush mouth with plenty of water, without swallowing. Obtain medical attention or contact the local Poison Control Center. INHALATION Remove individual to fresh air. Obtain medical attention if breathing becomes difficult. 5. FIRE FIGHTING MEASURES EXTINGUISHING MEDIA Use any extinguishing agent which is suitable for the surrounding fire. FIRE FIGHTING INSTRUCTIONS Wear self-contained breathing apparatus and protective clothing that is appropriate for fighting a typical fire involving chemical materials. 6. ACCIDENTAL RELEASE MEASURES Contain spill by placing a suitable absorbent material around the edges of the spill and work inward. Carefully scoop up into an appropriate waste container for disposal. Do not empty into drains. 7. HANDLING AND STORAGE HANDLING AND STORAGE PRECAUTIONS: Avoid contact with skin and eyes. Reference the product labeling for handling and storage instructions. Special requirements: Keep in a tightly closed container, stored in a cool, dry, ventilated area. Protect against physical damage. Containers of this material may be hazardous when empty since they retain product residues (vapors, liquid); observe all warnings and precautions listed for the product. WORK/HYGIENIC PRACTICES Wash hands with soap and water after use. Do not eat or drink while working with this product. Follow Good Manufacturing Practices. CO # Sheet 9 of 13 Part No Rev 03

10 8. EXPOSURE CONTROLS/PERSONAL PROTECTION This product does not contain great amounts of dangerous substances, therefore, the threshold limit values (TLV) do not have to be under control for exposure to people in the workplace. THRESHOLD LIMIT VALUES REGARDING THE RAW MATERIALS: -2-octyl-2H-isothiazol-3-one: ROHM and HAAS Co.: TWA: 0.2 mg / m³; STEL: 0.6 mg / m³ -Propylene Glycol: ROHM and HAAS Co.: TWA: 175 ppm; STEL: none. -Kathon 893 MW (as active ingredient): ROHM and HAAS Co.: TWA: 0.2 mg / m³; STEL: 0.6 mg / m³ -TLV-CEILING: Sodium Hydroxide 2 mg/m³ -ACGIH TLV: Triton X -100: 1 ppm -TLV-TWA: Isopropyl Alcohol 200 ppm; TLV- STEL 400 ppm AIRBORNE EXPOSURE LIMITS: -OSHA Permissible Exposure Limit (PEL): 10 mg/m³ total dust, 5 mg/m³ respirable fraction for glycerin (mists) -ACGIH Threshold Limit Value (TLV): 10 mg/m³ for glycerin mist containing no asbestos and <1% crystalline silica EYE/FACE PROTECTION: Safety glasses or splash goggles are recommended. HAND PROTECTION: Wear rubber or plastic gloves. SKIN PROTECTION: Wear rubber or plastic gloves and other protective clothing as required to prevent skin contact. RESPIRATORY PROTECTION: None normally required with adequate ventilation. HYGIENIC WORK PRACTICES: Wash promptly if skin becomes wet or contaminated. Promptly remove any clothing that becomes wet or contaminated. Follow Good Manufacturing Practices. Wash at the end of each work shift and before eating, 9. PHYSICAL AND CHEMICAL PROPERTIES Cal A Cal B Cal C Appearance: liquid liquid liquid Color: red colorless colorless Odor: odorless odorless odorless Density: 1.01 at 25 C 1.01 at 25 C 1.01 at 25 C ph: 6.9 at 37 C 7.4 at 37 C 8.0 at 37 C Vapor Pressure: not determined not determined not determined Specific Gravity: not determined not determined not determined Solubility (H20): complete complete complete Evaporation rate: not determined not determined not determined Viscosity: not determined not determined not determined Boiling point ( C): not determined not determined not determined Melting point ( C): not applicable not applicable not applicable Flash point: not applicable not applicable not applicable Lower Explosive Limit (%): not applicable not applicable not applicable Upper Explosive Limit (%): not applicable not applicable not applicable Fire and explosion Hazards: not applicable not applicable not applicable CO # Sheet 10 of 13 Part No Rev 03

11 9. PHYSICAL AND CHEMICAL PROPERTIES (Continued) Cal D Ref Sol Lysing Appearance: liquid liquid liquid Color: red colorless colorless Odor: odorless odorless odorless Density: 1.01 at 25 C 1.15 at 25 C 1.01 at 25 C ph: 7.3 at 37 C 6-8 at 37 C 7.2 at 37 C Vapor Pressure: not determined not determined not determined Specific Gravity: not determined not determined not determined Solubility (H20): complete complete complete Evaporation rate: not determined not determined not determined Viscosity: not determined not determined not determined Boiling point ( C): not determined not determined not determined Melting point ( C): not applicable not applicable not applicable Flash point: not applicable not applicable not applicable Lower Explosive Limit (%): not applicable not applicable not applicable Upper Explosive Limit (%): not applicable not applicable not applicable Fire and explosion Hazards: not applicable not applicable not applicable 10. STABILITY AND REACTIVITY STABILITY: Stable under ordinary conditions of use and storage. HAZARDOUS DECOMPOSITION PRODUCTS May emit oxides of carbon, oxides of nitrogen, and sulfur oxides when heated to decomposition INCOMPATIBLE MATERIALS: None Known HAZARDOUS POLYMERIZATION: Will not occur 11. TOXICOLOGICAL INFORMATION MISCELLANEOUS TOXICOLOGICAL INFORMATION Carcinogenicity: NTP: no IARC: no OSHA: no - MOPS 3-(N-Morpholino) propane sulfonic acid: Orl-Qal LD50: >316 mg/kg. - Sodium Hydroxide pellets: orl-rbt LDLo :500 mg/kg; ipr-mus LD50: 40 mg/kg; TLV-CEILING 2 mg/m³. Mutagenic data (NIOSH). -Choline Chloride: orl rat LD50: 3400 mg/kg; ipr mus LD50: 320 mg/kg. -Calcium Chloride: ipr mus LD50: mg/kg; orl-rat LD50: 1000 mg/kg (anhydrous form). Mutagenic tumorogenic data (anhydrous form) (NIOSH). -Amaranth: ipr rat LD50: 1 gr /Kg; intravenous rat LD50: 1gr/Kg. -Gentamicin Sulfate: orl rat LD50: > 5000 mg/kg; ipr rat LD50: 630 mg/kg. -Isopropyl alcohol: orl-rat LD50: 5045 mg/kg; ihl-rat LC ppm/8h; TLV-TWA 400 ppm; TLV- STEL 500 ppm skn-rbt LD50: mg/kg; mutation and reproductive effects data (NIOSH). -Kathon 893 MW: orl rat LD50: 750 mg/kg; Dermal rabbit LD50: 690 mg/kg. Reproductive / Teratology Data: Not a teratogen, not reproductive hazard. (Supplier s MSDS) -1-3-Phenylene Diamine: Orl-Rat LD50: 280 mg/kg; Ipr-Rat LD50: 283 mg/kg; Unr-Rat LD50: 351 mg/kg. CO # Sheet 11 of 13 Part No Rev 03

12 11. TOXICOLOGICAL INFORMATION (Continued) -Triton X-100 orl-rat LD mg/kg; orl rbt LD50: mg/kg (skin). Experimental reproductive effects and human mutagenic data (NIOSH). -Potassium Nitrate: Orl-Rat LD50: 3750 mg/kg; Orl-Rbt LD50: 1901 mg/kg; teratogenic, mutagenic and reproductive effects experimental data (NIOSH). -Brij (Ethozylated dodecyl alcohol): Orl-Rat LD50: 8600 mg/kg; Orl-Mus LD50: 3500 mg/kg. -Glycerol: Orl-rat LD50: mg/kg; Orl-Mus LD50: 4090 mg/kg; Ihl-rat LC50: >570 mg/m³/ 1 Hr. The health effects noted above are based on the extrapolation of data on the pure product ingredients. To the best of our knowledge, no health effects have been identified for the product mixture under normal conditions of use, although the health effects of the product have not been thoroughly investigated. MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: None known 12. ECOLOGICAL INFORMATION OTHER ENVIRONMENTAL INFORMATION: No ecotoxicological data are available on the product. Use in accordance with good laboratory practice. Do not waste in the environment. 13. DISPOSAL CONSIDERATIONS The product waste is classified as non toxic and harmful. Dispose of in accordance with local regulations. Used waste products, surplus products or spillage products shall be disposed of in accordance with national and local laws. It is up to the user to classify the waste correctly prior to disposal. 14. TRANSPORT INFORMATION ADR (road): none. IMDG (sea): none. RID (rail): none. ICAO/IATA (air): none No special precaution is required. 15. REGULATORY INFORMATION This product is classified and labeled in accordance with Directive 1999/45/EC and following modifications. The health hazard classification has been determined based on composition and hazard data of each ingredient. Physical and health hazard information on the reagent mixture has not been determined. Any physical and health hazard information noted is based on a) evaluation of data of the pure ingredient and b) concentration of each ingredient. Kit Hazard Classification - EC Symbol: N/A - Risk Code: N/A - Safety Code: S24/ S24/25: avoid contact with skin and eyes. S29: do not empty into drains. S36: wear suitable protective clothing. CO # Sheet 12 of 13 Part No Rev 03

13 16. OTHER INFORMATION REFERENCE DOCUMENTATION Primary references used in the preparation of this document: 1. Product Insert 2. Product Specification NOTE The information supplied in this Safety Data Sheet represents the data and best information available at the date of preparation. It is provided with the aim of allowing proper and safe use, storage, transport and disposal of the product. It is not to be considered as a warranty or specification of product quality. It is related to the materials specifically indicated and does not apply if these are used in combination with other materials or during processes not specifically indicated in the text of this Safety Data Sheet. CO # Sheet 13 of 13 Part No Rev 03