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1 Editing date : 10/01/2006 Revision date : 10/01/2006 Page 1 on 9 1. CHEMICAL AND COMPANY IDENTIFICATION 1.1 Substance identification Chemical name : IRON DEXTRAN 10% Trade names and synonyms : Endofer Chemical Abstract name: Iron dextran 1.2 Company identification Company identification : BIOFER S.p.A. Via Canina Bosco, 2/A Medolla (MO) Italy Tel Fax (52204) Emergency telephone numbers : COMPOSITION / INFORMATION ON INGREDIENTS Chemical Name CAS EINECS Molecular Molecular % W/W number number formula weight Iron dextran n.a. n.d. n.d. 37% Water H 2 O 18 Other components present in less than 1 per cent (or 0.1 per cent for potential carcinogens, reproductive toxics, respiratory tract sensitizer and mutagens) None of the other components contribute significant additional hazards at the concentration present in this product. Balance

2 Editing date : 10/01/2006 Revision date : 10/01/2006 Page 2 on 9 3. HAZARDS IDENTIFICATION This product is a dark-brown, viscous, aqueous solution, which is not-flammable and not reactive under a typical circumstances of a release. The primary health hazard associated with emergency response to this material is the potential for mild irritation of contaminated skin or eyes. 4. FIRST-AID MEASURES 4.1 Ingestion If this product is shallowed call local poison control center or physician for most current information. Never make an unconscious person vomit or drink fluids. Get medical attention immediately. 4.2 Inhalation If adverse effects occur, remove to uncontaminated area. Give artificial respiration if not breathing. Get immediate medical attention. 4.3 Skin contact Wash skin with soap and water for at least 15 minutes while removing contaminated clothing and shoes. Get medical attention, if needed. Thoroughly clean and dry contaminated clothing and shoe before reuse. 4.4 Contact with eyes Flush eyes with plenty of water for at least 15 minutes. Assure adequate flushing by separating the eyelids with fingers. Then get immediate medical attention.

3 Editing date : 10/01/2006 Revision date : 10/01/2006 Page 3 on 9 5. FIRE FIGHTING MEASURES 5.1 Fire and explosion hazards Negligible fire hazard 5.2 Flash point Not applicable 5.3 Extinguishing media Non flammable. Use extinguishing media appropriate for surrounding fire: water spray, carbon dioxide, foam, dry chemical. 5.4 Extinguishing media to avoid None 5.5 Fire fighting procedures Move container from fire area if it can be done without Risk. Avoid inhalation of material or combustion byproducts. Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. 5.6 Unusual fire and explosion hazard At extremely high temperature this product will decompose to produce irritating vapors and toxic gases (e.g. carbon dioxide, iron compounds).

4 Editing date : 10/01/2006 Revision date : 10/01/2006 Page 4 on 9 6. ACCIDENTAL RELEASE MEASURES 6.1 Collecting/cleaning measures Collect spilled material in appropriate container for disposal. Avoid producing spray or mist during cleanup. 6.2 Individual precautions Wear appropriate NIOSH/MSHA-approved respirator, chemical-resistant gloves, safety goggles, other protective clothing. 6.3 Other advices Ventilate area and wash spill site after material pickup is complete with copious amounts of water. 7. HANDLING AND STORAGE Refer to Section 8 (Exposure controls/personal protection) 8. EXPOSURE CONTROLS / PERSONAL PROTECTION 8.1 Exposure limits: no occupational exposure limits established 8.2 Ventilation: provide local exhaust or process enclosure ventilation system Eye protection: wear appropriate chemical resistant safety goggles. Provide an emergency eye wash fountain and quick drench shower in the immediate work area. 8.3 Clothing: wear appropriate chemical resistant clothing 8.4 Gloves: wear appropriate chemical resistant gloves 8.5 Respirator: Wear appropriate NIOSH/MSHA-approved respirator

5 Editing date : 10/01/2006 Revision date : 10/01/2006 Page 5 on 9 9. PHYSICAL AND CHEMICAL PROPERTIES 9.1 Appearance Physical state liquid Colour Brown-dark Physical form liquid Odour Odourless Molecular weight Variable [Iron Dextran] Boiling point Not available Freezing point Not available Vapour pressure Not available Vapour density Not available Specific gravity Not available Water solubility Soluble ph Volatility Not available Odour threshold Not available Evaporation rate Not available Solvent solubility Insoluble: organic solvents 10. STABILITY AND REACTIVITY 10.1 Reactivity Stable at normal temperatures and pressure 10.2 Conditions to avoid Avoid generating dust 10.3 Incompatibilities Incompatible with oxidizing agents and strong acids Hazardous decomposition Thermal decomposition products: miscellaneous decomposition products. In event of a fire may emit toxic gases (carbon oxides and iron compounds) 10.5 Hazardous polymerisation Will not polymerise

6 Editing date : 10/01/2006 Revision date : 10/01/2006 Page 6 on TOXICOLOGICAL INFORMATION The following data are for the active ingredient of this product, Iron Dextran. The other components of this product are not found on the following lists: U.S. Federa OSHA Z List, NTP, CAL/OSHA, and IARC, and therefore are neither considered to be nor suspected to be a cancer-causin agent by these agencies RTECS n NI Toxicity data Not available 11.2 Carcinogen status NTP: R (Reasonably Suspected to be a Human Carcinogen) IARC: Group 2B (Possible Carcinogenic to Humans) Tumorigenic data. 20 mg/kg intramuscular-woman TDLo/3 year(s)intermittent; 52 mg (Fe) /kg intramuscular-woman TD/6 week(s) intermittent; 2 gm(fe)/kg intramuscular-mouse TDLo/9 week(s)intermittent; 1150 mg/kg intramuscular-rat TDLo/17 week(s) intermittent; 3760 mg(fe)/kg intramuscular-rat TD/47 week(s) intermittent; 28 gm/kg intramuscular-rabbit TDLo/27 week(s) intermittent; 40 gm/kg subcutaneous-hamster TDLo/10 week(s) intermittent; 2300 mg/kg subcutaneous-mouse TDLo; 1120 mg(fe)/kg subcutaneous-mouse TD/28 week(s) intermittent; 104 gm/kg subcutaneous-mouse TD/13 week(s) intermittent; 750 mg(fe)/kg subcutaneous-rat TDLo/4 week(s) intermittent; 104 gm/kg subcutaneous-rat TD/26 week(s) intermittent; 1500 mg(fe)/kg subcutaneous-rat TD/8 week(s) intermittent; 2400 mg(fe)/kg subcutaneous-rat TD/24 week(s) intermittent

7 Editing date : 10/01/2006 Revision date : 10/01/2006 Page 7 on Reproductive effects data: 240 mg/kg intramuscular-rat TDLo 6 week(s) prior to copulation; 650 mg (Fe)/kg intramuscular-rabbit TDLo 6-18 day(s) pregnant; ug/kg intrauterine-rat TDLo 1 prior to copulation; 5250 ug/kg intrauterine-rat TDLo 1 day(s) prior to copulation; 2580 gm/kg intravenous-rat TDLo day(s) pregnant Acute toxicity data: LD > 450 mg(fe)/kg intramuscular- mouse; LDLo: 1617 mg (Fe)/kg intramuscular-rat; LD > 690 mg(fe)/kg intramuscular- rabbit; LDLo: 600 mg/kg intraperitoneal-mouse LD50: 3gm (Fe)/kg intraperitoneal-rat LDLo: 500 mg/kg intraperitoneal-rat LD50: 460 mg (Fe)/kg intravenous-mouse LDLo: 500 mg (Fe)/kg intravenous-rabbit LD50: 1 gm (Fe)/kg oral-mouse 11.7 Other data LDLo: 700 mg /kg/ 7 day-intermittent / intraperitoneal-rat 12. ECOLOGICAL INFORMATION Data not yet available. 13. DISPOSAL CONSIDERATIONS Small amounts may be washed down the drain with excess water. Incinerate in a furnace providing environmental regulations permit. Observe all state and local environmental regulations.

8 Editing date : 10/01/2006 Revision date : 10/01/2006 Page 8 on TRANSPORT INFORMATION 14.1 Packing group : No classification assigned 14.2 Railway and road transport Class No classification assigned 14.3 Air transport IATA number: No classification assigned Packing extraction No classification assigned Maximum delivery quantity No classification assigned 14.4 Sea transport AIMO No classification assigned EMS page number No classification assigned IMDG page number No classification assigned MSAG page number No classification assigned 15. REGULATORY INFORMATION 15.1 Danger / Hazard symbol Xn Harmful 15.2 R codes R 22/21 Harmful by inalation and in contact with skin

9 Editing date : 10/01/2006 Revision date : 10/01/2006 Page 9 on S codes S 2 Keep out of reach of children S 13 Keep away from food, drink and animal feeding stuffs S 24 Avoid contact with skin S 36 Wear suitable protective clothing S 46 If swallowed, seek medical advice immediately and show container label. 16. OTHER INFORMATION 16.1 Bibliography N. Irving Sax - Dangerous Properties of Industrial Materials (VI edition) RTECS databases. The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. BIOFER S.p.A. shall not be liable for any damage resulting from handling or from contact with the above product.

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