Editing date : 10/01/2006 Revision date : 10/01/2006 Page 1 on 9

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(EEC) – MATERIAL SAFETY DATA SHEET (Complies with the Directive 91/155/EEC)

Substance :

IRON DEXTRAN 10 %

Editing date : 10/01/2006 Revision date : 10/01/2006 Page 1 on 9

BIOFER SpASede legale/Registered Office:

Via Canina 2 - 41036 Medolla (Mo) Italy

Reg. Imprese di Modena - Cod. Fisc./TaxCode 03618030484

Part. IVA/VAT IT 01848610364

Capitale Sociale/Capital Stock Euro 1.237.600 i.v. R.E.A. Mo n. 246245 - Cod. ISO IT 01848610364 Iscriz. Trib. Modena N.29601

Sede Amministrativa e Magazzini/

Head Office and Warehouse:

Via E. Barbieri 3/5 - 41036 Medolla (Mo) Italy TeI. +39053552214

Fax +39 0535 51323 E-mail: [email protected] www.bioferspa.com

Stabilimento e Laboratori di Ricerca/

Manufacturing Site and Research Laboratories:

Via Canina 2 - 41036 Medolla (Mo) Italy TeI. +39053552214

1. CHEMICAL AND COMPANY IDENTIFICATION

1.1 Substance identification

1.1.1 Chemical name : IRON DEXTRAN 10% 1.1.2 Trade names and synonyms : Endofer

1.1.3 Chemical Abstract name: Iron dextran

1.2 Company identification

1.2.1 Company identification : BIOFER S.p.A. Via Canina Bosco, 2/A 41036 Medolla (MO)

Italy

Tel. +39.0535.52214 Fax +39.0535.51323 (52204) 1.2.2 Emergency telephone numbers : +39.0535.52214

2. COMPOSITION / INFORMATION ON INGREDIENTS

Chemical Name CAS

number

EINECS number

Molecular formula

Molecular weight

% W/W

Iron dextran 9004-66-4 n.a. n.d. n.d. ≈ 37%

Water 7732-18-5 231-791-2 H2O 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.

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Substance :

IRON DEXTRAN 10 %

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.

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Substance :

IRON DEXTRAN 10 %

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 by- products. 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).

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Substance :

IRON DEXTRAN 10 %

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.

8.2.1 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

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Substance :

IRON DEXTRAN 10 %

9. PHYSICAL AND CHEMICAL PROPERTIES

9.1 Appearance

9.1.1 Physical state liquid

9.1.2 Colour Brown-dark

9.1.3 Physical form liquid

9.1.4 Odour Odourless

9.1.5 Molecular weight Variable [Iron Dextran] 9.1.6 Boiling point Not available

9.1.7 Freezing point Not available 9.1.8 Vapour pressure Not available 9.1.9 Vapour density Not available 9.1.10 Specific gravity Not available 9.1.11 Water solubility Soluble

9.1.12 pH 4.5 ÷ 7.0

9.1.13 Volatility Not available

9.1.14 Odour threshold Not available 9.1.15 Evaporation rate Not available

9.1.16 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. 10.4 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

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Substance :

IRON DEXTRAN 10 %

11. 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.

11.1 RTECS n° NI2200000

11.2 Toxicity data Not available

11.2 Carcinogen status NTP: R (Reasonably Suspected to be a Human

Carcinogen)

IARC: Group 2B (Possible Carcinogenic to Humans) 11.4.1.1 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

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Substance :

IRON DEXTRAN 10 %

11.5 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; 52500 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 17-20 day(s) pregnant. 11.6 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.

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Substance :

IRON DEXTRAN 10 %

14. TRANSPORT INFORMATION

14.1 Packing group : No classification assigned 14.2 Railway and road transport

14.2.1 Class No classification assigned 14.3 Air transport

14.3.1 IATA number: No classification assigned 14.3.2 Packing extraction No classification assigned 14.3.3 Maximum delivery quantity No classification assigned 14.4 Sea transport

14.4.1 AIMO No classification assigned 14.4.2 EMS page number No classification assigned 14.4.3 IMDG page number No classification assigned 14.4.4 MSAG page number No classification assigned

15. REGULATORY INFORMATION

15.1 Danger / Hazard symbol Xn Harmful 15.2 R codes

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Substance :

IRON DEXTRAN 10 %

15.3 S codes

15.3.1 S 2 Keep out of reach of children

15.3.2 S 13 Keep away from food, drink and animal feeding stuffs 15.3.3 S 24 Avoid contact with skin

15.3.4 S 36 Wear suitable protective clothing

15.3.5 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.