1. Identification

Product identifier  Dalteparin Sodium
Other means of identification
Catalog number  1162487
Chemical name   Sulfated glucosaminoglycans sodium salt
Synonym(s)       Tinzaparin, ardeparin, or enoxaparin sodium * Heparin, sodium salt
Recommended use      Specified quality tests and assay use only.
Recommended restrictions      Not for use as a drug. Not for administration to humans or animals.

2.Hazard(s) identification
Note    Causes eye irritation.
Physical hazards   Not classified.
 Health hazards  Serious eye damage/eye irritation
 Not classified.  Category 2B
OSHA hazard(s)   Not classified.
Label elements 
Hazard symbol    No symbol.
Signal word    Warning
Hazard statement    Causes eye irritation.
Precautionary statement
Prevention    Wash thoroughly after handling.
Response            If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and                         easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.
Storage          Not available.
Disposal    Not available.

3.Composition/information on ingredients
Substance
Hazardous components

Chemical name	Common name and synonyms	CAS number	%
Dalteparin Sodium	Tinzaparin, ardeparin, or enoxaparin sodium Heparin, sodium salt	9041-08-1	100

4.First-aid measures

Inhalation      If breathing is difficult, remove to fresh air and keep at rest in a position comfortable for breathing.Call a physician if symptoms develop or persist.

Skin contact    Rinse skin with water/shower. Get medical attention if irritation develops and persists.

Eye contact    Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Get medical attention if irritation develops and persists.

Ingestion    Rinse mouth. If ingestion of a large amount does occur, call a poison control center immediately.

Most important symptoms/effects, acute and delayed    Irritation of eyes and mucous membranes.

Indication of immediate medical attention and special treatment needed    Provide general supportive measures and treat symptomatically.

General information       Remove from exposure. Remove contaminated clothing. For treatment advice, seek guidance from an occupational health physician or other licensed health-care provider familiar with workplace chemical exposures. In the United States, the national poison control center phone number is 1-800-222-1222. If person is not breathing, give artificial respiration. If breathing is difficult, give oxygen if available. Persons developing serious hypersensitivity (anaphylactic) reactions must receive immediate medical attention.

5.Fire-fighting measures
Suitable extinguishing media    Use fire-extinguishing media appropriate for surrounding materials. Water. Foam. Dry chemical or CO2.

Unsuitable extinguishing media  None known.

Specific hazards arising from the chemical   No unusual fire or explosion hazards noted. 

Special protective equipment and precautions for firefighters  Wear suitable protective equipment.

Fire-fighting equipment/instructions    Use water spray to cool unopened containers. As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing.

Specific methods    Use standard firefighting procedures and consider the hazards of other involved materials.

6.Accidental release measures

Personal precautions, protective equipment and emergency procedures  Keep unnecessary personnel away. Do not touch damaged containers or spilled material unless wearing appropriate protective clothing. Ensure adequate ventilation. Avoid inhalation of dust from the spilled material. Wear appropriate personal protective equipment.

Methods and materials for containment and cleaning up   Sweep up or vacuum up spillage and collect in suitable container for disposal. Avoid the generation of dusts during clean-up. For waste disposal, see section 13 of the SDS. Clean surface thoroughly to remove residual contamination.

7.Handling and storage

Precautions for safe handling     As a general rule, when handling USP Reference Standards, avoid all contact and inhalation of dust, mists, and/or vapors associated with the material. Clean equipment and work surfaces with suitable detergent or solvent after use. After removing gloves, wash hands and other exposed skin thoroughly.

Conditions for safe storage, including any incompatibilities    Store in tight container as defined in the USP-NF. This material should be handled and stored per label instructions to ensure product integrity
  
8.Exposure controls/personal protection
Exposure limit values
 Industrial Use

Material	Type	Value
Dalteparin Sodium (CAS 9041-08-1)	TWA	0.02 mg/m3

Biological limit values    No biological exposure limits noted for the ingredient(s).

Appropriate engineering controls
Airborne exposure should be controlled primarily by engineering controls such as general dilution ventilation, local exhaust ventilation, or process enclosure. Local exhaust ventilation is generally preferred to general exhaust because it can control the contaminant at its source, preventing dispersion into the work area. An industrial hygiene survey involving air monitoring may be used to determine the effectiveness of engineering controls. Effectiveness of engineering controls intended for use with highly potent materials should be assessed by use of nontoxic surrogate materials. Local exhaust ventilation such as a laboratory fume hood or other vented enclosure is recommended, particularly for grinding, crushing, weighing, or other dust-generating procedures.

ndividual protection measures, such as personal protective equipment

Eye/face protection        Safety glasses with sideshields are recommended. Face shields or goggles may be required if splash potential exists or if corrosive materials are present. Approved eye protection (e.g., bearing the ANSI Z87 or CSA stamp) is preferred. Maintain eyewash facilities in the work area.

Skin protection

Hand protection

    Chemically compatible gloves. For handling solutions, ensure that the glove material is protective against the solvent being used. Use handling practices that minimize direct hand contact.
Employees who are sensitive to natural rubber (latex) should use nitrile or other synthetic nonlatex gloves. Use of powdered latex gloves should be avoided due to the risk of latex allergy.

Other
    
For handling of laboratory scale quantities, a cloth lab coat is recommended. Where significant quantities are handled, work clothing may be necessary to prevent take-home contamination.

Respiratory protection
    
Where respirators are deemed necessary to reduce or control occupational exposures, use NIOSH-approved respiratory protection and have an effective respirator program in place (applicable U.S. regulation OSHA 29 CFR 1910.134).

Thermal hazards    Not available.

General hygiene considerations   Handle in accordance with good industrial hygiene and safety practice.

9.Physical and chemical properties

Appearance    White or almost white powder.
Physical state    Solid.
Form    Powder.
Odor    Not available.
Odor threshold    Not available.
pH    5.5 - 8 (1% aqueous solution)
Melting point/freezing point    Not available.

Initial boiling point and boiling range  Not available.

Flash point    Not available.
Evaporation rate    Not available.
 Flammability (solid, gas)    Not applicable. 
Upper/lower flammability or explosive limits

Flammability limit - lower (%)  Not available.
Flammability limit - upper (%)  Not available.
Explosive limit - lower (%)    Not available.
 Explosive limit - upper (%)    Not available. 
Vapor pressure        Not available.
Vapor density    Not available.
Relative density    Not available.
Solubility in water    Freely soluble.
Partition coefficient (n-octanol/water)  Not available.
Auto-ignition temperature    Not available. 
Decomposition temperature Not available.
Viscosity    Not available.
Other information
Chemical family    Mucopolysaccharide.
Molecular weight    2000 - 9000 daltons

10.Stability and reactivity
Reactivity    No reactivity hazards known.
Chemical stability    Material is stable under normal conditions.

Possibility of hazardous reactions  No dangerous reaction known under conditions of normal use.

Conditions to avoid     None known.
Incompatible materials    Oxidizing agents

Hazardous decomposition products    Irritating and/or toxic fumes or gases. Emits toxic fumes under fire conditions. NOx. SOx. Na2O.

11.Toxicological information
Information on likely routes of exposure
Ingestion      Based on available data, the classification criteria are not met.
Inhalation      Due to lack of data the classification is not possible.
Skin contact    Due to lack of data the classification is not possible.
Eye contact    Causes eye irritation.

Symptoms related to the physical, chemical, and toxicological characteristics   Heparin (injection; infusion): Nosebleeds. Blood in urine. Tarry stools. Bruising. Increased bleeding time. Hair loss.

Delayed and immediate effects of exposure   Heparin (injection; infusion): Thrombocytopenia. Kidney function impairment. Hypersensitivity.
Chronic effects    Heparin (injection; infusion): Osteoporosis.
Cross sensitivity    Persons sensitive to beef or pork may be sensitive to this material also.

Medical conditions aggravated by exposure  Heparin (injection; infusion): Bleeding disorders such as thromobcytopenia and hemophilia. Active bleeding. Stomach ulcers. Kidney or liver impairment. Hypertension.

Acute toxicity

Product	Species	Test Results
Dalteparin Sodium (CAS 9041-08-1)  Oral   LD50	Rat	> 5000 mg/kg

Skin corrosion/irritation    Based on available data, the classification criteria are not met.

Serious eye damage/eye irritation   Causes eye irritation.
Local effects
Result: Irritant
 Species: Rabbit
 Organ: Eye 
Severity: Mild
 Result: Irritant
 Species: Rabbit 
Organ: Skin
 Severity: Slight

Respiratory sensitization    Due to lack of data the classification is not possible.
Skin sensitization    Based on available data, the classification criteria are not met.
Sensitization
Passive cutaneous anaphylaxis assay 
Result: Negative
Species: Guinea pig

Germ cell mutagenicity    Due to lack of data the classification is not possible. Data from germ cell mutagenicity tests were not found. Results of genotoxicity tests in vitro were negative.

Carcinogenicity    Due to lack of data the classification is not possible. This material is not considered to be a carcinogen by IARC, NTP, or OSHA.

Reproductive toxicity    Based on available data, the classification criteria are not met.

Reproductivity
10 mg/kg/day (subcutaneous), NOAEL - fertility, fetotoxicity
 Species: Rat
10000 mg/kg/day (intravenous), LOAEL - fetotoxicity
 Species: Rat
2500 mg/kg/day (intravenous), LOAEL - fetotoxicity
 Species: Rabbit

Specific target organ toxicity - single exposure   Due to lack of data the classification is not possible. 

Specific target organ toxicity - repeated exposure     Due to lack of data the classification is not possible.

Aspiration hazard    Based on available data, the classification criteria are not met.

12.Ecological information
Ecotoxicity    No ecotoxicity data noted for the ingredient(s).
 Persistence and degradability      No data is available on the degradability of this product. 
Bioaccumulative potential      Not available
Mobility in soil    Not available.
Other adverse effects    Not available.

13.Disposal considerations

Disposal instructions    Dispose in accordance with all applicable regulations. Under RCRA, it is the responsibility of the user of the product to determine, at the time of disposal, whether the product meets RCRA criteria for hazardous waste.
Local disposal regulations    Not available.
Hazardous waste code    Not available.

Waste from residues / unused products    Dispose of in accordance with local regulations. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a safe manner (see: Disposal instructions).

Contaminated packaging    Empty containers should be taken to an approved waste handling site for recycling or disposal.Since emptied containers may retain product residue, follow label warnings even after container is emptied.

14.Transport information
DOT
Not regulated as a hazardous material by DOT.
IATA
Not regulated as a dangerous good.

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code  No information available.

15.Regulatory information
US federal regulations    CERCLA/SARA Hazardous Substances - Not applicable.
                                                 All components are on the U.S. EPA TSCA Inventory List.
Superfund Amendments and Reauthorization Act of 1986 (SARA)

 Hazard categories    

Immediate Hazard - Yes
Delayed Hazard - No
 Fire Hazard - No
 Pressure Hazard - No 
Reactivity Hazard - No

SARA 302 Extremely hazardous substance   No
SARA 311/312 Hazardous chemical      No

Other federal regulations

Safe Drinking Water Act (SDWA)  Not regulated.

Food and Drug   Not regulated.

Administration (FDA)

US state regulations       California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65): This material is not known to contain any chemicals currently listed as carcinogens or reproductive toxins.

注：证书信息仅供参考，以产品附带证书为准。