113 Hartwell Ave., Lexington, MA 02421
MATERIAL SAFETY
DATA SHEET
Chemtrec @ 1-800-424-9300
1. IDENTIFICATION OF PRODUCT
This Material Safety Data Sheet applies to:
Product Name Part No.
HemosIL Liquid Antithrombin 0020030100
鈥? Chromogenic Substrate
鈥? Factor Xa reagent
2. COMPOSITION
INGREDIENT NAME CONCENTRATION
PERCENT BY WEIGHT
Chromogenic Substrate S-2765
N-alpha-Z-D-Arg-Gly-Arg-pNA x 2 HCl 0.058
p-NA Chemically bound to peptide
CAS No.: 100-01-6 (p-NA)
EINECS No.: 202-810-1
Hazard Classification: T (as raw material)
Risk Code: R23/24/25-33-52/53
R23/24/25: Toxic by inhalation, in contact with skin or if swallowed.
R33: Danger of cumulative effect.
R52/53: Harmful to aquatic organism and may cause long-term
adverse effects in the aquatic environment.
Factor Xa Reagent
Tris-hydroxymethyl-aminomethane <1
CAS No.: 77-86-1
EINECS No.: 201-064-4
Hazard Classification: Xi (as raw material)
Risk Code: R36-37-38
R36: Irritating to eyes.
R37: Irritating to respiratory system.
R38: Irritating to skin.
Tris-hydroxymethyl-aminomethane hydrochloride <1
CAS No.: 1185-53-1
EINECS No.: 214-684-5
Hazard Classification: Xi (as raw material)
Risk Code: R36-37-38.
R36: Irritating to eyes.
R37: Irritating to respiratory system.
R38: Irritating to skin.
Bovine Factor Xa 40nKat/vial
CO 402590 Sheet 1 of 5 Part No. 190837-62 Rev 01
Eff. Date: 3/8/07
113 Hartwell Ave., Lexington, MA 02421
2 COMPOSITION (CONTINUED)
INGREDIENT NAME CONCENTRATION
PERCENT BY WEIGHT
Bovine Albumin 0.25
Sodium Omadine 40% (preservative) < 0.1
CAS No.: 3811-73-2
EINECS No.: 223-296-5
Hazard Classification: Xi (as raw material)
Risk Code: R22-36/38
R22: Harmful if swallowed.
R36/38: Irritating to eyes and skin.
3. HAZARD IDENTIFICATION
POTENTIAL HEALTH EFFECTS
EYES
Chromogenic Substrate S-2765 / Factor Xa reagent: may cause irritation.
SKIN
Chromogenic Substrate S-2765: may be absorbed through the skin with possible systemic effects.
Factor Xa reagent: may cause irritation and redness.
INGESTION
Chromogenic Substrate S-2765: may be harmful if swallowed. May cause blood damage with blueness of the lips (cyanosis),
strong headache.
Factor Xa reagent: may be harmful if swallowed.
INHALATION
Chromogenic Substrate S-2765: May cause blood damage with blueness of the lips (cyanosis), strong headache, nausea,
coughing.
Factor Xa reagent: may cause irritation to the mucous membranes and upper respiratory tract.
4. FIRST AID MEASURES
EYES
In case of eye contact, flush eyes with plenty of water for at least 15 minutes. Obtain medical attention if irritation develops.
SKIN
Wash well with soap and water. Remove contaminated clothing and launder before use. Obtain medical attention if irritation
develops.
INGESTION
Flush mouth with water, without swallowing. Obtain medical attention or contact the local Poison Control Center.
INHALATION
Remove the individual to fresh air. If breathing is difficult, give oxygen and obtain medical attention.
5. FIRE FIGHTING MEASURES
EXTINGUISHING MEDIA
Use any extinguishing agent that 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.
CO 402590 Sheet 2 of 5 Part No. 190837-62 Rev 01
Eff. Date: 3/8/07
113 Hartwell Ave., Lexington, MA 02421
6. ACCIDENTAL RELEASE MEASURES
Wear appropriate personal protective equipment as specified in Section 8.
Clean up spills in a manner which does not disperse dust into the air or create aerosols of prepared solutions. Dry spills should
be moistened with water or an EPA approved disinfectant. Contain spill and decontaminate the area. Pick up material and
dispose in biohazard/sharps container as appropriate.
Do not empty into drains.
7. HANDLING AND STORAGE
HANDLING AND STORAGE PRECAUTIONS:
Reference the product labeling for handling and storage instructions.
Factor Xa Reagent:
CAUTION: All blood products should be treated as potentially infectious.
The animal serum was tested for the presence of pathologies and found negative. The animal serum was treated during the
production processes to inactive viruses. No known test method can offer assurance that products derived from animal blood
will not transmit infectious agents. Handle as potentially infectious. Wear personal protective equipment.
WORK/HYGIENIC PRACTICES
Wash hands with soap and water after use.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
The product does not contain great amounts of dangerous substances. The threshold limit values (TLV) do not have to be under
control for the exposure to people in the workplace.
Threshold limit values regarding the raw material:
ACGIH TLV-TWA
p-nitroaniline 3 mg/m3 (skin)
US OSHA PEL:
p-nitroaniline 8H TWA 1 ppm 3 mg/m3 (skin)
EYE/FACE PROTECTION
Safety glasses or splash goggles are recommended.
SKIN PROTECTION
Wear protective (latex/non-latex) gloves and laboratory coat as required to prevent skin contact.
RESPIRATORY PROTECTION
None normally required with adequate ventilation.
OTHER/GENERAL PROTECTION
Wash promptly if skin becomes wet or contaminated. Promptly remove any clothing that becomes wet or contaminated. Wash
as the end of each work shift and before eating.
9. PHYSICAL AND CHEMICAL PROPERTIES
Substrate Factor Xa Reagent
Appearance: liquid liquid
Color: colorless colorless
Odor: odorless odorless
Density: not available not available
pH: 4.2 at 25掳C 7.4 at 25掳C
Vapor Pressure: not determined not determined
Specific Gravity: not determined not determined
Solubility (H20): complete complete
Evaporation rate: not determined not determined
Viscosity: not available not available
Boiling point (掳C): not determined not determined
Melting point (掳C): not applicable not applicable
Flash Point: not applicable not applicable
CO 402590 Sheet 3 of 5 Part No. 190837-62 Rev 01
Eff. Date: 3/8/07
113 Hartwell Ave., Lexington, MA 02421
9. PHYSICAL AND CHEMICAL PROPERTIES (continued)
Substrate Factor Xa Reagent
Lower Explosive Limit (%): not applicable not applicable
Upper Explosive Limit (%): not applicable not applicable
Fir and Explosion Hazards: not applicable not applicable
10. STABILITY AND REACTIVITY
STABILITY: Stable
INCOMPATIBLE MATERIALS:
pNA: Strong oxidizing agents, strong acids and bases.
Tris-hydroxymethyl-aminomethane: Copper, brass, aluminum and oxidizing materials.
HAZARDOUS DECOMPOSITION PRODUCTS:
- Chromogenic Substrate S2765 / Factor Xa: Harmful fumes of oxides of carbon, nitrogen and SOx may be formed during
thermal decomposition.
HAZARDOUS POLYMERIZATION: Will not occur.
11. TOXICOLOGICAL INFORMATION
MISCELLANEOUS TOXICOLOGICAL INFORMATION
-Tris-hydroxymethyl-aminomethane: orl-rat LD50 5900 mg/kg. No toxic effected noted. (NIOSH).
-p-nitroaniline (pNA): orl-rat LD50 750 mg/Kg; orl-mouse LD50:810mg/Kg; intraperitoneal mouse LD50: 800 mg/Kg.
TVL-TWA 3.0 mg/m3; mutagenic data (NIOSH)
-Sodium Omadine: orl-mus LD50 870 mg/Kg: no toxic effect noted; OYYAA2 4,883,70. (Oyo Yakuri).
ipr-mus LD50 370 mg/Kg: no toxic effect noted; OYYAA2 4,883,70. (Oyo Yakuri).
ivn-mus LD50 320 mg/Kg: no toxic effect noted; CSLNX* NX#04703. (US Army Data NIOSH EXCH Chem).
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 non-harmful. Dispose of waste product, unused product and contaminated
packaging in compliance with federal, state and local regulations. If unsure of the applicable requirements, contact the
authorities for information. It is up to the user to classify the waste correctly prior to disposal.
14. TRANSPORT INFORMATION
No special precaution is required
ADR: (road) None
IMDG (sea) None
RID (rail) None
ICAO/IATA (air) None
CO 402590 Sheet 4 of 5 Part No. 190837-62 Rev 01
Eff. Date: 3/8/07
113 Hartwell Ave., Lexington, MA 02421
15. REGULATORY INFORMATION
This product is classified and labeled in accordance with EEC 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:
EEC Symbol: Not Applicable
Risk Code: Not Applicable
Safety Code: S24/25 - 29 鈥? 36
S24/25: Avoid contact with skin and eyes.
S29: Do not empty into drains.
S36: Wear suitable protective clothing.
16. OTHER INFORMATION
REFERENCE DOCUMENTATION
Primary references used in the preparation of this document:
1. Product Specification.
2. Product Insert
NOTE
The information supplied in this Material 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
Material Safety Data Sheet.
CO 402590 Sheet 5 of 5 Part No. 190837-62 Rev 01
Eff. Date: 3/8/07
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