113 Hartwell Ave., Lexington, MA 02421
CO 407144 Sheet 1 of 4 Part No. 190836-59 Rev 02
Eff. Date: 09/08/2008
Emergency number: Chemtrec @ 1-800-424-9300
1. IDENTIFICATION OF PRODUCT
This Material Safety Data Sheet applies to:
Product Name Part No.
HemosIL High Abnormal Control ASSAYED 0020003310
HemosIL High Abnormal Control 3 UNASSAYED 0020003320
2. COMPOSITION
INGREDIENT NAME CONCENTRATION
PERCENT BY WEIGHT
Treated Human Plasma (Lyophilized)
Sodium Omadine 40% (Preservative) 0.02
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.
Ciprofloxacin hydrochloride (Preservative) 0.005
CAS No.: 93107-08-05
Bovine Serum Albumin 2.35
CAS No.: 9048-46-8
EINECS No.: 232-936-2
3. HAZARD IDENTIFICATION
POTENTIAL HEALTH EFFECTS
EYES
Direct contact may cause redness and irritation.
SKIN
Prolonged or repeated contact may cause skin irritation.
INGESTION
Harmful if swallowed.
INHALATION
Mild irritant.
MATERIAL SAFETY
DATA SHEET
113 Hartwell Ave., Lexington, MA 02421
CO 407144 Sheet 2 of 4 Part No. 190836-59 Rev 02
Eff. Date: 09/08/2008
4. FIRST AID MEASURES
EYES
In case of eye contact, flush eyes with plenty of water for at least 15 minutes. Ensure adequate flushing by separating the eyelids
with fingers. Obtain medical attention if irritation develops.
SKIN
Promptly wash exposed areas thoroughly with soap and water. Obtain medical attention if irritation develops.
INGESTION
Rinse mouth with plenty of water. 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
FLAMMABLE PROPERTIES
FLASH POINT
LOWER EXPLOSIVE LIMIT (%): Not Applicable
UPPER EXPLOSIVE LIMIT (%): Not Applicable
FIRE AND EXPLOSION HAZARDS:
None known.
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.
6. ACCIDENTAL RELEASE MEASURES
Wear appropriate personal protective equipment as specified in Section 8.
Clean up spills in a manner that 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.
7. HANDLING AND STORAGE
HANDLING AND STORAGE PRECAUTIONS
Reference the product labeling for handling and storage instructions.
CAUTION: All blood products should be treated as potentially infectious.
The human source material was found negative for the presence of the antibody to HIV, HBSAg and HCV when tested in
accordance with FDA approved tests. 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 human and 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.
113 Hartwell Ave., Lexington, MA 02421
CO 407144 Sheet 3 of 4 Part No. 190836-59 Rev 02
Eff. Date: 09/08/2008
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
ENGINEERING CONTROLS
None normally required.
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
None normally required.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance lyophilized powder
Color: white to yellowish powder
Odor: odorless
Density: not determined
pH: 7.40 at 25°C
BASIC PHYSICAL PROPERTIES
VAPOR PRESSURE: Not determined.
SPECIFIC GRAVITY: Not determined.
SOLUBILITY (H20): Not determined.
10. STABILITY AND REACTIVITY
STABILITY: Stable
CONDITIONS TO ALLOW (STABILITY): See Insert Sheet.
HAZARDOUS DECOMPOSITION PRODUCTS
Harmful fumes of oxides, carbon, nitrogen and Na2O may be formed during thermal decomposition.
HAZARDOUS POLYMERIZATION: Will not occur.
11. TOXICOLOGICAL INFORMATION
MISCELLANEOUS TOXICOLOGICAL INFORMATION
Carcinogenicity: NTP: no IARC: no OSHA: no
-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.
113 Hartwell Ave., Lexington, MA 02421
CO 407144 Sheet 4 of 4 Part No. 190836-59 Rev 02
Eff. Date: 09/08/2008
12. ECOLOGICAL INFORMATION
OTHER ENVIRONMENTAL INFORMATION
No ecotoxicological data are available on the product.
Sodium Omadine: effect toxic to fish LC 50: 0.0073-8.6 mg/L (96 hours).
Use in accordance with good laboratory practice. Do not waste in the environment.
13. DISPOSAL CONSIDERATIONS
Based on EEC Directive No. 75/442 and 78/319 and following modifications, 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
Not Regulated
15. REGULATORY INFORMATION
This product is classified and labeled in accordance with EEC Directive 88/379 and EEC Directive 91/155 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: S24/25-29-36
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.