REAGENT SAFETY
DATA SHEET
1. IDENTIFICATION OF PRODUCT AND COMPANY
This Reagent Safety Data Sheet applies to:
Product name Kit Congfiguration Code
?br>
COAMATIC?Heparin Substrate S-2732 2 vials 823393-63
Factor Xa 35 nkat 2 vials
Distributor : Chromogenix - Instrumentation Laboratory S.p.A. - Viale Monza, 338 - 20128 Milan
Tel. +39-02-25221 Fax +39-02-2575250
+39-02-2522884 +39-02-2522889
2 COMPOSITION - Information on ingredients
INGREDIENT NAME CONCENTRATION
PERCENT BY WEIGHT
-Substrate S-2732:
Suc-lle-Glu (gamma-pip)-Gly-Arg-pNA x HCl < 0.5
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
and if swallowed.
R33: danger of cumulative effect.
R52/53: Harmful to aquatic organism, may cause
long-term adverse effects in the aquatic environment.
Safety Code: S 28-36/37-45-61
-Factor Xa 35 nkat:
EDTA Disodium salt x 2H2O 1.28
CAS No.: 6381-92-6
EINECS No.: 205-358-3
Hazard Classification: Xn (as raw material)
Risk Code: R22-36/37/38
R22: Harmful if swallowed
R36/37/38: Irritating to eyes, respiratory system and skin.
Safety Code: S 26-36
Tris-hydroxymethyl-aminomethane 1.82
CAS No.: 77-86-1
EINECS No. : 201-064-4
Hazard Classification: Xi (as raw material)
Risk Code: R36-37-38
COAMATIC Heparin
page 1 of 5
2 COMPOSITION - Information on ingredients
INGREDIENT NAME (ctd.) CONCENTRATION
PERCENT BY WEIGHT
R36: irritating to eyes
R37: irritating to respiratory system
R38: irritating to skin
Safety Code: S 26 -36
Tris-hydroxymethyl-aminomethane hydrochloride 3.53
CAS No.: 1185-53-1
EINECS No. : 214-684-5
Risk Code: R36-37-38
R36: irritating to eyes
R37: irritating to respiratory system
R38: irritating to skin
Safety Code: S 26 -36
Bovine Albumin 1
Lyophilized purified bovine F Xa
3. HAZARD IDENTIFICATION
POTENTIAL HEALTH EFFECTS
EYES
Substrate S-2732 / Factor Xa: may cause irritation
SKIN
Substrate S-2732: may be absorbed through the skin with possible systemic effects.
Factor Xa: may cause irritation.
INGESTION
Substrate S-2732: may be harmful if swallowed. May cause blood damage with blueness of the lips (cyanosis),
strong headache.
Factor Xa: may be harmful if swallowed.
INHALATION
Substrate S-2732: May cause blood damage with blueness of the lips (cyanosis), strong headache, nausea,
coughing.
Factor Xa: may cause irritation to the mucous membranes and upper respiratory tract.
4. FIRST AID MEASURES
EYES
Substrate S-2732 / Factor Xa:
in case of eye contact, flush eyes with plenty of water for at least 15 minutes. Get medical attention if irritation develops.
SKIN
Substrate S-2732 / Factor Xa:
wash well with soap and water. Remove contaminated clothing and launder before use. If irritation persists,
get medical attention
COAMATIC Heparin
page 2 of 5
INGESTION
Substrate S-2732 / Factor Xa:
flush mouth with water, without swallowing .Get medical attention or contact the local Poison Control Center.
INHALATION
Substrate S-2732 / Factor Xa:
remove the individual to fresh air. If breathing is difficult give oxygen, get medical attention.
5. FIRE FIGHTING MEASURES
FLAMMABLE PROPERTIES
FLASH POINT
LOWER EXPLOSIVE LIMIT (%): N/A
UPPER EXPLOSIVE LIMIT (%): N/A
FIRE AND EXPLOSION HAZARDS:
None known.
EXTINGUISHING MEDIA
Use any extinguishing agent which 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 .
Contain spill by placing a suitable absorbent material around the edges of the spill and work inward. Carefully
scoop up into appropriate waste container for disposal.
7. HANDLING AND STORAGE
HANDLING AND STORAGE PRECAUTIONS
The sealed reagents are stable until the expiration dates shown on the labels when stored at 2-8 癈.
Factor Xa:
Animal serum test was tested for the presence of pathologies and found negative. Animal serum was treated during the
production processes to inactive viruses. However these reagents should be handled with care as potentially infectious
biological sample. Wear personal protective equipment.
WORK/HYGIENIC PRACTICES
Wash hands with soap and water after use.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Engineering Controls
None normally required.
Eye/Face protection
Safety glasses or splash goggles are recommended.
Skin Protection
Wear rubber or plastic gloves and other protective clothing (lab coat) as required to prevent skin contact.
Respiratory Protection
None normally required with adequate ventilation.
Other/General Protection
None normally required.
COAMATIC Heparin
page 3 of 5
9. PHYSICAL AND CHEMICAL PROPERTIES
Substrate S-2732 Factor Xa 35nkat
Appearance: lyophilized powder lyophilized powder
Colour: white white
Odour: odourless odourless
Density: N/A N/A
pH: not available 8.0 at 20-25癈
BASIC PHYSICAL PROPERTIES
VAPOUR PRESSURE: not determined
SPECIFIC GRAVITY: not determined
SOLUBILITY (H20): not determined
10. STABILITY AND REACTIVITY
STABILITY: stable
CONDITIONS TO ALLOW (STABILITY)
See Insert Sheet.
INCOMPATIBLE MATERIALS
-pNA: strong oxidizing agents, strong acids and bases.
-Tris-hydroxymethyl-aminomethane: copper, brass, aluminum and oxidizing materials.
-EDTA: strong oxiding materials.
HAZARDOUS DECOMPOSITION PRODUCTS
-Substrate S-2732 / Factor Xa: oxides of carbon and nitrogen 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).
-pNA: orl-rat LD50 750 mg/Kg; TLV-TWA 3.0 mg/m3; mutagenic data (NIOSH).
Peptide: ivn-mouse LD50 appr. 100mg/kg.
-EDTA Na2 x 2H2O: orl-rat LD50 2000 mg/Kg; orl-rbt LD50 2300 mg/Kg; experimental mutagenic and teratogenic
data (NIOSH).
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.
12. ECOLOGICAL INFORMATION
OTHER ENVIRONMENTAL INFORMATION
pNA: Daphnia Magna : 48 Hr-LC50 = 20-30 ppm, slightly toxic.
Use in accordance with good laboratory practice. Do not waste in the environment.
COAMATIC Heparin
page 4 of 5
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 in accordance with local regulations.
Used waste products, surplus products or spillage products shall be disposed of in accordance with national and local
laws. It is up to the user to classify the waste correctly prior to disposal.
14. TRANSPORT INFORMATION
None.
15. REGULATORY INFORMATION
This product is classified and labelled 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: N/A
- Risk Code: N/A
- 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 Insert
NOTE
The information supplied in this 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 Safety Data Sheet.
Rev. Date Drawn by
0 June 2000
A. Lavezzari
COAMATIC Heparin
page 5 of 5
|