MSDS
MATERIAL SAFETY DATA SHEET
According to EC Directive 91/155/EEC.
Date of Issue: 01-05-2003
Identification of the substance/preparation and of the company
Product Name: PSA-IRMA CT
Product Code: RK-10CT
Product Formal Name: Diagnostic reagent
Use of the substance/preparation: In-vitro diagnostic test KIT
Company identification:
Institute of Isotopes Co., Ltd.
Konkoly Thege Mikl贸s 煤t 29-33
H-1121 Budapest, Hungary
Phone number: (36-1) 391-0826
Fax number: (36-1) 392-2575, 395-9247
Composition / Infor mation on ingredients:
Component No. Component Name Description
1 Tracer 1 vial, 125I-antibody in buffer < 740 kBq
2 Standards 6 vials, containing animal serum
3 Serum Control 1 vial, containing human serum
4 Coated Tubes Protein coated polystyrene test tubes,
2 packs, 50 tubes/pack
5 Washing Buffer Concentrate 1 vial, containing detergent in buffer
Hazard identification:
Component No. Hazard
Contains radioactive material and sodium azide (NaN3 ) as preservatives (< 0.1%)
1
Contains animal origin, biologically derived material
Contain human and/or animal origin, biologically derived material and Kathon CG as
2
preservatives (< 0.1%)
3
Contains animal origin, biologically derived material
4
Contains detergent and sodium azide as preservatives (< 0.1%)
5
Iodine 125 is a radioactive tracer element with 60.2 day radioactive half-life. Emits gamma rays.
Sodium azide and Kathon CG are toxic substances. Avoid contact with components, which contain sodium azide
or Kathon CG, and do not ingest. All components may contain human or animal biologically derived materials.
MSDS RK-10CT Page 1/4
First Aid:
Eye contact: Flush with copious amount of fresh water for at least 15 minutes.
Skin contact: Wash well with mild soap and copious amount of fresh water.
Ingestion: Flush mouth with copious water (do not swallow rinse water).
If ingested, seek medical advice urgently.
If possible, save sample of material that caused reaction for use in determination of appropriate treatment.
Fire extinguishing measur es:
Use extinguishing media (dry sand, cement) appropriate to surrounding fire. Dangerous gases, which are
damaging to health, do not form in dangerous quantities. No special equipment or procedures are required.
Accidental release measures:
After spillage:
Biological vials: Absorb spills of reagents and patient samples with absorbent paper. Clean spill area
with a freshly prepared sodium hypochlorite (bleach) solution and absorb it.
Radioactive vials: The radioactive material should be wiped up immediately. Wastes have to be treated
according to the country's legislation.
Handling and storage:
Handling: Do not eat, drink, smoke or apply cosmetics in laboratory areas. Do not pipette patient
samples or reagents by mouth. Avoid splashing. Use all reagents in accordance with
relevant package insert. Avoid high temperature and freezing.
Store at 2-8o C. Do not store together with ignitable and flammable substances.
Storage:
Exposure controls/per sonal protection:
Wear appropriate personal protective equipment, including lab coats, disposable (rubber) gloves and eye
protection. Avoid contact with skin and/or mouth. Adopt general hygienic measures. Avoid absorption through
non-protected wound. Avoid splashing or aerosol formation. Use all reagents in accordance with the relevant
package insert.
Sodium Azide: CAS # 26628-22-8
Kathon CG: is a mixture in the ratio 3:1 of 5-chloro-2methyl-4-isothiazolin-3-one (Methylisothiazolinone; MI)
and 2-methyl-4-isothiazolin-3-one (Methylchloroisothiazolinone; CMI).
MI: CAS # 2682-20-4
CMI: CAS # 26172-55-4
MSDS RK-10CT Page 2/4
Physical and chemical pr oper ties:
Component No. 1 2, 3 4 5
Physical state liquid liquid solid liquid
Colour red yellow clear clear
Odour odourless modest odourless odourless
pH 7.2 鈥? 7.6 6.0 鈥? 8.0 not applicable 6.5-7.5
Solubility in water complete complete not applicable complete
o o
0 oC
Melting point 0C 0C ca. 240 掳C
o o
100 o C
Boiling point 100 C 100 C not applicable
Stability and r eactivity:
No hazardous reactions when used appropriately. The reagents in the kit are stable under the storage conditions
described in the package insert. Avoid contact with acids, explosive, heavy metals and metallic salts (explosive
metal azide complex, when azide built up occur).
Toxicological infor mation:
This product contains radionuclide, a chemical known to cause cancer and reproductive harm.
After ingestion, may cause irritations of mucous membranes in the mouth, pharynx, oesophagus and
gastrointestinal tract. Danger of skin absorption.
Ecological infor mation:
Sodium Azide is toxic for aquatic organisms.
Radioactivity: Dispose of following local regulations and guidelines.
Disposal considerations:
Contact appropriate local authorities, approved waste disposal companies who will advise you on how to dispose
of special waste.
If drain disposed, dilute and flush with copious amount of running water to prevent azide build -up.
Transpor t information:
(Radioactive material, N.O.S., UN 2910 鈥? excepted package)
Land transport AIEA/ADR/RID regulation (Class 7, fiche 1 鈥? ADR)
Sea transport IMDG regulation
Air transport OACI/IATA regulation
Regulator y infor mation:
Labelling according to EEC directives.
NaN3 :
if present at > 0,1 % Symbol T+ Very toxic
R-phrases: 28-32 Very toxic if swallowed. Contact with acids liberates very toxic gases.
S phrases: 28 After contact with skin, wash immediately with plenty of water.
EEC-No.: 247-852-1 EEC-Label
MSDS RK-10CT Page 3/4
Radioactive material in accordance with 鈥淎.R. of 28/02/1963 art. 31鈥? and following, relating to the protection of
the population and workers against the danger of ionising radiations.
Other infor mation:
The human blood components included in this kit have been tested and found negative for HBsAg, anti-HCV
and anti-HIV-1 and 2. No known method can offer complete assurance that human blood derivatives will not
transmit hepatitis, AIDS or other infections. Therefore, handling of reagents, serum or plasma specimens should
be in accordance with local safety procedures.
All animal products and derivatives are collected in healthy animals without any disease.
The BSA (Bovine Serum Albumin) originates from countries where BSE (Bovine Spongiform Encephalopathy)
as not been reported.
The information herein is believed to be correct as of the date hereof but is provided without warranty of any
kind. The recipient of our products is responsible for observing any laws and guidelines.
For in vitro diagnostics only.
This radioactive product can be transferred to and used only by authorised persons; purchase, storage, use and
exchange of radioactive products are subject to the legislation of the enduser鈥檚 country.
In no case the product must be administered to humans or animals.
Do not smoke, drink, eat or apply cosmetics in the working area.
Do not pipette by mouth.
Use protective clothing and disposable gloves.
All radioactive handling should be executed in a designated area, away from regular passage.
A logbook for receipt and storage of radioactive materials must be kept in the lab.
Laboratory equipment and glassware, which could be contaminated with radioactive substances, should be
segregated to prevent cross contamination of different radioisotopes.
Any radioactive spills must be cleaned immediately in accordance with the radiosafety procedures.
The radioactive waste must be disposed of following the local regulations and guidelines of the notified bodies
holding jurisdiction over the laboratory.
Adherence to the basic rules of the radiation safety provides adequate protection.
MSDS RK-10CT Page 4/4
|