X SAFETY DATA SHEET INFORMATION FORM FOR CHEMICALS
DATA
Date: 16.02.2005 Former date: 05.09.2004
1. IDENTIFICATION OF THE CHEMICAL AND OF THE MANUFACTURER, IMPORTER OR OTHER
UNDERTAKING
1.1 Identification of the substance or preparation
Trade name
Neonatal GALT kit
Code of the preparation
NG-1100, NG-4100
1.2 Use of the chemical
1.2.1 The intended uses of the chemical
This kit is intended for the quantitative determination of galactose-1-phosphate uridyl transferase
(GALT) concentrations in blood specimens dried on filter paper as an aid in screening newborns for
classical galactosemia caused by GALT deficiency.
1.2.2 Standard industrial classification (SIC)
1.2.3 Use categories (UC62)
1.2.4 The chemical can be used by the general public
1.2.5 The chemical is used by the general public only
1.3 Identification of the manufacturer, importer or other undertaking
1.3.1 Manufacturer, importer, other undertaking PerkinElmer Life and Analytical Sciences, Wallac Oy
1.3.2 Contact information:
Mustionkatu 6
Street address
FIN-20750 Turku
Postcode and post office
P.O.Box 10
Post-office box
FIN-20101 Turku
Postcode and post office
+ 358-2-2678 111
Telephone number
+ 358-2-2678 357
Telefax
0937168-4
Y code
1.3.3 Information on foreign manufacturer
1.4 Emergency telephone
1.4.1 Telephone number, name and address
PerkinElmer Life and Analytical Sciences; Belgium, Tel: 32-2-717-7924
Chemtrec (USA) Tel: +1-800-424-9300
Myrkytystietokeskus, Haartmaninkatu 4, PO Box 340, FIN-00029 HUS (Helsinki), Finland:
+358-9-2414392 or +358-9-4711
2. COMPOSITION AND INFORMATION ON INGREDIENTS
2.1 Hazardous ingredients
2.1.1 CAS number or 2.1.2 Name of the 2.1.3 2.1.4 Warning symbol, R phrases and
other code ingredient Concentration other data on the ingredient
2.1.5 There has been a request for confidentiality of a substance
according to Annex 3 of the decree
2.1.6 A substance not dangerous has been indicated as confidential
2.1.7 Other information
This kit contains reagents manufactured from sheep blood components.
The kit contains following components:
鈥? GALT Substrate Reagent
鈥? GALT Reconstitution Buffer
鈥? GALT calibrators and controls
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Trade name: Neonatal GALT kit
Date: 16.02.2005 Former date: 05.09.2004
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The concentrations of hazardous chemicals in all these components are so low that the reagents
are not classified as hazardous material. The components do not contain hazardous chemicals
in reportable quantities.
3. HAZARDS IDENTIFICATION
All the components may be irritating. The product is not classified as hazardous material.
4. FIRST AID MEASURES
4.1 Special instructions
All recommended precautions for the handling of blood derivatives should be observed
4.2 Inhalation
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4.3 Skin contact
Rinse immediately with copious amount of water
4.4 Eye contact
Rinse immediately with copious amount of water at least 15 minutes and if irritation occurs seek medical
advice.
4.5 Ingestion
Wash out mouth with plenty of water and seek medical advise if feeling unwell.
4.6 Information to doctor or other trained persons giving first aid
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5. FIRE-FIGHTING MEASURES
5.1 Suitable extinguishing media
Dry chemical, water, foam, carbon dioxide
5.2 Extinguishing media which must not be used for safety reasons
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5.3 Special exposure hazards in a fire
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5.4 Special protective equipment for fire-fighters
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5.5 Other instructions
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6. ACCIDENTAL RELEASE MEASURES
6.1 Personal precautions
Wear appropriate protective clothing.
6.2 Environmental precautions
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6.3 Methods for cleaning up
Spillage can be cleaned using water.
6.4 Other instructions
7. HANDLING AND STORAGE
7.1 Handling
Wear suitable protective clothes. For in vitro diagnostic use.
7.2 Storage
Store in a cool (+2-+8掳C, calibrators and controls -20掳C), dry place. The expiry date of the complete
package is stated on the outer label.
7.3 Specific use(s)
For in vitro diagnostic use
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
8.1 Exposure limit values
8.1.1 HTP values
8.1.2 Other limit values
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8.1.3 Limit values in other countries
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Trade name: Neonatal GALT kit
Date: 16.02.2005 Former date: 05.09.2004
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8.2 Exposure controls
8.2.1 Occupational exposure controls
Use good laboratory practices.
8.2.1.1 Respiratory protection
Not needed in laboratory scale.
8.2.1.2 Hand protection
Gloves
8.2.1.3 Eye protection
If the risk of splashing occurs, wear protective goggles
8.2.1.4 Skin protection
Working clothing
8.2.2 Environmental exposure controls
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9. PHYSICAL AND CHEMICAL PROPERTIES
9.1 General information (physical state, colour and odour)
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9.2 Important health, safety and environmental information
9.2.1 pH
N/A
9.2.2 Boiling point/boiling range
N/A
9.2.3 Flash point
N/A
9.2.4 Flammability (solid, gas)
N/A
9.2.5 Explosive properties
9.2.5.1 Lower explosive limit
N/A
9.2.5.2 Upper explosive limit
N/A
9.2.6 Oxidising properties
N/A
9.2.7 Vapour pressure
N/A
9.2.8 Relative density
N/A
9.2.9 Solubility
9.2.9.1 Water solubility
soluble
9.2.9.2 Fat solubility (solvent-oil to be specified)
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9.2.10 Partition coefficient: n-octanol/water
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9.2.11 Viscosity
N/A
9.2.12 Vapour density
N/A
9.2.13 Evaporation rate
N/A
9.3 Other information
10. STABILITY AND REACTIVITY
10.1 Conditions to avoid
Heating
10.2 Materials to avoid
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10.3 Hazardous decomposition products
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Trade name: Neonatal GALT kit
Date: 16.02.2005 Former date: 05.09.2004
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11. TOXICOLOGICAL INFORMATION
11.1 Acute toxicity
Products have not been thoroughly investigated
11.2 Irritation and corrosiveness
The components of this kit may irritate very sensitive persons.
11.3 Sensitisation
.
11.4 Sub-acute, sub-chronic and prolonged toxicity
.
11.5 Empirical data on effects on humans
11.6 Other information on health effects
Products have not been thoroughly investigated.
12. ECOLOGICAL INFORMATION
12.1 Ecotoxicity
12.1.1 Aquatic toxicity
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12.1.2 Toxicity to other organisms
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12.2 Mobility
-
12.3 Persistence and degradability
12.3.1 Biodegradation
12.3.2 Chemical degradation
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12.4 Bioaccumulative potential
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12.5 Other adverse effects
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13. DISPOSAL CONSIDERATIONS
Disposal of all waste shall be in accordance with local regulations
14. TRANSPORT INFORMATION
14.1 UN number
14.2 Packing group
14.3 Land transport
14.3.1 Transport class
14.3.2 Risk code
14.3.3 Name according to bill of freight
14.3.4 Other information
This product is not regulated under the transport regulations.
14.4 Sea transport
14.4.1 IMDG class
14.4.2 Correct technical name
14.4.3 Other information
This product is not regulated under the transport regulations.
14.5 Air transport
14.5.1 ICAO/IATA class
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Trade name: Neonatal GALT kit
Date: 16.02.2005 Former date: 05.09.2004
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14.5.2 Correct technical name
14.5.3 Other information
This product is not regulated under the transport regulations.
15. REGULATORY INFORMATION
15.1 Information on the warning label
15.1.1 Letter code of the warning symbol and indications of danger for the preparation
15.1.2 Names of the ingredients given on the warning label
15.1.3 R phrases
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15.1.4 S phrases
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15.1.5 Special regulations on certain preparations
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15.2 National regulations
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16. OTHER INFORMATION
16.1 List of the relevant R phrases
16.2 Training advice
See instructions for use. This kit should only be used by adequately trained personnel.
16.3 Restrictions on use
For in vitro diagnostic use.
16.4 Further information
Wallac Oy
16.5 Sources of key data used
Information given by manufacturer
16.6 Information which has been added, deleted or revised
This Safety Data Sheet has been created according to European Directive 2001/58/EC.
16.02.2005 Chemtrec emergency number added (1.4)
The above information is believed to be correct, but does not purport to be all inclusive and shall be used only as a
guide. Wallac shall not be held liable for any damage resulting from handling or from contact with the above
product.
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