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Material Safety Data Sheet

Manufacturer: ERBA diagnostics Mannheim GmbH


Mallaustr. 69 73
D-68219 Mannheim / Germany

phone +49 621 87 99 770


fax. +49 621 87 99 688

Date of card issue: 19.01.2004


Date of card update: 01.07.2011
1. Identification of the preparation.

ERBA Norm (Reference No. REKT901, 4 x 5 ml + 1 x 20 ml)

The sets are designed for Health Service laboratories for Quality Control.

2. Hazards Identification.

Classification of the mixture:

The preparation is not regarded as dangerous.

Emergency overview: Non flammable material.


The human material, from which this product has derived, is from controlled voluntary donors. Each
unit is tested negative for HBs antigen, HCV - HIV-I -HIV-II antibodies by CE-approved tests. No test
method can offer complete assurance that products containing human material will be absent of
these and of other infectious agents. Normal laboratory precautions should be taken as for potential
infectious material.
Health Hazard: Regarded as low health hazard.

Label elements:

None

3. Composition / information on components.

Main ingredients:
CAS No.: None.
Content: Human based matrix 100% (serum, plasma or whole blood)

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Identification number: MSDS/Human based Serum
Updating no: 02
Number of pages: 6
4. First-Aid Measures.

Description of first aid measures


General advice - Consult a physician. Show this safety data sheet to the doctor in attendance.
If inhaled - If breathed in, move person into fresh air.
In case of skin contact - wash off with large amount of water. Take off the contaminated clothing.
In case of eye contact - rinse with large amount of water.
If swallowed - give the sufferer a large amount of water to drink. Evoke vomiting. Administer activated
charcoal.

Most important symptoms and effects, both acute and delayed


no data available

Indication of immediate medical attention and special treatment needed


no data available

5. Fire Fighting Measures:


Extinguishing media

Suitable
The mixture is not a flammable. In adaptation to materials stored in the immediate neighbourhood.
Unsuitable extinguishing media
Not known.
Special hazards arising from the substance or mixture
None known.
Precautions for fire-fighters
According to the existing fire-fighting regulations.

6. Accidental Release Measures:


Personal precautions, protective equipment and emergency procedures
Avoid contamination with the preparation.
Environmental precautions
Do not discharge into the drains, surface waters, and groundwater.
Methods and materials for containment and cleaning up
Collect small quantities with the use of an absorbing agent, rinse with large amount of water if
necessary.

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Identification number: MSDS/Human based Serum
Updating no: 02
Number of pages: 6
7. Handling and Storage:

Precautions for safe handling


In accordance with the norms generally accepted for chemicals in laboratories.
Conditions for safe storage, including any incompatibilities
Hermetically closed. In temperature from +2oC do +8oC.
Specific end uses
no data available

8. Exposure Controls/ Personal Protection:

Appropriate control parameter:


See Polish regulations.
no data available
Exposure controls
Appropriate engineering controls
Avoid prolonged contact with skin and eye, swallowing the product. Ensure washing facilities (warm
water) after working hours and before breaks. Was thoroughly hand after using the product.

Personal protective equipment


Eye/face protection: Safety goggles
Respiratory protection: not required with adequate ventilation, otherwise breathing apparatus.
Skin protection: required (Handle with gloves)
Body Protection: required (Complete suit protecting against chemicals)

9. Physical and Chemical Properties.


REAGENTS
Appearance: clear colourless solution

Odour (aroma): odourless


Odour Threshold: no data available
pH: 6-10
Melting/freezing point: no data available
Initial boiling point and
boiling range: no data available
Flash point: no data available
Evaporation rate: no data available
Flammability (solid, gas): no data available
Upper/lower
flammability or
explosive limits: no data available
Vapour pressure: no data available
Vapour density: no data available
Relative density: no data available
Water solubility: no data available
Partition coefficient
noctanol/water: no data available
Autoignition temperature: no data available
Decomposition temperature: no data available
Viscosity: no data available
Explosive properties: no data available
Oxidizing properties: no data available

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Identification number: MSDS/Human based Serum
Updating no: 02
Number of pages: 6
10. Stability and Reactivity:

Reactivity
no data available
Chemical stability
no data available
Possibility of hazardous reactions
no data available
Conditions to avoid
The preparation is stable in conditions provided by the manufacturer.
Incompatible materials
Heavy metals, metal salts, acids.
Hazardous decomposition products
In the case of fire nitrose gases.

11. Toxicological Information:


Acute toxicity
Human oral LD50 (g.kg-1)......................................not applicable
Rat oral LD50 (mg.kg-1).........................................not applicable
Rabbit dermal LD50 (mg.kg-1)...............................not applicable
Rat inhalation TLS (g.kg-1)..................................not applicable
Irritant
Not applicable.
Corrosion
Not applicable.
Sensitization
No data available.
Toxicity on repeated exposure
No data available.
Carcinogenicity
No data available.
Mutagenity
No data available.
Reproductive toxicity
Not available.

Further data:
The product should be handled with the care usual when dealing with chemicals.

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Identification number: MSDS/Human based Serum
Updating no: 02
Number of pages: 6
12. Ecological Information:

Ecotoxicity
LC50 96 hrs, fish (Lepomis macrochirus) (mg.l-1)...............................not applicable
EC50 48 hrs, daphnia pulex (mg.l-1) ..................................................not applicable
IC50 72 hrs algae (mg.l-1)...................................................................not applicable
CHSK...............................................................................................not applicable
BSK5.................................................................................................not applicable
Persistence and degradability
Not applicable.
Bioaccumulative potential
Not applicable.
Mobility in soil
Not applicable.
Results of PBT and vPvB assessment
Not applicable.
Other adverse effects
Not applicable.

Further ecological data:


Ecological problems should not be expected if you use and apply the product appropriately.

13. Disposal Considerations:


Product:
Chemical residues, in general, are included into special waste. Disposing of the latter is regulated by
appropriate laws and ordinances. We recommend contacting the appropriate authorities, or waste
disposal enterprises that will advise you on how to dispose of special waste.

Contaminated packaging
Remove in accordance with official regulations. Treat contaminated packages in the same way as the
substance itself. If the regulations do not provide otherwise, non-contaminated packages can be treated
like household waste or forward them to be utilized.

14. Transportation Information:


The product is not subject to transport regulations.

15. Regulatory Information:

Material Safety Data Sheet was prepared in accordance with:


The EC Directive Nr UE2001/58/WE, the EC Directive Nr 1999/45/EG, the EC Directive 67/548 EEC,
the EC Directive No. 1907/2006 (Dangerous Product Regulations incl. EC Guidelines).

Chemical Safety Assessment


no data available

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Identification number: MSDS/Human based Serum
Updating no: 02
Number of pages: 6
16. Other Information.

The foregoing information is based on the present state of our knowledge. It characterizes the
product with respect to the appropriate safety measures. They do not guarantee the properties of the
product.

We do not take responsibility for damage and losses that may result from inappropriate use of the
preparation.

Reason of changes: change in legislation

General updating

The foregoing safety chart prepared in electronic version is legally valid without sign manual.

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Identification number: MSDS/Human based Serum
Updating no: 02
Number of pages: 6

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