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Safety Data Sheet EN

Sigma ROTROL N

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
Sigma ROTROL N
Product Code
555205 / 555203

Regulatory Identifiers

CAS Number
N/A

Identified Uses

Kit component of in vitro diagnostic test for the examination of the blood coagulation system.

Manufacturers & Suppliers

T

Tem Innovations GmbH

manufacturer

Martin-Kollar-Strasse 13-15, D-81829 Munich, Germany

+49 (0)89 454295 0

Emergency Contacts

Toxicological Information Centre Munich

+49 (0)89 19240

24h/7d

EN

02

Hazard Identification

GHS classification, signal word, pictograms, and hazard statements

Classified no signal word

Hazard Classifications

Not Classified

GHS Pictograms

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03

Composition / Information on Ingredients

Chemical components, concentration ranges, and hazardous substance identification

Type mixture

Sigma ROTROL N (555201) contains the following components: Sigma ROTROL N Lyo (555203): Lyophilized human plasma with HEPES and bovine fibrinogene for reconstitution with Aqua dest. Sigma ROTROL N Dil (555205): Aqua dest. De-ionized with <0.1% sodium azide (NaN).

Chemical Name CAS Number Concentration Hazardous
Sigma ROTROL N Lyo --- --- No
Sigma ROTROL N Dil --- --- No
sodium azide EC: 247-852-1 26628-22-8 0.1% Yes

SVHC According to current knowledge no SVHC contained.

04

First Aid Measures

Emergency procedures for chemical exposure incidents

Inhalation

Move individual to fresh air, seek medical advice in case of complaints.

Skin contact

Immediately wash with water and soap and rinse thoroughly.

Eye contact

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

Ingestion

If symptoms persist consult doctor.

05

Firefighting Measures

Extinguishing media, specific hazards, and firefighter protection

Suitable media

CO₂, powder or water spray. Fight larger fires with water spray or alcohol resistant foam.

Firefighter Protection

No special measures required.

06

Accidental Release Measures

Spill cleanup procedures, containment, and environmental protection

Environmental

Do not allow product to reach sewage system or any water course.

Cleanup methods

Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust).

Materials: sand, diatomite, acid binders, universal binders, sawdust

Related Products

Similar products with comparable safety profiles

07

Handling and Storage

Safe handling precautions, storage conditions, and workplace requirements

Handling

No special measures required.

Storage

Store between 2 - 8 °C. Keep container tightly sealed.

Fire prevention

No special measures required.

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Engineering

No further data; see item 7.

Hands

Protective gloves

Eyes

Safety glasses

Respiratory

Not required.

Environmental

Do not allow product to reach sewage system or any water course.

09

Physical and Chemical Properties

Appearance, physical state, melting point, boiling point, and material characteristics

Vapor Pressure
Not applicable.
Lower Explosive Limit
Not applicable.
Solubility In Water
Soluble.
Flash Point
Not determined.
Physical State Data
---
Odor Threshold
Not determined.
Vapor Density
Not applicable.
Upper Explosive Limit
Not applicable.
Cloud Point
---
Odor
Characteristic
Bulk Density
---
Boiling Point
Not determined.
Relative Evaporation Rate
---
Properties Status
---
Form
Sigma ROTROL N Lyo (555203): Solid, Sigma ROTROL N Dil (555205): Liquid
Solidification Point
---
Voc Content
Not determined.
Colour
Sigma ROTROL N Lyo (555203): White
Density
---
Molecular Weight
---
Kinematic Viscosity
Not applicable.
Explosive Limits
---
Decomposition Temperature
Not determined.
Metal Corrosion
---
Flammability
Not determined.
Ph
7.4
Partition Coefficient
Not applicable.
Relative Density
Not applicable.
Auto Ignition Temperature
Not determined.
Softening Point
---
Evaporation Rate
Not applicable.
Crystallisation Point
---
Appearance
---
State Under Standard Conditions
---
Dynamic Viscosity
Not applicable.
Melting Point
Not determined.
Solubility
---
Freezing Point
---
Physical State
Sigma ROTROL N Lyo (555203): Solid, Sigma ROTROL N Dil (555205): Liquid
Colour Intensity
---
Solubility In Fat
---
10

Stability and Reactivity

Chemical stability, hazardous reactions, and incompatible materials

Stability

No decomposition if used according to specifications.

Reactivity

No further relevant information available.

Hazardous reactions

No dangerous reactions known.

Avoid

No further relevant information available.

Incompatible

Avoid contact with strong acids.

Decomposition

Sodium azide develops very toxic gases upon contact with acids.

12

Ecological Information

Environmental toxicity, biodegradation, and bioaccumulation data

The data for this section has not been processed yet.

13

Disposal Considerations

Waste treatment methods, disposal recommendations, and waste codes

Treatment

Disposal must be made according to official regulations.

Disposal

Disposal must be made according to official regulations.

Waste Codes

18 00 00 WASTES FROM HUMAN OR ANIMAL HEALTH CARE AND/OR RELATED RESEARCH (except kitchen and restaurant wastes not arising from immediate health care) EWC
18 01 00 wastes from natal care, diagnosis, treatment or prevention of disease in humans EWC
18 01 06* chemicals consisting of or containing dangerous substances EWC
14

Transport Information

UN numbers, shipping names, transport classes, and regulatory requirements

UN Number
Void
Shipping Name
Void
Transport Class
Void
Packing Group
Void
15

Regulatory Information

Chemical regulations, safety assessments, and compliance status

No further relevant information available.

Chemical Safety Assessment Not performed
?

Frequently Asked Questions

Common questions about safety, handling, and properties

What is the hazard signal word for Sigma ROTROL N?

The signal word is no signal word.

What is the physical form of Sigma ROTROL N?

Sigma ROTROL N is a sigma rotrol n lyo (555203): solid, sigma rotrol n dil (555205): liquid with sigma rotrol n lyo (555203): white color. It has characteristic odor.

What is Sigma ROTROL N used for?

Kit component of in vitro diagnostic test for the examination of the blood coagulation system.

What is the melting point of Sigma ROTROL N?

The melting point is Not determined. and the boiling point is Not determined..