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Safety Data Sheet EN

ROTEM® sigma complete+hep

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
ROTEM® sigma complete+hep
Product Code
555502

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 warning

Hazard Classifications

Skin Irrit. Cat. 2 H315
Eye Irrit. Cat. 2 H319

GHS Pictograms

GHS07 - Health hazard

GHS07

Hazard Statements

H315 Causes skin irritation.
H319 Causes serious eye irritation.

Precautionary Statements

P280 Wear protective gloves / eye protection.
P337 + P313 If eye irritation persists: Get medical advice/attention.
P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

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03

Composition / Information on Ingredients

Chemical components, concentration ranges, and hazardous substance identification

Type mixture

ROTEM sigma complete+hep (555502) consists of 20 cartridges and includes the following components: - Bead Type Calcium chloride (Emerald Green) - Bead Type Recombiplastin (Red) - Bead Type APTT (Blue) - Bead Type Heparinase (Orange) - Bead Type Cytochalasin (Fuchsia) - Bead Type Polybrene (Yellow)

Chemical Name CAS Number Concentration Hazardous
polybrene 28728-55-4 1 - 2.5% Yes
sodium hydroxide EC: 215-185-5 1310-73-2 1 - 2.5% Yes
phenol EC: 203-632-7 108-95-2 0.1 - 1% Yes
boric acid EC: 233-139-2 10043-35-3 0.1 - 1% Yes
sodium azide EC: 247-852-1 26628-22-8 0.1% Yes

For the wording of the listed risk phrases refer to section 16.

Notes

The components contain the substances listed below with nonhazardous additions (concentrations indicated refer to the individual "beads")

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

Rinse opened eye for several minutes under running water. If symptoms persist, consult a doctor.

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

No special measures required.

Cleanup methods

Pick up mechanically.

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 at room temperature. Keep container tightly sealed.

Fire prevention

No special measures required.

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Hands

Protective gloves

Eyes

Tightly sealed goggles

Respiratory

Not required.

Environmental

Do not allow to enter sewers/ surface or ground water.

09

Physical and Chemical Properties

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

Flash Point
Not determined.
Relative Density
Not determined.
Lower Explosive Limit
Not determined.
Molecular Weight
---
Auto Ignition Temperature
Not determined.
Dynamic Viscosity
Not applicable.
Colour Intensity
---
Cloud Point
---
Solubility In Fat
---
State Under Standard Conditions
---
Physical State
Solid
Vapor Density
Not determined.
Partition Coefficient
Not determined.
Solubility
Not determined.
Ph
Not determined.
Solidification Point
---
Vapor Pressure
Not determined.
Boiling Point
Not determined.
Metal Corrosion
---
Freezing Point
---
Decomposition Temperature
Not determined.
Upper Explosive Limit
Not determined.
Melting Point
Not determined.
Appearance
---
Evaporation Rate
Not determined.
Colour
Coloured
Softening Point
---
Odor
Characteristic
Voc Content
Not determined.
Bulk Density
---
Relative Evaporation Rate
---
Odor Threshold
Not determined.
Crystallisation Point
---
Form
Solid
Explosive Limits
---
Solubility In Water
Not determined.
Properties Status
---
Density
---
Kinematic Viscosity
Not applicable.
Flammability
Not determined.
Physical State Data
solid
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 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

Chemical Safety Assessment Not performed
?

Frequently Asked Questions

Common questions about safety, handling, and properties

What is the hazard signal word for ROTEM® sigma complete+hep?

The signal word is warning.

What is the physical form of ROTEM® sigma complete+hep?

ROTEM® sigma complete+hep is a solid with coloured color. It has characteristic odor.

What is the solubility of ROTEM® sigma complete+hep?

Not determined.

What is ROTEM® sigma complete+hep used for?

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

What are the hazard statements for ROTEM® sigma complete+hep?

This substance has 2 hazard statements:

  • H315: Causes skin irritation.
  • H319: Causes serious eye irritation.

What is the melting point of ROTEM® sigma complete+hep?

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