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Safety Data Sheet EN

in-tem® S

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
in-tem® S
Product Code
503-12

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

Muta. Cat. 2 H341
Acute Tox. Cat. 4 H302
Skin Irrit. Cat. 2 H315
Eye Irrit. Cat. 2 H319

GHS Pictograms

GHS07 - Health hazard

GHS07

GHS08 - Serious health hazard

GHS08

Hazard Statements

H302 Harmful if swallowed.
H315 Causes skin irritation.
H319 Causes serious eye irritation.
H341 Suspected of causing genetic defects.

Precautionary Statements

P280 Wear protective gloves/protective clothing/eye protection/face protection.
P281 Use personal protective equipment as required.
P308 + P313 IF exposed or concerned: Get medical advice/attention.
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

Kit (503-12-20) consists of 20x 503-12 and contains mixture of substances listed below with nonhazardous additions.

Chemical Name CAS Number Concentration Hazardous
Albumins, blood serum EC: 232-936-2 9048-46-8 10 - 25% Yes
calcium chloride EC: 233-140-8 10043-52-4 10 - 25% Yes
phenol EC: 203-632-7 108-95-2 1 - 2.5% Yes
boric acid EC: 233-139-2 10043-35-3 1 - 2.5% Yes
aluminium trilactate EC: 242-670-9 18917-91-4 0.1% Yes

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

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

Call for a doctor immediately.

Immediate Medical Attention

No further relevant information available.

Medical Treatment

No further relevant information available.

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.

Specific hazards

No further relevant information available.

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

Pick up mechanically.

—

Related Products

Similar products with comparable safety profiles

07

Handling and Storage

Safe handling precautions, storage conditions, and workplace requirements

Handling

Prevent formation of dust.

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

Ensure good ventilation/exhaustion at the workplace.

Hands

Protective gloves

Eyes

Tightly sealed goggles

Respiratory

Use suitable respiratory protective device in case of insufficient ventilation.

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

Language Code
---
Physical State
solid
Physical State Data
solid
State Under Standard Conditions
---
Appearance
---
Colour
According to product specification
Colour Intensity
---
Form
Powder
Odor
Characteristic
Odor Threshold
Not determined.
Ph
7.4 after dissolution in water.
Melting Point
Not determined.
Boiling Point
Not determined.
Flash Point
Not determined.
Freezing Point
---
Softening Point
---
Solidification Point
---
Cloud Point
---
Crystallisation Point
---
Relative Evaporation Rate
---
Evaporation Rate
Not determined.
Vapor Pressure
Not determined.
Vapor Density
Not determined.
Relative Density
Not determined.
Bulk Density
---
Density
Not determined.
Flammability
Not determined.
Upper Explosive Limit
Not determined.
Lower Explosive Limit
Not determined.
Explosive Limits
---
Auto Ignition Temperature
Not determined.
Decomposition Temperature
Not determined.
Solubility
---
Partition Coefficient
Not determined.
Solubility In Water
Easily soluble.
Solubility In Fat
---
Molecular Weight
---
Voc Content
Not determined.
Metal Corrosion
---
Dynamic Viscosity
Not applicable.
Kinematic Viscosity
Not applicable.
Properties Status
---
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 decomposition if used according to specifications.

Incompatible

No further relevant information available.

Decomposition

No dangerous decomposition products known.

12

Ecological Information

Environmental toxicity, biodegradation, and bioaccumulation data

12.1 Toxicity

Aquatic toxicity: Based on the ingredients product is not classified as harmful for the environment.

Based on the ingredients, the product is not classified as harmful for the environment.

12.2 Persistence and degradability

No further relevant information available.

12.3 Bioaccumulative potential

No further relevant information available.

No further relevant information available.

12.4 Mobility in soil

No further relevant information available.

12.5 Results of PBT and vPvB assessment

PBT: According to current knowledge, the product contains no PBT. vPvB: According to current knowledge, the product contains no vPvB.

The product is assessed as containing no PBT or vPvB substances based on current knowledge.

12.6 Other adverse effects

No further relevant information available.
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

15

Regulatory Information

Chemical regulations, safety assessments, and compliance status

Chemical Safety Assessment Not performed

Employment restrictions concerning juveniles must be observed. Employment restrictions concerning pregnant and lactating women must be observed.

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Frequently Asked Questions

Common questions about safety, handling, and properties

What is the hazard signal word for in-tem® S?

The signal word is warning.

What is the physical form of in-tem® S?

in-tem® S is a solid with according to product specification color. It has characteristic odor.

What is in-tem® S used for?

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

What are the hazard statements for in-tem® S?

This substance has 4 hazard statements:

  • H302: Harmful if swallowed.
  • H315: Causes skin irritation.
  • H319: Causes serious eye irritation.
  • H341: Suspected of causing genetic defects.

What is the melting point of in-tem® S?

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