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Safety Data Sheet EN

KIT DNA ISOLATION 24T IVD

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
KIT DNA ISOLATION 24T IVD
Product Code
05985536190

Regulatory Identifiers

CAS Number
N/A

Identified Uses

For professional users only.

Manufacturers & Suppliers

R

Roche Diagnostics Limited

manufacturer

Charles Avenue, Burgess Hill, RH15 9RY West Sussex, United Kingdom

+44 1444 256000

Emergency Contacts

Roche Diagnostics Ltd.

+44 1444 256500

Roche Diagnostics Ltd.

+44 7802 260498

Roche Diagnostics Ltd.

+44 1444 256561

Roche Diagnostics Ltd.

+44 7710 391653

NPIS

+44 844 892 0111

NHS Direct

+44 845 4647

NHS 24

+44 8454 242424

02

Hazard Identification

GHS classification, signal word, pictograms, and hazard statements

Classified danger

GHS Pictograms

GHS07 - Health hazard

GHS07

GHS08 - Serious health hazard

GHS08

GHS09 - Environmental hazard

GHS09

Hazard Statements

H302 + H332 Harmful if swallowed or if inhaled.
H315 Causes skin irritation.
H317 May cause an allergic skin reaction.
H319 Causes serious eye irritation.
H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled.
H335 May cause respiratory irritation.
H411 Toxic to aquatic life with long lasting effects.

Precautionary Statements

P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
P273 Avoid release to the environment.
P280 Wear protective gloves/ eye protection/ face protection.
P342 + P311 If experiencing respiratory symptoms: Call a POISON CENTER/ doctor.
P391 Collect spillage.
IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER/ doctor if you feel unwell.

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03

Composition / Information on Ingredients

Chemical components, concentration ranges, and hazardous substance identification

Type mixture
Chemical Name CAS Number Concentration Hazardous
guanidinium chloride EC: 200-002-3 50-01-1 50 - 70% Yes
Polidocanol EC: 500-002-6 9002-92-0 10 - 20% Yes
Proteinase, Tritirachium album serine EC: 254-457-8 39450-01-6 70 - 90% Yes
04

First Aid Measures

Emergency procedures for chemical exposure incidents

Inhalation

Call a physician or poison control centre immediately. Move to fresh air. If unconscious, place in recovery position and seek medical advice.

Skin contact

If skin irritation persists, call a physician. If on skin, rinse well with water. If on clothes, remove clothes.

Eye contact

Immediately flush eye(s) with plenty of water. Remove contact lenses. Protect unharmed eye. Keep eye wide open while rinsing. If eye irritation persists, consult a specialist.

Ingestion

Clean mouth with water and drink afterwards plenty of water. Keep respiratory tract clear. Do not give milk or alcoholic beverages. Never give anything by mouth to an unconscious person. If symptoms persist, call a physician. Take victim immediately to hospital. Rinse mouth with water.

Immediate Medical Attention

Call a physician or poison control centre immediately. Take victim immediately to hospital.

Medical Treatment

The first aid procedure should be established in consultation with the doctor responsible for industrial medicine.

05

Firefighting Measures

Extinguishing media, specific hazards, and firefighter protection

Suitable media

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.

Unsuitable media

High volume water jet

Specific hazards

Do not allow run-off from fire fighting to enter drains or water courses.

Firefighter Protection

Wear self-contained breathing apparatus for firefighting if necessary.

06

Accidental Release Measures

Spill cleanup procedures, containment, and environmental protection

Emergency procedures

Use personal protective equipment. Ensure adequate ventilation. Refer to protective measures listed in sections 7 and 8.

Environmental

Prevent product from entering drains. Prevent further leakage or spillage if safe to do so.

Cleanup methods

Soak up with inert absorbent material (e.g. sand, silica gel, acid binder, universal binder, sawdust). Keep in suitable, closed containers for disposal.

Materials: inert absorbent material (e.g. sand, silica gel, acid binder, universal binder, sawdust)

—

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---

07

Handling and Storage

Safe handling precautions, storage conditions, and workplace requirements

Handling

Avoid formation of aerosol. Do not breathe vapours/dust. Avoid exposure - obtain special instructions before use. Avoid contact with skin and eyes. For personal protection see section 8. Smoking, eating and drinking should be prohibited in the application area. Persons susceptible to skin sensitisation problems or asthma, allergies, chronic or recurrent respiratory disease should not be employed in any process in which this mixture is being used.

Storage

Keep container tightly closed in a dry and well-ventilated place. Containers which are opened must be carefully resealed and kept upright to prevent leakage.

Hygiene

When using do not eat or drink. When using do not smoke. Wash hands before breaks and at the end of workday.

Fire prevention

Normal measures for preventive fire protection.

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Hands

Material: In case of contact through splashing: Nitrile rubber, Break through time: > 30 min, Glove thickness: > 0,11 mm. Material: In case of full contact: butyl-rubber, Break through time: > 480 min, Glove thickness: > 0,4 mm. The selected protective gloves have to satisfy the specifications of Regulation (EU) 2016/425 and the standard EN 374 derived from it.

Eyes

Tightly fitting safety goggles. Wear face-shield and protective suit for abnormal processing problems. Use eye protection according to EN 166.

Respiratory

In the case of vapour formation use a respirator with an approved filter.

Skin/Body

Impervious clothing: Choose body protection according to the amount and concentration of the dangerous substance at the work place.

09

Physical and Chemical Properties

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

Language Code
---
Physical State
liquid
Physical State Data
liquid
State Under Standard Conditions
---
Appearance
---
Colour
colourless
Colour Intensity
---
Form
---
Odor
No data available
Odor Threshold
No data available
Ph
8,6
Melting Point
No data available
Boiling Point
No data available
Flash Point
does not flash
Freezing Point
---
Softening Point
---
Solidification Point
---
Cloud Point
---
Crystallisation Point
---
Relative Evaporation Rate
---
Evaporation Rate
No data available
Vapor Pressure
---
Vapor Density
---
Relative Density
---
Bulk Density
---
Density
1,012 g/cm3
Flammability
Does not sustain combustion.
Upper Explosive Limit
No data available
Lower Explosive Limit
No data available
Explosive Limits
---
Auto Ignition Temperature
Not applicable / No data available
Decomposition Temperature
---
Solubility
---
Partition Coefficient
---
Solubility In Water
completely miscible
Solubility In Fat
---
Molecular Weight
---
Voc Content
---
Metal Corrosion
---
Dynamic Viscosity
No data available
Kinematic Viscosity
No data available
Properties Status
---
10

Stability and Reactivity

Chemical stability, hazardous reactions, and incompatible materials

Stability

Stable under normal conditions.

Reactivity

No dangerous reaction known under conditions of normal use.

Hazardous reactions

No dangerous reaction known under conditions of normal use. No decomposition if stored and applied as directed.

Avoid

Heat, flames and sparks. Exposure to moisture

Incompatible

Strong oxidizing agents, Bases, Strong acids

Decomposition

Carbon oxides, Gaseous hydrogen chloride (HCl), Nitrogen oxides (NOx), Ammonia

12

Ecological Information

Environmental toxicity, biodegradation, and bioaccumulation data

12.1 Toxicity

guanidinium chloride: Toxicity to fish : LC50 (Leuciscus idus (Golden orfe)): 1.758 mg/l End point: mortality Exposure time: 48 h Test Type: static test GLP: yes Toxicity to daphnia and other aquatic invertebrates : EC50 (Daphnia magna (Water flea)): 70,2 mg/l End point: Immobilization Exposure time: 48 h Test Type: static test Analytical monitoring: yes Method: OECD Test Guideline 202 GLP: No information available. Toxicity to algae/aquatic plants : EC50 (Pseudokirchneriella subcapitata (green algae)): 33,5 mg/l End point: Growth rate Exposure time: 72 h Test Type: static test Analytical monitoring: yes Method: Regulation (EC) No. 440/2008, Annex, C.3 GLP: yes : EC50 (Pseudokirchneriella subcapitata (green algae)): 11,8 mg/l Exposure time: 72 h Test Type: static test Analytical monitoring: yes Method: Regulation (EC) No. 440/2008, Annex, C.3 GLP: yes : NOEC (Pseudokirchneriella subcapitata (green algae)): 6,3 mg/l End point: Growth rate Exposure time: 72 h Test Type: static test Analytical monitoring: yes Method: Regulation (EC) No. 440/2008, Annex, C.3 GLP: yes Toxicity to microorganisms : EC10 (Pseudomonas putida): 7.125 mg/l End point: Growth rate Exposure time: 18 h Test Type: static test Method: DIN 38 412 Part 8 GLP: yes Toxicity to fish (Chronic toxicity) : NOEC: > 181 mg/l End point: mortality Exposure time: 35 d Species: Pimephales promelas (fathead minnow) Test Type: flow-through test Analytical monitoring: yes Method: OECD Test Guideline 210 GLP: No information available. Toxicity to daphnia and other aquatic invertebrates (Chronic toxicity) : NOEC: 2,9 mg/l End point: reproduction rate Exposure time: 21 d Species: Daphnia magna (Water flea) Analytical monitoring: yes Method: OECD Test Guideline 211 GLP: No information available.

12.1 Toxicity

Polidocanol: Toxicity to fish : LC50 (Salmo salar (Atlantic salmon)): 1,5 mg/l End point: mortality Exposure time: 96 h Toxicity to daphnia and other aquatic invertebrates : EC50 (Daphnia magna (Water flea)): 6,46 mg/l Exposure time: 48 h Toxicity to algae/aquatic plants : ErC50 (Desmodesmus subspicatus (green algae)): 0,237 mg/l Exposure time: 72 h Method: OECD Test Guideline 201 EbC50 (Desmodesmus subspicatus (green algae)): 1.502 mg/l Exposure time: 72 h Method: OECD Test Guideline 201 M-Factor (Acute aquatic toxicity) : 1 Toxicity to microorganisms : (Photobacterium phosphoreum): 2,5 mg/l Test Type: EC50 Toxicity to daphnia and other aquatic invertebrates (Chronic toxicity) : NOEC: 0,144 mg/l Exposure time: 21 d ic toxicity) Species: Daphnia magna (Water flea) Method: QSAR

12.1 Toxicity

guanidinium chloride: Toxicity to fish - LC50 (Leuciscus idus (Golden orfe)): 1.758 mg/l End point: mortality Exposure time: 48 h Test Type: static test GLP: yes Toxicity to daphnia and other aquatic invertebrates - EC50 (Daphnia magna (Water flea)): 70,2 mg/l End point: Immobilization Exposure time: 48 h Test Type: static test Analytical monitoring: yes Method: OECD Test Guideline 202 GLP: No information available. Toxicity to algae/aquatic plants - EC50 (Pseudokirchneriella subcapitata (green algae)): 33,5 mg/l End point: Growth rate Exposure time: 72 h Test Type: static test Analytical monitoring: yes Method: Regulation (EC) No. 440/2008, Annex, C.3 GLP: yes - EC50 (Pseudokirchneriella subcapitata (green algae)): 11,8 mg/l Exposure time: 72 h Test Type: static test Analytical monitoring: yes Method: Regulation (EC) No. 440/2008, Annex, C.3 GLP: yes - NOEC (Pseudokirchneriella subcapitata (green algae)): 6,3 mg/l End point: Growth rate Exposure time: 72 h Test Type: static test Analytical monitoring: yes Method: Regulation (EC) No. 440/2008, Annex, C.3 GLP: yes Toxicity to microorganisms - EC10 (Pseudomonas putida): 7.125 mg/l End point: Growth rate Exposure time: 18 h Test Type: static test Method: DIN 38 412 Part 8 GLP: yes Toxicity to fish (Chronic toxicity): NOEC: > 181 mg/l End point: mortality Exposure time: 35 d Species: Pimephales promelas (fathead minnow) Test Type: flow-through test Analytical monitoring: yes Method: OECD Test Guideline 210 GLP: No information available. Toxicity to daphnia and other aquatic invertebrates (Chronic toxicity): NOEC: 2,9 mg/l End point: reproduction rate Exposure time: 21 d Species: Daphnia magna (Water flea) Analytical monitoring: yes Method: OECD Test Guideline 211 GLP: No information available.

12.2 Persistence and degradability

guanidinium chloride: Biodegradability : Test Type: aerobic Inoculum: activated sludge, adapted Concentration: 10 mg/l Result: Not readily biodegradable. Biodegradation: 0 % Exposure time: 33 d Method: OECD Test Guideline 301C GLP: yes Impact on Sewage Treatment : Do not discharge product into the aquatic environment without pretreatment (biological treatment plant).

12.2 Persistence and degradability

Biodegradability : Test Type: aerobic Inoculum: activated sludge Concentration: 30 mg/l Result: Readily biodegradable. Biodegradation: 74 % Exposure time: 28 d Method: OECD Test Guideline 301C

12.2 Persistence and degradability

guanidinium chloride: Biodegradability : Test Type: aerobic Inoculum: activated sludge, adapted Concentration: 10 mg/l Result: Not readily biodegradable. Biodegradation: 0 % Exposure time: 33 d Method: OECD Test Guideline 301C GLP: yes Impact on Sewage Treatment : Do not discharge product into the aquatic environment without pretreatment (biological treatment plant).

12.3 Bioaccumulative potential

Partition coefficient: n-octanol/water : log Pow: < -1,7 (20 °C) pH: 7,4 Method: OECD Test Guideline 107 GLP: yes

12.3 Bioaccumulative potential

Polidocanol: Partition coefficient: n-octanol/water : Remarks: No data available

12.3 Bioaccumulative potential

guanidinium chloride: Partition coefficient: n-octanol/water : log Pow: < -1,7 (20 °C) pH: 7,4 Method: OECD Test Guideline 107 GLP: yes

12.3 Bioaccumulative potential

Proteinase, Tritirachium album serine: Partition coefficient: n-octanol/water : Remarks: No data available

No data available regarding the bioaccumulative potential of Proteinase, Tritirachium album serine.

12.4 Mobility in soil

DNA Tissue Lysis Buffer No data available Lysis/Binding Buffer/DNA PBB No data available Wash Buffer I No data available Wash Buffer II No data available DNA SD/EB No data available Proteinase K No data available

12.5 Results of PBT and vPvB assessment

DNA Tissue Lysis Buffer Not relevant Lysis/Binding Buffer/DNA PBB Not relevant Wash Buffer I Not relevant Wash Buffer II Not relevant DNA SD/EB Not relevant Proteinase K Not relevant

12.6 Endocrine disrupting properties

DNA Tissue Lysis Buffer No data available Lysis/Binding Buffer/DNA PBB No data available Wash Buffer I No data available Wash Buffer II No data available DNA SD/EB No data available Proteinase K No data available

12.7 Other adverse effects

DNA Tissue Lysis Buffer No data available Lysis/Binding Buffer/DNA PBB No data available Wash Buffer I No data available Wash Buffer II No data available DNA SD/EB No data available Proteinase K No data available
13

Disposal Considerations

Waste treatment methods, disposal recommendations, and waste codes

Disposal

Send to a licensed waste management company. Can be disposed as waste water, when in compliance with local regulations.

14

Transport Information

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

15

Regulatory Information

Chemical regulations, safety assessments, and compliance status

Safety, health and environmental regulations/legislation specific for the substance or mixture

Chemical Safety Assessment Not performed

Take note of Law on the protection of mothers at work, in education and in studies (Maternity Protection Act - MuSchG). Take note of Directive 94/33/EC on the protection of young people at work or stricter national regulations, where applicable.

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Frequently Asked Questions

Common questions about safety, handling, and properties

What is the hazard signal word for KIT DNA ISOLATION 24T IVD?

The signal word is danger.

What is the physical form of KIT DNA ISOLATION 24T IVD?

KIT DNA ISOLATION 24T IVD is a liquid with colourless color. It has no data available odor.

What is KIT DNA ISOLATION 24T IVD used for?

For professional users only.

What are the hazard statements for KIT DNA ISOLATION 24T IVD?

This substance has 7 hazard statements:

  • H302 + H332: Harmful if swallowed or if inhaled.
  • H315: Causes skin irritation.
  • H317: May cause an allergic skin reaction.
  • H319: Causes serious eye irritation.
  • H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled.
  • H335: May cause respiratory irritation.
  • H411: Toxic to aquatic life with long lasting effects.

What is the melting point of KIT DNA ISOLATION 24T IVD?

The melting point is No data available and the boiling point is No data available.