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Safety Data Sheet EN

KIT CAP-G/CTM HIV-1 V2.0 EXPT-IVD

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
KIT CAP-G/CTM HIV-1 V2.0 EXPT-IVD
Product Code
05212294190

Regulatory Identifiers

CAS Number
N/A

Manufacturers & Suppliers

R

Roche Diagnostics Limited

manufacturer

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

+44 1444 256000

Emergency Contacts

Health, Safety & Environment

+44 1444 256500

Health, Safety & Environment

+44 7802 260498

Product Safety / Vigilance

+44 1444 256561

Product Safety / Vigilance

+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

GHS02 - Flammable

GHS02

GHS05 - Corrosive

GHS05

GHS07 - Health hazard

GHS07

GHS08 - Serious health hazard

GHS08

GHS09 - Environmental hazard

GHS09

Hazard Statements

H225 Highly flammable liquid and vapour.
H302 + H332 Harmful if swallowed or if inhaled.
H314 Causes severe skin burns and eye damage.
H317 May cause an allergic skin reaction.
H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled.
H336 May cause drowsiness or dizziness.
H411 Toxic to aquatic life with long lasting effects.

Precautionary Statements

P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
P273 Avoid release to the environment.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.
P303 + P361 + P353 IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
P304 + P340 + P310 IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER/ doctor.
P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor.
P342 + P311 If experiencing respiratory symptoms: Call a POISON CENTER/ doctor.
P370 + P378 In case of fire: Use dry sand, dry chemical or alcohol-resistant foam to extinguish.
P391 Collect spillage.

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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
reaction mass of 5-chloro-2-methyl-2H-isothiazol-3-one and 2-methyl-2H-isothiazol-3-one (3:1) 55965-84-9 0.0025 - 0.025% 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

Immediate medical treatment is necessary as untreated wounds from corrosion of the skin heal slowly and with difficulty. If on skin, rinse well with water. If on clothes, remove clothes.

Eye contact

Rinse immediately with plenty of water and seek medical advice. Continue rinsing eyes during transport to hospital. Remove contact lenses. Protect unharmed eye. Keep eye wide open while rinsing. If eye irritation persists, consult a specialist.

Symptoms: Small amounts splashed into eyes can cause irreversible tissue damage and blindness.

Ingestion

Clean mouth with water and drink afterwards plenty of water. Keep respiratory tract clear. Do NOT induce vomiting. 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

Alcohol-resistant foam, Carbon dioxide (CO2), Dry chemical

Unsuitable media

High volume water jet

Instructions

Use a water spray to cool fully closed containers.

Firefighter Protection

Wear self-contained breathing apparatus for firefighting if necessary.

06

Accidental Release Measures

Spill cleanup procedures, containment, and environmental protection

Emergency procedures

Evacuate personnel to safe areas.

Environmental

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

Cleanup methods

collect with non-combustible absorbent material, and place in container for disposal according to local / national regulations (see section 13)

Materials: non-combustible absorbent material (e.g. sand, earth, diatomaceous earth, vermiculite)

—

Related Products

Similar products with comparable safety profiles

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. Take precautionary measures against static discharges. Provide sufficient air exchange and/or exhaust in work rooms. Open drum carefully as content may be under pressure. Dispose of rinse water in accordance with local and national regulations. 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. To prevent leaks or spillages from spreading, provide a suitable liquid retention system.

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

Do not spray on a naked flame or any incandescent material. Take necessary action to avoid static electricity discharge (which might cause ignition of organic vapours). Use only explosion-proof equipment. Keep away from open flames, hot surfaces and sources of ignition.

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Engineering

No data available

Hands

Material: Nitrile rubber, Break through time: > 30 min, Glove thickness: > 0,11 mm. Material: butyl-rubber, Break through time: > 480 min, Glove thickness: > 0,4 mm. Remarks: The selected protective gloves have to satisfy the specifications of Regulation (EU) 2016/425 and the standard EN 374 derived from it. This recommendation is only valid for the product mentioned in the safety data sheet and provided by us and for the application specified by us. Please observe the instructions regarding permeability and breakthrough time which are provided by the supplier of the gloves. Also take into consideration the specific local conditions under which the product is used, such as the danger of cuts, abrasion, and the contact time. The suitability for a specific workplace should be discussed with the producers of the protective gloves.

Eyes

Eye wash bottle with pure water. 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
suspension
Physical State Data
liquid
State Under Standard Conditions
---
Appearance
black
Colour
black
Colour Intensity
---
Form
---
Odor
strong
Odor Threshold
No data available
Ph
No data available
Melting Point
-89 °C
Boiling Point
82 °C
Flash Point
12 °C
Freezing Point
---
Softening Point
---
Solidification Point
---
Cloud Point
---
Crystallisation Point
---
Relative Evaporation Rate
---
Evaporation Rate
< 0,6
Vapor Pressure
42 hPa (20 °C)
Vapor Density
---
Relative Density
---
Bulk Density
---
Density
0,78 g/cm3
Flammability
Does not sustain combustion.
Upper Explosive Limit
12 % (V)
Lower Explosive Limit
2 % (V)
Explosive Limits
---
Auto Ignition Temperature
485 °C
Decomposition Temperature
Hazardous decomposition products formed under fire conditions.
Solubility
---
Partition Coefficient
---
Solubility In Water
partly 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

Toxic gases may be released if in contact with the following: sodium hypochlorite, Acids, Strong oxidizing agents. Vapours may form explosive mixture with air.

Avoid

Heat, flames and sparks.

Incompatible

sodium hypochlorite, Acids, Strong oxidizing agents

Decomposition

Toxic gases

12

Ecological Information

Environmental toxicity, biodegradation, and bioaccumulation data

12.1 Toxicity

Magnetic Glass Particles (MGPs) Suspension

12.2 Persistence and degradability

No data available

12.3 Bioaccumulative potential

No data available

12.4 Mobility in soil

No data available

12.5 Results of PBT and vPvB assessment

No data available

12.6 Endocrine disrupting properties

No data available

12.7 Other adverse effects

No data available

12.1 Toxicity

Toxicity to fish : LC50 (Pimephales promelas (fathead minnow)): 10.000 mg/l End point: mortality Exposure time: 96 h Test Type: flow-through test Analytical monitoring: yes Method: OECD Test Guideline 203 GLP: no Toxicity to daphnia and other aquatic invertebrates : LC50 (Daphnia magna (Water flea)): > 10.000 mg/l End point: Immobilization Exposure time: 24 h Test Type: static test Analytical monitoring: no Method: OECD Test Guideline 202 GLP: no Toxicity to algae/aquatic plants : EC10 (Scenedesmus quadricauda (Green algae)): 1.800 mg/l Exposure time: 7 d Test Type: static test Analytical monitoring: no GLP: no Toxicity to microorganisms : (Pseudomonas putida): 1.050 mg/l Exposure time: 16 h Test Type: static test Analytical monitoring: no Method: DIN 38 412 Part 8 GLP: no

12.1 Toxicity

Toxicity to fish : LC50 (Poecilia reticulata (guppy)): 89,1 mg/l End point: mortality Exposure time: 96 h Test Type: static test Analytical monitoring: no Method: OECD Test Guideline 203 GLP: no Toxicity to daphnia and other aquatic invertebrates : EC50 (Daphnia (water flea)): 42,4 mg/l End point: Immobilization Exposure time: 48 h Test Type: static test Analytical monitoring: no Method: OECD Test Guideline 202 GLP: no Toxicity to algae/aquatic plants : EC50 (Desmodesmus subspicatus (green algae)): 130 mg/l End point: Growth rate Exposure time: 72 h Test Type: static test GLP: No information available. Toxicity to microorganisms : EC50 (activated sludge): > 185 mg/l Exposure time: 28 d Test Type: static test Method: OECD Test Guideline 302B GLP: yes

12.1 Toxicity

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 Species: Daphnia magna (Water flea) Method: QSAR

The substance exhibits acute toxicity to fish, daphnia, and algae, with the most sensitive endpoint being algae (ErC50 0,237 mg/l). An M-Factor of 1 is assigned for acute aquatic toxicity. Chronic toxicity to daphnia was estimated via QSAR at 0,144 mg/l.

12.1 Toxicity

Other organisms relevant to the environment : No data available

No data available regarding other organisms relevant to the environment.

12.4 Mobility in soil

Toxicity Data on Soil : Not expected to adsorb on soil.

The substance is not expected to adsorb on soil.

12.1 Toxicity

Toxicity to fish : LC50 (Fish): 0,36 mg/l Exposure time: 96 h M-Factor (Acute aquatic toxicity) : 100 M-Factor (Chronic aquatic) : 100

Ecotoxicology Assessment

Toxicity Data on Soil: Not expected to adsorb on soil. Other organisms relevant to the environment: No data available

12.4 Mobility in soil

Toxicity Data on Soil: Not expected to adsorb on soil.

12.1 Toxicity

Toxicity to fish: LC50 (Fish): 0,36 mg/l Exposure time: 96 h M-Factor (Acute aquatic toxicity): 100 M-Factor (Chronic aquatic toxicity): 100

12.2 Persistence and degradability

propan-2-ol: Biodegradability : Test Type: aerobic Inoculum: activated sludge Result: Readily biodegradable. Biodegradation: 53 % Exposure time: 5 d GLP: no

12.2 Persistence and degradability

guanidinium thiocyanate: Biodegradability : Test Type: aerobic Inoculum: activated sludge, non-adapted Concentration: 343 mg/l Result: Inherently biodegradable. Biodegradation: 46 % Exposure time: 28 d Method: OECD Test Guideline 302B GLP: no

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

12.3 Bioaccumulative potential

propan-2-ol: Partition coefficient: n-octanol/water : log Pow: 0,05 (25 °C) GLP: no

12.3 Bioaccumulative potential

guanidinium thiocyanate: Partition coefficient: n-octanol/water : log Pow: -1,11 (25 °C) pH: > 5,1 Method: Regulation (EC) No. 440/2008, Annex, A.8 GLP: no

12.3 Bioaccumulative potential

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

12.3 Bioaccumulative potential

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

No data available regarding the partition coefficient.

12.3 Bioaccumulative potential

Nucleotidyltransferase, deoxyribonucleate: Partition coefficient: n-octanol/water : Remarks: No data available

No data available regarding the bioaccumulative potential of Nucleotidyltransferase, deoxyribonucleate.

12.3 Bioaccumulative potential

Uracil DNA Glycosylase: Partition coefficient: n-octanol/water : Remarks: No data available

12.3 Bioaccumulative potential

reaction mass of 5-chloro-2-methyl-2H-isothiazol-3-one and 2-methyl-2H-isothiazol-3-one (3:1): Partition coefficient: n-octanol/water : Remarks: No data available

No data available

12.3 Bioaccumulative potential

reaction mass of 5-chloro-2-methyl-2H-isothiazol-3-one and 2-methyl-2H-isothiazol-3-one (3:1): Partition coefficient: n-octanol/water : Remarks: No data available

No data available regarding the partition coefficient (n-octanol/water).

12.3 Bioaccumulative potential

reaction mass of 5-chloro-2-methyl-2H-isothiazol-3-one and 2-methyl-2H-isothiazol-3-one (3:1): Partition coefficient: n-octanol/water : Remarks: No data available

No data available for partition coefficient.

12.4 Mobility in soil

Magnetic Glass Particles (MGPs) Suspension No data available Lysis Buffer (R2 / LYS RGT / [HIV/HBV/HCV/DPX/MPX/MPX2 - CS2]) No data available HBV/HCV/HIV/WNV/MPX/CMV/DPX/CS3/LYSIS [Pase] / P2 No data available [CS3 - EB] / R3 / EB 2 No data available [HIV-1 CS4] QS No data available CS4 [MMX] No data available CS4 [Mn2+] No data available CTM (-)C (Human Plasma) No data available HIV-1 L(+)C / HIV (+)C No data available HIV-1/HCV H(+)C No data available

No data available for the listed components.

12.5 Results of PBT and vPvB assessment

Magnetic Glass Particles (MGPs) Suspension Not relevant Lysis Buffer (R2 / LYS RGT / [HIV/HBV/HCV/DPX/MPX/MPX2 - CS2]) Not relevant HBV/HCV/HIV/WNV/MPX/CMV/DPX/CS3/LYSIS [Pase] / P2 Not relevant [CS3 - EB] / R3 / EB 2 Not relevant [HIV-1 CS4] QS Not relevant CS4 [MMX] Not relevant CS4 [Mn2+] Not relevant CTM (-)C (Human Plasma) Not relevant HIV-1 L(+)C / HIV (+)C Not relevant HIV-1/HCV H(+)C Not relevant

The substances listed are assessed as not relevant for PBT and vPvB criteria.

12.6 Endocrine disrupting properties

Magnetic Glass Particles (MGPs) Suspension No data available Lysis Buffer (R2 / LYS RGT / [HIV/HBV/HCV/DPX/MPX/MPX2 - CS2]) No data available HBV/HCV/HIV/WNV/MPX/CMV/DPX/CS3/LYSIS [Pase] / P2 No data available [CS3 - EB] / R3 / EB 2 No data available [HIV-1 CS4] QS No data available CS4 [MMX] No data available CS4 [Mn2+] No data available CTM (-)C (Human Plasma) No data available HIV-1 L(+)C / HIV (+)C No data available

No data available for the listed substances.

12.7 Other adverse effects

Magnetic Glass Particles (MGPs) Suspension No data available Lysis Buffer (R2 / LYS RGT / [HIV/HBV/HCV/DPX/MPX/MPX2 - CS2]) No data available HBV/HCV/HIV/WNV/MPX/CMV/DPX/CS3/LYSIS [Pase] / P2 No data available [CS3 - EB] / R3 / EB 2 No data available [HIV-1 CS4] QS No data available CS4 [MMX] No data available CS4 [Mn2+] No data available CTM (-)C (Human Plasma) Components: reaction mass of 5-chloro-2-methyl-2H-isothiazol-3-one and 2-methyl-2H-isothiazol-3-one (3:1): Additional ecological information : An environmental hazard cannot be excluded in the event of unprofessional handling or disposal. Very toxic to aquatic life with long lasting effects. HIV-1 L(+)C / HIV (+)C Components: reaction mass of 5-chloro-2-methyl-2H-isothiazol-3-one and 2-methyl-2H-isothiazol-3-one (3:1): Additional ecological information : An environmental hazard cannot be excluded in the event of unprofessional handling or disposal. Very toxic to aquatic life with long lasting effects. HIV-1/HCV H(+)C Components: reaction mass of 5-chloro-2-methyl-2H-isothiazol-3-one and 2-methyl-2H-isothiazol-3-one (3:1): Additional ecological information : An environmental hazard cannot be excluded in the event of unprofessional handling or disposal. Very toxic to aquatic life with long lasting effects.

Most substances listed have no data available. The reaction mass of 5-chloro-2-methyl-2H-isothiazol-3-one and 2-methyl-2H-isothiazol-3-one (3:1) is noted as very toxic to aquatic life with long-lasting effects.

13

Disposal Considerations

Waste treatment methods, disposal recommendations, and waste codes

Treatment

Special treatment as infectious material is mandatory in compliance with local regulations (disinfection and incineration).

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

UN Number
1219
Shipping Name
ISOPROPANOL
Transport Class
3
Packing Group
II
15

Regulatory Information

Chemical regulations, safety assessments, and compliance status

?

Frequently Asked Questions

Common questions about safety, handling, and properties

What is the hazard signal word for KIT CAP-G/CTM HIV-1 V2.0 EXPT-IVD?

The signal word is danger.

What is the physical form of KIT CAP-G/CTM HIV-1 V2.0 EXPT-IVD?

KIT CAP-G/CTM HIV-1 V2.0 EXPT-IVD is a suspension appearing as black with black color. It has strong odor.

What are the hazard statements for KIT CAP-G/CTM HIV-1 V2.0 EXPT-IVD?

This substance has 7 hazard statements:

  • H225: Highly flammable liquid and vapour.
  • H302 + H332: Harmful if swallowed or if inhaled.
  • H314: Causes severe skin burns and eye damage.
  • H317: May cause an allergic skin reaction.
  • H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled.
  • H336: May cause drowsiness or dizziness.
  • H411: Toxic to aquatic life with long lasting effects.

What is the melting point of KIT CAP-G/CTM HIV-1 V2.0 EXPT-IVD?

The melting point is -89 °C and the boiling point is 82 °C.