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Safety Data Sheet EN

BIOFIRE® FILMARRAY® Meningitis/Encephalitis (ME) Panel – Sample Buffer

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
BIOFIRE® FILMARRAY® Meningitis/Encephalitis (ME) Panel – Sample Buffer
Product Code
RFIT-ASY-0118, RFIT-ASY-0119
Synonyms
None.

Regulatory Identifiers

CAS Number
N/A

Identified Uses

In vitro diagnostic medical device

Uses advised against

None known.

Manufacturers & Suppliers

B

BioFire Diagnostics, LLC

manufacturer

515 Colorow Drive, Salt Lake City, Utah 84108, USA

1-801-736-6354

Emergency Contacts

Emergency Contact

999

02

Hazard Identification

GHS classification, signal word, pictograms, and hazard statements

Classified danger

Hazard Classifications

Acute Tox. Cat. 4 H302
Skin Irrit. Cat. 2 H315
Eye Irrit. Cat. 2
Aquatic Acute Cat. 1 H400
Aquatic Chronic Cat. 1 H410

GHS Pictograms

GHS05 - Corrosive

GHS05

GHS07 - Health hazard

GHS07

GHS09 - Environmental hazard

GHS09

Hazard Statements

H302 Harmful if swallowed.
H315 Causes skin irritation.
H318 Causes serious eye damage.
H400 Very toxic to aquatic life.
H410 Very toxic to aquatic life with long lasting effects.

Precautionary Statements

P273 Avoid release to the environment.
P280 Wear protective gloves/protective clothing/eye protection/face protection.
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P330 Rinse mouth.
P332 + P313 If skin irritation occurs: Get medical advice/attention.
P391 Collect spillage.
P501 Dispose of contents/container to an appropriate treatment and disposal facility in accordance with applicable laws and regulations, and product characteristics at time of disposal.

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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; guanadine hydrochloride EC: 200-002-3 50-01-1 50 - 60% Yes
Triton X100 9002-93-1 10 - 20% Yes

Notes

All concentrations are in percent by weight unless ingredient is a gas. Gas concentrations are in percent by volume.

04

First Aid Measures

Emergency procedures for chemical exposure incidents

Inhalation

Remove victim to fresh air and keep at rest in a position comfortable for breathing. For breathing difficulties, oxygen may be necessary. Call a physician if symptoms develop or persist.

Skin contact

Wash with plenty of soap and water. For minor skin contact, avoid spreading material on unaffected skin. Get medical attention if irritation develops and persists.

Symptoms: Skin irritation. May cause redness and pain.

Eye contact

Immediately flush eyes with plenty of water for at least 15 minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Get medical attention if irritation develops and persists.

Symptoms: Severe eye irritation. Symptoms may include stinging, tearing, redness, swelling, and blurred vision. Permanent eye damage including blindness could result.

Ingestion

IF SWALLOWED: Immediately call a POISON CENTRE or doctor/physician. Rinse mouth. Do not induce vomiting without advice from poison control center. If vomiting occurs, keep head low so that stomach content doesn't get into the lungs.

Symptoms: Irritating to mouth, throat, and stomach.

Immediate Medical Attention

Call a physician if symptoms develop or persist. Immediately call a POISON CENTRE or doctor/physician.

05

Firefighting Measures

Extinguishing media, specific hazards, and firefighter protection

Suitable media

Foam. Powder.

Unsuitable media

Do not use water jet as an extinguisher, as this will spread the fire.

Specific hazards

During fire, gases hazardous to health may be formed.

Instructions

Move containers from fire area if you can do so without risk. Use standard firefighting procedures and consider the hazards of other involved materials.

Firefighter Protection

Self-contained breathing apparatus and full protective clothing must be worn in case of fire.

06

Accidental Release Measures

Spill cleanup procedures, containment, and environmental protection

Emergency procedures

Do not touch damaged containers or spilled material unless wearing appropriate protective clothing. Do not touch or walk through spilled material. Keep unnecessary personnel away. Ensure adequate ventilation.

Small spill

Wipe up with absorbent material (e.g. cloth, fleece). Clean surface thoroughly to remove residual contamination.

Large spill

Stop the flow of material, if this is without risk. Dike the spilled material, where this is possible. Absorb in vermiculite, dry sand or earth and place into containers. Following product recovery, flush area with water.

Environmental

Avoid release to the environment. Inform appropriate managerial or supervisory personnel of all environmental releases. Prevent further leakage or spillage if safe to do so.

Cleanup methods

Absorb in vermiculite, dry sand or earth and place into containers. Following product recovery, flush area with water. Wipe up with absorbent material (e.g. cloth, fleece). Clean surface thoroughly to remove residual contamination.

Materials: vermiculite, dry sand, earth, absorbent material (e.g. cloth, fleece)

—

Related Products

Similar products with comparable safety profiles

07

Handling and Storage

Safe handling precautions, storage conditions, and workplace requirements

Handling

Do not breathe vapour. Do not get this material in contact with eyes. Avoid contact with eyes, skin, and clothing. When using, do not eat, drink or smoke. Wear appropriate personal protective equipment. Wash hands thoroughly after handling.

Storage

Store in tightly closed container.

Hygiene

When using, do not eat, drink or smoke. Wash hands thoroughly after handling. Observe good industrial hygiene practices.

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Engineering

Good general ventilation should be used. Ventilation rates should be matched to conditions. If applicable, use process enclosures, local exhaust ventilation, or other engineering controls to maintain airborne levels below recommended exposure limits. If exposure limits have not been established, maintain airborne levels to an acceptable level. Provide eyewash station and safety shower.

Hands

Use protective gloves made of: Nitrile.

Eyes

Avoid contact with eyes. Face shield is recommended. Wear safety glasses with side shields (or goggles). Eye wash fountain is recommended.

Respiratory

No personal respiratory protective equipment normally required.

Skin/Body

Avoid contact with the skin. Wear suitable protective clothing.

Environmental

Inform appropriate managerial or supervisory personnel of all environmental releases. Emissions from ventilation or work process equipment should be checked to ensure they comply with the requirements of environmental protection legislation. Fume scrubbers, filters or engineering modifications to the process equipment may be necessary to reduce emissions to acceptable levels.

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
Clear colorless or nearly colorless
Colour Intensity
---
Form
Not available.
Odor
Not available.
Odor Threshold
Not available.
Ph
Not available.
Melting Point
Not available.
Boiling Point
Not available.
Flash Point
Not available.
Freezing Point
---
Softening Point
---
Solidification Point
---
Cloud Point
---
Crystallisation Point
---
Relative Evaporation Rate
---
Evaporation Rate
Not available.
Vapor Pressure
Not available.
Vapor Density
Not available.
Relative Density
Not available.
Bulk Density
---
Density
---
Flammability
Not applicable.
Upper Explosive Limit
Not available.
Lower Explosive Limit
Not available.
Explosive Limits
---
Auto Ignition Temperature
Not available.
Decomposition Temperature
Not available.
Solubility
---
Partition Coefficient
Not available.
Solubility In Water
Not available.
Solubility In Fat
---
Molecular Weight
---
Voc Content
---
Metal Corrosion
---
Dynamic Viscosity
---
Kinematic Viscosity
---
Properties Status
---
10

Stability and Reactivity

Chemical stability, hazardous reactions, and incompatible materials

Stability

Material is stable under normal conditions.

Reactivity

The product is stable and non-reactive under normal conditions of use, storage and transport.

Hazardous reactions

No dangerous reaction known under conditions of normal use.

Avoid

Contact with incompatible materials.

Incompatible

Strong oxidising agents.

Decomposition

No hazardous decomposition products are known.

12

Ecological Information

Environmental toxicity, biodegradation, and bioaccumulation data

12.1. Toxicity

Very toxic to aquatic life with long lasting effects. | Product | Species | | Test Results | | --- | --- | --- | --- | | BIOFIRE® FILMARRAY® Meningitis/Encephalitis (ME) Panel – Sample Buffer | | | | | Aquatic | | | | | Fish | LC50 | Fish | 401.3714 mg/l, 96 hours | | Components | | Species | Test Results |

12.1. Toxicity

| Components | | Species | Test Results | | Triton X100 (CAS 9002-93-1) | | | | | Aquatic | | | | | Acute | | | | | Fish | LC50 | Bluegill (Lepomis macrochirus) | > 2.8 - < 3.2 mg/l, 96 hours |

12.2. Persistence and degradability

No data is available on the degradability of this product.

12.3. Bioaccumulative potential

No data available. Partition coefficient n-octanol/water (log Kow): Not available. Bioconcentration factor (BCF): Not available.

12.4. Mobility in soil

No data available.

12.5. Results of PBT and vPvB assessment

This mixture does not contain substances assessed to be vPvB / PBT according to Regulation (EC) No 1907/2006, Annex XIII.

The mixture does not contain substances assessed to be vPvB or PBT according to Regulation (EC) No 1907/2006, Annex XIII.

12.6. Other adverse effects

No other adverse environmental effects (e.g. ozone depletion, photochemical ozone creation potential, endocrine disruption, global warming potential) are expected from this component.

No other adverse environmental effects are expected from this component.

13

Disposal Considerations

Waste treatment methods, disposal recommendations, and waste codes

Treatment

Dispose of in accordance with local regulations. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a safe manner. Avoid discharge into water courses or onto the ground.

Disposal

Collect and reclaim or dispose in sealed containers at licensed waste disposal site. Do not allow this material to drain into sewers/water supplies. Dispose of contents/container in accordance with local/regional/national/international regulations.

Waste Codes

To be assigned The Waste code should be assigned in discussion between the user, the producer and the waste disposal company. Waste codes should be assigned by the user based on the application for which the product was used. EU waste code
14

Transport Information

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

UN Number
UN3082
Shipping Name
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S. (Triton X100)
Transport Class
9
Packing Group
III
15

Regulatory Information

Chemical regulations, safety assessments, and compliance status

This Safety Data Sheet complies with the requirements of Regulation (EC) No 1907/2006. The product is classified and labelled in accordance with EC directives or respective national laws. This product is classified and labelled in accordance with the retained CLP Regulation (EC) No 1272/2008, as amended for Great Britain. This Safety Data Sheet is compiled in accordance with REACH Regulation (EC) No 1907/2006, as amended by UK REACH Regulations SI 2019/758.

Chemical Safety Assessment Not performed

Follow the requirements of the Control of Substances Hazardous to Health Regulations 2002 [SI 2002/2677], as amended, when using this material.

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Frequently Asked Questions

Common questions about safety, handling, and properties

What other names is BIOFIRE® FILMARRAY® Meningitis/Encephalitis (ME) Panel – Sample Buffer known by?

BIOFIRE® FILMARRAY® Meningitis/Encephalitis (ME) Panel – Sample Buffer is also known as: None.

What is the hazard signal word for BIOFIRE® FILMARRAY® Meningitis/Encephalitis (ME) Panel – Sample Buffer?

The signal word is danger.

What is the physical form of BIOFIRE® FILMARRAY® Meningitis/Encephalitis (ME) Panel – Sample Buffer?

BIOFIRE® FILMARRAY® Meningitis/Encephalitis (ME) Panel – Sample Buffer is a liquid. with clear colorless or nearly colorless color. It has not available. odor.

What is BIOFIRE® FILMARRAY® Meningitis/Encephalitis (ME) Panel – Sample Buffer used for?

In vitro diagnostic medical device

What are the hazard statements for BIOFIRE® FILMARRAY® Meningitis/Encephalitis (ME) Panel – Sample Buffer?

This substance has 5 hazard statements:

  • H302: Harmful if swallowed.
  • H315: Causes skin irritation.
  • H318: Causes serious eye damage.
  • H400: Very toxic to aquatic life.
  • H410: Very toxic to aquatic life with long lasting effects.

What is the melting point of BIOFIRE® FILMARRAY® Meningitis/Encephalitis (ME) Panel – Sample Buffer?

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