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Safety Data Sheet EN

FX(h)-FVIII:C

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
FX(h)-FVIII:C
Product Code
BIOPHEN™ FIX – R1

Regulatory Identifiers

CAS Number
N/A

Identified Uses

FX(h)-FVIII:C

Manufacturers & Suppliers

H

HYPHEN BioMed

manufacturer

155 rue d'Eragny, 95000 Neuville-sur-Oise, France

+33.1.34.40.65.10

Emergency Contacts

HYPHEN BioMed

+33.1.34.40.65.10

during normal business hours only

Poisons Information Service in France

+33.1.45.42.59.59

Emergency Poison Advice

+61 13 11 26

24 hours

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
STOT SE Cat. 3 H335
Aquatic Chronic Cat. 3 H412

GHS Pictograms

GHS07 - Health hazard

GHS07

Hazard Statements

H315 Causes skin irritation.
H319 Causes serious eye irritation.
H335 May cause respiratory irritation.
H412 Harmful to aquatic life with long lasting effects.

Precautionary Statements

P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
P264 Wash skin thoroughly after handling.
P271 Use only outdoors or in a well-ventilated area.
P273 Avoid release to the environment.
P280 Wear protective gloves/protective clothing/eye protection/face protection.
P302 + P352 IF ON SKIN: Wash with plenty of soap and water.
P304 + P340 IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P312 Call a POISON CENTER or doctor/physician if you feel unwell.
P332 + P313 If skin irritation occurs: Get medical advice/attention.
P337 + P313 If eye irritation persists: Get medical advice/attention.
P362 Take off contaminated clothing and wash before reuse.
P403 + P233 Store in a well-ventilated place. Keep container tightly closed.
P405 Store locked up.
P501 Dispose of contents/container in consultation with your regional waste disposer

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03

Composition / Information on Ingredients

Chemical components, concentration ranges, and hazardous substance identification

Type mixture

This product contains material of animal origin and should be considered as potentially capable of transmitting infectious diseases. The preparation contains material of human origin which has been tested and found negative for HBSAg, anti-HIV and HCV. As with all materials of human origin, this product should be regarded as potentially hazardous to health. Therefore, it should be handled in compliance with appropriate laboratory safety procedures to minimise the risk of transmitting infectious pathogens.

Chemical Name CAS Number Concentration Hazardous
Tris-(hydroxyméthyl) aminométhane 77-86-1 20% Yes
Calcium Chloride Dihydrate 10035-04-8 10% Yes
Copper Sulfate 7758-98-7 1% Yes

Notes

Do not inject or ingest. This product contains material of animal origin and should be considered as potentially capable of transmitting infectious diseases. The preparation contains material of human origin which has been tested and found negative for HBSAg, anti-HIV and HCV. As with all materials of human origin, this product should be regarded as potentially hazardous to health. Therefore, it should be handled in compliance with appropriate laboratory safety procedures to minimise the risk of transmitting infectious pathogens.

04

First Aid Measures

Emergency procedures for chemical exposure incidents

Inhalation

IF INHALED: Remove victim to fresh air. Keep warm and at rest. If irritation occurs, get medical advice.

Skin contact

SKIN CONTACT: Wash off immediately with plenty of soap and water water – emergency showers should preferably be used. Take off immediately all contaminated clothing, send contaminated clothing to a specialist cleaning company before reuse. If skin reaction occurs, get medical advice.

Eye contact

EYE CONTACT: Rinse immediately with plenty of water for at least 15 minutes holding the eyelids open. If possible, remove contact lenses. Continue to rinse, get medical advice.

Ingestion

INGESTION: call immediately a POISON CENTER. Do not induce vomiting, rinse mouth. Never give anything by mouth to an unconscious person.

05

Firefighting Measures

Extinguishing media, specific hazards, and firefighter protection

Suitable media

Product itself is non-combustible; adapt fire extinguishing measures to surrounding areas

Unsuitable media

Water spray

Specific hazards

In the event of fire, the following can be released: Carbon dioxide (CO₂); Carbon monoxide (CO)

Instructions

Do not breathe fire/explosion fumes.

Firefighter Protection

Wear protective equipment. Self-contained breathing apparatus.

06

Accidental Release Measures

Spill cleanup procedures, containment, and environmental protection

Emergency procedures

Refer to protective measures listed in section 7 and 8. Avoid contact with skin, eyes and clothing. Avoid dust formation. Do not breathe gas/mist/vapours.

Environmental

Prevent further spillage if safe. Do not allow product to enter drains or any water course. Avoid release to the environment.

Cleanup methods

Collect spilled material with absorbent material. Clean contaminated surfaces and devices in compliance with all applicable legal requirements and regulations. Transfer to suitable, closed and labelled containers for storage/disposal.

Materials: absorbent material

Related Products

Similar products with comparable safety profiles

07

Handling and Storage

Safe handling precautions, storage conditions, and workplace requirements

Handling

Design and operate processes, insofar as the state of technology permits, in such a way that dangerous substances may not be released / contact with the skin can be ruled out.

Storage

Keep container tightly closed in a cool, well-ventilated place. Store locked up. Containers which are opened must be carefully closed and kept upright to prevent leakage.

Hygiene

Do not eat, drink or smoke during work time. Keep away from food, drink and animal feeding stuffs. Wash hands and skin before breaks and after work. Do not inhale vapours. Avoid contact with eyes and skin. Remove soiled or soaked clothing immediately.

Fire prevention

No special measures necessary.

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Engineering

Technical measures and appropriate working operations should be given priority over the use of personal protective equipment. To handle under an extraction system.

Hands

Wear appropriate protective gloves. Prior to use, check in any case suitability of protective glove for the specific workplace conditions. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Protective gloves must be tested and approved under EN374 standard. Replace protective gloves immediately when they become worn and damaged.

Eyes

Use equipment for eye and face protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).

Respiratory

If this is not possible, provide for appropriate respiratory and face protection according to the quantity of product to handle: large scale activities / emergency use: breathing apparatus tested and certified to EN136– full-face mask and particulate filter tested and certified to EN143; small scale activities / laboratory use: breathing apparatus tested and certified to EN140 – half face particulate (air-purifying) mask / quarter mask and particulate filter tested and certified to EN 143; breathing apparatus tested and certified to EN 149 – half face particulate (air-purifying) mask. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).

Skin/Body

During product handling, wear appropriate protective clothing in compliance with the applicable rules. The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.

Environmental

Prevent further spillage/release of material if safe. Do not allow product to enter drains or any water course. Avoid release to the environment.

09

Physical and Chemical Properties

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

Freezing Point
---
Molecular Weight
---
Kinematic Viscosity
---
Physical State Data
solid
Physical State
Lyophilised Powder
Density
---
Dynamic Viscosity
---
Flash Point
---
Cloud Point
---
Voc Content
---
Appearance
Lyophilised Powder
Vapor Pressure
---
Metal Corrosion
---
Form
Powder
Crystallisation Point
---
Auto Ignition Temperature
---
Boiling Point
---
Solidification Point
---
Colour
White / Yellow
Ph
---
Properties Status
---
Partition Coefficient
---
Softening Point
---
Solubility
---
Vapor Density
---
Evaporation Rate
---
Melting Point
---
Flammability
---
Odor Threshold
---
Upper Explosive Limit
---
Lower Explosive Limit
---
Relative Evaporation Rate
---
Bulk Density
---
Solubility In Fat
---
Relative Density
---
Explosive Limits
---
Solubility In Water
---
Colour Intensity
---
Odor
---
Decomposition Temperature
---
State Under Standard Conditions
---
10

Stability and Reactivity

Chemical stability, hazardous reactions, and incompatible materials

Stability

The preparation is stable if handled and stored as recommended under section 7.

Reactivity

No dangerous reactions known if handled in compliance with applicable provisions/under normal conditions of use.

Hazardous reactions

None if used for the intended purpose.

Avoid

None if used for the intended purpose.

Incompatible

None known.

Decomposition

None if used for the intended purpose.

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

Dispose of waste in compliance with national rules and consultation with environmental services.

Disposal

Dispose of waste in compliance with national rules and consultation with environmental services. The waste code is established in consultation with your regional waste disposer.

14

Transport Information

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

15

Regulatory Information

Chemical regulations, safety assessments, and compliance status

This MSDS file is comply to the requirements described on the Regulation (EC) No 1907/2006 (REACH) and 1272/2008 (CLP).

Chemical Safety Assessment Not performed
?

Frequently Asked Questions

Common questions about safety, handling, and properties

What is the hazard signal word for FX(h)-FVIII:C?

The signal word is warning.

What is the physical form of FX(h)-FVIII:C?

FX(h)-FVIII:C is a lyophilised powder appearing as lyophilised powder with white / yellow color.

What is FX(h)-FVIII:C used for?

FX(h)-FVIII:C

What are the hazard statements for FX(h)-FVIII:C?

This substance has 4 hazard statements:

  • H315: Causes skin irritation.
  • H319: Causes serious eye irritation.
  • H335: May cause respiratory irritation.
  • H412: Harmful to aquatic life with long lasting effects.