Identification
Product identifiers, regulatory numbers, and supplier information
Product Information
- Product Name
- BIOPHEN™ FVIII:C (6)
- Product Code
- 221406
Regulatory Identifiers
- CAS Number
- N/A
Identified Uses
In vitro medical device
Manufacturers & Suppliers
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
Hazard Identification
GHS classification, signal word, pictograms, and hazard statements
Hazard Classifications
GHS Pictograms
GHS07
Hazard Statements
Precautionary Statements
Get a free compliance audit
Upload your SDS inventory and get a detailed compliance report
Composition / Information on Ingredients
Chemical components, concentration ranges, and hazardous substance identification
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.
| Chemical Name | CAS Number | Concentration | Hazardous |
|---|---|---|---|
| Tris-(hydroxyméthyl) aminométhane | 77-86-1 | 20% | Yes |
| Calcium Chloride Dihydrate | 10035-04-8 | 10% | Yes |
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.
Notes
Do not inject or ingest. 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.
First Aid Measures
Emergency procedures for chemical exposure incidents
IF INHALED: Remove victim to fresh air. Keep warm and at rest. If irritation occurs, get medical advice.
SKIN CONTACT: Wash off immediately with plenty of soap and water. Take off immediately all contaminated clothing. Wash contaminated clothing before reuse. If skin reaction occurs, get medical advice.
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. Seek medical attention preferably an ophthalmologist.
INGESTION: call immediately a POISON CENTER. Do not induce vomiting. Never give anything by mouth to an unconscious person.
Immediate Medical Attention
Seek medical attention preferably an ophthalmologist.
Medical Treatment
No data available.
Firefighting Measures
Extinguishing media, specific hazards, and firefighter protection
Product itself is non-combustible; adapt fire extinguishing measures to surrounding areas
Water spray
In the event of fire, the following can be released: Carbon dioxide (CO₂); Carbon monoxide (CO)
Do not allow extinguishing water to enter sewerage or any water course. Do not breathe fire/explosion fumes.
Firefighter Protection
Wear protective equipment. Self-contained breathing apparatus.
Accidental Release Measures
Spill cleanup procedures, containment, and environmental protection
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.
Prevent further spillage if safe. Do not allow product to enter drains or any water course. Avoid release to the environment.
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
Handling and Storage
Safe handling precautions, storage conditions, and workplace requirements
For safe product handling, select and apply appropriate prevention and control measures that will reduce to a minimum the intrinsic risk hazard. 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.
Keep container tightly closed in a cool, well-ventilated place. Store locked up.
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.
No special measures necessary.
Exposure Controls / PPE
Occupational exposure limits, engineering controls, and protective equipment
Technical measures and appropriate working operations should be given priority over the use of personal protective equipment. Provide for appropriate exhaust ventilation at places where product is handled.
During handling, 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.
Use equipment for eye and face protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).
Where extraction systems to protect from nuisance levels of dusts cannot be installed, use type N95 (US) or type P1 (EN 143) dust masks. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).
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.
Prevent further spillage/release of material if safe. Do not allow product to enter drains or any water course. Avoid release to the environment.
Physical and Chemical Properties
Appearance, physical state, melting point, boiling point, and material characteristics
Stability and Reactivity
Chemical stability, hazardous reactions, and incompatible materials
The preparation is stable if handled and stored as recommended under section 7.
No dangerous reactions known if handled in compliance with applicable provisions/under normal conditions of use.
None if used for the intended purpose.
None if used for the intended purpose.
None known.
None if used for the intended purpose.
Ecological Information
Environmental toxicity, biodegradation, and bioaccumulation data
The data for this section has not been processed yet.
Disposal Considerations
Waste treatment methods, disposal recommendations, and waste codes
Dispose of waste in compliance with national rules and consultation with environmental services.
Dispose of waste in compliance with national rules and consultation with environmental services.
Transport Information
UN numbers, shipping names, transport classes, and regulatory requirements
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).
Frequently Asked Questions
Common questions about safety, handling, and properties
What is the hazard signal word for BIOPHEN™ FVIII:C (6)?
The signal word is warning.
What is the physical form of BIOPHEN™ FVIII:C (6)?
BIOPHEN™ FVIII:C (6) is a lyophilised powder, liquid appearing as lyophilised powder, liquid with white / yellow, colorless color.
What is BIOPHEN™ FVIII:C (6) used for?
In vitro medical device
What are the hazard statements for BIOPHEN™ FVIII:C (6)?
This substance has 3 hazard statements:
- H315: Causes skin irritation.
- H319: Causes serious eye irritation.
- H335: May cause respiratory irritation.