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Safety Data Sheet EN

Brava® Skin Barrier Spray

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01

Identification

Product identifiers, regulatory numbers, and supplier information

Product Information

Product Name
Brava® Skin Barrier Spray
Product Form
Pump Spray
Product Code
12020

Regulatory Identifiers

CAS Number
N/A

Identified Uses

Medical device. A skin barrier spray which provides a thin protective layer on the skin.

Manufacturers & Suppliers

C

Coloplast A/S

manufacturer

Holtedam 1, DK-3050 Humlebaek, Denmark

+45 49111111

Emergency Contacts

Emergency Contact

+45 82 12 12 12

Emergency Contact

1-800-222-1222

Emergency Contact

1-877-820-7008

02

Hazard Identification

GHS classification, signal word, pictograms, and hazard statements

Classified danger

Hazard Classifications

Flam. Liq. Cat. 2 H225
Aquatic Acute Cat. 1 H400
Aquatic Chronic Cat. 2 H411

GHS Pictograms

GHS02 - Flammable

GHS02

GHS09 - Environmental hazard

GHS09

Hazard Statements

H225 Highly flammable liquid and vapour
H410 Very 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
P211 Do not spray on an open flame or other ignition source
P251 Do not pierce or burn, even after use
P273 Avoid release to the environment
P391 Collect spillage
P410 Protect from sunlight. Do not expose to temperatures exceeding 50 °C/122°F

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03

Composition / Information on Ingredients

Chemical components, concentration ranges, and hazardous substance identification

Type mixture

The product contains Substance of Very High Concern (SVHC) in a concentration above 0.1% w/w according to the candidate list, article 59 (10) European REACH regulation (EC) No. 1907/2006. This substance is cyclopentasiloxane D5 (CAS # 541-02-6) and it is of concern due to environmental toxicity. The main ingredients are: Hexamethyldisiloxane, Cyclopentasiloxane

Chemical Name CAS Number Concentration Hazardous
Hexamethyl-disiloxane EC: 203-492-7 107-46-0 85 - 95% Yes
Cyclopenta-siloxane EC: 208-764-9 541-02-6 5 - 10% No

Wording of H-statements - see section 16.

04

First Aid Measures

Emergency procedures for chemical exposure incidents

Inhalation

Move the affected person to fresh air. Keep at rest. If needed: Get medical attention.

Symptoms: Irritation to the upper air-ways.

Skin contact

This product is intended to be in contact with the skin when used as stated in the instructions for use. In case of skin problems: Seek medical advice. For burns: Flush with water until pain ceases. Remove clothes that are not burnt to the skin. If needed seek medical attention, continue to flush on the way.

Symptoms: Slight irritation.

Eye contact

Immediately flush with water or physiological salt water for at least 15 minutes, holding eye lids open, remember to remove contact lenses, if any. If irritation persists: Seek medical advice.

Symptoms: Slight irritation.

Ingestion

Rinse mouth and drink plenty of water. Do not induce vomiting. If vomiting occurs keep head down to avoid vomit in the lungs. In case of discomfort: Seek medical advice.

Immediate Medical Attention

Show this Safety Data Sheet to a physician or emergency ward.

05

Firefighting Measures

Extinguishing media, specific hazards, and firefighter protection

Suitable media

Extinguish with powder, foam, carbon dioxide or water mist. Use water or water mist to cool non-ignited stock.

Unsuitable media

Do not use water stream, as it may spread the fire.

Specific hazards

Can generate harmful flue gases containing carbon monoxide in the event of fire.

Instructions

Move containers from danger area if it can be done without risk.

Firefighter Protection

Wear Self-Contained Breathing Apparatus (SCBA) with chemical resistant gloves. Avoid inhalation of vapour and flue gases – seek fresh air.

06

Accidental Release Measures

Spill cleanup procedures, containment, and environmental protection

Environmental

Do not empty into drains - see section 12. Inform appropriate authorities in accordance with local regulations.

Cleanup methods

Absorb spilled liquid with paper towel

Materials: paper towel

Related Products

Similar products with comparable safety profiles

07

Handling and Storage

Safe handling precautions, storage conditions, and workplace requirements

Handling

Use the product under well-ventilated conditions. Running water and eye wash equipment must be available. Wash hands before breaks, before using restroom facilities, and at the end of work. Smoking and naked flames prohibited.

Storage

Store safely and keep out of reach of children. Pressurized container: Protect from sunlight and do not expose to temperatures exceeding 50°C/122°F.

Hygiene

Wash hands before breaks, before using restroom facilities, and at the end of work.

Fire prevention

Smoking and naked flames prohibited.

08

Exposure Controls / PPE

Occupational exposure limits, engineering controls, and protective equipment

Engineering

Wear the personal protective equipment specified below.

Hands

Plastic or rubber gloves recommended.

Eyes

Not required.

Respiratory

Not required.

Environmental

Ensure compliance with local regulations for emissions.

09

Physical and Chemical Properties

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

Physical State
Liquid
Physical State Data
liquid
State Under Standard Conditions
---
Appearance
---
Colour
---
Colour Intensity
---
Form
---
Odor
characteristic
Odor Threshold
---
Ph
_-_
Melting Point
-68 °C
Boiling Point
100 °C
Flash Point
-6 °C
Freezing Point
-68 °C
Softening Point
---
Solidification Point
---
Cloud Point
---
Crystallisation Point
---
Relative Evaporation Rate
---
Evaporation Rate
---
Vapor Pressure
44 hPa (0°C) (Hexamethyldisiloxane)
Vapor Density
---
Relative Density
approx. 0,76 (Hexamethyldisiloxane)
Bulk Density
---
Density
approx. 0,76 g/cm³ (Hexamethyldisiloxane)
Flammability
---
Upper Explosive Limit
26
Lower Explosive Limit
0,68
Explosive Limits
---
Auto Ignition Temperature
340 °C
Decomposition Temperature
_-_
Solubility
<0,001 g/l (Hexamethyldisiloxane)
Partition Coefficient
>4 (25 °C) (Hexamethyldisiloxane)
Solubility In Water
---
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

The product is stable when used in accordance with the supplier's directions – see section 7.

Reactivity

Not reactive.

Hazardous reactions

Vapours may form explosive mixtures with air.

Avoid

Avoid heating and contact with ignition sources. Avoid direct sunlight. Store at temperatures below 50°C/122°F.

Incompatible

None known.

Decomposition

Carbon monoxide and carbon dioxide.

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

The recommended disposal technology at any approved facility.

Disposal

Collect spills and waste in closed, leak-proof containers for disposal at the local hazardous waste site.

Waste Codes

16 05 08* discarded organic chemicals consisting of or containing dangerous substances EWC
14

Transport Information

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

UN Number
1993
Shipping Name
FLAMMABLE LIQUID, N.O.S. (HEXAMETHYLDISILOXANE)
Transport Class
3
Packing Group
II
15

Regulatory Information

Chemical regulations, safety assessments, and compliance status

Medical devices are exempt from classification and labelling according to CLP (1272/2008). Special care should be applied for employees under the age of 18.

Chemical Safety Assessment Not performed

Special care should be applied for employees under the age of 18. Young people under the age of 18 may not carry out any work causing harmful exposure to this product.

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Frequently Asked Questions

Common questions about safety, handling, and properties

What is the hazard signal word for Brava® Skin Barrier Spray?

The signal word is danger.

What is the physical form of Brava® Skin Barrier Spray?

Brava® Skin Barrier Spray is a liquid . It has characteristic odor.

What is the solubility of Brava® Skin Barrier Spray?

<0,001 g/l (Hexamethyldisiloxane)

What is Brava® Skin Barrier Spray used for?

Medical device. A skin barrier spray which provides a thin protective layer on the skin.

What are the hazard statements for Brava® Skin Barrier Spray?

This substance has 2 hazard statements:

  • H225: Highly flammable liquid and vapour
  • H410: Very toxic to aquatic life with long lasting effects

What is the melting point of Brava® Skin Barrier Spray?

The melting point is -68 °C and the boiling point is 100 °C.