Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

First-aid measures

Inhalation


In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible).


Skin Contact


Remove contaminated clothing. Rinse contaminated skin immediately with plenty of water and seek medical advice.


Eye Contact


Immediately rinse eyes thoroughly with running water as long as possible (approx. 15 min). Take injured quickly to factory medical center or call an ambulance (code word: eye accident).


Ingestion


Do not induce vomiting. In case of consciousness wash mouth with water and let drink some of water. Seek medical advice. Keep patient at rest. If swallowed, seek medical advice immediately and show this container or label.


Indication of any immediate medical attention and special treatment needed


Notes to Physician


General measures to eliminate the substance and to reduce absorption.


Apply general supportive and symptomatic treatment.

Fire-fighting measures

Extinguishing media


Suitable Extinguishing Media


Water spray or fog, foam, dry chemical powder, CO2, dry sand Unsuitable


Extinguishing Media


No restrictions


Advice for firefighters


Protective equipment for firefighters


Wear self-contained breathing apparatus and fire protective suite.

Accidental release measures

Personal precautions, protective equipment and emergency procedures


Avoid contact with skin, eyes and clothing.


Methods and material for containment and cleaning up


Methods for cleaning


Transfer large quantities into a container, rinse the rest with plenty of water. Consult experts for decontamination.


Environmental precautions


Do not release into the environment.

Handling and storage

Precautions for safe handling


Storage and Handling Precautions


Keep container tightly closed in a dry, cool and well-ventilated place.


 


Conditions for safe storage, including any incompatibilities


Do not store together with


strong acids,


strong bases


Technical measures/Precautions


Handle product only in closed system or provide appropriate exhaust ventilation at machinery.


Preventive Precautions (fire/explosion)


Avoid formation of dust. Observe the usual precautionary measures required for chemicals with dust explosive properties (Observe national regulations).

Transport information

Land transport (UN RTDG/ADR/RID)

UN number:
3077
Shipping information
Proper shipping name and description:
Environmentally hazardous substance, solid, n.o.s.
(Contains: DABRAFENIB MESYLATE)
Chemical name:
Dabrafenib
Language:
English
Labels:
Environmentally Hazardous
SpecialProvisionsopen allclose all
Shippingopen allclose all
Remarksopen allclose all

Marine transport (UN RTDG/IMDG)

UN number:
3077
Shipping information
Proper shipping name and description:
Environmentally hazardous substance, solid, n.o.s.
(Contains: DABRAFENIB MESYLATE)
Chemical name:
Dabrafenib
Remarksopen allclose all

Air transport (UN RTDG/ICAO/IATA)

UN number:
3077
Shipping information
Proper shipping name and description:
Environmentally hazardous substance, solid, n.o.s.
(Contains: DABRAFENIB MESYLATE)
Chemical name:
Dabrafenib
Remarksopen allclose all
SpecialProvisionsopen allclose all

Exposure controls / personal protection

Industrial Hygiene


The personal protective measure may be adapted appropriately when working in closed systems or under laboratory conditions.


Regular cleaning of equipment, work area and clothing.


No open handling without using reliable equipment. One technical barrier between substance and employee resp. environment.


Restricted and controlled access for trained personnel only.


Designated washing, changing and shower facilities must be available.


Internal working procedures available to personnel covering personal hygiene, decontamination /cleaning, consideration of worst case incidents, spills, emergency, alarms, waste disposal and maintenance.


Personnel comprehensively instructed, highly trained and experienced. Regular refresher training established including appropriate record keeping.


Equipment and protective garments must either be decontaminated or properly contained for disposal before leaving the area.


Disposable protective equipment is to be decontaminated before removal (decontamination shower).


Open Handling


Respiration : If the Breathing Zone sampling results exceed the established occupational exposure limit (OEL) or the minimum concentration


defined by the occupational hazard band, use respiratory protection with sufficient protection factor to ensure exposure is below the exposure limit. Unless the exposure results indicate the requirement for cartridge or canister filters for vapors and gases.


Filter : P3 (EN143)


Eye : Yes, by face mask


Hand : Normal length chemical-mechanical-resistant gloves (EN374/EN388)


worn over disposable gloves


Glove Material : Nitrile


Breakthrough time: 240 min


Thickness: 0.4 mm


Additional protection : Disposable dust-proof suit (EN465, type 4) worn over long underwear Disposable boot covers, conductive


 


These values are derived from experiments, literature and information from the glove manufacturer.


They can also be derived from similar materials. In daily work please be aware that the using time depends on several


factors and can be shorter than the oficially tested permeation time.

Stability and reactivity

Reactivity


Reaction products with water


None known


 


Possibility of hazardous reactions


Materials to avoid


strong acids


strong bases


 


Conditions to avoid


Stable at normal conditions


 


Hazardous decomposition products


None, when used and handled as intended.

Disposal considerations

Waste treatment methods


Disposal Requirements Incineration in an approved, controlled furnace with combustion gas scrubbing and emission gas control.


Container Disposal


Empty containers can be disposed or re-used after cleaning, when in compliance with the environmental regulations (Duty of Care).


Empty but uncleaned containers for hazardous substances have to be regarded as hazardous until they have been cleaned.