Registration Dossier

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.