Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of first aid measures
General advice: Show this safety data sheet to the doctor in attendance.
If inhaled: If breathed in, move person into fresh air.
                Artificial respiration and/or oxygen may be necessary.
                Call a physician immediately.
In case of skin contact: Take off contaminated clothing and shoes immediately.
                                   Wash off with soap and water.
                                   Call a physician immediately.
                                   Immediately remove contaminated clothing and shoes and place in double, properly labeled, sealable waste disposal
bags.
In case of eye contact : Rinse immediately with plenty of water, also under the eyelids,for at least 15 minutes.
                                   Remove contact lenses.
                                   If eye irritation persists, consult a specialist.
If swallowed: If swallowed, rinse mouth with water (only if the person is conscious).
                    Call a physician immediately.


Most important symptoms and effects, both acute and delayed


risk: No information available


Indication of any immediate medical attention and special treatment needed


treatment: treat symptomatically 

Fire-fighting measures

Extinguishing media
Suitable extinguishing media: Water mist
                                            Dry powder
                                            Foam
                                            Carbon dioxide (CO2)
                                            Sand
                                            Aqueous film forming foam (AFFF).
                                            Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.


Unsuitable extinguishing media: Water spray jet


Special hazards arising from the substance or mixture


Hazardous combustion products: Carbon oxides
                                                Nitrogen oxides (NOx)


Advice for firefighters
Special protective equipment for firefighters: In the event of fire, wear self-contained breathing apparatus.
Further information: In the event of fire, cool tanks with water spray.
                               Avoid dust formation.

Accidental release measures

Personal precautions, protective equipment and emergency procedures
Personal precautions: Avoid dust formation.
                                Avoid breathing dust.
                                Evacuate personnel to safe areas.
                                Isolate the area.
                                Keep away from open flames, hot surfaces and sources of ignition.
                                Personal protection through wearing a tightly closed chemical protection suit and a self-contained breathing apparatus.


Environmental precautions: Should not be released into the environment.
                                             Do not flush into surface water or sanitary sewer system.
                                             Mark the contaminated area with signs and prevent access to unauthorized personnel.
                                             Evacuate danger area.
                                             Immediately notify the person in charge.


Methods and material for containment and cleaning up


In case of dispersion of the substance, mark off the contaminated zone. Immediately notify the person in charge.
Use disposable towels moistened with an appropriate cleaning agent to complete cleaning process.
All waste must be placed in double, properly labeled, sealable waste disposal bags.
This material and its container must be disposed of as hazardous waste.

Handling and storage

Precautions for safe handling
Advice on safe handling: Plan first aid action before beginning work with this product.
                                    Clean work surfaces at the end of each day. Work only in a designated area, handle on easily cleanable, non-porous,
smooth surfaces.
                                    Ensure all equipment is electrically grounded before beginning transfer operations.
                                    To avoid thermal decomposition, do not overheat.
                                    Use personal protective equipment as required.
                                    Keep away from heat and sources of ignition.
                                    Avoid inhalation, ingestion and contact with skin and eyes.
                                    Avoid formation of dust and aerosols.


Advice on protection against fire and explosion: Avoid dust formation.


Hygiene measures: Handle in accordance with good industrial hygiene and safety practice.


Conditions for safe storage, including any incompatibilities


Requirements for storage areas and containers: To maintain product quality, do not store in heat or direct
sunlight. Store in original container. Store at room temperature. Store and transport in double, properly labeled,
sealed bags, contained within rigid drums or appropriate closed containers in a manner that minimizes the potential of spillage or container damage. Primary containers shall be overpacked into sealed unbreakable packaging. Contamination of the exterior of the primary container should be avoided. Sealed primary containers shall be handled only with clean gloves. Keep containers tightly closed in a dry, cool and well-ventilated place.


Recommended storage temperature: 15 - 25 °C


Specific use(s): Consult the technical guidelines for the use of this substance/mixture.

Transport information

Land transport (UN RTDG/ADR/RID)

UN number:
UN 2811
Shipping information
Proper shipping name and description:
TOXIC SOLID, ORGANIC, N.O.S.

Chemical name:
LAZERTINIB
Class or division:
Class 6: Toxic and infectious substances; Division 6.1
Packing group:
Packing group III: Substances presenting low danger
Labels:
6.1
Special provisions / remarks
Special provisions:
Packing group : III
Classification Code : T2
Hazard Identification Number : 60
Labels : 6.1
Tunnel restriction code : (E)
Remarks:
This substance can be shipped under 'de minimi's quantities' provisions if the net quantity per inner package <= 1mL for liquids or <= 1g for solids and the net quantity per outer package does not exceed 100mL for liquids or 100g for solids and provided packaging provisions of ADR/RID/ADN/IMDG §3.5.1.4 are met.

Inland waterway transport (UN RTDG/ADN(R))

UN number:
UN 2811
Shipping information
Proper shipping name and description:
TOXIC SOLID, ORGANIC, N.O.S.
Chemical name:
LAZERTINIB
Class or division:
Class 6: Toxic and infectious substances; Division 6.1
Packing group:
Packing group III: Substances presenting low danger
Labels:
6.1
Special provisions / remarks
Special provisions:
Packing group : III
Classification Code : T2
Hazard Identification Number : 60
Labels : 6.1
Remarks:
This substance can be shipped under 'de minimi's quantities' provisions if the net quantity per inner package <= 1mL for liquids or <= 1g for solids and the net quantity per outer package does not exceed 100mL for liquids or 100g for solids and provided packaging provisions of ADR/RID/ADN/IMDG §3.5.1.4 are met.

Marine transport (UN RTDG/IMDG)

UN number:
UN 2811
Shipping information
Proper shipping name and description:
TOXIC SOLID, ORGANIC, N.O.S.
Chemical name:
LAZERTINIB
Class or division:
Class 6: Toxic and infectious substances; Division 6.1
Packing group:
Packing group III: Substances presenting low danger
EmS code:
F-A
S-A
Labels:
6.1
Special provisions / remarks
Special provisions:
Packing group : III
Labels : 6.1
EmS Code : F-A, S-A
Remarks:
This substance can be shipped under 'de minimi's quantities' provisions if the net quantity per inner package <= 1mL for liquids or <= 1g for solids and the net quantity per outer package does not exceed 100mL for liquids or 100g for solids and provided packaging provisions of ADR/RID/ADN/IMDG §3.5.1.4 are met.

Air transport (UN RTDG/ICAO/IATA)

UN number:
UN 2811
Shipping information
Proper shipping name and description:
Toxic solid, organic, n.o.s
Chemical name:
LAZERTINIB
Class or division:
Class 6: Toxic and infectious substances; Division 6.1
Packing group:
Packing group III: Substances presenting low danger
Labels:
6.1
Special provisions / remarks
Special provisions:
Packing instruction (cargo aircraft): 677
Packing instruction (passenger aircraft): 670
Packing instruction (LQ) : Y645
Packing instruction (EQ) : E1
Packing group : III
Labels : 6.1
Remarks:
This substance can be shipped under 'de minimi's quantities' provisions if the net quantity per inner package <= 1mL for liquids or <= 1g for solids and the net quantity per outer package does not exceed 100mL for liquids or 100g for solids and provided packaging provisions of IATA DGR §2.6.10 are met.
SpecialProvisionsopen allclose all

Exposure controls / personal protection

Engineering measures
Engineering controls should be used as the primary means to control possible exposures. Use process enclosures, local exhaust ventilation or other engineering controls to keep exposure levels below recommended exposure limits.
All personal protective equipment should be based on a risk assessment. Consult an Environment and Health Safety expert if necessary.


Personal protective equipment


Eye protection: Safety glasses with side-shields Hand protection


Material: Nitrile rubber


Remarks : Impervious gloves Take note of the information given by the producer concerning permeability and break through times, and of special workplace conditions (mechanical strain, duration of contact).


Skin and body protection: closed work clothing disposable one-piece overall
Respiratory protection: Engineering controls should always be the primary method of controlling exposures.
If respiratory protective equipment is needed for certain activities, the type, as well as the corresponding protection factor, will depend upon the risk assessment and air concentrations, hazards, physical and warning properties of substances present.
Use only respiratory protection that conforms to international/ national standards.
Suitable mask with particle filter P3


Protective measures: The type of protective equipment must be selected according to the concentration and amount of the dangerous substance
at the specific workplace.

Stability and reactivity

Reactivity: None reasonably foreseeable.


Chemical stability: Stable under recommended storage conditions.


Possibility of hazardous reactions: Risk of dust explosion.


Conditions to avoid: To avoid thermal decomposition, do not overheat. Heat, flames and sparks.


Materials to avoid : Oxidizing agents


Hazardous decomposition products: Carbon oxides, Nitrogen oxides (NOx)

Disposal considerations

Waste treatment methods
Product : In accordance with National, Federal, State and Local regulations.
Must be incinerated in a suitable incineration plant holding a permit delivered by the competent authorities.


Contaminated packaging : Empty containers should be taken to an approved waste handling site for recycling or disposal.