Registration Dossier

Administrative data

First-aid measures

INHALATION
Immediately move exposed subject to fresh air. If not breathing, give artificial respiration (AR). If breathing is labored, administer oxygen. Immediately notify medical personnel and supervisor.

SKIN CONTACT
Remove contaminated clothing/shoes. Wash exposed skin with soap and water. If irritation occurs or persists, notify medical personnel and supervisor.

MOST IMPORTANT SYMPTOMS AND EFFECTS, BOTH ACUTE AND DELAYED
As a pharmaceutical intermediate, the toxicity and potency of this substance are not fully known. Skin rash, gastrointestinal inflammation, pneumonia, hematological abnormalities and increased liver enzymes have been associated with clinical use of final product/API and may not be excluded for this intermediate/substance.

INDICATION OF ANY IMMEDIATE MEDICAL ATTENTION AND SPECIAL TREATMENT NEEDED
Treat symptomatically and supportively. If accidental exposure occurs to an individual who is also taking one or more concomitant medications, consult the respective package or prescribing information for potential drug interactions.


EYE CONTACT
If easy to do, remove contact lenses if worn. Immediately flush eyes with copious quantities of water for at least 15 minutes, occasionally lifting the upper and lower eyelids. Notify medical attention and supervisor if irritation occurs or persists.

INGESTION
If swallowed, call a physician immediately. Do not induce vomiting unless directed by medical personnel. Do not give anything to drink unless directed by medical personnel. Never give anything by mouth to an unconscious person. Notify medical personnel and supervisor.

Fire-fighting measures

EXTINGUISHING MEDIA
• Suitable extinguishing media:
Use water spray, foam, dry powder or carbon dioxide as appropriate for surrounding fire and materials.
• Unsuitable extinguishing media:
No limitations given for this substance.

SPECIAL HAZARDS ARISING FROM THE SUBSTANCE OR MIXTURE
Combustible, but not flammable. In case of fire toxic fumes of nitrogen oxides (NOx), carbon monoxide (CO), fluorine-containing compounds and other unidentified gases and fumes.

No explosivity or flammability data identified. High concentrations of finely divided airborne organic particles can potentially explode if ignited.

ADVICE FOR FIREFIGHTERS
In case of fire in the surroundings: use the appropriate extinguishing agent. Wear full protective clothing and an approved, positive pressure, self-contained breathing apparatus. Decontaminate all equipment after use.

Accidental release measures

PERSONAL PRECAUTIONS, PROTECTIVE EQUIPMENT AND EMERGENCY PROCEDURES
If product is released or spilled, take proper precautions to minimize exposure by using appropriate personal protective equipment (see Section Exposure controls/personal protection). Area should be adequately ventilated.

ENVIRONMENTAL PRECAUTIONS
Do not let the substance enter into drains. Avoid release to the environment.

METHODS AND MATERIAL FOR CONTAINMENT AND CLEANING UP
For small spills (such as in a laboratory), soak up material with absorbent, e.g. damp paper towel, and wash spill area thoroughly with soap and water. For large spills in manufacturing, use an industrial vacuum cleaner equipped with a high efficiency particulate (HEPA) filter if available. Alternatively if in solid or dried form, do not raise dust by utilizing wet clean-up methods. Surround spill or powder with absorbents and place a damp cloth or towel over the area to minimize powder from entering the air. Add excess liquid to allow for the material to enter solution. Capture remaining liquid onto spill absorbents. Place spill materials into a leak-proof container suitable for disposal. Dispose material in a manner that is compliant with national, federal, state and local laws.

Handling and storage

PRECAUTIONS FOR SAFE HANDLING
Follow recommendations for handling pharmaceutical agents (i.e. use of engineering controls and/or other personal protective equipment if needed). Minimize dust generation and accumulation. Avoid breathing dust. Wash thoroughly after handling.

CONDITIONS FOR SAFE STORAGE, INCLUDING ANY INCOMPATIBILITIES
Store ambient in a closed container.

Transport information

Land transport (ADR/RID)

UN number:
Not classified as dangerous goods according to transport regulations.
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Marine transport (IMDG)

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Air transport ICAO/IATA

Remarks
Not classified as dangerous goods according to transport regulations.
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Exposure controls / personal protection

CONTROL PARAMETERS
To the best of our knowledge, established occupational exposure limit value is not available.

EXPOSURE CONTROL

Appropriate engineering controls:

The substance is considered to be a Category 2 of 4 (OEL 10- 500 microgram/m3, intermediate toxicity) compound based on its chemical structure, toxicological assessment and use as an intermediate. The objective containment, controls and work practices should be to contain worker breathing zone concentrations to below OEL for each task or operation. In general, Category 2 handling practices, some of which are described in general in this Section, are capable of achieving the OEL. However, verification of the acceptability of these Category 2 recommended containment, controls and work practices to meet the OEL through industrial hygiene monitoring of tasks or operations is recommended.

Selection and use of containment devices and personal protective equipment should be based on a risk assessment of exposure potential. Use local exhaust and/or enclosure at dust-generating points. Emphasis is to be placed on closed material transfer systems and process containment, with limited open handling of powders. High-energy operations such as milling, particle sizing, spraying or fluidizing should be done within an approved emission control or containment system.

Personal protective equipment

Eye face protection: Wear safety glasses with side shields, chemical splash goggles, or full face shield if necessary. Base the choice of protection on the job activity and potential for contact with eyes or face. An emergency eye wash station should be available.

Skin protection: ear appropriate gloves, lab coat, or other protective overgarment if skin contact is likely. Base the choice of skin protection on the job activity, potential for skin contact and solvents and reagents in use.

Protective clothinf: Use impervious clothing to prevent skin contact. The type should be selected according to concentrations, quantities and duration of handling at the specific workplace.

Respiratory protection: Choice of respiratory protection should be appropriate to the task and level of existing engineering controls. For routine powder handling of quantities of powder equal to or less than 100 grams (total weight transferred or handled), an approved and properly worn and properly fitted air-purifying respirator with HEPA filters should provide ancillary protection based on the known or foreseeable limitations of existing engineering controls. Use a powered, air-purifying respirator (PAPR) or a positive-pressure air-supplied respirator for quantities of powder exceeding 100 grams or for smaller quantities if there is any potential for an uncontrolled release, when exposure levels are not known, or in any other circumstances where air purifying respirators may not provide adequate protection. A powered, air-purifying respirator (PAPR) is to be equipped with HEPA filters or combination filters. The assigned protection factor (APF) of selected PAPR should be at least 1000. Use fume hoods or laminar flow booth in laboratory scale.

Environmental exposure controls: Avoid release to the environment and operate within closed systems wherever practical. Air and liquid emissions should be directed to appropriate pollution control devices. In case of spill, do not release to drains. Implement appropriate and effective emergency response procedures to prevent release or spread of contamination and to prevent inadvertent contact by personnel.

Other protective measures: Wash hands in the event of contact with this substance, especially before eating, drinking and smoking. Protective equipment is not to be worn outside the work area (e.g. in common areas or out-of-doors). Decontaminate all protective equipment following use.

Stability and reactivity

REACTIVITY
No known reactivity hazards under normal conditions.

CHEMICAL STABILITY
The substance is chemically stable at standard room temperature conditions, generally 15 to 25°C.

POSSIBILITY OF HAZARDOUS REACTIONS AND CONDITIONS TO AVOID
Not expected to occur.

INCOMPATIBLE MATERIALS
No information available.

HAZARDOUS DECOMPOSITION PRODUCTS
Carbon monoxide (CO), nitrogen oxides (NOx), fluorine-containing compounds and other unidentified toxic substances.

Disposal considerations

WASTE TREATMENT METHODS
Used product should be disposed according to local, state, federal and national regulations. Do not send down the drain. All wastes containing the material should be properly labeled. Dispose of wastes in accordance to prescribed national, federal, state and local guidelines, e.g. appropriately permitted chemical waste incinerator. Rinse waters resulting from spill cleanups should be discharged in an environmentally safe manner, e.g. appropriately permitted municipal or on-site wastewater treatment facility.

INFORMATION ON RECYCLING AND METHODS OF DISPOSAL FOR INDUSTRY
Avoid dust generation and inhalation of dust. Avoid contact with eyes, skin and other mucous membranes. Do not ingest. Wear all recommended personal protective equipment. Wash thoroughly after handling. Dispose waste at authorized plant, in accordance with applicable national, federal, state or local legislation. Disposal could be sent for external waste handling company for incineration. Do not empty into drains or water courses.