Registration Dossier

Administrative data

First-aid measures

- General advice: In the case of accident: Contact a doctor or casualty department – take the label or the safety data sheet. Contact a doctor if in doubt about the injured person’s condition or if the symptoms persist. Never give an unconscious person water or other drink.
- Following inhalation: Bring the person into fresh air and stay with him/her.
- Following skin contact: Remove contaminated clothing and shoes immediately. Ensure to wash exposed skin thoroughly with soap and water. Skin cleanser can be used. DO NOT use solvents or thinners.
- Following eye contact: Remove contact lenses. Flush eyes immediately with plenty of water or isotonic water (20-30°C) for at least 15 minutes and continue until irritation stops. Make sure to flush under the upper and lower eyelids. If irritation continues, contact a doctor. Continue flushing during transport.
- Following ingestion: Provide plenty of water for the person to drink and stay with him/her. In case of malaise, seek medical advice immediately and bring the safety data sheet or label from the product. Do not induce vomiting, unless recommended by the doctor. Have the victim lean forward with head down to avoid inhalation of- or choking on vomited material.
- Most important symptoms and effects: Irritation effects: This product contains substances, which may cause irritation upon exposure to skin, eyes or lungs. Exposure may result in an increased absorption potential of other hazardous substances at the area of exposure.

If eye irritation persists: Get medical advice/attention. Bring the safety data sheet.

Fire-fighting measures

- Suitable extinguishing media: Recommended: alcohol-resistant foam, carbonic acid, powder, water mist.
- Unsuitable extinguishing media: Waterjets should not be used, since they can spread the fire
- Special hazards arising from the substance or mixture: If the product is exposed to high temperatures, e.g. in the event of fire, dangerous catabolic substances are produced. These are: Nitrogen oxides. Carbon oxides. Fire will result in dense black smoke. Exposure to combustion products may harm your health. Fire fighters should wear appropriate protection equipment. Closed containers, which are exposed to fire, should be cooled with water. Do not allow fire-extinguishing water to enter the sewage system and nearby surface waters.
- Advice for fire fighter: Wear self-contained breathing apparatus and protective clothing to prevent contact. Upon direct exposure contact The National Poisons Information Service (dial 111, 24 h service) in order to obtain further advice.

Accidental release measures

- Personal precautions, Protective equipment and emergency procedures: Operators and technicians are periodically trained and certified to respond to emergencies, including to react in case of accidents and incidents resulting in unexpected releases of the substance in order to minimize risks of exposures to humans and the environment.
- Environmental precautions: In the event of accidental spill, spills are collected and kept in closed containers/bags and destructed by incineration.
- Methods and material for containment and cleaning up: Collect spills carefully. Moist the material with water in order to prevent the formation and propagation of dust. To the extent possible cleaning is performed with normal cleaning agents. Avoid use of solvents.

See attached SDS section on “Disposal considerations” in regard of handling of waste.
See attached SDS section on 'Exposure controls/personal protection' for protective measures.

Handling and storage

- Precautions for safe handling: Smoking, storage of tobacco, consumption and storage of food or liquids are not allowed in the workrooms. .
The substance is received in plastic containers in closed bags sealed with strips. Sealing are controlled at arrival at Novo Nordisk A/S. The substance is kept closed and in original bags.
Special procedures applied before cleaning and maintenance:
Personnel are trained, tested and supervised. Procedures are documented in a quality management system for pharmaceutical production (cGMP).
Permit-to-work is required to initiate maintenance activities. Permit are granted only to trained and authorised personnel equipped with specified PPE.
See SDS section on 'Exposure controls/personal protection' for information on personal protection.
- Conditions for safe storage, including any incompatibilities: Sensitive to air. Store at -20°C (+/-5°C).
Always store in containers of the same material as the original container. Containers that have been opened must be carefully resealed and kept upright to prevent leakage.

Transport information

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Marine transport (UN RTDG/IMDG)

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Additional transport information

Additional information
Special provisions / remarks / other:
Not dangerous goods according to ADR, IATA and IMDG.

Exposure controls / personal protection

1. Technical protection measures:
Procedural and control technologies used to minimise any emissions/ exposure:
Pressure in the ventilation system is continuously monitored to ensure early detection of loss of integrity and initiate corrective action.
Airborne gas and/or dust concentrations must be kept at a minimum and below current limit values (see above). Provide efficient mechanical ventilation. Ensure emergency eyewash and showers are close by.
Handling of dry substance in large scale (amounts in kilo):
Minimize dust generation. Whenever possible use closed processes when handling dry substance, for example by using a powder weighing hood or equivalent ventilated containment system. If not available, a non-ventilated hood should be used with Local Exhaust Ventilation covering breaches. Use a shield or cover when transferring the substance. If closed handling is not possible use a filtering respirator.
Weighing and loading must be performed in air-flow booth or by the use of local exhaust ventilation (LEV) placed in the vicinity of the process tank and covering the process area. When using LEV, appropriate measures should be implemented as good practice, e.g. the use of filtering respirator.
Handling of dry substance in small scale (amounts in grams):
Minimize dust generation. When handling in the laboratory preferably use fume hood or as a minimum use local exhaust ventilation with a hood. If closed handling is not possible use a filtering respirator.
Handling of substance in solution:
Avoid aerosol-generating processes. Use local exhaust ventilation close to the source and if this is not possible use filtering respirator.
Hygiene measures:
Direct contact with the product should be avoided. In between use of the product and at the end of the working day all potentially exposed areas of the body must be washed thoroughly. Pay special attention to hands, forearms and face.
Measures to avoid environmental exposure:
No specific requirements.
2. Organisational protection measures
3. Hand protection: Nitrile rubber, or other materials, suited for the purpose
4. Feet protection: None specified
5. Body protection: Dedicated work clothing should be worn.
Direct contact with the product should be avoided. In between use of the product and at the end of the working day all potentially exposed areas of the body must be washed thoroughly. Pay special attention to hands, forearms and face.
6. Eye protection: Wear safety glasses with side shields
7. Respiratory protection: Use suitable protective breathing equipment, if the ventilation is not sufficient. The choice depends on the specific work situation. At oxygen deficient atmospheres or usage more than 3 hours (turbofilter excluded) self-contained respirator must be used: Using mask with filter, use filter type SL. P3 . White
Use respirator at dust producing work.

Generally: Use only CE marked protective equipment.
Normal operation:
Use PPE as a good practice to minimise possible exposures from minor accidental leaks during loading and unloading the reaction vessel, even though rigorous containment is ensured through technical means; Ensure procedures are in place for disposal or cleaning of contaminated PPE, as appropriate.
Maintenance:
Special PPE specified in permit to work system. To enter the system full respirator is required and full body protection.
Accident and incidents:
PPE as specified in emergency procedures and training are required in case of accidents and incidents. PPE include respirator, gloves and chemical-resistant clothing, etc. Procedures are in place for disposal or cleaning of contaminated PPE, as appropriate.

Stability and reactivity

1. Reactivity : No data available.
2. Chemical stability : Shelf life at least 3 years.
3. Possibility of hazardous reactions : Dust can combine with air to form an explosive mixture.
4. Conditions to avoid . None
5. Incompatible materials : Strong acids, strong bases, strong oxidizing agents, and strong reducing agents.
6. Hazardous decomposition products: The product is not degraded when used as specified.

Disposal considerations

Waste treatment methods:
Dispose in accordance with local and national regulations
Exhausted air from handling of powder is filtered and incinerated subsequently.
In production, residual substance is inactivated by acid treatment and further processed. Before cleaning, fractions from flushing of mixing and acylation steps including pipe systems are led to chemical waste and incinerated. Liquids from cleaning in place (CIP) are led to process drain and further to local waste water treatment plant consisting of biological treatment and/or treatment in biogas plant.
Small amounts of substance in laboratories are sent for destruction as chemical waste.
Solid waste from cleaning/spill are kept in closed containers/bags and destructed by incineration. Empty containers are destructed by incineration.
Product is covered by the regulations on hazardous waste.
Waste:
EWC code
Specific labelling:
Not appropiate
Contaminated packing:
Contaminated packaging must be disposed of similarly to the product.