Registration Dossier

Administrative data

First-aid measures

4.1. Description of first aid measures
In case of doubt or in the presence of symptoms contact a physician, and show him/her the material safety data sheet. In case of severe symptoms, call your local health care emergency number. Call a poison control center in order to receive toxicological advice for the clinical management of poisoning. Do not administer anything by mouth to an unconscious person.

Inhalation
Move the person to fresh air. In the case of respiratory symptoms (cough, dyspnea) place the person in a semi-seated position and administer oxygen. Provide artificial respiration if the person is not breathing.

Skin contact
Flush the skin with copious amounts of water (and soap, if possible) for at least 15 minutes. Consult a physician if there are symptoms of skin irritation and/or pain.

Eye contact
Remove contact lenses, if present and easy to do. Flush the eyes, kept open, with copious amounts of running water for at least 15 minutes. Consult a physician, especially if there are symptoms of eye irritation and/or pain.

Ingestion
Do not induce emesis. Do not administer anything by mouth unless advised to do so by a poison control center. Rinse the mouth and consult a physician.

4.2. Most important symptoms and effects, both acute and delayed
Most important symptoms and effects, both acute and delayed, are described in the end-point study records.

4.3. Indication of any immediate medical attention and special treatment needed
Need for immediate medical attention
If the victim has severe symptoms, immediately call your local health care emergency number to request the intervention of a physician. Refer to each case a poison control center for advice and medical toxicology specialist from the early stages of the rescue. Consult a physician if in any case any symptoms, even mild, persists.

Special treatment needed and antidotes to be available on the workplace
Freshwater for washing skin and eye. Oxygen. Activated charcoal, to be administered after toxicological advice.

Personal protective equipment for first aid responders
Wear appropriate protective equipment to prevent the contamination of the first aid responder from the victim.

Removal and handling of contaminated clothing and shoes
In case of gross contamination, remove clothing and shoes. Place them into a suitable, closed, temporary storage away from the working area.

Fire-fighting measures

5.1. Extinguishing media
SUITABLE EXTINGUISHING MEDIA
No special extinguishing media is advisable for this substance. Use the standard extinguishing media. In the choice of extinguishing media, consider the other materials involved in the fire.

EXTINGUISHING MEDIA WHICH SHALL NOT BE USED FOR SAFETY REASONS
None.

5.2. Special hazards arising from the substance or mixture
EXPOSURE HAZARDS ARISING FROM THE SUBSTANCE ITSELF, COMBUSTION PRODUCTS, RESULTING GASES
In the case of fire, irritant or toxic fumes may develop from the substance and from the other materials involved in the fire.

HAZARDOUS COMBUSTION PRODUCTS: carbon oxides (COx), nitrogen oxides (NOx).

5.3. Advice for firefighters
GENERAL INFORMATION
Move all people away and stay upwind of the fire. Do not enter closed rooms without adequate protection. Use jets of water to cool the containers to prevent product decomposition and the development of substances potentially hazardous for health. Always wear full fire prevention gear. Collect extinguishing water to prevent it from draining into the sewer system. Dispose of contaminated water used for extinction and the remains of the fire according to applicable regulations.

SPECIAL PROTECTIVE EQUIPMENT FOR FIRE-FIGHTERS
Hardhat with visor, fireproof clothing (fireproof jacket and trousers with straps around arms, legs and waist), work gloves (fireproof, cut proof and dielectric), a depressurized mask with facemask covering the whole of the operator`s face or a self-respirator (self-protector) in the event of large quantities of fume.

Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures

6.1.1. For non-emergency personnel
(a) eliminate sources of ignition (cigarettes, flames, sparks, etc.) from the area in which the leak occurred;
(b) send away individuals who are not suitably equipped.

6.1.2. For emergency responders
(a) do not handle damaged containers or leaked product before donning appropriate protective gear (Section 8 of the safety data
sheet) to prevent any contamination of skin, eyes and personal clothing;
(c) if there are no contraindications, spray powder with water to prevent the formation of dust and provide sufficient ventilation.

6.2. Environmental precautions
The product must not penetrate the sewer system, surface water, ground water and neighboring areas.

6.3. Methods and material for containment and cleaning up

6.3.1. Appropriate advice on how to contain a spill
(a) make sure the leakage site is well aired.

6.3.2. Appropriate advice on how to clean up a spill
(a) use spark proof mechanical tools to collect the leaked product and place in a plastic container;
(b) if there are no contraindications, use jets of water to eliminate product residues.

6.3.3. Any other information relating to spills and releases,including advice on inappropriate containment or clean up techniques
(a) contaminated material should be disposed of in compliance with the national provisions.

Handling and storage

7.1. Precautions for safe handling

7.1.1. Protective measure
Measures to prevent fire
(a) eliminate sources of ignition (cigarettes, flames, sparks, etc.);
(b) wear antistatic cloths and shoes when handling this substance;
(c) use antistatic primary packagings;
(d) avoid shaking the powder or creating dust clouds;
(e) ground and bound equipment; work as much as possible with inertization systems to avoid the formation of potentially explosive atmospheres;
(f) use spark proof mechanical tools to collect the leaked product.

Measures to prevent aerosol and dust generation
(a) avoid shaking packagings when filling/empting them;
(b) keep containers tightly sealed when not in use.

Measures to protect the environment
(a) general ventilation;
(b) LEV;
(c) filters or water scrubbers on exhaust ventilation.

7.1.2. Advice on general occupational hygiene
(a) not to eat, drink and smoke in work areas;
(b) to wash hands after use;
(c) to remove contaminated clothing and protective equipment before entering eating areas.

7.2. Conditions for safe storage, including any incompatibilities

Technical measures and storage conditions
Store away from oxidizing agents and strong alkalies.
The substance should be stored in a manner to prevent degradation, contamination, and cross-contamination, keeping material in properly labeled tightly closed containers.
The substance stored in fiber drums should be stored off the floor and suitably spaced to permit cleaning and inspection.

Packaging materials
Single antistatic polythene bag inside an aluminium bag (inner packaging); fiber (outer packaging).

Requirements for storage rooms and vessels
There should not be present sources of ignition (cigarettes, flames, sparks, etc.).

7.3. Specific end use(s)
The substance is an Active Pharmaceutical Ingredient whose use is under relevant regulations and specific guidelines (such as EudraLex Volume 4 "The rules governing medicinal products in the European Union" containing guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use) of the pharmaceuticals industrial sector.

Transport information

Land transport (ADR/RID)

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Inland waterway transport (ADN(R))

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Marine transport (IMDG)

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Air transport ICAO/IATA

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Exposure controls / personal protection

Exposure controls

Appropriate engineering controls
Charge/discharge equipments under nitrogen purging, using local exhaust ventilation next to equipments openings, proper ventilation and conveying emissions to abatement systems.

Individual protection measures, such as personal protective equipment

(a) Eye/face protection: full mask.
(b) Skin protection
(i) Hand protection: natural rubber gloves.
(ii) Other: professional disposable overall with hood for use with chemicals.
(c) Respiratory protection: full mask with P3 filter.

These protection measures are aimed to prevent:
- negative effects on health of the personnel handling this substance due to both health hazards of the substance and its pharmacological activity;
- contamination of the substance due to biological material (such as, hair, skin cells, droplets of saliva, etc.) from the human body.

Stability and reactivity

These information refer to the mixture in its original formulation; any change during its use depends on actual process and/or plant.

10.1. Reactivity
There are no particular risks of reaction with other substances in normal conditions of use.

10.2. Chemical stability
The susbstance is stable in normal condition of use.

10.3. Possibility of hazardous reactions
Airborne particles may fuel fires/explosion in presence of source of ignition.

10.4. Conditions to avoid
As a precautionary measure, avoid dust generation and keep away from source of ignition like heat sources or electrostatic discharges.

10.5. Incompatible materials
Keep away from oxidizing agents and strong alkalies.

10.6. Hazardous decomposition products
In the event of thermal decomposition or fire, vapours potentially dangerous to health may be released.

Possible combustion products: carbon oxides (COx), nitrogen oxides (NOx).

Disposal considerations

13.1. Waste treatment methods

13.1 Waste treatment methods
Incineration (product).
Reuse, when possible, the packagings for other purposes.

13.1.1 Product / Packaging disposal:
Product residues should be considered special hazardous waste. Disposal must be performed through an authorized waste management firm, in compliance with national and local regulations. Contaminated packaging must be recovered or disposed of in compliance with national waste management regulations.

13.1.2 Waste treatment-relevant information:
The hazard level of waste containing this product should be evaluated according to applicable regulations.

13.1.3 Sewage disposal-relevant information:
Waste should not be disposed of by release to sewers.

13.1.4 Other disposal recommendations:
To ensure that risks are adequately controlled at the waste stage, disposal must be in accordance with current applicable laws and regulations and material characteristics at the time of disposal. Final decisions on the appropriate waste management method, in line
with regional, national and European legislation, and possible adaptation to local conditions, remains the responsibility of the waste treatment operator.