Registration Dossier

Diss Factsheets

Administrative data

First-aid measures

Eye Contact:
Immediately flush eyes with copious amounts of water for at least 15 minutes. If irritation persists, seek medical attention.

Skin Contact:
After contact with skin, wash immediately with plenty of water. Gently and thoroughly wash the contaminated skin with running water and non-abrasive soap. Be particularly
careful to clean folds, crevices, creases and groin. Cover the irritated skin with an emollient. If irritation persists, seek medical attention. Wash contaminated clothing before
reusing.

Inhalation:
Allow the victim to rest in a well ventilated area. Evacuate the victim to a safe area as soon as possible. Loosen tight clothing such as a collar, tie, belt or waistband. If
breathing is difficult, administer oxygen. If the victim is not breathing, perform mouth-to-mouth resuscitation. In severe cases or if symptoms persists, seek medical attention.

Ingestion:
Do not induce vomiting. Loosen tight clothing such as a collar, tie, belt or waistband. If the victim is not breathing, perform mouth-to-mouth resuscitation. If symptoms appears,
seek immediate medical attention

Fire-fighting measures

Extinguishing media:
In case of fire use water, chemical type foam, carbon dioxide, dry chemical. Prevent run off of water from entering drains

Hazardous combustion products:
The substance evolves toxic fumes due to the presence of CO, CO2, NOx, HCl.

Fire-fighting equipment:
Respiratory and eye protection for fire-fighting personnel

Accidental release measures

Person-related safety precautions:
- Wear protective equipment
- Keep unprotected persons away

Measures for cleaning / collecting:
- Damp down to avoid dust generation
- Do not allow to enter public sewers and watercourses
- Sweep or shovel-up spillage and remove to a safe place
- Absorb spillage in earth or sand

Handling and storage

- This product should be handled only by, or under the close supervision of, those properly qualified in the handling and use of potentially hazardous chemicals, who should
take into account the fire, health and chemical hazard data given on this dossier.
- It should always be handled in an efficient fume hood or equivalent system and, if necessary, wear protective equipment.
- Care should be taken to prevent the chemical from coming into contact with the skin or eyes and from contaminating personal clothing.
- Keep in unopened containers in a cool, dry and well ventilated place.
- This material should be handled and stored per label instructions to ensure product integrity.
- Avoid contact with oxidising substances

Transport information

Land transport (UN RTDG/ADR/RID)

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

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Marine transport (UN RTDG/IMDG)

UN number:
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Air transport (UN RTDG/ICAO/IATA)

UN number:
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Exposure controls / personal protection

regularly by Italian Ministry of Health and FDA of USA. The controlled conditions
are required also by Good Manufacturing Practices to minimize cross contamination.

Sampling procedure: in vented cabinets and Hepa-filters (controlled area)

Dispensing: in vented cabinets and Hepa-filters (controlled area)

Charging of materials:
Liquids: from tank farm, by means of pump and pipe (closed system), from drums: by
vacuum transfer
Solids: through manhole, with aspiration inside vessel and local aspiration around
manhole

Reactions: all in closed system

Discharge of materials: Liquids: by closed system
Solids: bulk containers for intermediate
Liquid wastes: by closed system to a tanks for external disposal

Control of emissions:
From reaction equipments: collected by pipes to a waste gas incinerator
From the working environment: collected by pipes to a wet scrubber treatment

Environmental monitoring of working area: performed by external and approved firm

Training of personnel:
Periodical and repeated course for safe handling of materials and equipment, GMP
procedure, emergency procedure.
The personnel have access to MDS of row materials, intermediates and finished
products. Only properly trained and authorized personnel handle the substance.

Health management:
the company strictly applies the legislation in force procedural and control technologies
shall be used that minimize emission and any resulting exposure;
only properly trained and authorized personnel handle the substance;
in the case of cleaning and maintenance works, special procedures such as purging and
washing are applied before the system is opened and entered;
in cases of accident and where waste is generated, procedural and/or control technologies
are used to minimize emissions and the resulting exposure during purification or cleaning
and maintenance procedures;
substance-handling procedures are well documented and strictly supervised by the site
operator.

Waste gas incineration:
complete destruction of waste gases at high temperatures for a specified minimum residence time, as calculated by an engineer .
Condenser – low temperature devices through which waste vapours are sent causing
them to liquefy and be collected.
Scrubber – number of types available. Usually packed columns around which an
appropriate scrubbing solution circulates, as specified by an engineer. The waste
vapours from a process and/or area are passed through the scrubber causing the fumes
to be trapped in the scrubbing solution. The waste scrubber solution is then disposed for waste water treatment.

Stability and reactivity

Hazardous polimerization not occurs
Conditions to avoid heat, flames and sparks
Incompatible materials strong oxidising agents
Stability the product is stable at room temperature and in usual working conditions
Hazardous decomposition products the substance evolves toxic fumes due to the presence of CO, CO2, NOx, SOx.

Disposal considerations

Product wastes Do not empty into drains. Use appropriate containment to avoid environmental contamination. Disposal should be in accordance with local, state or national regulation
Wasted containers / drums Wastes have to be disposed in a site approved for chemical and hazardous waste or burned in a specialised burning centre