Registration Dossier

Diss Factsheets

Administrative data

First-aid measures

General advices: Remove contaminated clothes. In case of unconsciousness move the person on his side to fresh air in a stable position. First aiders must take care first of all of their self-protection

In case of Inhalation: Move the affected person from the area and make it stretch, if breathing is difficult, give oxygen, if breathing is absent use mechanical ventilation. Consult a physician in symptoms appear.

In case of Ingestion: Do not induce vomiting unless on the advice of medical personnel, in case of vomiting tilt the patient forward or put it on the side with head facing down to keep the airways open and prevent aspiration. Don’t give anything by mouth to people who give signs of drowsiness or numbness, or who are about to lose consciousness. Consult a physician in symptoms appear.

In case of Skin contact: Remove contaminated clothing and wash thoroughly with water. Consult a physician in symptoms appear.

In case of Eyes contact: Wash immediately with plenty of water for at least 15 minutes taking care to keep the eyelids separated the eye, contact lens should be removed only by experienced personnel. Consult a physician in symptoms appear.

Fire-fighting measures

Extinguishing media: Water spray, foam, dry chemical, carbon dioxide.

Special hazards arising from the substance or mix.: When heated to decomposition or under fire conditions it could be emitted toxic fumes like carbon monoxide or other typical organic combustion products

Advice for firefighters Fire fighters should use self-contained breathing apparatus and protective clothing

Accidental release measures

Small Losses:

Remove any source of ignition, stopping the source of the spillage, avoid contact with skin or inhalation, use PPE (see section 8), clean up immediately using adsorbent materials. Collected material should be placed in proper container, labeled and sent to for final disposal.

Large losses:

Report immediately the incident and remove of unnecessary personnel from the area. Stop the spread and isolate the spilled material; Isolate sewers discharging to superficial waters and/or segregate any water runoff into collection basins or tanks to facilitate processing or disposal.

The personnel involved in containment and cleaning should wear appropriate personal protective equipment to minimize exposure.

The area must be thoroughly cleaned using adsorbent materials. Collected material should be placed in proper container, labeled and sent to for final disposal.

Handling and storage

The substance is a trasported isolated intermediate only used in a synthesis process to produce an Active Pharmaceutical Ingredient (A.P.I.).

See attached file in section 13 for Information on details of the risk management measures applied at the manufacturing/use site a in order to achieve strictly controlled conditions.

Precautions for safe handling: The substance must be handled in ventilated environment or with the appropriate local air extraction;

minimize dust formation and avoid accumulation on surfaces; use antistatic equipment and clothing and prevent dust contact with possible ignition sources; avoid contact with eyes, skin and clothing. Remove contaminated clothes and wash thoroughly after handling.

Conditions for safe storage/incompatibilities: Use container tightly closet and resistant, away from moisture and sunlight. Avoid contact with air and light. Properly label containers in case of pouring and clean external container surfaces with proper detergents and /or solvents.

Transport information

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Marine transport (UN RTDG/IMDG)

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Exposure controls / personal protection

1,5 mg/m3 (8 –hr TWA - Merck Exposure Control Limit)

Protection for airways:

Use protective mask with P2 or P3 type dust filter (EN14387). If the substance is dissolved in organic solvent and manipulated in an open environment in significant quantities use an appropriate filter for chemicals (A type for boiling temperature > 65°C or Ax type for boiling temperature < 65°C) or ABEK type if simultaneous presence of others substances like, inorganic vapors, ammonia, etc

Protection for eyes /face:

Safety glasses goggles (EN 166), face shield or other full-face protection if it is required also airways protection.

Protection for skin /hands:

Use chemical resistant gloves (EN374) with material compatible with solvent in which the substance is dissolved; the actual permeation time through te gloves and their life can be affected by mode of use, temperature and substance quantities handled

Other protection:

In production or packaging plants is recommended full-body suite like Tyvek® type, resistano to penetration by solid particles sprayed (EN ISO 13982-2), low intensity sprays (EN 13034 and EN468) and antistatic (EN 1149).

Technical controls and ventilation

In Production or re-packaging plants: use general ventilation systems, or closed systems to ensure the isolation of the substance from the working personnel. Can be provided additional security according to specific “control band” established for the substance.

Laboratory: no general ventilation required for small quantities, low handling time and while using good laboratory practices. It’s always recommended to use fume cupboard or cabinet.; Can be provided additional security according to specific “control band” established for the substance.

Warning: Substance properties, local substance concentration, quantity handled and conditions of use determine the type of protective equipment needed.

Stability and reactivity

Chemical stability DSC results: a main significant endothermic effect at T=180-200°C (T onset = 192°C), due to the melting point of the product. In general we can consider that our system does not show further thermal effects, and the product may be considered stable until the temperature of 280°C.

Conditions to avoid Material is stable when kept in recommended normal storage conditions, No known chemical incompatibilities.

Disposal considerations

Avoid material contact with round or water (do not dispose in sewer systems). Small quantities can be disposed of with same

laboratory procedures: the product should be stored in closed containers and disposed of preferably by burning. Containers should be

sent to appropriate treatment and final disposal according to local regulations.