Registration Dossier

Administrative data

First-aid measures

Fire-fighting measures

Accidental release measures

Handling and storage

HANDLING: Avoid breathing vapors. Keep container tightly closed and properly labeled. Do not get in eyes, on skin or clothing. Wear personal protective measures:
- RESPIRATORY: Wear a NIOSH/MSHA approved respirator following manufacturers recommendations, where airborne contaminants may occur.
- EYE/FACE: Wear safety glasses with side shields or chemical safety goggles.
- SKIN: Wear protective clothing to minimize skin contact. Wear chemical resistant gloves such as nitrile.

SPECIAL MIXING AND HANDLING INSTRUCTIONS: Keep container closed except when transferring material. Wash contaminated clothing before reuse. Do not allow contact with materials such as oxidizing agents, alkalis, metals, amines, moisture and alcohols. The substance corrodes steel.

STORAGE: Store in a cool dry area. Prevent entry of atmospheric moisture.

ENGINEERING CONTROLS: Provide good room ventilation plus local exhaust at points of emission and low level floor exhaust in immediate handling area.
Emergency shower and eyewash facility should be in close proximity.

Transport information

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Marine transport (IMDG)

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Exposure controls / personal protection

The substance is an isolated and transported intermediate manufactured outside Europe. The substance is used as intermediate for the synthesis of a dimer substance used for coating of medical devices and high technology applications. The substance is completely converted during the synthesis process.

The following strictly controlled conditions are fulfilled:
(a) The substance is rigorously contained by technical means during its whole lifecycle;
(b) Procedural and control technologies are used to minimize emission and any resulting exposure;
(c) Only properly trained and authorized personnel handle the substance;
(d) Special procedures are applied in the case of cleaning and maintenance works;
(e) Special procedures are applied in cases of accident and where waste is generated
(f) Substance-handling procedures are well documented and strictly supervised by the site operator.

Technical measures and procedures are used to minimize the exposure of humans and the environment during substance lifecycle. Used technical measures and procedures can be summarized as follow:

1. Receipt of the substance and sampling operations:
- The substance is packed in closed containers and it is received in a dedicated area protected by a mobile stand.
- For sampling operations some containers are transferred to a cleanroom classified as class ISO 8 (class 100.000). Strictly controlled conditions are assured by emission control by air conditioning and air filtration equipment. Termobarometric conditions are regulated by aeraulic equipment and by air treatment unit.
- Weigh operations are conducted in the cleanroom under laminar flow containment area by trained operators according to the company Standard Operative Procedure (SOP). Personal protective equipment such as Tyvek® garments, latex gloves, mask and protective gloves are used by operators.
- A sample of 100 cc is collected using single use probes and placed in a closed container. The container is transferred to the laboratory where it is analyzed under extractor hood by trained laboratory technicians. Laboratory technicians use personal protective equipments.

2. Synthesis process:
- Operators wear proper personal protection equipments and are adequately trained about the dangerous properties and the use of chemicals. Substance-handling procedures are known by the operators and are documented in the working procedure sheet
- The substance is transferred in the reactor using transfer pumps. Air emissions are contained by technical means placing an aspiration system plugged on container nozzle. Fumes are washed away by a scrubber.
- The chemical reaction takes place in a closed system under nitrogen. Fumes are contained and washed away by an aqueous alkaline solution in a scrubber.
- The substance is completely consumed after the synthesis. At the end of the reaction, samples are collected through the reactor hatch. Fumes are contained using an aspiration system.
- Samples are collected in close containers and transferred to the laboratory for analysis.

3. Disposal:
- Residual materials are sent to waste water/solvents treatment plants as required by national laws.
- Empty containers are cleaned up and sent to specialized companies for disposal as chemical waste as required by national laws.
- There is no release into the environment of process water and solvents, cleaning water and scrubber water.

Strictly controlled conditions are fulfilled using company Standard Operative Procedures (SOP).

Stability and reactivity

Disposal considerations