Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 242-500-3 | CAS number: 18683-91-5
Guidance on Safe Use
Administrative data
First-aid measures
If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. CALL A PHYSICIAN IMMEDIATELY.
In case of contact with skin, immediately flush skin with plenty of soap and water for at least 15 minutes while removing contaminated clothing and shoes. Wash clothing before reuse.
Eye Contact: immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper eyelids occasionally. Get medical attention immediately.
Fire-fighting measures
Fire Extinguishing Media: dry chemical, foam or carbon dioxide. Water may be used to flush spills away from exposures and to dilute spills to non-flammable mixtures.
Special Information: in the event of a fire, wear full protective clothing self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. Water spray may be used to keep fire exposed containers cool.
Accidental release measures
Ventilate area of leak or spill. Remove all sources of ignition. Wear appropriate personal protective equipment. Isolate hazard area. Keep unnecessary and unprotected personnel from entering. Contain and recover liquid when possible. Collect liquid in an appropriate container or absorb with an inert material (e. g., vermiculite, dry sand, earth), and place in a chemical waste container. Do not flush to sewer!
Handling and storage
The company produce APIs (Active Pharmaceutical Ingredients) and is inspected regularly by Italian Ministry of Health and FDA of USA. The strictly controlled conditions are required also by Good Manufacturing Practices to minimise cross contamination.
Sampling and dispensing procedure: 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.
Exposure controls / personal protection
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 authorised personnel handle the substance.
Health management: the company strictly applies the legislation in force procedural and control technologies shall be used that minimise emission and any resulting exposure;
only properly trained and authorised 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 minimise 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.
Disposal consideration
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 of by incineration.
Transport information
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Marine transport (UN RTDG/IMDG)
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Exposure controls / personal protection
Stability and reactivity
Disposal considerations
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
