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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 426-370-7 | CAS number: 1017183-70-8
Guidance on Safe Use
Administrative data
First-aid measures
Emergency measure - Inhalation: Remove to fresh air. Promptly ask for physician.
Emergency measure - Eyes: Immediately flush eyes with copious amounts of water for at least 15 minutes. Promptly ask for physician.
Emergency measure - Skin: Remove any contaminated clothes. Immediately wash skin with soap and copiuous amounts of water. Treat scars as burning.
Promptly ask for physician.
Emergency measure - Ingestion: Not induce vomiting. Give water or milk. Promptly ask for physician
Fire-fighting measures
Recommended extinguishing agent: CO2, extinguisher powders.
Product arising from burning: COx, HCl, phosgene.
Protective equipment: Suitable protective wear and self-breathing apparatus.
Accidental release measures
Emergency measures in case of spillage: Wear self-contained breathing apparatus, rubber/PVC boots and heavy rubber/PVC gloves.
Absorb on sodium bicarbonate and sand or other inert material.
Sweep up, place in a drum, hold sealed for waste disposal in incinerator with post-combustion chamber. Ventilate area and wash spill sita with water and soap after material pick-up is completed.
Handling and storage
The SOLE 3 is used as intermediate for pharmaceutical products under strictly controlled conditions.
The plant is certified ISO14000, is conform to cGMP practice and is member of responsible care program.
Handling: Quality control procedures on incoming raw materials.
Storage: Warehouse controls and procedures.
Charging /loading of intermediate to chemical reaction vessel by using vacuum on the reaction vessel. Workers use specific PPE defined in the batch record.
All reaction sealed and operating in a closed state with venting in accordance with IPPC permit. Regular checks on equipment. Preventive maintenance to detect and repair leaks.
Routine operations:
Process design and equipment drawings.
Risk assessment in advance of the production.
Manufacturing batch sheet.
Emergency response procedure in place.
Non routines and maintenance operation
Permit to work with job hazard analysis.
Ongoing assurance
Inspections and audits
Exposure measurement .
Incident investigation reported in site management system and investigated by site personnel.
Sampling: the sampling is done in accordance with the control procedure and in accordance with the cGMP rules. The samples are brought in a closed bottle to the quality control for analysis. The specific PPE is definied by the risk assessment done this process.
SDS are available for the people in charge of sampling and for the people in charge of the analysis.
Maintenance: Purging, flushing venting procedure to prepare the equipment for intrusive maintenance. Permit to work with risk assessment.
Maintenance with Confined atmosphere: Control of the atmosphere, Mechanical and electrical blocking, specific procedure.
Cleaning: Cleaning procedure in place in accordance with cGMP rules. Cleaning by solvent and water in closed equipment. Analytical control to be sure that the cleaning is sufficient.
Transport information
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Marine transport (UN RTDG/IMDG)
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Exposure controls / personal protection
Plant personnel are trained in the process and the hazards of substance involved.
Only competent operators are authorized to operate the plant.
Personal protective equipment: chemical safety goggles, rubber/PVC gloves, acid vapours respirator or self-breathing apparatus.
Stability and reactivity
Danger other than fire: Reaction with oxidizing agents.
Chemical reaction with water: The substance reacts immediately and vigorously with water releasing HCl fumes.
Disposal considerations
All reactions systems vented to specific emission points in accordance with IPPC permit conditions. Emission control is based on techniques like BREF or BAT.
Most of the air emission point are collected and treated in a scrubber containing a caustic soda solution.
The solution of caustic will destroy the sole 3.
The point not treated is the vent from the vacuum pump.
The pump used is a water pump and the sole 3 will be decomposed by the water.
The emission of sole 3 is not expected on this point.
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.
