Registration Dossier
Registration Dossier
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EC number: 262-075-8 | CAS number: 60142-95-2
Guidance on Safe Use
Guidance on Safe Use
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Administrative data
First-aid measures
Ingestion : if swallowed wash mouth with water provided person if conscious. Get medical advice if adverse symptoms will appear.
Contact with skin : remove contaminated clothes and shoes immediately. Wash affected area with soap or mild detergent and large amount of water until no evidence of substance remains. Get medical advice if adverse symptoms will appear.
Inhalation : avoid breathing dusts that might be generated by handling of the product. Remove the person from the exposed area to fresh air immediately. Get medical advice if adverse symptoms will appear.
Contact with eyes : wash immediately with large amounts of water or normal saline. Keep eyelid open with the finger. Get medical advice if adverse symptoms will appear.
Contact with skin : remove contaminated clothes and shoes immediately. Wash affected area with soap or mild detergent and large amount of water until no evidence of substance remains. Get medical advice if adverse symptoms will appear.
Inhalation : avoid breathing dusts that might be generated by handling of the product. Remove the person from the exposed area to fresh air immediately. Get medical advice if adverse symptoms will appear.
Contact with eyes : wash immediately with large amounts of water or normal saline. Keep eyelid open with the finger. Get medical advice if adverse symptoms will appear.
Fire-fighting measures
Suitable extinguishing means: regular foam, CO2, dry powder, water spray.
Mean of extinguishing NOT to be used: not known.
Known hazards caused by combustion: thermal decomposition or combustion may generate toxic and hazardous fumes (e.g. COx, NOx).
Equipment for self-protection (fire fighters) : self-contained breathing apparatus, flame and chemical resistant clothing, boots and gloves.
Mean of extinguishing NOT to be used: not known.
Known hazards caused by combustion: thermal decomposition or combustion may generate toxic and hazardous fumes (e.g. COx, NOx).
Equipment for self-protection (fire fighters) : self-contained breathing apparatus, flame and chemical resistant clothing, boots and gloves.
Accidental release measures
Personal precautions: suitable protective clothing, gloves and shoes, eye/face protection goggles, mask complete of suitable filter protection.
Environmental precautions: do not let the product enter drainage system, surface and ground-water and soil. Contact local authorities in case of environmental release.
Cleaning procedure to recover spilled material: collect and clean with plenty of water. Send to the storage waiting for disposal procedures.
Environmental precautions: do not let the product enter drainage system, surface and ground-water and soil. Contact local authorities in case of environmental release.
Cleaning procedure to recover spilled material: collect and clean with plenty of water. Send to the storage waiting for disposal procedures.
Handling and storage
1.Description of process steps (in which substance is used) and of production plant
Gabapentin HCl is produced by means of chemical synthesis under controlled conditions of temperature and pressure starting from raw material and adding solvents and reactive agents.
Process conditions are according to quality standards applicable.
Loading of raw material, solvents and reactive agents is performed following working instruction, by trained operators equipped with Personal Protective Equipments (PPE) in controlled conditions.
After the process all in closed line, Gabapentin HCl is downloaded in big-bags following working instructions, by trained operators with PPE under controlled conditions.
2.Description of technical measures to control/minimize environmental emissions
Air emission treatment system are available.
Waste water and liquid waste treatment are transferred in closed system to tanks and shipped to external authorized waste water treatment plant. Disposal is done in accordance with national and local laws.
Solid waste (packaging) are stored in close containers and sent to external authorized disposal facilities, in accordance with law. Personnel in charge of waste handling has been trained and equipped with PPE.
3.Storage at production site: conditions
The material is packed in big bags and stored in a dedicated and closed warehouse, access is limited to authorised personnel.
Sampling is done in a dedicated sampling room with ventilation and appropriate Personal Protective Equipment, as defined by procedures.
4.Cleaning operations of plant equipments and contaminated materials
Methodology of cleaning is defined in specific working instruction and performed only by trained personnel, equipped with Personal Protective Equipment.
5.Waste treatment and disposal
Liquid waste and solvents are sent by close pipes into tanks. They are internally recovered in close tanks and are shipped to authorized external disposal companies. Solid waste (packaging) are stored in containers and sent to external authorized disposal facilities.
Waste handling and storage is performed in order to avoid any possible impact to environment, in compliance with local regulation.
6.Emergency procedures in case of spill and related workers protections
Emergency procedures are detailed in Emergency Plan. Workers are trained on emergency procedures periodically. Spill collection is done by trained operators protected by personal protective equipment as close PVC suit, gas/solid mask and gloves.
7.Risk Management procedures (ex. D.81)
Comprehensive Risk Management System is in place, regulated by internal Standard Operating Procedures composed by following elements.
Risk analysis are performed. Workers safety and environment training program is planned yearly. Standard Operating Procedures on Safety, Health and Ecology are available on site in compliance with local regulation. Audit and inspections program is part of activity. Industrial Hygiene Monitoring and Noise Monitoring program is performed according to local rules and results are in compliance with defined limits.
Description of use at the use site
From the information of the use process at the use site, it has been concluded that the substance is used under strictly controlled conditions.
Declaration of strictly controlled condition use has been provided by site manager and is described here below.
1. Storage conditions (type of container and room description)
The substance is packed in Big Bags and stored in a close warehouse, with monitored T conditions.
Sampling is done in a dedicated sampling room with laminar flow hood and with appropriate Personal Protective Equipment, as defined by procedures.
In case of spillage Personal Protective Equipment are used as described in the material safety data sheet and in internal Standard Operating Procedure.
2. Description of process step and plant
Gabapentin HCl is used as a raw material to be chemically transformed into the final product. Process conditions are according to quality standard.
Loading and sampling are performed following working instruction reported in production batch record and by trained operators by means of a monorail. Loading operations of the reactor are done in a dedicated, close and controlled room with filters to avoid air emissions. Workers are equipped with Personal Protective Equipments including close disposable suit, air mask and gloves.
Air emission are minimized by air condenser on the reactor. Air emissions are in compliance with local regulation.
Waste treatment is performed by trained operators, in compliance with local regulations. Operators are equipped with Personal Protective Equipment.
3. Methodology of Cleaning of plant equipment and containers and PPE used by workers
Methodology of cleaning is defined in specific working instruction and performed only by trained personnel, equipped with Personal Protective Equipment.
4. Waste treatment and disposal
Waste handling is done only by trained operators protected by means of Personal Protective Equipment: close disposal suit gas/solid mask and gloves. Liquid waste are handled by close system, as for liquid waste and solvents sent by close pipes into tanks. They are either internally recovered or conveyed in close tanks, loaded by close system, to authorized external disposal or recycling companies. Solid waste are stored in close containers and sent to external authorized disposal facilities.
Waste handling and storage is performed in order to avoid any possible impact to environment, in compliance with local regulation.
5. Emergency procedures in case of spill and related workers protections
Emergency procedures are detailed in Emergency Plan. Workers are trained on emergency procedures periodically also based on a specific training kit. Periodically are performed drills including scenarios of possible spill to train the emergency team to be prepared to possible real cases. Are available on site tools and equipment to collect spills and minimize it.
Spill collection is done by operators protected by personal protective equipment as close PVC suit, gas/solid mask and gloves.
6. Risk Management procedures:
Comprehensive Risk Management System is in place, regulated by internal Standard Operating Procedures composed by following actions.
Risk analysis are performed. Workers safety and environment training program is planned yearly. Standard Operating Procedures on Safety, Health and Ecology are available on site in compliance with local regulation. Audit and inspections program is part of activity. Industrial Hygiene Monitoring and Noise Monitoring program is performed according to local rules and results are in compliance with defined limits.
Gabapentin HCl is produced by means of chemical synthesis under controlled conditions of temperature and pressure starting from raw material and adding solvents and reactive agents.
Process conditions are according to quality standards applicable.
Loading of raw material, solvents and reactive agents is performed following working instruction, by trained operators equipped with Personal Protective Equipments (PPE) in controlled conditions.
After the process all in closed line, Gabapentin HCl is downloaded in big-bags following working instructions, by trained operators with PPE under controlled conditions.
2.Description of technical measures to control/minimize environmental emissions
Air emission treatment system are available.
Waste water and liquid waste treatment are transferred in closed system to tanks and shipped to external authorized waste water treatment plant. Disposal is done in accordance with national and local laws.
Solid waste (packaging) are stored in close containers and sent to external authorized disposal facilities, in accordance with law. Personnel in charge of waste handling has been trained and equipped with PPE.
3.Storage at production site: conditions
The material is packed in big bags and stored in a dedicated and closed warehouse, access is limited to authorised personnel.
Sampling is done in a dedicated sampling room with ventilation and appropriate Personal Protective Equipment, as defined by procedures.
4.Cleaning operations of plant equipments and contaminated materials
Methodology of cleaning is defined in specific working instruction and performed only by trained personnel, equipped with Personal Protective Equipment.
5.Waste treatment and disposal
Liquid waste and solvents are sent by close pipes into tanks. They are internally recovered in close tanks and are shipped to authorized external disposal companies. Solid waste (packaging) are stored in containers and sent to external authorized disposal facilities.
Waste handling and storage is performed in order to avoid any possible impact to environment, in compliance with local regulation.
6.Emergency procedures in case of spill and related workers protections
Emergency procedures are detailed in Emergency Plan. Workers are trained on emergency procedures periodically. Spill collection is done by trained operators protected by personal protective equipment as close PVC suit, gas/solid mask and gloves.
7.Risk Management procedures (ex. D.81)
Comprehensive Risk Management System is in place, regulated by internal Standard Operating Procedures composed by following elements.
Risk analysis are performed. Workers safety and environment training program is planned yearly. Standard Operating Procedures on Safety, Health and Ecology are available on site in compliance with local regulation. Audit and inspections program is part of activity. Industrial Hygiene Monitoring and Noise Monitoring program is performed according to local rules and results are in compliance with defined limits.
Description of use at the use site
From the information of the use process at the use site, it has been concluded that the substance is used under strictly controlled conditions.
Declaration of strictly controlled condition use has been provided by site manager and is described here below.
1. Storage conditions (type of container and room description)
The substance is packed in Big Bags and stored in a close warehouse, with monitored T conditions.
Sampling is done in a dedicated sampling room with laminar flow hood and with appropriate Personal Protective Equipment, as defined by procedures.
In case of spillage Personal Protective Equipment are used as described in the material safety data sheet and in internal Standard Operating Procedure.
2. Description of process step and plant
Gabapentin HCl is used as a raw material to be chemically transformed into the final product. Process conditions are according to quality standard.
Loading and sampling are performed following working instruction reported in production batch record and by trained operators by means of a monorail. Loading operations of the reactor are done in a dedicated, close and controlled room with filters to avoid air emissions. Workers are equipped with Personal Protective Equipments including close disposable suit, air mask and gloves.
Air emission are minimized by air condenser on the reactor. Air emissions are in compliance with local regulation.
Waste treatment is performed by trained operators, in compliance with local regulations. Operators are equipped with Personal Protective Equipment.
3. Methodology of Cleaning of plant equipment and containers and PPE used by workers
Methodology of cleaning is defined in specific working instruction and performed only by trained personnel, equipped with Personal Protective Equipment.
4. Waste treatment and disposal
Waste handling is done only by trained operators protected by means of Personal Protective Equipment: close disposal suit gas/solid mask and gloves. Liquid waste are handled by close system, as for liquid waste and solvents sent by close pipes into tanks. They are either internally recovered or conveyed in close tanks, loaded by close system, to authorized external disposal or recycling companies. Solid waste are stored in close containers and sent to external authorized disposal facilities.
Waste handling and storage is performed in order to avoid any possible impact to environment, in compliance with local regulation.
5. Emergency procedures in case of spill and related workers protections
Emergency procedures are detailed in Emergency Plan. Workers are trained on emergency procedures periodically also based on a specific training kit. Periodically are performed drills including scenarios of possible spill to train the emergency team to be prepared to possible real cases. Are available on site tools and equipment to collect spills and minimize it.
Spill collection is done by operators protected by personal protective equipment as close PVC suit, gas/solid mask and gloves.
6. Risk Management procedures:
Comprehensive Risk Management System is in place, regulated by internal Standard Operating Procedures composed by following actions.
Risk analysis are performed. Workers safety and environment training program is planned yearly. Standard Operating Procedures on Safety, Health and Ecology are available on site in compliance with local regulation. Audit and inspections program is part of activity. Industrial Hygiene Monitoring and Noise Monitoring program is performed according to local rules and results are in compliance with defined limits.
Transport information
Land transport (UN RTDG/ADR/RID)
- UN number:
- 3261
Shipping information
- Proper shipping name and description:
- CORROSIVE SOLID, ACIDIC, ORGANIC, N.O.S. (Gabapentin HCl)
- Chemical name:
- Gabapentin hydrochloride
- Language:
- English
- Labels:
- 8
SpecialProvisionsopen allclose all
Shippingopen allclose all
Remarksopen allclose all
Marine transport (UN RTDG/IMDG)
- UN number:
- 3261
Shipping information
- Proper shipping name and description:
- CORROSIVE SOLID, ACIDIC, ORGANIC, N.O.S. (Gabapentin HCl)
- Chemical name:
- Gabapentin hydrochloride
- Labels:
- 8
Remarksopen allclose all
Air transport (UN RTDG/ICAO/IATA)
- UN number:
- 3261
Shipping information
- Proper shipping name and description:
- CORROSIVE SOLID, ACIDIC, ORGANIC, N.O.S. (Gabapentin HCl)
- Chemical name:
- Gabapentin hydrochloride
- Labels:
- 8
Special provisions / remarks
- Remarks:
- Passenger and cargo: Packaging instructions (814), max net q.ty per pack: 15KG.
Passenger and cargo ( Limited Quantity): Packaging instructions (Y814), max net q.ty per pack: 5KG.
Cargo only: Packaging instructions (816), max net q.ty per pack: 50KG.ù
Special provision: A3
Additional transport information
Additional information
- Special provisions / remarks / other:
- Passenger and cargo: Packaging instructions (814), max net q.ty per pack: 15KG.
Passenger and cargo ( Limited Quantity): Packaging instructions (Y814), max net q.ty per pack: 5KG.
Cargo only: Packaging instructions (816), max net q.ty per pack: 50KG.ù
Special provision: A3
Exposure controls / personal protection
Protective Gloves, protective clothing, goggles, mask with approved filter.
Stability and reactivity
Stable under normal storage conditions.
Disposal considerations
National laws on disposal must be considered, local and UE requirements for wastes recycling must be respected.
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.
