Registration Dossier

Manufacture, use & exposure

Manufacture

Documentsopen allclose all

Manufacture

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC1: Manufacture of the substance
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Related assessment:
use assessed in an own CSR

Manufacture

Contributing activity / technique for the environmentopen allclose all
Environmental release category (ERC):
ERC2: Formulation into mixture
Environmental release category (ERC):
ERC1: Manufacture of the substance
Name of activity / technique:
Industrial Manufacturing of H4EDTA powder (conc. up to 100 %)
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Process category (PROC):
PROC 5: Mixing or blending in batch processes
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Process category (PROC):
PROC 15: Use as laboratory reagent
Name of activity / technique:
Industrial Manufacturing of H4EDTA powder (conc. up to 100 %)
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Name of activity / technique:
Industrial Manufacturing of H4EDTA powder (conc. up to 100 %)
Process category (PROC):
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
Name of activity / technique:
Industrial Manufacturing of H4EDTA powder (conc. up to 100 %)
Process category (PROC):
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
Name of activity / technique:
Industrial Manufacturing of H4EDTA powder (conc. up to 100 %)
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Name of activity / technique:
Industrial Manufacturing of H4EDTA powder (conc. up to 100 %)
Process category (PROC):
PROC 5: Mixing or blending in batch processes
Name of activity / technique:
Industrial Manufacturing of H4EDTA powder (conc. up to 100 %)
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Name of activity / technique:
Industrial Manufacturing of H4EDTA powder (conc. up to 100 %)
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Name of activity / technique:
Industrial Manufacturing of H4EDTA powder (conc. up to 100 %)
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Name of activity / technique:
Industrial Manufacturing of H4EDTA powder (conc. up to 100 %)
Process category (PROC):
PROC 15: Use as laboratory reagent
ContribScenEnvirWorkerRepopen allclose all

Contributing scenario for the environment (related to workers activities)

Conditions of use for the environment

Conditions and measures related to Biological Sewage Treatment Plant

Biological Sewage Treatment Plant (STP):
no

Contributing scenario for the environment (related to workers activities)

Conditions of use for the environment

Conditions and measures related to Biological Sewage Treatment Plant

Biological Sewage Treatment Plant (STP):
no
ContribScenWorkersRepopen allclose all

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Other conditions affecting workers exposure

Place of use:
indoor
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3
Type of exposure:
dermal (internal) long-term exposure
Type of exposure:
dermal (internal) short-term exposure
Type of exposure:
dermal (external) long-term exposure
Type of exposure:
dermal (external) short-term exposure

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Other conditions affecting workers exposure

Place of use:
indoor
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3
Type of exposure:
dermal (internal) long-term exposure
Type of exposure:
dermal (internal) short-term exposure
Type of exposure:
dermal (external) long-term exposure
Type of exposure:
dermal (external) short-term exposure

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Other conditions affecting workers exposure

Place of use:
indoor
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3
Type of exposure:
dermal (internal) long-term exposure
Type of exposure:
dermal (internal) short-term exposure
Type of exposure:
dermal (external) long-term exposure
Type of exposure:
dermal (external) short-term exposure

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

Technical and organisational conditions
Effectiveness
Route affected:
inhalation

Other conditions affecting workers exposure

Place of use:
indoor
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3
Type of exposure:
dermal (internal) long-term exposure
Type of exposure:
dermal (internal) short-term exposure
Type of exposure:
dermal (external) long-term exposure
Type of exposure:
dermal (external) short-term exposure

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

Technical and organisational conditions
Effectiveness
Route affected:
inhalation

Other conditions affecting workers exposure

Place of use:
indoor
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3
Type of exposure:
dermal (internal) long-term exposure
Type of exposure:
dermal (internal) short-term exposure
Type of exposure:
dermal (external) long-term exposure
Type of exposure:
dermal (external) short-term exposure

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

Technical and organisational conditions
Effectiveness
Route affected:
inhalation

Other conditions affecting workers exposure

Place of use:
indoor
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3
Type of exposure:
dermal (internal) long-term exposure
Type of exposure:
dermal (internal) short-term exposure
Type of exposure:
dermal (external) long-term exposure
Type of exposure:
dermal (external) short-term exposure

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

Technical and organisational conditions
Effectiveness
Route affected:
inhalation

Other conditions affecting workers exposure

Place of use:
indoor
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3
Type of exposure:
dermal (internal) long-term exposure
Type of exposure:
dermal (internal) short-term exposure
Type of exposure:
dermal (external) long-term exposure
Type of exposure:
dermal (external) short-term exposure

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Technical and organisational conditions and measures

Technical and organisational conditions
Effectiveness
Route affected:
inhalation

Other conditions affecting workers exposure

Place of use:
indoor
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3
Type of exposure:
dermal (internal) long-term exposure
Type of exposure:
dermal (internal) short-term exposure
Type of exposure:
dermal (external) long-term exposure
Type of exposure:
dermal (external) short-term exposure

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

OtherProdCharRepopen allclose all

Amounts used (or contained in articles), frequency and duration of use/exposure

Other conditions affecting workers exposure

Place of use:
indoor
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3
Type of exposure:
dermal (internal) long-term exposure
Type of exposure:
dermal (internal) short-term exposure
Type of exposure:
dermal (external) long-term exposure
Type of exposure:
dermal (external) short-term exposure

Manufacture

Contributing activity / technique for the environmentopen allclose all
Environmental release category (ERC):
ERC2: Formulation into mixture
Environmental release category (ERC):
ERC6a: Use of intermediate
Environmental release category (ERC):
ERC1: Manufacture of the substance
Name of activity / technique:
In the chemical safety assessment performed according to Article 14(3) in connection with Annex I section 3 (Environmental Hazard Assessment) and section 4 (PBT/ vPvB Assessment) no hazard was identified. Therefore according to REACH Annex I (5.0) an exposure estimation is not necessary.
Consequently all identified uses of the substance are assessed as safe for the environment.
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Process category (PROC):
PROC 5: Mixing or blending in batch processes
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Process category (PROC):
PROC 15: Use as laboratory reagent
Name of activity / technique:
Industrial Manufacturing of H4EDTA powder (conc. up to 100 %) and its use as intermediate, not requiring RMM (LEV or Respiratory protection)
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
Name of activity / technique:
Industrial Manufacturing of H4EDTA powder (conc. up to 100 %) and its use as intermediate, requiring RMM (LEV or Respiratory protection)
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
PROC 5: Mixing or blending in batch processes
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
PROC 15: Use as laboratory reagent

Contributing scenario for the environment (related to workers activities)

ContribScenWorkersRepopen allclose all

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

Other product (article) characteristics

Amounts used (or contained in articles), frequency and duration of use/exposure

Other conditions

Technical and organisational conditions and measures

Technical and organisational conditions

Conditions and measures related to personal protection, hygiene and health evaluation

Other conditions affecting workers exposure

Place of use:
indoor

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Type of exposure:
inhalation (external) short-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

Other product (article) characteristics

Amounts used (or contained in articles), frequency and duration of use/exposure

Other conditions

Technical and organisational conditions and measures

Technical and organisational conditions
Effectiveness
Route affected:
inhalation

Conditions and measures related to personal protection, hygiene and health evaluation

Effectiveness
Route affected:
inhalation

Other conditions affecting workers exposure

Place of use:
indoor

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Type of exposure:
inhalation (external) short-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers

Manufacture

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC1: Manufacture of the substance
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Process category (PROC):
PROC 5: Mixing or blending in batch processes
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Process category (PROC):
PROC 14: Tabletting, compression, extrusion, pelletisation, granulation
Process category (PROC):
PROC 15: Use as laboratory reagent

Manufacture

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC1: Manufacture of the substance
Contributing activity / technique for workers
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises

Manufacture

Contributing activity / technique for the environmentopen allclose all
Environmental release category (ERC):
ERC2: Formulation into mixture
Environmental release category (ERC):
ERC1: Manufacture of the substance
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Process category (PROC):
PROC 5: Mixing or blending in batch processes
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Process category (PROC):
PROC 15: Use as laboratory reagent