Registration Dossier

Manufacture, use & exposure

Formulation

Formulation

Use name:
FEICA-F1.6.1, FEICA-F1.5.1, FEICA-F1.7.1, FEICA-F1.3.1, FEICA-F1.1.1, FEICA-F1.2.1, FEICA-F1.8.1, FEICA-F1.4.1, MP0023; MP0024, MS0011 MW0011: Formulation - ERC2 Formulation of preparations
Contributing activity / technique for the environmentopen allclose all
Environmental release category (ERC):
ERC2: Formulation into mixture
Name of activity / technique:
Formulation - ERC2 Formulation of preparations (MS0011 MW0011)
Name of activity / technique:
Formulation - ERC2 Formulation of preparations (FEICA-F1.1.1)
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 10: Roller application or brushing
Process category (PROC):
PROC 14: Tabletting, compression, extrusion, pelletisation, granulation
Name of activity / technique:
Formulation - ERC2 Formulation of preparations; Filtering and filling - filtering or sieving and filling - dedicated lines OR Filtering and filling - filtering or sieving and filling - dedicated lines; Industrial - 9 - Transfer of chemicals into small containers (dedicated filling line) (FEICA-F1.6.1)
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Name of activity / technique:
Formulation - ERC2 Formulation of preparations; Industrial - 8b - Transfer of chemicals from/to vessels/ large containers at dedicated facilities; Raw material assembly and charging - raw material dispensing - manually from bulk storage or packaged goods - liquids and solids OR Waste management - transfer of process wastes to storage containers - in workplace - off-line OR Manufacturing equipment maintenance OR Raw material assembly and charging - raw material dispensing - manually from bulk storage or packaged goods OR Waste management - transfer of process wastes to storage containers - in workplace - off-line OR Manufacturing equipment maintenance; Receipt and storage of raw materials - raw material delivery - bulk - solids and liquids - outdoor OR Raw material assembly and charging - raw material dispensing - manually from bulk storage or packaged goods - liquids and solids OR Waste management - transfer of recovered solvent into bulk storage tanks or IBCs OR Receipt and storage of raw materials - raw material delivery - bulk - solids - outdoor (FEICA-F1.5.1)
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Name of activity / technique:
Formulation - ERC2 Formulation of preparations; Industrial - 10 - Roller application or brushing (FEICA-F1.7.1)
Process category (PROC):
PROC 10: Roller application or brushing
Name of activity / technique:
Formulation - ERC2 Formulation of preparations; Industrial - 4 - Use in batch and other process (synthesis) where opportunity for exposure arises (FEICA-F1.3.1)
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Name of activity / technique:
Formulation - ERC2 Formulation of preparations; Blending/dissolving/ dispersion - mixing, milling, dispersing, completion - continuous - closed - sampling OR Manufacturing equipment cleaning - enclosed - in workplace OR Blending/dissolving/ dispersion - mixing, milling, dispersing, completion - continuous - closed OR Manufacturing equipment cleaning - enclosed - in workplace; Industrial - 2 - Use in closed, continuous process with occasional controlled exposure (FEICA-F1.1.1)
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:
Formulation - ERC2 Formulation of preparations; Industrial - 3 - Use in closed batch process (synthesis or formulation); Receipt and storage of raw materials - raw material storage - indoor OR Blending/dissolving/ dispersion - mixing, milling, dispersing, completion - batch - closed OR Receipt and storage of raw materials - raw material storage - indoor OR Blending/dissolving/ dispersion - mixing, milling, dispersing, completion - batch - closed; Receipt and storage of raw materials OR Waste management OR Receipt and storage of raw materials - raw material delivery OR Waste management - storage of waste prior to removal for off-site management (FEICA-F1.2.1)
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:
Formulation - ERC2 Formulation of preparations; Industrial - 8a - Transfer of chemicals from/to vessels/ large containers at non dedicated facilities
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Name of activity / technique:
Formulation - ERC2 Formulation of preparations; Industrial - 14 - Production of preparations or articles by tabletting, compression, extrusion, pelletisation (FEICA-F1.8.1)
Process category (PROC):
PROC 14: Tabletting, compression, extrusion, pelletisation, granulation
Name of activity / technique:
Formulation - ERC2 Formulation of preparations; Blending/dissolving/ dispersion - mixing, milling, dispersing, completion - batch - open OR Manufacturing equipment cleaning - open - in workplace OR Laboratory use OR Blending/dissolving/ dispersion - mixing, milling, dispersing, completion - batch - open OR Manufacturing equipment cleaning - open - in workplace OR Laboratory use; Industrial - 5 - Mixing or blending in batch processes (multistage and/or significant contact) (FEICA-F1.4.1)
Process category (PROC):
PROC 5: Mixing or blending in batch processes
Name of activity / technique:
Formulation - ERC2 Formulation of preparations; Industrial - 1 - Use in closed process, no likelihood of exposure; Raw material assembly and charging - raw material dispensing - pipeline from bulk storage - liquids and solids -; Raw material assembly and charging - raw material dispensing - pipeline from bulk storage - solids - i; Raw material assembly and charging - raw material dispensing - pipeline from bulk storage - solids - o (MP0023; MP0024)
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Substance supplied to that use in form of:
as such
ContribScenEnvirWorkerRepopen allclose all

Contributing scenario for the environment (related to workers activities)

Conditions of use for the environment

Amounts used, frequency and duration of use (or from service life)

Conditions and measures related to Biological Sewage Treatment Plant

Biological Sewage Treatment Plant (STP):
yes
Application of site specific biological STP sludge on agricultural soil:
yes

Other conditions affecting environmental exposure

Releases to waste and the environment

Release to the environment

ReleaseEnvirRepopen allclose all
Release from the site to::
surface water
Release estimation method:
SpERC
Remarks:
ERC2 Formulation of preparations CEPE SPERC 2.1a.v1
Release from the site to::
ambient air
Release estimation method:
SpERC
Remarks:
ERC2 Formulation of preparations CEPE SPERC 2.1a.v1
Release from the site to::
non-agricultural soil
Release estimation method:
SpERC
Remarks:
ERC2 Formulation of preparations CEPE SPERC 2.1a.v1

Exposure of the environment

PECopen allclose all
Exposed compartment:
freshwater
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
sediment (freshwater)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
marine water
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
sediment (marine water)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
sewage treatment plant
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
agricultural soil
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES

Contributing scenario for the environment (related to workers activities)

Conditions of use for the environment

Amounts used, frequency and duration of use (or from service life)

Conditions and measures related to Biological Sewage Treatment Plant

Biological Sewage Treatment Plant (STP):
yes
Application of site specific biological STP sludge on agricultural soil:
yes

Other conditions affecting environmental exposure

Releases to waste and the environment

Release to the environment

ReleaseEnvirRepopen allclose all
Release from the site to::
surface water
Release estimation method:
SpERC
Remarks:
ERC2 Formulation of preparations FEICA SPERC 2.1a.v1
Release from the site to::
ambient air
Release estimation method:
SpERC
Remarks:
ERC2 Formulation of preparations FEICA SPERC 2.1a.v1
Release from the site to::
non-agricultural soil
Release estimation method:
SpERC
Remarks:
ERC2 Formulation of preparations FEICA SPERC 2.1a.v1

Exposure of the environment

PECopen allclose all
Exposed compartment:
freshwater
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
sediment (freshwater)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
marine water
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
sediment (marine water)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
sewage treatment plant
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
agricultural soil
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
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

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
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (internal) 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
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3

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

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
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (internal) 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
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3

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

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
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (internal) 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
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3

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

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
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (internal) 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
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3

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

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
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (internal) 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
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3

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

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
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (internal) 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
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3

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

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 (internal) 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
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3

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

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
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (internal) 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
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3

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

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
OtherCondRepopen allclose all

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (internal) 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
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3

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

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 (internal) 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
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3