Registration Dossier

Manufacture, use & exposure

Uses at industrial sites

Documentsopen allclose all

Uses at industrial sites

Registration/ Notification status for the use:
use as intermediate registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Contributing activity / technique for the environment
Name of activity / technique:
Use as intermediate for synthesis of pharmaceutical substance
Environmental release category (ERC):
ERC6a: Use of intermediate
Contributing activity / technique for workersopen allclose all
Name of activity / technique:
Sampling of CAET
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Name of activity / technique:
Analysis of CAET
Process category (PROC):
PROC 15: Use as laboratory reagent
Name of activity / technique:
Opening of drums bungs before charging the drums in the oven.
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Name of activity / technique:
Transfer of the CAET in the saponification reactor
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Sector of end use:
SU 0: Other:
Substance supplied to that use in form of:
as such
Related assessment:
use assessed in an own CSR

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)

Technical and organisational conditions and measures

Other technical and organisational conditions
EffectivenessRepopen allclose all
Route affected:
water
Route affected:
air

Conditions and measures related to Biological Sewage Treatment Plant

Biological Sewage Treatment Plant (STP):
no

Conditions and measures related to external treatment of waste (including article waste)

Particular considerations on the waste treatment operations:
no

Other conditions affecting environmental exposure

Place of use:
indoor

Releases to waste and the environment

Release to the environment

ReleaseEnvirRepopen allclose all
Release from the site to::
surface water
Release estimation method:
estimated release factor
Release from the site to::
ambient air
Release estimation method:
estimated release factor
Release from the site to::
non-agricultural soil
Release estimation method:
estimated release factor
Remarks:
0

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:
air
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
Exposed compartment:
predators' prey (freshwater)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
predators' prey (marine water)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
top predators' prey (marine water)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
predators' prey (terrestrial)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES

Exposure of humans via the environment

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

Physical form of the used product:
liquid

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

Technical and organisational conditions and measures

TechCondRepopen allclose all
EffectivenessRepopen allclose all
Route affected:
inhalation
Route affected:
dermal

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

Effectiveness
Route affected:
dermal

Other conditions affecting workers exposure

Place of use:
indoor
Other conditions of use

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
Stoffenmanager
Type of exposure:
inhalation (external) short-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
Stoffenmanager
Type of exposure:
dermal (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Type of exposure:
dermal (external) local concentration on skin
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

Physical form of the used product:
liquid

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

Technical and organisational conditions and measures

TechCondRepopen allclose all
Effectiveness
Route affected:
inhalation
EffectivenessRepopen allclose all
Route affected:
inhalation
Route affected:
dermal

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

Effectiveness
Route affected:
dermal

Other conditions affecting workers exposure

Place of use:
indoor
Other conditions of use

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
Stoffenmanager
Type of exposure:
inhalation (external) short-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
Stoffenmanager
Type of exposure:
dermal (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Type of exposure:
dermal (external) local concentration on skin
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

Physical form of the used product:
liquid

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

Technical and organisational conditions and measures

TechCondRepopen allclose all
EffectivenessRepopen allclose all
Route affected:
inhalation
Route affected:
dermal

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

Effectiveness
Route affected:
dermal

Other conditions affecting workers exposure

Place of use:
indoor
Other conditions of use

Exposure of workers

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

Physical form of the used product:
liquid

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

Technical and organisational conditions and measures

TechCondRepopen allclose all
Effectiveness
Route affected:
inhalation
EffectivenessRepopen allclose all
Route affected:
inhalation
Route affected:
dermal

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

PPERepopen allclose all
Effectiveness
Route affected:
inhalation
Effectiveness
Route affected:
dermal

Other conditions affecting workers exposure

Place of use:
indoor
Other conditions of use

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:
dermal (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers

Uses at industrial sites

Registration/ Notification status for the use:
use as intermediate registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Contributing activity / technique for the environment
Name of activity / technique:
Purification of CAE with activated carbon.
Environmental release category (ERC):
ERC4: Use of non-reactive processing aid at industrial site (no inclusion into or onto article)
Contributing activity / technique for workersopen allclose all
Name of activity / technique:
Charging the CAE into the reactor
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Name of activity / technique:
Filling the drums with CAET
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Name of activity / technique:
Removal of the activated carbon impregnated of CAE from the filter
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Product category used:
PC 29: Pharmaceuticals
Substance supplied to that use in form of:
as such
Related assessment:
use assessed in an own CSR

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):
site specific and municipal biological STP
Application of site specific biological STP sludge on agricultural soil:
yes

Conditions and measures related to external treatment of waste (including article waste)

Particular considerations on the waste treatment operations:
no

Other conditions affecting environmental exposure

Place of use:
indoor
Other conditions of use

Releases to waste and the environment

Release to the environment

ReleaseEnvirRepopen allclose all
Release from the site to::
wastewater
Release estimation method:
estimated release factor
Release from the site to::
ambient air
Release estimation method:
estimated release factor
Release from the site to::
non-agricultural soil
Release estimation method:
estimated release factor

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:
air
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
Exposed compartment:
predators' prey (freshwater)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
predators' prey (marine water)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
top predators' prey (marine water)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Exposed compartment:
predators' prey (terrestrial)
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES

Exposure of humans via the environment

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

Physical form of the used product:
liquid

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

Technical and organisational conditions and measures

TechCondRepopen allclose all
EffectivenessRepopen allclose all
Route affected:
inhalation
Route affected:
dermal

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

Effectiveness
Route affected:
dermal

Other conditions affecting workers exposure

Place of use:
indoor
Other conditions of use

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
Stoffenmanager
Type of exposure:
inhalation (external) short-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
Stoffenmanager
Type of exposure:
dermal (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Type of exposure:
dermal (external) local concentration on skin
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

Physical form of the used product:
liquid

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

Technical and organisational conditions and measures

TechCondRepopen allclose all
EffectivenessRepopen allclose all
Route affected:
inhalation
Route affected:
dermal

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

Effectiveness
Route affected:
dermal

Other conditions affecting workers exposure

Place of use:
indoor
Other conditions of use

Exposure of workers

ExpEstopen allclose all
Type of exposure:
inhalation (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
Stoffenmanager
Type of exposure:
inhalation (external) short-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
Stoffenmanager
Type of exposure:
dermal (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Type of exposure:
dermal (external) local concentration on skin
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

Physical form of the used product:
solid (unspecified form)

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

Technical and organisational conditions and measures

TechCondRepopen allclose all
Effectiveness
Route affected:
inhalation
EffectivenessRepopen allclose all
Route affected:
inhalation
Route affected:
dermal

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

PPERepopen allclose all
Effectiveness
Route affected:
inhalation
Effectiveness
Route affected:
dermal

Other conditions affecting workers exposure

Place of use:
indoor
Other conditions of use

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
Type of exposure:
dermal (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Type of exposure:
dermal (external) local concentration on skin
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers