Registration Dossier

Manufacture, use & exposure

Uses at industrial sites

Uses at industrial sites

Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Use name:
API manufacturing from Scopolamine
Contributing activity / technique for the environment
Name of activity / technique:
Synthesis by industrial processing and wet separation techniques.
Environmental release category (ERC):
ERC6a: Use of intermediate
Contributing activity / technique for workersopen allclose all
Name of activity / technique:
Chemical reaction of Scopolamine to APIs
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:
Filling, cleaning, maintenance
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Name of activity / technique:
Laboratory Use
Process category (PROC):
PROC 15: Use as laboratory reagent
Product category used:
PC 29: Pharmaceuticals
Sector of end use:
SU 0: Other: precursor to active pharmaceutical ingredient
Substance supplied to that use in form of:
as such
Subsequent service life relevant for this use:
no
Related assessment:
use assessed in an own CSR

Contributing scenario for the environment (related to workers activities)

Conditions of use for the environment

Technical and organisational conditions and measures

Other technical and organisational conditions

Conditions and measures related to Biological Sewage Treatment Plant

Biological Sewage Treatment Plant (STP):
municipal biological STP

Other conditions affecting environmental exposure

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
Remarks:
0

Release to external waste

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:
solid (material with medium dustiness)

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
Effectiveness
Route affected:
inhalation

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

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

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

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

Physical form of the used product:
solid (material with high dustiness)

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
Effectiveness
Route affected:
inhalation

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

PPERepopen allclose all
Effectiveness
Route affected:
dermal
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:
measured data
Exposure estimation tool name:
other: emptying of suction filter in unit 4224 B001.01 / BI report 2015_30.pdf
Type of exposure:
dermal (external) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
Riskofderm

Contributing scenario for the workers

Conditions of use for workers

Product (article) characteristics

Physical form of the used product:
solid (material with medium dustiness)

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
Effectiveness
Route affected:
inhalation

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

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

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