Registration Dossier

Manufacture, use & exposure

Manufacture

Manufacture

Manufacture name:
Manufacture of bis(2-butoxyethyl)adipate
Contributing activity / technique for the environmentopen allclose all
Name of activity / technique:
Manufacture of BDEA
Environmental release category (ERC):
ERC1: Manufacture of the substance
Name of activity / technique:
Bis(2-butoxyethyl)adipate is not classified for the environment, so an exposure assessment of the environment is not required.
According to the REACH Guidance on information requirements and chemical safety assessment, Part E (page 27/58), the assessment of "human via the environment" should be performed on a case by case basis for acutely toxic substances cat 1, 2 and 3 and strong sensitizers. Bis(2-butoxyethyl)adipate is classified as harmful by oral intake (Acute tox. cat 4) and is not a strong sensitizer. Consequently the assessment of man via the environment is not required. Moreover, the exposure of man via the environment is not a likely route of exposure because releases to the environment are minimal. The substance is manufactured in a closed process and formulated in a polymer film that is enclosed in safety glass.
Environmental release category (ERC):
ERC1: Manufacture of the substance
Contributing activity / technique for workersopen allclose all
Name of activity / technique:
Manufacrure of DBEA
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:
Manufacrure of DBEA
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:
Manufacrure of DBEA
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Name of activity / technique:
Manufacrure of DBEA
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Name of activity / technique:
Manufacrure of DBEA
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Name of activity / technique:
Manufacrure of DBEA
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Name of activity / technique:
Manufacrure of DBEA
Process category (PROC):
PROC 15: Use as laboratory reagent
Name of activity / technique:
Synthesis of bis(2-butoxyethyl)adipate in closed system that is a combination of a continuous and a batch system; sampling on the reactor is via a closed loop system with damp retour
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:
Synthesis of bis(2-butoxyethyl)adipate in closed system that is a combination of a continuous and a batch system; sampling on the reactor is via a closed loop system with damp retour
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:
Synthesis of bis(2-butoxyethyl)adipate in closed system that is a combination of a continuous and a batch system; sampling on the reactor is via a closed loop system with damp retour.
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Name of activity / technique:
Charging/uncharging the equipment. The empty packages are collected for controlled disposal.
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Name of activity / technique:
Maintenance and cleaning
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Name of activity / technique:
Transfer of bis(2-butoxyethyl)adipate to small containers
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Name of activity / technique:
Quality control of the synthesised product
Process category (PROC):
PROC 15: Use as laboratory reagent
Related assessment:
use assessed in an own CSR

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

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
Effectiveness
Route affected:
dermal

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

PPERepopen allclose all
Effectiveness
Route affected:
dermal

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

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

Technical and organisational conditions and measures

TechCondRepopen allclose all

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

PPERepopen allclose all
Effectiveness
Route affected:
dermal

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

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

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

PPERepopen allclose all
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 (internal) long-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3
Type of exposure:
inhalation (internal) short-term exposure
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers v3
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:
inhalation (external) short-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:
other: Riskofderm 2.1
Type of exposure:
dermal (external) 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

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

Technical and organisational conditions and measures

TechCondRepopen allclose all

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

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

Other conditions

Technical and organisational conditions and measures

TechCondRepopen allclose all

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

PPERepopen allclose all
Effectiveness
Route affected:
dermal

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

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

Technical and organisational conditions and measures

TechCondRepopen allclose all

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

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

Technical and organisational conditions and measures

Technical and organisational conditions

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

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