Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
fish early-life stage toxicity
Data waiving:
exposure considerations
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Registration/ Notification status for the use:
use registered according to REACH Article 10; total tonnage manufactured/imported >=10tonnes/year per registrant
Use name:
Use as intermediate in the manufacture of other substances (squalane)
Name of activity / technique:
Use as intermediate in the manufacture of other substances (squalane)
Environmental release category (ERC):
ERC6a: Use of intermediate
Name of activity / technique:
Closed process without likelihood of exposure
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:
Closed continuous process with occasional controlled exposure
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:
Closed batch process with occasional controlled exposure
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:
Transfer of the substance at dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Name of activity / technique:
Transfer of substance or mixture into small containers
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Name of activity / technique:
Laboratory analysis of samples
Process category (PROC):
PROC 15: Use as laboratory reagent
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
Linked contributing activity:
01710c11-e21d-4639-bd3b-cb21416ab2c9
Biological Sewage Treatment Plant (STP):
no
Particular considerations on the waste treatment operations:
no
Receiving surface water flow rate (m³/day):
18 000
Other conditions of use impacting on environmental exposure:
Discharge rate of effluent: >= 2E3 m3/day
Release from the site to::
surface water
Release estimation method:
estimated release factor
Remarks:
Industry-specific
Release factor from the site after on-site risk management (%):
0
Release from the site to::
ambient air
Release estimation method:
estimated release factor
Remarks:
Industry-specific
Release factor from the site after on-site risk management (%):
0
Release from the site to::
non-agricultural soil
Release estimation method:
estimated release factor
Remarks:
Industry-specific
Release factor from the site after on-site risk management (%):
0
Release factor to external waste (%):
0
Exposed compartment:
freshwater
Clocal:
0 mg/L
Predicted exposure concentration:
0 mg/L
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Version of exposure estimation tool:
2.1.2
Exposed compartment:
sediment (freshwater)
Predicted exposure concentration:
0 mg/kg dw
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Version of exposure estimation tool:
2.1.2
Exposed compartment:
marine water
Clocal:
0 mg/L
Predicted exposure concentration:
0 mg/L
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Version of exposure estimation tool:
2.1.2
Exposed compartment:
sediment (marine water)
Predicted exposure concentration:
0 mg/kg dw
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Version of exposure estimation tool:
2.1.2
Exposed compartment:
sewage treatment plant
Predicted exposure concentration:
0 mg/L
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Version of exposure estimation tool:
2.1.2
Exposed compartment:
air
Clocal:
0 mg/m³
Predicted exposure concentration:
0 mg/m³
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Version of exposure estimation tool:
2.1.2
Exposed compartment:
agricultural soil
Clocal:
0 mg/kg dw
Predicted exposure concentration:
0 mg/kg dw
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Version of exposure estimation tool:
2.1.2
Exposed compartment:
predators' prey (freshwater)
Predicted exposure concentration:
0 mg/kg ww
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Version of exposure estimation tool:
2.1.2
Exposed compartment:
predators' prey (marine water)
Predicted exposure concentration:
0 mg/kg ww
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Version of exposure estimation tool:
2.1.2
Exposed compartment:
top predators' prey (marine water)
Predicted exposure concentration:
0 mg/kg ww
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Version of exposure estimation tool:
2.1.2
Exposed compartment:
predators' prey (terrestrial)
Predicted exposure concentration:
0 mg/kg ww
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Version of exposure estimation tool:
2.1.2
Daily intake via food consumption:
0 mg/kg bw/day
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
EUSES
Version of exposure estimation tool:
2.1.2
Linked contributing activity:
c55aa072-b928-4f08-956e-be488769fc85
Percentage (w/w) of substance in mixture/article:
100
Physical form of the used product:
liquid, including paste/slurry/suspension
Duration of activity (hour/day):
8
Technical and organisational conditions and measures:
General ventilation: Basic general ventilation (1-3 air changes per hour)
Effectiveness (%):
0
Route affected:
inhalation
Technical and organisational conditions and measures:
Occupational Health and Safety Management System: Advanced
Technical and organisational conditions and measures:
Local exhaust ventilation: No
Effectiveness (%):
0
Route affected:
inhalation
Effectiveness (%):
0
Route affected:
dermal
Personal protection equipment:
Respiratory protection: No
Effectiveness (%):
0
Route affected:
inhalation
Personal protection equipment:
Dermal protection: No
Effectiveness (%):
0
Route affected:
dermal
Place of use:
indoor
Operating temperature (°C):
40
Type of exposure:
inhalation (external) long-term exposure
Exposure estimate:
0.208 mg/m³
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Type of exposure:
inhalation (external) short-term exposure
Exposure estimate:
0.208 mg/m³
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Type of exposure:
dermal (external) long-term exposure
Exposure estimate:
0.034 mg/kg bw/day
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Linked contributing activity:
62f9ad30-937e-46a0-939f-d99b683975da
Percentage (w/w) of substance in mixture/article:
100
Physical form of the used product:
liquid, including paste/slurry/suspension
Duration of activity (hour/day):
8
Technical and organisational conditions and measures:
General ventilation: Basic general ventilation (1-3 air changes per hour)
Effectiveness (%):
0
Route affected:
inhalation
Technical and organisational conditions and measures:
Occupational Health and Safety Management System: Advanced
Technical and organisational conditions and measures:
Local exhaust ventilation: No
Effectiveness (%):
0
Route affected:
inhalation
Effectiveness (%):
0
Route affected:
dermal
Personal protection equipment:
Respiratory protection: No
Effectiveness (%):
0
Route affected:
inhalation
Personal protection equipment:
Dermal protection: No
Effectiveness (%):
0
Route affected:
dermal
Place of use:
indoor
Operating temperature (°C):
40
Type of exposure:
inhalation (external) long-term exposure
Exposure estimate:
2.083 mg/m³
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Type of exposure:
inhalation (external) short-term exposure
Exposure estimate:
2.083 mg/m³
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Type of exposure:
dermal (external) long-term exposure
Exposure estimate:
1.37 mg/kg bw/day
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Linked contributing activity:
49b22a54-be7e-4a72-b57e-5d7425954ccf
Percentage (w/w) of substance in mixture/article:
100
Physical form of the used product:
liquid, including paste/slurry/suspension
Duration of activity (hour/day):
8
Technical and organisational conditions and measures:
General ventilation: Basic general ventilation (1-3 air changes per hour)
Effectiveness (%):
0
Route affected:
inhalation
Technical and organisational conditions and measures:
Occupational Health and Safety Management System: Advanced
Technical and organisational conditions and measures:
Local exhaust ventilation: No
Effectiveness (%):
0
Route affected:
inhalation
Effectiveness (%):
0
Route affected:
dermal
Personal protection equipment:
Respiratory protection: No
Effectiveness (%):
0
Route affected:
inhalation
Personal protection equipment:
Dermal protection: No
Effectiveness (%):
0
Route affected:
dermal
Place of use:
indoor
Operating temperature (°C):
40
Type of exposure:
inhalation (external) long-term exposure
Exposure estimate:
2.083 mg/m³
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Type of exposure:
inhalation (external) short-term exposure
Exposure estimate:
2.083 mg/m³
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Type of exposure:
dermal (external) long-term exposure
Exposure estimate:
0.69 mg/kg bw/day
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Linked contributing activity:
6e475610-dca6-41de-85d4-6254f819e10a
Percentage (w/w) of substance in mixture/article:
100
Physical form of the used product:
liquid, including paste/slurry/suspension
Duration of activity (hour/day):
8
Technical and organisational conditions and measures:
General ventilation: Basic general ventilation (1-3 air changes per hour)
Effectiveness (%):
0
Route affected:
inhalation
Technical and organisational conditions and measures:
Occupational Health and Safety Management System: Advanced
Technical and organisational conditions and measures:
Local exhaust ventilation: No
Effectiveness (%):
0
Route affected:
inhalation
Effectiveness (%):
0
Route affected:
dermal
Personal protection equipment:
Respiratory protection: No
Effectiveness (%):
0
Route affected:
inhalation
Personal protection equipment:
Dermal protection: Yes (Chemically resistant gloves conforming to EN374) and (other) appropriate dermal protection
Effectiveness (%):
80
Route affected:
dermal
Place of use:
indoor
Operating temperature (°C):
40
Type of exposure:
inhalation (external) long-term exposure
Exposure estimate:
2.083 mg/m³
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Type of exposure:
inhalation (external) short-term exposure
Exposure estimate:
2.083 mg/m³
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Type of exposure:
dermal (external) long-term exposure
Exposure estimate:
2.742 mg/kg bw/day
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Linked contributing activity:
908f15ff-2afa-4c8b-acb9-dc02866e4583
Percentage (w/w) of substance in mixture/article:
100
Physical form of the used product:
liquid, including paste/slurry/suspension
Duration of activity (hour/day):
8
Technical and organisational conditions and measures:
General ventilation: Basic general ventilation (1-3 air changes per hour)
Effectiveness (%):
0
Route affected:
inhalation
Technical and organisational conditions and measures:
Occupational Health and Safety Management System: Advanced
Technical and organisational conditions and measures:
Local exhaust ventilation: No
Effectiveness (%):
0
Route affected:
inhalation
Effectiveness (%):
0
Route affected:
dermal
Personal protection equipment:
Respiratory protection: No
Effectiveness (%):
0
Route affected:
inhalation
Personal protection equipment:
Dermal protection: Yes (Chemically resistant gloves conforming to EN374) and (other) appropriate dermal protection
Effectiveness (%):
80
Route affected:
dermal
Place of use:
indoor
Operating temperature (°C):
40
Type of exposure:
inhalation (external) long-term exposure
Exposure estimate:
2.083 mg/m³
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Type of exposure:
inhalation (external) short-term exposure
Exposure estimate:
2.083 mg/m³
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Type of exposure:
dermal (external) long-term exposure
Exposure estimate:
1.372 mg/kg bw/day
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Linked contributing activity:
adbb84a9-50b8-410f-bd42-b1f3f52e980e
Percentage (w/w) of substance in mixture/article:
100
Physical form of the used product:
liquid, including paste/slurry/suspension
Duration of activity (hour/day):
8
Technical and organisational conditions and measures:
General ventilation: Basic general ventilation (1-3 air changes per hour)
Effectiveness (%):
0
Route affected:
inhalation
Technical and organisational conditions and measures:
Occupational Health and Safety Management System: Advanced
Technical and organisational conditions and measures:
Local exhaust ventilation: No
Effectiveness (%):
0
Route affected:
inhalation
Effectiveness (%):
0
Route affected:
dermal
Personal protection equipment:
Respiratory protection: No
Effectiveness (%):
0
Route affected:
inhalation
Personal protection equipment:
Dermal protection: Yes (Chemically resistant gloves conforming to EN374) and (other) appropriate dermal protection
Effectiveness (%):
80
Route affected:
dermal
Place of use:
indoor
Operating temperature (°C):
40
Type of exposure:
inhalation (external) long-term exposure
Exposure estimate:
2.083 mg/m³
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Type of exposure:
inhalation (external) short-term exposure
Exposure estimate:
2.083 mg/m³
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Type of exposure:
dermal (external) long-term exposure
Exposure estimate:
0.068 mg/kg bw/day
Exposure estimation method:
exposure estimation tool
Exposure estimation tool name:
ECETOC TRA workers
Version of exposure estimation tool:
3.0
Reason / purpose for cross-reference:
data waiving: supporting information
Reference

The water solubility of the test substance, was determined using the shake flask method according to OECD Guideline 105 and EU Method A.6 (Wohr, 2019).

Water solubility:
10.2 mg/L
at the temperature of:
20 °C

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion