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Ecotoxicological information

Toxicity to microorganisms

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Administrative data

Endpoint:
activated sludge respiration inhibition testing
Data waiving:
exposure considerations
Justification for data waiving:
other:
Justification for type of information:
The test substance, 'Squalene-rich fraction obtained from vegetable oil deodorizer distillate by transesterification, crystallisation and vacuum distillation’ is produced by ADM (in a closed system) in the US and imported into the EU by the further processors (downstream users). Thereafter, the ADM substance is processed by their customers/importers in a dedicated industrial setting, to produce first crude squalene and then in another process to produce pure squalene. Squalene can be marketed as such, or more usually, converted by further processors to squalane. Therefore, the CSR/exposure assessment only covers the use of the test substance, in the manufacture of other substances (e.g., crude squalene, squalane). No other uses are covered in the CSR, since the first processing of the ADM substance to crude squalene is the end use of the ADM substance.

There is no likelihood of exposure of the ADM substance as such to the environment, due to the extensive processing of the substance by the importers in closed reactors for the manufacturing of other substances. There is no evidence of residues of the ADM substance in the end product (confirmed by the customers) or in the STP as the reactors are not flushed with water but are instead sequentially batch filled with new material. Further, there is also no likelihood of exposure to the ADM substance via air, as all reactors at the customer site are closed and there is no release to air.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 24 June 2019 to 03 July 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
yes
Remarks:
As per study director deviation is seen to have no relevant effect on the solubility value.
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
As per study director deviation is seen to have no relevant effect on the solubility value.
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
yes
Remarks:
As per study director deviation is seen to have no relevant effect on the solubility value.
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Key result
Water solubility:
ca. 10.2 mg/L
Conc. based on:
other: saturation mass concentrations of the test substance using TOC - determination.
Temp.:
20 °C
pH:
ca. 6.01
Details on results:
The water solubility of the test item was determined using the shake flask method. The saturation mass concentrations of the test substance were determined using TOC - determination.
The results showed no tendency to increase and met all validity criteria, therefore the study is considered to be valid. Corresponding to the analyses the water solubility was determined to be 10.2 mg/L at a temperature of 20 ± 0.7 °C.
Conclusions:
Under the study conditions, the water solubility of the test substance was determined to be 10.2 mg/L at 20.0 ± 0.7°C.
Executive summary:

A study was conducted to determined the water solubility of the test substance using the shake flask method according to the OECD Guideline 105 and EU Method A.6, in compliance with GLP. Under the study conditions, the water solubility of the test substance was determined to be 10.2 mg/L at 20.0 ± 0.7°C (Wohr, 2019).

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

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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