Squalene-rich fraction obtained from vegetable oil deodorizer distillate by transesterification, crystallisation and vacuum distillation

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

long-term toxicity to aquatic invertebrates

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-reference

Cross-reference 1

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

Cross-reference 2

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