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

Long-term toxicity to fish

Administrative data

Endpoint:

fish early-life stage toxicity

Data waiving:

exposure considerations

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

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

Cross-reference 2

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