Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Environmental fate & pathways

Other distribution data

Currently viewing:

Administrative data

Endpoint:
other distribution data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2014
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No standardized method was followed, anyway method and results are well documented and scientifically valid.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The scope of the study was to verify the partition of Galden LMW between the phases sediment/water/air in condition of open system (semi-closed system with a gentle aereation) and therefore to evaluate the feasibility of the ecotoxicological study on invertebrates “Sediment-Water Chironomid toxicity test Using Spiked Sediment” described in OECD 218.
A defined amount of GALDEN LMW was added to artificial sediment, water was then added over the sediment layer. The bottles were closed with a perforated stopper and gentle aereation of the water layer was applied by the mean of a Pasteur across the stopper. Concentration of GALDEN LMW in sediment, water and in headspace was analytically verified at defined sampling times.
GLP compliance:
no
Type of study:
other: distribution in different media
Media:
other: water -sediment -air

Test material

Constituent 1
Reference substance name:
161075-00-0
IUPAC Name:
161075-00-0
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Galden SV 70
- Substance type: pure substance
- Physical state: liquid
- Analytical purity: >99.9%
- Lot/batch No.: Lot. 2021SP
- Stability under test conditions: stable
- Storage condition of test material: refrigerated

Results and discussion

Any other information on results incl. tables

HEAD SPACE concentration

 

% of Test Item in head space

Sampling time

Bottle A

Bottle B

Time 0

36.1 %

8.4 %

24 hour

< LOD

< LOD

48 hour

< LOD

< LOD

7 days

< LOD

< LOD

14 days

< LOD

< LOD

21 days

< LOD

< LOD

 

 

The percentage are expressed as:

mg Galden SV70 in head space x Kdil / mg tot Galden SV70*100

Where:

mg SV70 in head space =conc of test item in head space from cal curve (ug/ml) x head

space ml/1000

 

WATER concentration

At the day 21 sampling, in the water of both the bottles no residual Galden LMW was found.

 

SEDIMENT concentration

At day 21, the concentration of GALDEN LMW in the sediment were:

 

 

% of Test Item

Sampling time

Bottle A

Bottle B

Day 21

0.29 %

0.37 %

 

 

 The two repetitions of the test performed did not give similar and comparable results at time 0.

The values however suggest that Galden LMW is partly in the head space. Nevertheless, after time 0, the substance disappears completely, and no Galden LMW was detected in the gas phase after 24h, 48h, 7d, 14d or 21 d. This observation demonstrates that the test substance is lost from the system via the air flow that leaves the bottles via the septum.

The analysis of the water phase showed that no residual Galden LMW was present in water phase at study termination (day 21). This finding is in line with the very low water solubility determined for Galden LMW.

The analysis of the sediment phase showed only very low concentrations of Galden LMW in the sediment at study termination (day 21). This finding indicates that the test item does not remain significantly in sediment phase.

The validation trial for the extraction and analysis of GALDEN LMW from the sediment showed the test item was transferred almost completely into the gas phase after conditioning at a temperature of 70°C for 30 minutes. The validation trial therefore confirms the validity of the extraction protocol, and the analytical procedure based on GCMS

Applicant's summary and conclusion

Conclusions:
Galden LMW will not remain significantly in water nor sediment. This is consistent with the expected behavior of Galden LMW, as it is known that the substance has a high volatility. The mass balance in the experiment is not complete. It has been hypothized that Galden LMW was lost as a consequence of:
- the 1h mechanically mixing at the beginning of the experiment and,
- the aeration of the system via the Pasteur pipette, which causes a light air flow to leave the experimental bottles via the septum.
Executive summary:

The scope of the study was to verify the partitioning of Galden LMW between the sediment, water and air phases in a semi-closed system with gentle aereation.

The goal of theexperiment was to evaluate the feasibility of an ecotoxicological study on invertebrates “Sediment-Water Chironomid toxicity test Using Spiked Sediment” described in OECD 218.

 

A known amount of Galden LMW was weighted directly in the dry sediment at a concentration of about 1000 mg/Kg and mixed mechanically at 320 rpm speed for 1 hour.

The container was closed with a cap and a silicone septum. Subsequently, water was added over the sediment layer. The bottles were closed with a perforated stopper and gentle aereation of the water layer was applied by the mean of a Pasteur across the stopper.

The concentration of Galden LMW in the air headspace was analytically verified at the beginning of the test and at 24 hours, 48 hours, 7 days, 14 days and 21 days from the beginning of the test. The concentration of Galden LMW in sediment and water was analytically verified at the completion of the test (21 days).

 

At the beginning of the test (time 0), 36.1% of the initial amount of Galden LMW was found in the headspace air of bottle A, and 8.4% of the initial amount of Galden LMW was found in the headspace air of bottle B. On later sampling occasions (24h, 48h, 7d, 14 and 21d), no residual Galden LMW was detected in the gas phase anymore.

At study termination (day 21), the water of both the bottles did not contain any residual Galden LMW.

At study termination (day 21),0.29% of the initial concentration of Galden LMW was found

in the sediment of bottle A and 0.37% was found in the sediment of bottle B.

 

The analysis confirms that Galden LMW will not remain significantly in the water, nor in the sediment. This is consistent with the expected behaviour of Galden LMW, as it is known that the substance has a high volatility. The mass balance in the experiment is not complete.

By the end of the experiment, > 99% of the Galden LMW was lost from the test system.

It has been hypothized that Galden LMW was lost as a consequence of:

- the 1h mechanically mixing at the beginning of the experiment,

- the aeration of the system via the Pasteur pipette, which causes a light air flow to leave the experimental bottles via the septum.