Fatty acids, C18-unsatd., reaction products with diethylenetriamine, acetates

Sediment toxicity

Description of key information

3 sediment phase studies (conducted using Corophium volutator and Corophium sp.), using marine sediment, have been assessed.
The resulting LC50 and NOEC results (based on mortality) were: 
- 10 day LC50: 1148 mg/kg dry weight sediment, NOEC 65 mg/kg dry weight sediment
- 10 day LC50: 1067 mg/kg dry weight sediment, NOEC 254 mg/kg dry weight sediment
- 10 day LC50: 1376 mg/kg dry weight sediment, NOEC 387 mg/kg dry weight sediment
The results of these studies have been used in a 'geometric mean' approach (see discussion) to calculate the key LC50 value (based on growth rate).

Key value for chemical safety assessment

EC50 or LC50 for marine water sediment:

1 190 mg/kg sediment dw

EC10, LC10 or NOEC for marine water sediment:

185 mg/kg sediment dw

Additional information

Marine Data:

Three marine phase sediment studies with Corophium volutator and Corophium sp.have been conducted on the substance (Fatty acids, C18 unsaturated, reaction products with diethylenetriamine, acetate salts), the results of which are discussed below:

Study reference: Frederiksen M T (2007)

The Corophium volutator sediment reworker test was performed on the test substance BL5060, based on the draft from 1994 of the Paris Commission Guideline: "MAFF/ERT Harmonised Protocol. A Sediment Bioassay using an amphipod Corophium sp."

The test substance BL5060 was supplied as a 25.82% solution in water (i.e. activie ingredient 25.82%).

 

Lethality testing with the sediment reworker amphipod Corophium volutator was performed.

Adult Corophium were exposed to sediment spiked with the test substance for a period of 10days. The test was performed using 5 test dosages (50, 252, 877, 3005 and 10005 mg/kg (whole product) dry weight sediment, with 3 parallels for each dosage and (number) controls. Ten animals, 5 mm or greater in length, were used in each parallel. The water quality were monitored throughout the test.

 

The LC50 value for the test substance was found to be 4447 mg/kg (based on whole product) dry weight of sediment after 10 days. The 95% confidence range was 2741 - 8682 mg/kg (dry weight) of sediment. The NOEC value was 252 mg/kg (based on whole product) dry weight of sediment.

The LC50 value for the test substance was found to be 1148 mg/kg (based on active ingredient) dry weight of sediment after 10 days. The NOEC value was 65 mg/kg (based on active ingredient) dry weight of sediment.

 In the test, the control parameters for temperature, dissolved oxygen, pH and salinity were within the recommended ranges and the test considered to be valid.

Study reference: Beslagic (2006)

The Corophium volutator sediment reworker test was performed on the test substance A01C2 ACETATE, based on the draft from 1994 of the Paris Commission Guideline: "MAFF/ERT Harmonised Protocol. A Sediment Bioassay using an amphipodCorophium sp."

 

Lethality testing with the sediment reworker amphipod Corophium volutator was performed.

Adult Corophium were exposed to sediment spiked with the test substance for a period of 10 days. The test was performed using 5 test dosages (51, 254, 880, 3002 and 10011 mg/kg dry weight sediment), with 3 parallels for each dosage and 5 controls. Ten animals, 5 mm or greater in length, were used in each parallel. The water quality were monitored throughout the test.

 

The LC₅₀value for the test substance was found to be 1067 mg/kg (dry weight) of sediment after 10 days. The 95% confidence range was calculated to be 747 -1520 mg/kg (dry weight) of sediment. The NOEC value was 254 mg/kg (whole product) dry weight of sediment.

In the test, the control parameters for temperature, dissolved oxygen, pH and salinity were within the recommended ranges and the test considered to be valid.

Study reference: Sacker D J (2004)

A study was performed to investigate the toxicity of PR-9026 Salt to Corophium sp. The objective of the study was to determine the 10 day LC₅₀, which is defined as the concentration which kills 50% of the test animals after a 10 day exposure period at 15°C.

The toxicity test was carried according to the procedures given in PARCOM (1994) Paris Commission Guideline: A Sediment Bioassay using an amphipod Corophium sp."

Corophium were exposed to sediment spiked with the test substance for a period of 10days. The test was performed using nominal testing concentrations of 0, 121, 387, 1199, 3815 and 11934 mg/kg dry sediment. 20 Corophium were used per test concentrations.

The highest no-observed (lethal) effect concentration (NOEC) was estimated as 387 mg/kg dry sediment. The lowest observed (lethal) effect concentration (LOEC) was 1199 mg/kg dry sediment. The lowest concentration giving 100% mortality was 38 15mg/kg dry sediment.

The 10 day LC50 was estimated to be 1376 mg/kg dry sediment as determined by the Spearman-Karber Method.

The water quality measurements of the test solutions were within acceptable limits.

One (5%) of the twenty control Corophium died during the study and this represents an acceptable level of health of the test organisms under test conditions.

Key value for sediment toxicity:

As three studies in Corophium (Corophium volutator and Corophium sp)

have been conducted (i.e. there are three validated short-term/acute toxicity studies available for the same species and end-point), it is considered appropriate to calculate a geometric mean result value, to harmonise the results of the separate studies.

This approach is in accordance with ECHA Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment. This guidance states that multiple values for the same endpoint with the same species should be investigated, looking for differences between results. For equivalent data on the same end-point and species, the geometric mean should be used as the input value.

An assessment of the three sediment studies conducted concluded that the results were of a sufficiently similar magnitude to validate a 'geometric mean' approach. The studies were also run to sufficiently similar methods and under sufficiently similar test conditions. The differences in the three results obtained were assessed to be caused by normal biological variation between studies done on the same test substance (studies performed on different batches of test material with minor differences, differences between laboratories etc). It is therefore considered that the 'geometric mean' approach is justified in this case and no one study should be taken as the definitive result.

The key EC50 value (for growth rate) for marine algae is therefore given as the 'geometric mean' result of the three Corophium studies.