Amides, from C8-10-fatty acids and tetraethylenepentamine

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13th June 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

Adopted 13 April 2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: BBD02611V1-1.STEP
- Expiration date of the lot/batch: 6/12/2017

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

Juvenile Daphnia magna (Straus), less than 24 hours old, were taken from healthy parental laboratory cultures, held and maintained at the test facility. The culture was originally obtained from Smithers Viscient, Shawbury, UK.

Test type:

semi-static

Water media type:

other: Elendt M4 Medium

Limit test:

no

Total exposure duration:

48 h

Test temperature:

19.5 - 20.1°C

pH:

7.46 - 7.63 @ 48hours

Dissolved oxygen:

96 - 97 % (9.06 - 9.23mg/l) @ 48 hours

Nominal and measured concentrations:

Nominal concentrations: 0.625, 1.25, 2.5, 5.0 and 10mg/l

Details on test conditions:

Range-finding Test
The range-finding test was conducted at nominal test substance concentrations of 0.10, 1.0, 10 mg/L and 100% saturated solution; the 100% saturated solution concentration was prepared using a (water accommodated fraction) WAF preparation, consisting of ca 24-hour stir, ca 1-hour settling period followed by syphoning of aqueous phase. The test was performed under semi-static test conditions with renewal of test media at 24 hours. A control group was also included. Duplicate test vessels were prepared for the control and each test concentration. Based on nominal concentrations, the results of the range-finding test indicated that the 48-hour EC50 value would be between 1.0 and 10 mg/L.

Definitive Test
Based on the results of the range-finding test, for which the key results only have been reported, the definitive test was conducted at nominal test concentrations of 0.625, 1.25, 2.5, 5.0 and 10 mg/L.
The test was conducted with a semi-static test system design. Media was prepared at 0 and 24 hours.
Glass beakers (100mL) were used as test vessel (filled to approximately 50 mL) with clear petri dish lids. Four replicate test vessels were prepared for the control and for each test concentration.
At the start of the test and at the 24-hour media renewal, the 10 mg/L top concentration was prepared by weighing ca 10 mg of test substance and adding to 1000 mL of Elendt M4 medium. The remaining test concentrations were prepared by serial dilution from the 10 mg/L test concentration. A control treatment was prepared by adding Elendt M4 medium only to the control vessels.
Five juvenile Daphnia magna, less than 24 hours old, were added to each test vessel, using a wide bore pipette to avoid damaging the animals during transfer. The Daphnia magna were not fed during the test.
After 24 and 48 hours, the Daphnia magna in each test vessel were observed for evidence of immobility.
The observations differentiated between mobile and immobile daphnids. An individual was considered immobile if, when the contents of the test vessel were briefly agitated, it did not swim during a 15-second period of observation. In addition, Daphnia magna submerged in the body of the test media and those that were held at the surface of the test media were also recorded.

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 3.58 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

ca. 2.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

Based on nominal concentrations, the 48-hour EC50 value was determined to be 3.58 mg/L. The corresponding No Observed Effect Concentration (NOEC) was considered to be 2.5 mg/L.

Validity criteria fulfilled:

yes

Conclusions:

The 48-hour acute toxicity of TEPA C8-10 FA to the freshwater planktonic crustacean, Daphnia magna, was determined in accordance with the requirements of OECD Chemicals Testing Guideline No. 202 Daphnia sp. Acute Immobilisation Test (adopted April 13 2004).
Based on nominal concentrations, the 48-hour EC50 value was determined to be 3.58 mg/L. The corresponding No Observed Effect Concentration (NOEC) was considered to be 2.5 mg/L.
The validity criteria for control immobility (≤10%) and dissolved oxygen (≥3 mg/L) were both satisfied. The test is therefore considered valid.

Executive summary:

The objective of the study was to determine the 48-hour acute toxicity of TEPA C8-10 FA against the mobility of the freshwater planktonic crustacean, Daphnia magna.

The study was conducted in accordance with the requirements of OECD Chemicals Testing Guideline No. 202 Daphnia sp. Acute Immobilisation Test (adopted April 13 2004).

Based on the results of a range-finding test, for which the key results only have been reported, a definitive test was conducted at nominal test concentrations of 0.625, 1.25, 2.5, 5.0 and 100 mg/L. A control (test medium only) was also included. The test was conducted under semi-static test conditions with media renewal at 24 hours.

At the start of the test, five juvenile Daphnia magna were added to each test vessel. The Daphnids were not fed during the test and were observed at 24 and 48 hours.

For the 0.625, 1.25, 2.5, 5.0, and 10 mg/L test concentrations, analysis of the freshly prepared media at 0 hours showed TOC concentrations to be 1.31, 2.35, 4.49, 9.24 and 18.6 ppm TOC, respectively. Analysis of the freshly-prepared media at 24 hours showed TOC concentrations to be 0.78, 0.58, 1.29, 2.96 and 6.35 ppm TOC. At 24 hours, analysis of the old, pooled media showed TOC concentrations of 0.51, 0.84, 1.61, 6.27 and 13.7 ppm TOC. At 48, hours analysis of the old, pooled media showed TOC concentrations of 0.30, 0.65, 1.37, 3.13 and 6.38 ppm TOC, respectively.

After 48 hours exposure during the definitive phase, all Daphnids at Control, 0.625, 1.25 and 2.5 mg/L nominal exposure concentrations were observed as mobile. All Daphnids observed at 5.0 and 10 mg/L nominal exposure concentrations were observed as immobile.

The ¹EC50 values, the corresponding ²NOEC and ³LOEC values are presented in the table below. Results are based on nominal exposure concentrations.

Nominal concentration (mg/L)
	24-hour	48-hour
EC50	9.41 (8.66 – NC)	3.58 (2.5 – 5.0)*
NOEC	5	2.5
LOEC	10	5

(x-x)    95% Confidence Limits

NC       Not calculable

*           Due to 100% inhibition observed at 5 mg/L and 0% mortality observed at 2.5 mg/L these were considered the confidence limits at 48 hours as CETIS cannot calculate confidence limits without partial mortality

¹ Concentration resulting in 50% immobility of exposed Daphnia magna

² No observed effect concentration

³ Lowest observed effect concentration

The validity criteria for control immobility (≤10%) and dissolved oxygen (≥3 mg/L) were both satisfied. The test is therefore considered valid.

Study Number 3201561

Final Report

- 8 -

The validity criteria for control immobility (≤10%) and dissolved oxygen (≥3 mg/L) were both satisfied. The test is therefore considered valid.

Description of key information

The test substance (85029 -55 -6; Aradur 223) was tested in accordance with OECD Test Guideline 202 under GLP conditions and without deviations. The resulting EC50 after 48 hours of contact was determined to be 3.58mg/l based on nominal concentrations.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

3.58 mg/L

Additional information

Supporting studies are available and presented. These are based on structural analogues.