Alcohols, C10-16, ethoxylated, sulfosuccinates, disodium salts

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 Dec 2017 - 31 Jan 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Württemberg, Karlsruhe, Germany

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C10-16, ethoxylated, sulfosuccinates, disodium salts

EC Number:

500-232-7

EC Name:

Alcohols, C10-16, ethoxylated, sulfosuccinates, disodium salts

Cas Number:

68815-56-5

Molecular formula:

not applicable to UVCB

IUPAC Name:

Alcohols, C10-16, ethoxylated, sulfosuccinates, disodium salts

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Sampling method: Analytical samples taken at 0 hours (initial value) and 24 hours from fresh and 24 hours and 48 hours from aged test solutions were analysed from control and all test item concentrations. Two sample sets were taken. For each sampling also retain samples were taken.
- Sample storage conditions before analysis: All samples were stored deep frozen until they were transferred to the analytical laboratory.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The necessary amount of test item for preparing the stock solution was weighed on a weighing scoop and transferred to a volumetric flask. Test medium was added up to the bench mark and the solution was homogenised by shaking. Lower test solutions were prepared by dilution of the appropriate solution with test medium. Approx. 50 mL of the prepared solutions were transferred to each test vessel.
- Controls: blank control without the test item
- Eluate: no
- Differential loading: no
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): The solution was clear and transparent after homogenisation by shaking.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: Continuously bred in the laboratory and originally purchased in a healthy condition from the Federal Environment Agency in Berlin/Germany.
- Age: Freshly hatched daphnids less than 24 hours old were used for the test.
- Breeding conditions: Daphnia magna was bred as single culture (1 daphnid per 100 mL) in Elendt M4 medium. The pHvalue of the aerated water was within a range of 6.0 – 9.0. The dissolved oxygen was above 60 % saturation and the total hardness 140 - 250 mg/L (as CaCO3), corresponding to 7.8 - 14°dH. The animals were fed with single cell green algae (Desmodesmus subspicatus, formerly Scenedesmus subspicatus) at least three times a week. The daphnids were reared at a temperature of 20 ± 2 °C in a climatic chamber with 16 hours of illumination and 8 hours of darkness.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

12°dH (214 mg/L as CaCO3)

Test temperature:

19.5 ± 0.4

pH:

7.84 ± 0.10

Dissolved oxygen:

8.9 ± 0.2 mg O2/L

Nominal and measured concentrations:

nominal: 10.0, 4.55, 2.07, 0.939, 0.427 mg/L, and control
measured: 9.07-10.1, 4.28-4.22, 1.92-2.08, 0.849-0.930, 0.382-0.392 mg/L, and < LOD

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass vessel (100 mL), were filled up with ~ 50 mL test solution. The test units were covered with a glass plate.
- Renewal rate of test solution: The test solutions were freshly prepared at 0 and 24 h.
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Elendt M4 standard medium was used as test medium. At test initiation the pH-value of the control (untreated test medium) was 7.61, the dissolved oxygen concentration was 9.0 mg/L and the total hardness was 12°dH (214 mg/L as CaCO3).
- Intervals of water quality measurement: The test temperature and the pH-value as well as the oxygen concentration of the test solutions were measured at all loading rates and control at t = 0 h fresh and t = 24 h from fresh test solutions and after t = 24 h and t = 48 h from aged test solutions in one separate replicate per test item loading rate without test organisms.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours photoperiod /8 hours darkness daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Immobility after 24 and 48 h
- Behavioural changes of daphnids were recorded at 24 and 48 hours after starting the test.

RANGE-FINDING STUDY
- A range finder was performed but the results are not reported.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

4.04 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CI: 3.54 - 4.60 mg/L

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

2.07 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Mortality of control: 0%
- Behavioural changes: No behavioural changes were observed.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No; Test solutions were clear and colorless

Results with reference substance (positive control):

- Results with reference substance valid? yes
- EC50 (24 h) < 1.00 mg/L

Reported statistics and error estimates:

The 24 h and 48 h EC50 are the calculated concentrations where 50 % of the daphnids were immobilised after 24 and 48 hours, respectively. The values for EC50 were determined by Weibull analysis using linear max. likelihood regression. The evaluation of data was performed by ToxRat Professional 3.2.1. The NOEC was established based on the highest concentration at which the immobilisation is not higher than the allowed control immobilisation (≤ 10 % immobilisation).

Any other information on results incl. tables

Table 1: Determined concentration of the test substance

Test item		Test substance	Sampling	Test substance
nominal [mg/L]		nominal [mg/L]	[h]	[mg/L]	% of nominal
Control	0		0 fresh	n.d.	-
			24 aged	n.d.	-
			24 fresh	n.d.	-
			48 aged	n.d.	-
0.427	0.427		0 fresh	0.382	89
			24 aged	0.388	91
			24 fresh	0.388	91
			48 aged	0.392	92
0.939	0.939		0 fresh	0.849	90
			24 aged	0.930	99
			24 fresh	0.892	95
			48 aged	0.915	97
2.07	2.07		0 fresh	2.03	98
			24 aged	2.08	100
			24 fresh	1.92	93
			48 aged	1.94	94
4.55	4.55		0 fresh	4.42	97
			24 aged	4.40	97
			24 fresh	4.28	94
			48 aged	4.30	95
10.0	10.0		0 fresh	9.65	97
			24 aged	10.1	101
			24 fresh	9.07	91
			48 aged	9.50	95

 - = not calculated; n.d. = not detectable; LOQ = 0.0400 mg/L test substance

Table 2:         Results of the test, 48 h values

	Nominal test item concentration [mg/L]
	Control	0.427	0.939	2.07	4.55	10.0
	Immobilised daphnids after 48 h
Group 1	0	0	0	0	5	5
Group 2	0	0	0	0	2	5
Group 3	0	0	0	0	2	5
Group 4	0	0	0	0	5	5
Σ	0	0	0	0	14	20
%	0	0	0	0	70	100

Table 3: Validity criteria

Criterion from the guideline	Outcome	Validity criterion fulfilled
In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized.	Control: 0%	yes
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels.	≥ 8.6 mg/L	yes

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

For further details please refer to “Any other information on results incl. tables”.