Alcohols, C10-16, ethoxylated, sulfates, mono(hydroxyethyl)ammonium salts

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please refer to the analogue approach justification provided in section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

6.38 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Basis for effect:

mobility

Remarks on result:

other: 95% CI: 5.7 - 12.5 mg/L

Remarks:

Source, key, 157627-92-4 (C12-13), P&G, 2000

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 - 28 Okt 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

1984

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

1992

GLP compliance:

yes

Remarks:

incl. GLP compliance statement by the study director

Analytical monitoring:

yes

Details on sampling:

- Concentrations: samples were taken from all exposure concentrations in all exposure chambers at the start and end of each 24 h cycle
- Sampling method: sampling amount was 25 ml for test solutions =< 1 mg/L, 15 ml for test solutions =< 20 mg/L and 5 mL for test solutions >20 mg/L. All replicate samples were taken in polyethylene bottles
- Replica samples: 2 of each test vessel and test concentration
- Sample storage conditions before analysis: in the deepfreezer (<-15 °C) until analysis

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: every 24 h, a stock solution was prepared by dissolving 663.2 mg test substance in 500 mL of demineralised water to obtain a 1.0 g/L solution (nominal concentration). The stock solutions were magnetic stirred at room temperature for at least 1 hour. The following concentrations were prepared by appropriate dilution of the stock solution with demineralized water: 0, 1.2-2.6-5.7-12.5 and 27.6 mg/L (concentration based on the active component)

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: freshwater flea
- Source: LISEC laboratory culture
- Age at study initiation: <24 h
- Method of breeding: culturing of Daphnia magna was done according to standard operation procedure of LISEC (ETX/SOP/WE-01-3). Parent daphnids were about three weeks old
- Feeding during test: no

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20.9 - 21.0 °C

pH:

7.91 - 8.09

Dissolved oxygen:

8.32 - 8.80 mg/L

Nominal and measured concentrations:

Nominal concentrations: 0, 1.2, 2.6, 5.7, 12.5, 27.6 mg/L
Measured concentrations (geometric mean): 0.01, 0.98, 2.16, 4.63, 9.67, 21.26 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 50 mL borosilicate glass beakers
- Volume of test solution: 50 mL of test solution per vessel
- Renewal rate of test solution: renewed after 24 h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels for control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: the dilution water used was reconstituted water (ISO-6341). The pH of the medium was 7.83
- Ca/Mg ratio: CaCl2.2H2O: 294 mg/L - MgSO4.7H2O: 123 mg/L
- Intervals of water quality measurement: temperature, pH and dissolved oxygen concentrations were measured in one test vessel of each test concentration immediately before introduction of the daphnids and at the end of the test (48 h)

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: daily photoperiod of 14 h, uniform illumination was provided by Philips TL-33 lamps yielding at the surface of the test solutions

EFFECT PARAMETERS MEASURED: mobility was determined at 24 and 48 hours

TEST CONCENTRATIONS
- Range finding study: yes, not GLP, results are not included in the final report

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

6.38 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Basis for effect:

mobility

Remarks on result:

other: 95% CI: 5.7 - 12.5 mg/L

Details on results:

- Mortality of control: no

Reported statistics and error estimates:

EC50 values were calculated based on the measured active component of test item geometric mean concentrations using the TOXDAT Multi-mehtod program.

48 h NOEC value was 2.2 mg/L based on the measured active component.

Validity criteria were fulfilled:

- no immobilisation or floating daphnids in the control at the end of the test were observed

- the dissolved oxygen concentrations at the end of the test was always higher than 2 mg/L in each test vessel

- the pH varied not more than 1 unit

Table 1: Immobilisation of the exposed daphnids

		Number of immobilized daphnids		Immobilization (%)
Exposure time (h):		24	48	24	48
Geom. mean of measured concentrations	Replicates
0 mg/L	A	0	0	0	0
	B	0	0
	C	0	0
	D	0	0
1 mg/L	A	0	0	0	0
	B	0	0
	C	0	0
	D	0	0
2.2 mg/L	A	0	0	0	0
	B	0	0
	C	0	0
	D	0	0
4.6 mg/L	A	0	0	0	5
	B	0	0
	C	0	0
	D	0	1
9.7 mg/L	A	2	5	45	100
	B	3	5
	C	2	5
	D	2	5
21.3 mg/L	A	4	5	80	100
	B	3	5
	C	4	5
	D	5	5

Table 2: Analytical results of water samples at the beginning of the test and after 48 h

	sampling time [h]
	0		48
Nominal test concentration a.i. [mg/L]	Measured a.i concentration [mg/L]	Corrected measured a.i. concentration [mg/L]	Measured a.i concentration [mg/L]	Corrected measured a.i. concentration [mg/L]
0	<0.026	<0.029	<0.026	<0.029
1.2	1	1.1	1	1.1
2.6	2	2.5	2	2.4
5.7	5	5.1	5	5.2
12.5	9	10	9	11.1
27.6	22	23.6	22	24.1

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

27 - 29 Sep 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes

Analytical monitoring:

yes

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: waterflea
- Strain: clone 5
- Source: in-house culture
- Age at study initiation: approximately 24 h
- Method of breeding: for breeding, females are maintained in M4 medium in 1 L beakers.
- Feeding during test: none


ACCLIMATION
- Acclimation conditions (same as test or not): M4 medium in 1 L beakers
- Type and amount of food: the amount of food, comprising Scenedesmus subspicatus, is such that the amount added is consumed by the animals.
- Feeding frequency: daily

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20 +/- 1 °C

pH:

7.7 - 7.8

Dissolved oxygen:

7.9 - 8.1 % (there may be a mistake in the study) - mg/L instead of %

Nominal and measured concentrations:

nominal: 0.4, 0.7, 1.2, 2.0, 3.5, 6.0 and 10 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size: round-bottomed test tubes calibrated to 10 mL
- Aeration: none
- No. of organisms per vessel: 5 (+/-1)
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic fresh water: 294 mg/L CaCl2 x 2H2O, 123 mg/L MgSO4 x 7 H2O, 63 mg/L NaHCO3, 5.5 mg/L KCl
- Ca/Mg ratio: 4 : 1


OTHER TEST CONDITIONS
- Photoperiod: darkness

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

7.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

 

Concentration [mg/L]	Test period (h)
	24 h	48 h
	Immobility [%]	Immobility [%]
Control	5	5
0.4	0	0
0.7^*	5	30
1.2	5	0
2.0	0	0
3.5	0	5
6.0	0	0
10	40	100

^*not used for evaluation, because no effect could be

observed in case the next following concentration

Reference 4

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

25 - 27 Aug 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: EG Guideline 92/69/EWG

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes

Analytical monitoring:

yes

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: waterflea
- Strain: Klon 5
- Source: in-house culture
- Age at study initiation (mean and range, SD): neonates
- Method of breeding: isolation of parent daphnids approximately 24 h prior to test start.
- Feeding during test: none

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20 +/- 1 °C

pH:

7.3 - 7.5

Dissolved oxygen:

7.2 - 8.6 mg/L

Nominal and measured concentrations:

nominal: 5, 9, 15, 26, 45, 80 and 135 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: round bottom glasses
- Material, size, headspace, fill volume: filled with 10 mL test medium
- Aeration: none
- No. of organisms per vessel: 5 (20 animals per concentration)
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 2 mL per test organism


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4-medium according to Elendt
- Ca/mg ratio: 4 : 1
- Intervals of water quality measurement: test end

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

7.2 mg/L

Nominal / measured:

nominal

Conc. based on:

other: a-WAS

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

7.4 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Remarks on result:

other: endpoint re-calculated from the data given in the study: endpoint in a-WAS and purity of the test material

Concentration [mg/L]	Test duration
	24 h			48 h
	Number mobile	Number immobile	% immobile	Number mobile	Number immobile	% immobile
Control	20	0	0	20	0	0
5	20	0	0	20	0	0
9	19	1	5	4	16	80
15	7	13	65	0	20	100
26	0	20	100	0	20	100
45	0	20	100	0	20	100
80	0	20	100	0	20	100
135	0	20	100	0	20	100

Description of key information

48h EC50 (Daphnia magna, immobilization) = 6.38 mg a.i./L (measured, OECD 202)

Additional information

The assessment is based on the data currently available. New studies, based on the category review and the final decisions issued for some of the category substances, which are also relevant for this assessment, are currently being conducted. The hazard assessment with respect to aquatic toxicity will be updated once all ongoing studies have been finalised.

No acute invertebrates studies on toxic effects of AES(C10-16, 1-2.5 EO)MEA (CAS 157627-92-4) are available. Therefore, a read-across approach from structural similar AES mixtures was applied.

The key study was performed according to OECD guideline 202 in compliance with GLP requirements (P&G, 2000). Under semi-static conditions water fleas (Daphnia magna) were exposed to AES(C12-13, 0.85EO)MEA (CAS 157627-92-4). After 48h an EC50 of 6.38 mg a.i./L (measured) was determined.

This result is confirmed by two further GLP studies with Daphnia magna conducted according to OECD guideline 202. One study used AES(C12-14, 1-2.5EO)Na (CAS 68891-38-3) as test item and resulted in an EC50 (48h) of 7.4 mg a.i./L (Sasol, 1993). The other study was conducted with AES(C12-14, 1-2.5EO)MIPA (CAS 118774 -72-8) and resulted in an EC50 (48h) of 7.7 mg/L (nominal) (Sasol, 1999).