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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

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:

96 h

Dose descriptor:

LC50

Effect conc.:

7.1 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Source, key, 68891-38-3, Sasol, 1994

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

18 - 22 Okt 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

(1992)

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

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
- 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 the 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. Test concentrations were prepared by appropriate dilution of the stock solution with dilution water

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Source: commercial supplier 'de Siervis'- Leuven
- Length at study initiation: 3.5 ± 0.2 cm
- Weight at study initiation: 0.566 ± 0.137 g
- Method of breeding: fish were maintained according to standard operation procedure of LISEC (ETX/SOP/WE-03-1)
- Feeding during test: no

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions: same as test

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

178 mg CaCO3/L

Test temperature:

20.1 - 20.5°C

pH:

7.78 - 8.26

Dissolved oxygen:

8.17 - 9.64

Nominal and measured concentrations:

nominal test concentrations: 0, 3.7, 8.1, 17.9, 40, 86 mg/L
measured test concentrations: 0.01, 2.69, 5.85, 14.46, 30.50, 68.01 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 3 L borosilicate glass beakers
- Volume of test solution: 3 L per vessel
- Aeration: moderate bubble - aeration of each test vessel
- Renewal rate of test solution: every 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 1.3 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: the dilution water used for the preparation of test solutions was tap water
- Culture medium different from test medium: no
- Intervals of water quality measurement: temperature, pH and dissolved oxygen concentrations were measured daily in each test vessel

OTHER TEST CONDITIONS
- Photoperiod: a daily photoperiod of appr. 11 h illumination was provided by natural daylight

EFFECT PARAMETERS MEASURED: the fish were inspected after the first 2-4 hours, and daily thereafter for mortality and any other effects

TEST CONCENTRATIONS
- Spacing factor for test concentrations: appr. 2.2
- Range finding study: yes, not GLP, the results are not included in the final report

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

10.42 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% IC: 8.1 - 40 mg/L

Details on results:

- Behavioural abnormalities: no
- Mortality of control: no

Reported statistics and error estimates:

LC50 values were calculated based on the measured active component of test item geometric mean concentrations using the TOXDAT Multi-mehtod program.

Sublethal observations / clinical signs:

The highest nominal test concentration which did not kill the exposed fish within 96 h was 8.1 mg/L.

The lowest nominal concentration causing 100% mortality within 96 h was 40 mg/L.

Validity criteria were fulfilled:

- no mortality among the fish in the control after 96 h

- dissolved oxygen concentrations were always higher than 60% of air saturation value

- the pH varied not more than 1 unit

Table 1: Mortality of the exposed fish

	Number of dead fish				Mortality (%)
Exposure time (h):	24	48	72	96	24	48	72	96
Geom. mean of measured concentrations
0 mg/L	0	0	0	0	0	0	0	0
2.7 mg/L	0	0	0	0	0	0	0	0
5.9 mg/L	0	0	0	0	0	0	0	0
14.5 mg/L	3	5	6	6	43	71	86	86
31 mg/L	7	7	7	7	100	100	100	100
68 mg/L	7	7	7	7	100	100	100	100

Table 2: Analytical results of the water samples at the start of the test and after 96 h

	sampling time [h]
	0		96
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
3.7	2.7	3	2.2	2.4
8.1	5.9	6.5	4.6	5.1
17.9	14.3	15.7	14.2	15.6
40	30.7	33.7	-	-
86	71.6	78.7	-	-

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

10 - 14 Nov 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes

Analytical monitoring:

yes

Vehicle:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish
- Source: West Aquarium, Bad Lauterberg
- Length at study initiation (mean, SD): 3 cm +/- 0.5 cm
- Weight at study initiation (mean): approximately 0.26 g
- Feeding during test: none



ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): maintained in dechlorinated drinking water in 200 L tanks of in 300 L glass tanks at 20 +/- 2 °C with continuous flow.
- Type and amount of food: Trouvit at an amount of approximately 1% of body weight
- Feeding frequency: daily
- Health during acclimation (any mortality observed): the mortality was 7 days before the test start <= 5%

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

approximately 11 °dH

Test temperature:

20 °C - 23 °C

pH:

8.1 - 8.2

Dissolved oxygen:

90% - 103%

Nominal and measured concentrations:

nominal: 2.1, 3.5, 6.0, 10.0 and 17.0 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 45 L tanks
- Aeration: continuous in the test tanks
- Renewal rate of test solution (frequency/flow rate): flow rate: 10 L/h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1



TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water (Gelsenwasser AG)


OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h darkness

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

7.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

Concentration [mg/L]	Test period (h)
	24 h	48 h	72 h	96 h
	Mortality [%]	Mortality [%]	Mortality [%]	Mortality [%]
Control	0	0	0	0
2.1	0	0	0	0
3.5	0	0	0	0
6.0	0	0	0	0
10.0	100	100	100	100
17.0	100	100	100	100

Reference 4

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 - 16 Sep 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: EG Guideline 92/69 C.1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Analytical monitoring:

yes

Vehicle:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish
- Source: West Aquarium, Bad Lauterberg, Germany
- Length at study initiation (length definition, mean, range and SD): 3 cm +/- 0.5 cm
- Weight at study initiation (mean and range, SD): approximately 0.25 g
- Feeding during test
- Food type: no feeding


ACCLIMATION
- Acclimation period: 14 days
- Type and amount of food: TetraMin at a concentration of 1% of body weight
- Feeding frequency: daily
- Health during acclimation (any mortality observed): <= 5% seven days prior test until test start

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

11 ° dH

Test temperature:

19 °C - 20 °C

pH:

8.0 - 8.2

Dissolved oxygen:

80% - 99%

Nominal and measured concentrations:

nominal: 4.3, 6.0, 8.5, 11.8 and 17.1
mean measured (over 96 h): 4.6, 6.8, 13.9, 12.1 and 17.2

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: approximately 45 L aquaria
- Aeration: continuously
- Renewal rate of test solution (frequency/flow rate): approximately 10 L/h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 10



TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water - Gelsenwasser AG


OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h darkness

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

7.1 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Source, key, 68891-38-3, Sasol, 1994

Description of key information

96h LC50 (Danio rerio) = 7.1 mg a.i./L (nominal, OECD 203)

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 fish study on toxic effects of AES (C10-16, 1-2.5 EO)MEA (CAS 157627-92-4) is available. Therefore, a read-across approach from structural similar AES mixtures was applied.

The key study was performed according to OECD guideline 203 in compliance with GLP requirements. Under flow-through conditions zebra fish (Danio rerio) were exposed to AES(C12-14, 1-2.5EO)Na (CAS 68891-38-3). After 96 h a LC50 of 7.1 mg a.i./L (nominal) was determined (Sasol, 1995).

In the second GLP study zebra fish (Danio rerio) were exposed to AES(C12-14, 1-2.5EO)MIPA (CAS 1187742-72-8) according to OECD guideline 203 (Sasol, 1999). The resulting LC50 (96 h) was 7.7 mg a.i./L (nominal).

A further study with the zebra fish (Danio rerio) was conducted with AES(C12-13, 0.85EO)MEA (CAS 157627-92-4) according to OECD guideline 203 and GLP (P&G, 2000). The LC50 (96h) was 10.42 mg a.i./L (measured).