Sulfuric acid, mono-C8-18-alkyl esters, magnesium salts, compds. with triethanolamine

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

April 29 - May 6, 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

no GLP

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

other: EPA-600/489/001: Short term methods for measuring the chronic toxicity of effluents and receiving waters to freshwater organisms. Deviations, reliability and validity evaluated against USEPA OPPTS 850.1300 (Daphnid Chronic Toxicity Test).

Deviations:

no

GLP compliance:

no

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Samples were taken from all exposure concentrations on days 1, 4 and 7.
- Sampling method: 50 mL of sample water was removed from each of the replicate stream channels and combined to yield a 100 mL sample for each test concentration. Each sample was treated to three successive MBAS extractions using HPLC grade chloroform. Extracted material was combined and brought to 50 mL with fresh chloroform.
- Sample storage conditions before analysis: Not available

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test material stock solutions were prepared by diluting surfactants in distilled water. Stock mixtures of the test substance were made up in 4-L batches and placed on magnetic stirrers.
- Controls: in dilution water (no test substance)
- Evidence of undissolved material: slight precipitate

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

TEST ORGANISM
- Common name: Ceriodaphnia dubia
- Strain/clone: Not available
- Justification for species other than prescribed by test guideline: Not applicable
- Source: Virginia Polytechnic Institute and State University In-house breeding culture
- Age of parental stock: Not available
- Feeding during test: Yes
- Food type: trialgal diet containing equal portions of Chlamydomonas reinhardtii, Chlamydomonas vulgaris and Selenastrum capricornutum
- Amount: Not available
- Frequency: daily at each renewal


ACCLIMATION
- Acclimation period: Not available
- Acclimation conditions (same as test or not): Not available
- Type and amount of food: trialgal diet containing equal portions of Chlamydomonas reinhardtii, Chlamydomonas vulgaris and Selenastrum capricornutum
- Feeding frequency: Not available
- Health during acclimation (any mortality observed): Not available


METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: not provided

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

7 d

Post exposure observation period:

Not applicable

Hardness:

Not available

Test temperature:

24.9 - 25.3 ºC

pH:

Not available

Dissolved oxygen:

Not available

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal concentrations were 0, 0.05, 0.10, 0.50, 1.0 and 2.0 mg/L
Measured concentrations were 0, 0.02, 0.08, 0.20, 0.80, 1.29 mg/L
The measured concentrations were 40, 80, 40, 80 and 65 % of the nominal concentrations, respectively. Results are based on measured concentrations.

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type: open
- Material: Test chamber is a 35 mL disposable polystyrene cup fitted with 120-µM Nitex mesh on opposite sides
- Aeration: no (test was flow-through)
- Type of flow-through: peristaltic
- Renewal rate of test solution (frequency/flow rate): 360 mL/h
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- Biomass loading rate: 1 daphnid/35 mL


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water as described by Lauth et al (1990)
- Total organic carbon: Not available
- Particulate matter: Not available
- Metals: Not available
- Pesticides: Not available
- Chlorine: Not available
- Alkalinity: Not available
- Ca/mg ratio: Not available
- Conductivity: Not available
- Salinity: Not available
- Culture medium different from test medium: Not available
- Intervals of water quality measurement: days 1,4 and 7 for each exposure concentration


OTHER TEST CONDITIONS
- Adjustment of pH: Not available
- Photoperiod: 16 h light / 8 h dark
- Light intensity: 150 - 400 foot candles


EFFECT PARAMETERS MEASURED: mortality and number of young were assessed daily


RANGE-FINDING STUDY
- Test concentrations: 0-0.38 mg/L (see section 6.1.3., acute test, for details)
- Results used to determine the conditions for the definitive study: Yes, the results of the acute toxicity test were used to establish test concentrations for the chronic test.

Reference substance (positive control):

no

Key result

Duration:

7 d

Dose descriptor:

NOEC

Effect conc.:

0.204 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Duration:

7 d

Dose descriptor:

NOEC

Effect conc.:

1.3 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

7 d

Dose descriptor:

other: IC20

Effect conc.:

0.38 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

not specified

Remarks on result:

other: 0.25 - 0.45

Details on results:

- Mortality of parent animals: See section below (Remarks on results including tables and figures)
- No. of offspring produced per day per female: See section below (Remarks on results including tables and figures)
- Body length and weight of parent animals: Not available
- Type and number of morphological abnormalities: Not available
- Type and number of behavioural abnormalities: Not available
- Number of males and females (parental): Not available
- Time to first brood release or time to hatch: Not available
- Egg development time: Not available
- Brood size: Not available
- Time to sexual maturity: Not available
- Type and magnitude of biochemical changes: Not available
- Other biological observations: Not available
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

One-way analysis of variance was used to determine the NOEC and LOEC effect concentrations. The EC20 was determined using a nonlinear regression approach as described by Bruce and Versteeg (1992). All analyses of variance were conducted using Minitab (1993).

Chronic Effects of C16AS on Ceriodaphnia dubia (7 days; study 66165)

Actual Concentration (mg/L)	% Mortality	Neonates per Female	S.D.
0	10	22.8	4.3
0.02	0	26.5	3.9
0.08	0	23.6	3.2
0.20	0	25.1	1.5
0.80	0	11.8*	4.7
1.29	10	4.7*	2.9

*indicates a significant difference from control

C16AS = C16 -alkyl sulfate

Validity criteria fulfilled:

yes

Remarks:

80% or greater survival in controls, 15 or more young per surviving female

Conclusions:

The 7-day NOEC of C16AS (C16-alkyl sulfate) to Ceriodaphnia dubia was 0.20 mg/L, based on measured concentrations of test substance.

Executive summary:

In a 7-day chronic toxicity study, Ceriodaphnia dubia were exposed to C16AS (C16-alkyl sulfate) at nominal concentrations of 0, 0.05, 0.10, 0.50, 1.0 and 2.0 mg/L, and measured concentrations of 0, 0.02, 0.08, 0.20, 0.80 and 1.29 mg/L under flow-through conditions. The 7-day NOEC based on measured concentrations was 0.20 mg/L, based on the most sensitive endpoint (reproduction). The toxicity study is classified as acceptable and satisfies the validity critieria as stated in the study protocol.

Reference 2

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

16 - 23 March 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

no GLP

Qualifier:

equivalent or similar to guideline

Guideline:

other: EPA-600/489/001: Short term methods for measuring the chronic toxicity of effluents and receiving waters to freshwater organisms. Deviations, reliability and validity evaluated against USEPA OPPTS 850.1300 (Daphnid Chronic Toxicity Test).

Deviations:

no

GLP compliance:

no

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Samples were taken from all exposure concentrations on days 1, 4 and 7.
- Sampling method: 50 mL of sample water was removed from each of the replicate stream channels and combined to yield a 100 mL sample for each test concentration. Each sample was treated to three successive MBAS extractions using HPLC grade chloroform. Extracted material was combined and brought to 50 mL with fresh chloroform.
- Sample storage conditions before analysis: Not available

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test material stock solutions were prepared by diluting surfactants in distilled water. Stock mixtures of the test substance were made up in 4-L batches and placed on magnetic stirrers.
- Controls: in dilution water (without test substance)
- Evidence of undissolved material: none

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

TEST ORGANISM
- Common name: Ceriodaphnia dubia
- Strain/clone: Not available
- Justification for species other than prescribed by test guideline: Not applicable
- Source: Virginia Polytechnic Institute and State University In-house breeding culture
- Feeding during test: Yes
- Food type: trialgal diet containing equal portions of Chlamydomonas reinhardtii, Chlamydomonas vulgaris and Selenastrum capricornutum
- Frequency: daily at each renewal

ACCLIMATION
- Type and amount of food: trialgal diet containing equal portions of Chlamydomonas reinhardtii, Chlamydomonas vulgaris and Selenastrum capricornutum.
- Feeding frequency: Not available
- Health during acclimation (any mortality observed): Not available

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: not provided

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

7 d

Post exposure observation period:

Not applicable

Hardness:

Not available

Test temperature:

24.9 - 25.3 ºC

pH:

Not available

Dissolved oxygen:

Not available

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal concentrations were 0, 0.10, 0.25, 0.50, 1.0 and 2.50 mg/L
Measured concentrations were 0, 0.05, 0.25, 0.39, 1.73 and 2.53 mg/L
The measured concentrations were 50, 100, 78, 173 and 101% of the nominal concentrations, respectively. Results are based on measured concentrations.

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type: open
- Material: Test chamber is a 35 mL disposable polystyrene cup fitted with 120-µM Nitex mesh on opposite sides
- Aeration: no (test was flow-through)
- Type of flow-through: peristaltic
- Renewal rate of test solution (frequency/flow rate): 360 mL/h
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- Biomass loading rate: 1 daphnid/35 mL


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water as described by Lauth et al (1990)
- Intervals of water quality measurement: days 1,4 and 7 for each exposure concentration


OTHER TEST CONDITIONS
- Adjustment of pH: Not available
- Photoperiod: 16 h light / 8 h dark
- Light intensity: 150 - 400 foot candles


EFFECT PARAMETERS MEASURED: mortality and number of young were assessed daily


RANGE-FINDING STUDY
- Test concentrations: 0-6.38 mg/L (see section 6.1.3., acute test, for details)
- Results used to determine the conditions for the definitive study: Yes, the results of the acute toxicity test was used to establish test concentrations for the chronic test.

Reference substance (positive control):

no

Duration:

7 d

Dose descriptor:

NOEC

Effect conc.:

< 0.05 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

7 d

Dose descriptor:

NOEC

Effect conc.:

< 0.05 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Duration:

7 d

Dose descriptor:

other: IC20

Effect conc.:

0.18 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

not specified

Remarks on result:

other: 0.04 - 0.32

Details on results:

- Mortality of parent animals: See section below (Remarks on results including tables and figures)
- No. of offspring produced per day per female: See section below (Remarks on results including tables and figures)
- Body length and weight of parent animals: Not available
- Type and number of morphological abnormalities: Not available
- Type and number of behavioural abnormalities: Not available
- Number of males and females (parental): Not available
- Time to first brood release or time to hatch: Not available
- Egg development time: Not available
- Brood size: not available
- Time to sexual maturity: Not available
- Type and magnitude of biochemical changes: Not available
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

One-way analysis of variance was used to determine the NOEC and LOEC effect concentrations. The EC20 was determined using a nonlinear regression approach as described by Bruce and Versteeg (1992). All analyses of variance were conducted using Minitab (1993).

Chronic Effects of C14AS on Ceriodaphnia dubia (7 days; study 66165)

Actual Concentration (mg/L)	% Mortality	Neonates per Female	S.D.
0	0	25.3	4.5
0.05	0	20.5*	3.2
0.25	0	19.4*	2.0
0.39	0	15.9*	3.4
1.73	0	6.4*	3.1
2.5360	60	0*	0

*indicates a significant difference from control

C14AS = C14 -alkyl sulfate

Validity criteria fulfilled:

yes

Remarks:

80% or greater survival in controls, 15 or more young per surviving female

Conclusions:

The 7-day NOEC of C14AS (C14-alkyl sulfate) to Ceriodaphnia dubia was <0.05 mg/L, based on measured concentrations of test substance.

Executive summary:

In a 7-day chronic toxicity study, Ceriodaphnia dubia were exposed to C14AS (C14-alkyl sulfate) at nominal concentrations of 0, 0.10, 0.25, 0.50, 1.0 and 2.50 mg/L, and measured concentrations of 0, 0.05, 0.25, 0.39, 1.73, and 2.53 mg/L under flow-through conditions. The 7-day NOEC based on measured concentrations was <0.05 mg/L, based on the most sensitive endpoint (reproduction). The toxicity study is classified as acceptable and satisfies the validity critieria as stated in the study protocol.

Reference 3

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: control and all treatments
- Sampling method: The actual concentrations in the freshly prepared test solutions (0, 9 and 16 d) and aged test solutions (2, 12 and 19 d) were determined once a week.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The necessary amount of the substance was weighed into a weighing scoop, transferred to a volumetric flask and filled up to the bench mark with test medium. The lower test item solutions were made with test medium by dilution of the stock solutions. The test solution volume was 50 mL per test vessel. All solutions were prepared freshly on each day of application and renewal of test solutions.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain/clone: Clone V
- Source: originally obtained in a healthy condition from the Federal Environmental Agency in Berlin/Germany
- Age: freshly hatched daphnia of an age between 6 - 24 hours were used for the test
- Feeding during test: yes
- Food type: green algae (Desmodesmus subspicatus)
- Amount: 0.1 mg C/animal/day from day 1 to 7; 0.15 mg C/animal/day from day 8 to 14; 0.2 mg C/animal/day from day 15 to 21
- Frequency: at least three times a week

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Hardness:

11 - 15 °dH

Test temperature:

18.5 – 20.5 °C

pH:

7.15 – 9.08

Dissolved oxygen:

≥ 93 % of air saturation (approx. 9.3 mg O2/L)

Nominal and measured concentrations:

Nominal concentration: 0, 0.320, 1.00, 3.20, 10.0 and 32.0 mg/L
Measured concentration (TWA): 0, 0.079, 0.203, 0.497, 1.40 and 6.86 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beakers
- Size, fill volume: 100 mL, 50 mL
- Aeration: none
- Renewal rate of test solution: 3 times a week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10

TEST MEDIUM / WATER PARAMETERS
- Elendt M4 medium
- Intervals of water quality measurement: Measurements of temperature, pH-value and dissolved oxygen concentration were performed in the freshly prepared and in the aged test solutions of each renewal period (one vessel of each treatment group). The total hardness was determined in the test medium at each renewal.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours photoperiod daily
- Light intensity: ~1500 lux

EFFECT PARAMETERS MEASURED: Mortality of adult animals, number of offspring and number of broods were recorded daily.

Reference substance (positive control):

no

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

1.4 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

6.86 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

32 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Details on results:

The 21d-EC50 (reproduction) is determined to be > 6.86 mg/L (TWA), since only 27.0% inhibition was observed at 6.86 mg/L (TWA). The 21d LOEC (reproduction) was determined to be 6.86 mg/L (TWA), based on biological (but not statistical) significance. The corresponding 21d NOEC (reproduction) was determined to be 1.40 mg/L (TWA).

The mortality of parent animals did not exceed 20 % at the end of the test in the control.

The mean number of live offspring produced per parent animal alive at the end of the test was >= 60 in the control.

Validity criteria fulfilled:

yes

Reference 4

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

3 - 10 Dec 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

other: EPA-600/489/001: Short term methods for measuring the chronic toxicity of effluents and receiving waters to freshwater organisms. Deviations, reliability, and validity evaluated against USEPA OPPTS 850.1300 (Daphnid Chronic Toxicity Test).

Deviations:

no

GLP compliance:

no

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Samples were taken from all exposure concentrations on days 1, 4 and 7.
- Sampling method: 50 mL of sample water was removed from each of the replicate stream channels and combined to yield a 100 mL sample for each test concentration. Each sample was treated to three successive MBAS extractions using HPLC grade chloroform. Extracted material was combined and brought to 50 mL with fresh chloroform.
- Sample storage conditions before analysis: Not available

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test material stock solutions were prepared by diluting surfactants in distilled water. Stock mixtures of the test substance were made up in 4-L batches and placed on magnetic stirrers.
- Controls: in dilution water (no test substance present)
- Evidence of undissolved material: none

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

TEST ORGANISM
- Common name: Ceriodaphnia dubia
- Source: Virginia Polytechnic Institute and State University In-house breeding culture
- Age of parental stock: Not available
- Feeding during test: Yes
- Food type: trialgal diet containing equal portions of Chlamydomonas reinhardtii, Chlamydomonas vulgaris and Selenastrum capricornutum
- Frequency: daily at each renewal

ACCLIMATION
- Type and amount of food: trialgal diet containing equal portions of Chlamydomonas reinhardtii, Chlamydomonas vulgaris and Selenastrum capricornutum.

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

7 d

Post exposure observation period:

Not applicable

Hardness:

114-205 mg CaCO3/L
Alkalinity: 67.3-80.7 mg CaCO3/L

Test temperature:

24.9 - 25.3 ºC

pH:

7.4-8.0

Dissolved oxygen:

6.4-7.5 mg/L

Salinity:

306-576 µmhos/cm (conductivity)

Nominal and measured concentrations:

Nominal concentrations were 0, 0.5, 1.0, 2.0, 4.0 and 8.0 mg/L
Measured concentrations were 0, 0.14, 0.88, 1.20, 4.73, and 8.35 mg/L
The measured concentrations were 28, 88, 60, 118 and 104 % of the nominal concentrations, respectively. Results are based on measured concentrations.

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type: open
- Material: Test chamber is a 35 mL disposable polystyrene cup fitted with 120-µM Nitex mesh on opposite sides
- Aeration: no (test was flow-through)
- Type of flow-through: peristaltic
- Renewal rate of test solution: 360 mL/h
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- Biomass loading rate: 1 daphnid/35 mL


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water as described by Lauth et al (1990)
- Intervals of water quality measurement: days 1,4 and 7 for each exposure concentration


OTHER TEST CONDITIONS
- Adjustment of pH: Not available
- Photoperiod: 16 h light / 8 h dark
- Light intensity: 150 - 400 foot candles


EFFECT PARAMETERS MEASURED: mortality and number of young were assessed daily


RANGE-FINDING STUDY
- Test concentrations: 0-101 mg/L (see section 6.1.3., acute test, for details)
- Results used to determine the conditions for the definitive study: Yes, the results of the acute toxicity test was used to establish test concentrations for the chronic test.

Reference substance (positive control):

no

Key result

Duration:

7 d

Dose descriptor:

NOEC

Effect conc.:

0.88 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Duration:

7 d

Dose descriptor:

NOEC

Effect conc.:

1.2 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

7 d

Dose descriptor:

other: IC20

Effect conc.:

0.94 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

not specified

Remarks on result:

other: 0.70 - 1.05

Details on results:

- Mortality of parent animals: See section below (remarks on results including tables and figures)
- No. of offspring produced per day per female: See section below (remarks on results including tables and figures)
- Effect concentrations exceeding solubility of substance in test medium: none

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

One-way analysis of variance was used to determine the NOEC and LOEC effect concentrations. The EC20 was determined using a nonlinear regression approach as described by Bruce and Versteeg (1992). All analyses of variance were conducted using Minitab (1993).

Chronic Effects of C12AS on Ceriodaphnia dubia (7 days; study 66165)

Actual Concentration (mg/L)	% Mortality	Neonates per Female	S.D.
0	0	16.7	2
0.14	10	23.2	7.5
0.88	0	18	4.6
1.2	10	7.9*	8.3
4.73	100	0*	0
8.35	100	0*	0

*indicates a significant difference from control

C12AS = C12 -alkyl sulfate.

Validity criteria fulfilled:

yes

Remarks:

90% or greater survival in controls, 15 or more young per surviving female

Conclusions:

The 7-day NOEC of C12AS (C12-alkyl sulfate) to Ceriodaphnia dubia was 0.88 mg/L, based on measured concentrations of test substance.

Executive summary:

In a 7-day chronic toxicity study, Ceriodaphnia dubia were exposed to C12-AS (C12-alkyl sulfate) at nominal concentrations of 0, 0.5, 1.0, 2.0, 4.0 and 8.0 mg/L, and measured concentrations of 0, 0.14, 0.88, 1.20, 4.73, and 8.35 mg/L under flow-through conditions. The 7-day NOEC based on measured concentrations was 0.88 mg/L, based on the most sensitive endpoint (reproduction). The toxicity study is classified as acceptable and satisfies the validity critieria as stated in the study protocol.

Reference 5

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Multigeneration lethality test

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Age of parental stock (mean and range, SD): <24 hours

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

40 d

Post exposure observation period:

not relevant

Hardness:

175 ± 15 mg CaCO3/L

pH:

8.1 ± 0.2

Salinity:

Conductivity: 600 ± 100 µmhos/cm

Nominal and measured concentrations:

Nominal: 2, 4, 6 and 8 mg/L

Details on test conditions:

TEST SYSTEM
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): 3 times per week
- No. of organisms per vessel: 15
- No. of vessels per concentration (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted well water
- Alkalinity: 115 ± 10 mg CaCO3/L

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : After 10 days <24 h old offspring from first generation exposed to toxicant for another 10 day mortality study, 3 tests were conducted (4 generations)

Key result

Duration:

40 d

Dose descriptor:

NOEC

Effect conc.:

2 - 4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: Percentage survival through 4 consecutive generations

Remarks on result:

other: Mean of 3 tests

Survival through 4 consecutive generations in %

Generation No.	Control	2.0 mg/L	4.0 mg/L	6.0 mg/L	8.0 mg/l
1	100	100	97	77	0
2	100	100	33	0	-
3	97	100	33	-	-
4	98	100	40	-	-

Reference 6

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

no GLP

Qualifier:

according to guideline

Guideline:

other: proposed procedure for prolonged toxicity testing by UBA Berlin, Texte 16/85 (No. 5), p 133-142

Principles of method if other than guideline:

Method corresponding to OECD Guideline 202, part 2.

GLP compliance:

no

Analytical monitoring:

not specified

Vehicle:

not specified

Test organisms (species):

Daphnia magna

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Details on test conditions:

20 daphnia per test concentration 5/vessel.
Exchange of test solution 3 times/week.

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

16.5 mg/L

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

55.5 mg/L

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Reference 7

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

no GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Version / remarks:

Cited as OECD Guide-line 202, part 2 (Daphnia sp., Reproduction Test)

GLP compliance:

no

Analytical monitoring:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna, young females

Test type:

semi-static

Water media type:

freshwater

Key result

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

5.7 mg/L

Nominal / measured:

not specified

Conc. based on:

not specified

Basis for effect:

reproduction

Remarks on result:

other: 95% confidence limits: 4.5 - 6.5 mg/l

Reference 8

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

other: Cited as OECD Guideline 202, part 2 (Daphnia sp., Reproduction Test)

Deviations:

no

GLP compliance:

no

Analytical monitoring:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

Test organism: Daphnia magna
- Common name: water flea
- Source: no data
- Age: less than 24 h old, females
- Feeding during test: no data

Test type:

semi-static

Water media type:

not specified

Total exposure duration:

21 d

Details on test conditions:

TEST SYSTEM
- Test vessel: no data
- No. of vessels per concentration (replicates): 20
- No. of concentrations tested: 5 + control

OTHER TEST CONDITIONS
- Adjustment of pH: no data
- Photoperiod: 12 hours dark/ 12 hours light

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

4.2 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: 1.9 - 6.2 mg/L

Reference 9

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

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

Remarks:

constituents of the target substance

Adequacy of study:

weight of evidence

Justification for type of information:

The read across justification document is attached in chapter 13.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

1.4 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: CAS 142-87-0 (C10)

Key result

Duration:

7 d

Dose descriptor:

NOEC

Effect conc.:

0.88 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Remarks on result:

other: CAS 151-21-3 (C12)

Duration:

40 d

Dose descriptor:

NOEC

Effect conc.:

>= 2 - <= 4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: survival (4 consecutive generations)

Remarks on result:

other: CAS 151-21-3 (C12)

Key result

Duration:

7 d

Dose descriptor:

NOEC

Effect conc.:

< 0.05 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Remarks on result:

other: CAS 1191-50-0 (C14)

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

5.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: CAS 85586-07-8 (C12-14)

Key result

Duration:

7 d

Dose descriptor:

NOEC

Effect conc.:

0.204 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Remarks on result:

other: CAS 1120-01-0 (C16)

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

16.5 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

reproduction

Remarks on result:

other: CAS 68955-20-4 (C16-18)

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

4.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: CAS 68955-20-4 (C16-18)

Description of key information

NOEC(21d) = 0.22 mg/L for reproduction of Daphnia magna(based on homologues)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.22 mg/L

Additional information

Since no reliable chronic test involving aquatic invertebrates is available for C8-18AS Mg & TEA (CAS 85586-38-5), in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5, a read-across to

to the constituents was conducted. Read-across data from the following alkyl sulfates were used: C10AS Na (CAS 142-87-0), C12AS Na (CAS 151-21-3), C14AS Na (CAS 1191-50-0) and C12-14AS Na (CAS 85586-07-8), C16AS Na (CAS 1120-01-0) and C16-18As Na (CAS 68955-20-4). Toxicity of alkyl sulfates is dependent on the carbon chain length and the influence of the counter ion can be neglected. For the PNEC calculation, the NOEC value derived based on the NOECs available for the pure homologues C10AS Na, C12AS Na, C14AS Na and C16AS Na was used. The test results with the C18AS Na (CAS 1120-04-3) were disregarded and are not presented. Since C18AS Na is insoluble in calcium-containing water (i.e., Ceriodaphnia test waters), the effects (NOEC = 0.602 mg/L) are due to physical interactions, not the classic uptake into the organism and then elicit toxicity. The read across justification document is attached in chapter 13.

One long-term toxicity study with Daphnia magna is available for C10AS Na (CAS 142-87-0; BASF 2012). The test was performed according to OECD 211 guideline and GLP principles. Daphnids were exposed for 21 days under semi-static conditions to six test concentrations up to 6.86 mg/L (measured concentration). The followed parameters included mortality and reproduction of daphnids. The NOEC value based on the reproduction was determined to be 1.4 mg/L and the LOEC value as 6.86 mg/L (measured concentrations). 

A non-GLP, 7-day reproduction toxicity test with Ceriodaphnia dubia performed according to EPA-600/489/001 guideline is available for CAS 151-21-3 (Lauth 1996). Daphnids were exposed under flow-through conditions to five test concentrations up to 8 mg/L. Analytical check of test concentration proved that the nominal concentrations were in agreement with the measured ones. Mortality and reproduction were evaluated daily. The NOEC value determined after 7 days of exposure to test substance was 0.88 mg/L (measured concentration). This value was further taken for derivation of NOEC of C8-18AS Mg & TEA (CAS 85586-38-5). The result of Lauth (1996) is supported by a publication from LeBlanc (1982). In this non-GLP, 40-day test Daphnia magna was exposed to CAS 151-21-3 up to 8 mg/L (nominal concentration) over four consecutive generations under semi-static conditions. No special guideline was followed. Offspring daphnids of less than 24 hours of age were collected after 10 days of exposure to the test substance and exposed for another 10 days. This procedure was repeated three times. The overall NOEC ranged from 2 to 4 mg/L (nominal concentrations, analytics not performed). A non-GLP study with C14AS Na (CAS 1191-50-0) was carried according to the EPA-600/489/001 guidance under flow-through conditions (Lauth 1996). Ceriodaphnia dubia was exposed to the test substance up to 2.53 mg/L (measured concentrations) for 7 days. The 7-day NOEC for both reproduction and mortality was below 0.05 mg a.i./L (measured concentration). This value was further used for derivation of NOEC of C8-18AS Mg & TEA (CAS 85586-38-5). Additionally, one non-GLP study performed according to OECD 211 is available for C12-14AS Na (CAS 85586-07-8; Verge 2000). Daphnia magna was exposed to the test substance for 21 days under semi-static conditions. No analytical measurements are available. The 21-day EC50 value was calculated to be 5.7 mg/L (nominal concentration). The key, non-GLP, 7-day reproduction toxicity test with Ceriodaphnia dubia performed according to EPA-600/489/001 guideline is available for C16AS Na (CAS 1120-01-0, Lauth 1996). Daphnids were exposed under flow-through conditions to five test concentrations up to 1.29 mg/L (measured concentrations). Mortality and reproduction were evaluated daily. The NOEC value for reproduction determined after 7 days of exposure to test substance was 0.204 mg/L (measured concentration). This value is further used for derivation of PNEC freshwater value of C8-18AS Mg & TEA (CAS 85586-38-5). Moreover, a long-term test performed according to UBA procedure 16/85, No. 5 with C16-18AS Na (CAS 68955-20-4) is available (Steber 1988). Daphnia magna was exposed for 21 days under semi-static conditions to four test concentrations. The 21-day NOEC value based on reproduction was 16.5 mg/L (nominal concentration). No analytical monitoring of test concentrations is available. An additional non-GLP long term test with C16-18AS Na (CAS 68955-20-4, Verge 2000) was performed according to OECD 202 guideline with Daphnia magna. Daphnids were exposed under semi-static conditions for 21 days to five concentrations of the test substance. No analytical monitoring is available. The 21-day EC50 value of 4.2 mg/L (nominal concentration) is provided.

Since the tested homologues are the constituents of C8-18AS Mg & TEA (CAS 85586-38-5) the data can be used to determine the long-term toxicity of the target substance to aquatic invertebrates.

For the NOEC calculation, chronic data available for the pure homologues C10AS Na (CAS 142-87-0), C12AS Na (CAS 151-21-3) and C14AS Na (CAS 1191-50-0) and C16AS Na (CAS 1120-01-0) were used. Based on the results available from the Ceriodaphnia dubia and Daphnia magna tests, it can be seen that C. dubia is more sensitive to alkyl sulfates than D. magna. Therefore, the NOEC values obtained in C. dubia testing can be used as the conservative values in order to determine a 21-NOEC value of C8-18AS Mg & TEA (CAS 85586-38-5) for D. magna. The composition of C8-18AS Mg & TEA (CAS 85586-38-5) used for the NOEC calculation was based on the normalized mean values of provided ranges: C8: 15.8%, C10: 15.8%, C12: 44.7%, C14: 15.8%, C16: 5.3% and C18: 2.6%. Using the additivity formula stipulated in EC Regulation 1272/2008, the NOEC value of C8-18AS Mg & TEA (CAS 85586-38-5) is 0.22 mg/L. Since the result from aquatic invertebrate tests was the lowest chronic aquatic effect value, the NOEC of 0.22 mg/L was used for the PNEC calculation.