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Long-term toxicity to aquatic invertebrates

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Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted in compliance with GLP regulations
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
GLP compliance:
yes (incl. certificate)
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/LMeasured 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): 10TEST 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 luxEFFECT PARAMETERS MEASURED: Mortality of adult animals, number of offspring and number of broods were recorded daily.
Reference substance (positive control):
no
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.

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Dec. 3 - 10, 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Reason / purpose:
reference to same study
Qualifier:
equivalent or similar to
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- 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 renewalACCLIMATION- 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 availableMETHOD 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:
114-205 mg CaCO3/LAlkalinity: 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/LMeasured concentrations were 0, 0.14, 0.88, 1.20, 4.73, and 8.35 mg/LThe measured concentrations were 28, 88, 60, 118 and 104 % of the nominal concentrations, respectively. Results are based on measured concentrations.               4  
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 mLTEST 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 concentrationOTHER TEST CONDITIONS- Adjustment of pH: Not available- Photoperiod: 16 h light / 8 h dark- Light intensity: 150 - 400 foot candlesEFFECT PARAMETERS MEASURED: mortality and number of young were assessed dailyRANGE-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
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)- 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: 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.

Endpoint:
long-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:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Reason / purpose:
read-across source
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/LMeasured 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): 10TEST 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 luxEFFECT PARAMETERS MEASURED: Mortality of adult animals, number of offspring and number of broods were recorded daily.
Reference substance (positive control):
no
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.

Endpoint:
long-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:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Reason / purpose:
read-across source
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- 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 renewalACCLIMATION- 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/LAlkalinity: 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/LMeasured concentrations were 0, 0.14, 0.88, 1.20, 4.73, and 8.35 mg/LThe 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 mLTEST 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 concentrationOTHER TEST CONDITIONS- Adjustment of pH: Not available- Photoperiod: 16 h light / 8 h dark- Light intensity: 150 - 400 foot candlesEFFECT PARAMETERS MEASURED: mortality and number of young were assessed dailyRANGE-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
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)- 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: 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.

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Long-term (40d; multigeneration) toxicity test with Daphnia magna
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION- Method: A stock solution of the test item was prepared in distilled water. Several concentrations of the test pollutant were prepared by pipetting the appropriate volume of test pollutant stock solution into 500 ml of water and vigorously mixing the solution on a magnetic stirrer.- Evidence of undissolved material (e.g. precipitate, surface film, etc): none
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM- Common name: water flea- Source: obtained from cultures maintained at EG & G Bionomics, Wareham, Massachusetts, USA- Age of parental stock (mean and range, SD): <24 hours- Food type and amount: combination of Strike fish food prepared in water suspension (5 mg/mL) and unicellular green algae Selenastrum capricornutum concentrated to 10E7 cells/mL; ad libitumACCLIMATION- Acclimation conditions (same as test or not): same- Type and amount of food: same as culture daphnids
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
40 d
Hardness:
175 ± 15 mg/L as CaCO3
Test temperature:
not specified
pH:
8.1 ± 0.2
Dissolved oxygen:
not specified
Salinity:
Conductivity: 600 ± 100 µmhos/cm
Nominal and measured concentrations:
Nominal: 2, 4, 6 and 8 mg/L
Details on test conditions:
TEST SYSTEM- Test vessel: 2 L jars containing 1 L of test solution- Aeration: yes- Renewal rate of test solution: 3 times per week- No. of organisms per vessel: 15- No. of vessels per concentration (replicates): 1TEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: reconstituted well water (deionized with an anion-cation resin bed to remove solubilised metals- Alkalinity: 115 ± 10 mg/L as CaCO3EFFECT PARAMETERS MEASURED: survival of parental animals and offspring was recorded 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)
Reference substance (positive control):
no
Duration:
40 d
Dose descriptor:
NOEC
Effect conc.:
2 - 4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: parental survival through 4 consecutive generations (10 d per generation); mean value of 3 tests
Details on results:
Daphnids exposed to nominal concentrations of sodium lauryl sulphate for four consecutive generations exhibited what appeared to be cumulative toxicity from one generation to the next. This test was performed three times in order to substantiate this observation. All daphnids exposed to 8.0 mg/L of sodium lauryl sulphate died during the first generation exposure. A portion of the daphnids exposed to 6.0 mg/L also died, but this reduction in survival was not statistically significant (ANOVA, p = 0.05). Survival of daphnids exposed to 2.0 and 4.0 mg/L of sodium lauryl sulphate wascomparable with survival of control daphnids during the first generation exposure. Survival of second generation daphnids exposed to 4.0 and 6.0mg/L of sodium lauryl sulphate was significantly reduced as compared with survival of control daphnids. All daphnids exposed to 6.0 mg/L of sodium lauryl sulphate died during this generation's exposure. Survival of daphnids exposed to 2.0 mg/L of sodium lauryl sulphate was comparable with control survival. All daphnids exposed to 4.0 mg/L died during the third generation exposure in two of the three tests conducted. Only four offspring were produced by second generation daphnids exposed to 4.0 mg/L in test 3, and all of these offspring survived the third generation exposure. Survival of third generation daphnids exposed to 2.0 mg/L was comparable with survival of control daphnids. Survival of fourth generation daphnids exposed to 4.0 mg/L in test 3 was significantly reduced compared with survival of control daphnids. Survival of fourth generation daphnids exposed to 2.0mg/L was comparable with survival of control daphnids.No adverse effects of sodium lauryl sulphate on reproduction were observed at any treatments containing surviving daphnids for the entire four generation exposure

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

-

-

Validity criteria fulfilled:
not applicable
Conclusions:
A NOEC value of 2 mg/L was determied in a long-term toxicity test (40d; multigeneration) investigating the toxicity of sodium dodecyl sulfate to Daphnia magna.
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Reason / purpose:
read-across source
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): 1TEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: reconstituted well water- Alkalinity: 115 ± 10 mg CaCO3/LEFFECT 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)
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

-

-

Description of key information

21d NOEC (Daphnia magna, reproduction) = 1.1 mg/L

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater invertebrates:
1.1 mg/L

Additional information

Since no reliable chronic test involving aquatic invertebrates is available for C9-12AS Na, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5, a read-across to other structurally related category members was conducted. Read-across data from the following substances were used: C10AS Na (CAS 142-87-0) and C12AS Na (CAS 151-21-3), since toxicity of alkyl sulfates is dependent on the carbon chain length.

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).

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).

Due to structural and property similarities with the tested category member these results also can be used to determine the long-term toxicity to aquatic invertebrates of C9-12AS Na. 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 C9-12AS Na for D. magna. The composition of C9-12AS Na used for the NOEC calculation was based on the normalized mean values of provided ranges: C9: 15%; C10: 35%; C11: 25% and C12: 25%. The NOEC value of used C9AS Na and C10AS Na (CAS 142-87-0) was 1.4 mg/L. NOEC value used for C11AS Na and C12AS Na was 0.88 mg/L. Using the additivity formula stipulated in the EC Regulation 1272/2008, the NOEC of C9-12AS Na (CAS 85049-86-1) is 1.1 mg/L.

Since the result of Daphnia reproduction test was the lowest chronic aquatic effect value, the NOEC of 1.1 mg/L was used for the PNEC calculation.