Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Qualifier:
according to
Guideline:
other: Japanese Industrial Standard JIS K0102
Deviations:
not specified
GLP compliance:
no
Analytical monitoring:
yes
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM- Common name: carp, prelarvae, 1 week old- Source: Fish farm in Tokyo- Length at study initiation: 9 mm- Weight at study initiation: 4.4 mg
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
none
Hardness:
25 mg/L as CaCO3
Test temperature:
22 °C
pH:
7.0
Dissolved oxygen:
7.2 mg/L
Nominal and measured concentrations:
not reported
Details on test conditions:
TEST SYSTEM- Test vessel: 800 mL beaker- Renewal rate of test solution: the water was not changed during the experiment- No. of organisms per vessel: 20- No. of vessels per concentration (replicates): 1TEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: softened water was used. EFFECT PARAMETERS MEASURED: mortality
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
13 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

6h-LC50: 190 mg/L

12h-LC50: 180 mg/L
24h-LC50: 180 mg/L

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:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Reason / purpose:
read-across source
Analytical monitoring:
yes
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM- Common name: carp, prelarvae, 1 week old- Source: Fish farm in Tokyo- Length at study initiation: 9 mm- Weight at study initiation: 4.4 mg
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
none
Hardness:
25 mg/L as CaCO3
Test temperature:
22 °C
pH:
7.0
Dissolved oxygen:
7.2 mg/L
Nominal and measured concentrations:
not reported
Details on test conditions:
TEST SYSTEM- Test vessel: 800 mL beaker- Renewal rate of test solution: the water was not changed during the experiment- No. of organisms per vessel: 20- No. of vessels per concentration (replicates): 1TEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: softened water was used. EFFECT PARAMETERS MEASURED: mortality
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
13 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

6h-LC50: 190 mg/L

12h-LC50: 180 mg/L
24h-LC50: 180 mg/L

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
19 Nov - 23 Nov 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Non GLP study. The test has been conducted in 1982 following a company internal test guideline. The test is set up as a screening test for the evaluation of the non-hazardous concentration of chemicals for aquatic organisms. The test principle is to expose fish (B. rerio) to increasing concentrations of a test substance and determine the highest concentration at which none of the fish show signs of toxicity, i.e. where no mortality is observed. 1.000 mg/L was chosen as the highest test substance concentration, and 5 different lower concentrations were tested. This test design resulted in 250 mg/L as the lowest tested concentration. As the results clearly show, the concentrations below 500 mg/L did not cause any fish mortality. Therefore, it can be concluded that C10 alkyl sulfate, Na salt in not acutely toxic to fish at concentrations <= 100 mg/L. Although no blank (without test substance) has been included in the test, the test with 250 mg/L can be regarded as internal control that the animals in the test were healthy. Taking into account that this test is not regarded as a standard OECD 202, but as a tox limit screening test, a Klimisch grade 2 is justifiable.
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Qualifier:
according to
Guideline:
ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)
Deviations:
yes
Remarks:
(No control was conducted)
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM- Common name: zebra fish- Feeding during test: no- Pretreatment: none- Source: no data- Length at study initiation: no dataACCLIMATION- Health during acclimation: mortality <0.1%
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
not relevant
Hardness:
approx. 250 mg CaCO3/L
Test temperature:
22.5 - 23.5 °C
pH:
7.6 - 7.8
Dissolved oxygen:
1.0 - 8.8 mg/L
Nominal and measured concentrations:
Nominal: 250, 360, 500, 700 and 1000 mg product/L
Details on test conditions:
TEST SYSTEM- Test vessel: 10 L fish basins containing 5 L test water- Renewal rate of test solution (frequency/flow rate): daily- No. of organisms per vessel: 10- No. of vessels per concentration (replicates): 10- No. of vessels per control (replicates): 10TEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: standard dilution waterOTHER TEST CONDITIONS- Photoperiod: 16 hours light, 8 hours darknessEFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
150 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
177 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
210 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: none observed

Table 1: Mortality in %

Concentration Incubation time (in h)      

mg product/L

0 6 24 48 96
250 0 0 0 0 0
360 0 0 0 0 0
500 0 0 0 0 0
700 0 0 0 100 100
1000 0 0 100 100 100
Endpoint:
short-term toxicity to fish
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 national standard methods
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Qualifier:
according to
Guideline:
other: Japanese Industrial Standard JIS K0102
Deviations:
not specified
GLP compliance:
no
Analytical monitoring:
yes
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISMS - Age: eggs, within 1 hour at the height of the egg-spawning period
Test type:
semi-static
Water media type:
freshwater
Total exposure duration:
96 h
Hardness:
25 mg/L as CaCO3
Test temperature:
22 °C
pH:
6.7 - 7.1
Dissolved oxygen:
5.8 - 8.8 mg/L
Nominal and measured concentrations:
- Test concentrations: 50, 70, 100 mg/L (values taken from a graphics)
Details on test conditions:
TEST SYSTEM- Test vessel: 80 mL beaker maintained at 22 °C- Renewal rate of test solution (frequency/flow rate): every 24 hours- No. of vessels per concentration (replicates): 200 eggs- No. of vessels per control (replicates): not reportedTEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: softened water was usedEFFECT PARAMETERS MEASURED: egg spawning
Reference substance (positive control):
no
Details on results:
Endpoint: inhibition of hatching rate could not be calculated because hatching rate was  higher at 70 mg/L (ca. 40%) than at 50 mg/L (ca. 12%). No hatching at 100 mg/L.Hatching rate in controls was 87.3%. 
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2000-06-01 to 2003-09-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, followed guideline, with analytics
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:
OECD Guideline 203 (Fish, Acute 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):N/A
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Water samples were collected from all test concentrations on days 0 and 4, at a minimum.- Sampling method: not available- Sample storage conditions before analysis: preserved with 50% methanol
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION- Method: Deionized water was used to prepare the stock solution, and was mixed with the dilution water prior to entering the exposure chambers.- Controls: deionized water/well water blend- Evidence of undissolved material: None
Test organisms (species):
Pimephales promelas
Details on test organisms:
TEST ORGANISM- Common name: Fathead minnow- Source: In-house breeding culture (hatched and raised from eggs)- Age at study initiation: 11 weeks- Length at study initiation (mean, SD): 29 mm (3)- Weight at study initiation (mean, SD): 0.16 g wet weight (0.052)- Method of breeding: Fathead minnow breeders were initially obtained from Aquatic Research Organisms (Hampton, NH). Fish cultures were fed Tetramin daily and supplemented with frozen brine shrimp several times a week.ACCLIMATION- Acclimation period: not specified- Acclimation conditions (same as test or not): Same as test- Type and amount of food: See remarks on breeding above
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
199-200 mg/L as CaCO3
Test temperature:
21.9-22.5 °C
pH:
8.11
Dissolved oxygen:
7.6 mg/L
Nominal and measured concentrations:
Nominal test concentrations were 0, 3, 6, 12, 24, and 48 mg/L. Measured concentrations were 0, 2.0, 4.8, 10, 21, and 40 mg/L. Measured concentrations were 67-88% of nominal.
Details on test conditions:
TEST SYSTEM- Test vessel: 1 or 2 L beakers, with 500 um Nitex mesh covered notch to allow flow-through- Aeration: no (test was flow-through)- Type of flow-through: continuous, regulated by flow controllers- Renewal rate of test solution: 41-76 volume additions per exposure chamber per day, depending on test- No. of organisms per vessel: not specified- No. of vessels per concentration (replicates): 2- No. of vessels per control (replicates): 2TEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: Laboratory blended water (a mixture of well water and deionized water)- Alkalinity: 138-143 mg/L CaCO3 mg/L- Conductivity: 430-440 umhos/cm- Culture medium different from test medium: no- Intervals of water quality measurement: dailyOTHER TEST CONDITIONS- Adjustment of pH: no- Photoperiod: 16 h light/ 8 h darkEFFECT PARAMETERS MEASURED: Mortality was recorded every 24 h throughout the test period.
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
29 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 95% CL: 21-40
Reported statistics and error estimates:
The LC50 values and associated 95% confidence intervals were estimated using the trimmed Spearman-Karber Method or the Binomial Probability Method. EC values and associated 95% confidence intervals were estimated using Probit. All statistics except Spearman-Karber were conducted with SAS 8.01. Statistical significance was established at p<0.05.
Validity criteria fulfilled:
yes
Conclusions:
The 96 hr LC50 of dodecyl sulfate (C12-alkyl sulfate) to fathead minnows was 29 mg/L, based on measured concentration.
Executive summary:

The acute effect of dodecyl sulfate (C12 -alkyl sulfate) on Fathead minnows was evaluated in a continuous flow-through system. Nominal test concentrations were 0, 3, 6, 12, 24, and 48 mg/L. Measured concentrations were 0, 2.0, 4.8, 10, 21, and 40 mg/L. Measured concentrations were 67 -88% of nominal, and test results are based on measured concentrations.

There were two replicates per test concentration, and the test began with 11 -week old fish. Mortality was monitored daily. Results are based on survival.

The 96 hr LC50 of dodecyl sulfate to Fathead minnows was 29 mg/L, based on measured concentrations (21 -40, 95% CL).

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Qualifier:
according to
Guideline:
other: ASTM E-35: Standard practices for conducting acute toxicity tests with fishes, macroinvertebrates and amphibians adopted in 1980
GLP compliance:
not specified
Analytical monitoring:
yes
Details on sampling:
not specified
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION- Method: Test substance was directly added to the test tanks.
Test organisms (species):
other: Menidia menidia, Cyprinodon variegatus
Details on test organisms:
TEST ORGANISM- Common name:Menidia menidia: American silversideCyprinodon variegatus: sheepshead minnow- Source:M. menidia: collected by 15 m beach seine with 6 mm mesh from the Chesapeake Bay at Drum Point near the mouth of the Patuxent riverC. variegatus: purchased from Sea Plantations Inc., Salem, MA, US- Age at study initiation (mean and range, SD):- Length at study initiation (length definition, mean, range and SD):M. menidia: 59.4 ± 5.11 mmC. variegatus: 25.8 ± 2.87 mm- Weight at study initiation (mean and range, SD):M. menidia: 2.15 ± 0.56 gC. variegatus: 0.7 ± 0.27 g- Method of breeding: These two species were held separately in two 893-L (236-gallon) circular tanks which received a continuous flow of ambient bay water (salinity 8-15 %0) for at least one week. After the holding period, both species were acclimated simultaneously in the same two tanks, refilled with filteredbay water at the temperature of 22 °C. The- Feeding during test: noACCLIMATION- Acclimation period: The acclimation period was at least seven days. During the holding and acclimation periods, both species were fed three times a day with Tetramin | Flake Food supplied from a local aquarmm store. Feeding was halted 48 hr before the beginning of a test.
Test type:
static
Water media type:
saltwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
22 ± 1 °C
pH:
7.8 ± 0.18
Dissolved oxygen:
6.4 ± 0.62 mg/L
Salinity:
8 - 15 ‰
Nominal and measured concentrations:
Nominal: not specified
Details on test conditions:
TEST SYSTEM- Test vessel: 19 L tanks with 15 L test volume- Aeration: ~ 100 fine bubbles/min- No. of organisms per vessel: 10- No. of vessels per concentration (replicates): 2- No. of vessels per control (replicates): 2TEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water::synthetic seawater salts adjusted well water- Intervals of water quality measurement: dailyEFFECT PARAMETERS MEASURED: Mortality was recorded every 12h throughout the test period of 96h.
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
4.1 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: Cyprinodon variegatus, 3.83 - 4.47 mg/L
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
2.8 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: Menidia menidia, 2.55 - 2.98 mg/L
Validity criteria fulfilled:
yes
Endpoint:
short-term toxicity to fish
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):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM- Common name: zebra fish- Feeding during test: no- Pretreatment: none- Source: no data- Length at study initiation: no dataACCLIMATION- Health during acclimation: mortality <0.1%
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
not relevant
Hardness:
approx. 250 mg CaCO3/L
Test temperature:
22.5 - 23.5 °C
pH:
7.6 - 7.8
Dissolved oxygen:
1.0 - 8.8 mg/L
Nominal and measured concentrations:
Nominal: 250, 360, 500, 700 and 1000 mg product/L
Details on test conditions:
TEST SYSTEM- Test vessel: 10 L fish basins containing 5 L test water- Renewal rate of test solution (frequency/flow rate): daily- No. of organisms per vessel: 10- No. of vessels per concentration (replicates): 10- No. of vessels per control (replicates): 10TEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: standard dilution waterOTHER TEST CONDITIONS- Photoperiod: 16 hours light, 8 hours darknessEFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
150 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
177 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
210 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: none observed

Table 1: Mortality in %

Concentration Incubation time (in h)      

mg product/L

0 6 24 48 96
250 0 0 0 0 0
360 0 0 0 0 0
500 0 0 0 0 0
700 0 0 0 100 100
1000 0 0 100 100 100
Endpoint:
short-term toxicity to fish
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:
yes
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISMS - Age: eggs, within 1 hour at the height of the egg-spawning period
Test type:
semi-static
Water media type:
freshwater
Total exposure duration:
96 h
Hardness:
25 mg/L as CaCO3
Test temperature:
22 °C
pH:
6.7 - 7.1
Dissolved oxygen:
5.8 - 8.8 mg/L
Nominal and measured concentrations:
- Test concentrations: 50, 70, 100 mg/L (values taken from a graphics)
Details on test conditions:
TEST SYSTEM- Test vessel: 80 mL beaker maintained at 22 °C- Renewal rate of test solution (frequency/flow rate): every 24 hours- No. of vessels per concentration (replicates): 200 eggs- No. of vessels per control (replicates): not reportedTEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: softened water was usedEFFECT PARAMETERS MEASURED: egg spawning
Reference substance (positive control):
no
Details on results:
Endpoint: inhibition of hatching rate could not be calculated because hatching rate was  higher at 70 mg/L (ca. 40%) than at 50 mg/L (ca. 12%). No hatching at 100 mg/L.Hatching rate in controls was 87.3%. 
Endpoint:
short-term toxicity to fish
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:
yes
Details on sampling:
- Concentrations: Water samples were collected from all test concentrations on days 0 and 4, at a minimum.- Sampling method: not available- Sample storage conditions before analysis: preserved with 50% methanol
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION- Method: Deionized water was used to prepare the stock solution, and was mixed with the dilution water prior to entering the exposure chambers.- Controls: deionized water/well water blend- Evidence of undissolved material: None
Test organisms (species):
Pimephales promelas
Details on test organisms:
TEST ORGANISM- Common name: Fathead minnow- Strain: not available- Source: In-house breeding culture (hatched and raised from eggs)- Age at study initiation: 11 weeks- Length at study initiation (mean, SD): 29 mm (3)- Weight at study initiation (mean, SD): 0.16 g wet weight (0.052)- Method of breeding: Fathead minnow breeders were initially obtained from Aquatic Research Organisms (Hampton, NH). Fish cultures were fed Tetramin daily and supplemented with frozen brine shrimp several times a week.- Feeding during test: not availableACCLIMATION- Acclimation period: not specified- Acclimation conditions (same as test or not): Same as test- Type and amount of food: See remarks on breeding above- Health during acclimation (any mortality observed): N/A
Test type:
flow-through
Water media type:
freshwater
Total exposure duration:
96 h
Post exposure observation period:
N/A
Hardness:
199-200 mg/L as CaCO3
Test temperature:
21.9-22.5 ºC
pH:
8.11
Dissolved oxygen:
7.6
Salinity:
N/A
Nominal and measured concentrations:
Nominal test concentrations were 0, 3, 6, 12, 24, and 48 mg/L. Measured concentrations were 0, 2.0, 4.8, 10, 21, and 40 mg/L. Measured concentrations were 67-88% of nominal. Results are based on measured concentrations.
Details on test conditions:
TEST SYSTEM- Test vessel:- Type: open- Material: 1 or 2 L beakers, with 500 um Nitex mesh covered notch to allow flow-through- Aeration: no (test was flow-through)- Type of flow-through: continuous, regulated by flow controllers- Renewal rate of test solution: 41-76 volume additions per exposure chamber per day, depending on test- No. of organisms per vessel: not specified- No. of vessels per concentration (replicates): 2- No. of vessels per control (replicates): 2TEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: Laboratory blended water (a mixture of well water and deionized water)- Alkalinity: 138-143 mg/L CaCO3 mg/L- Conductivity: 430-440 umhos/cm- Culture medium different from test medium: no- Intervals of water quality measurement: DailyOTHER TEST CONDITIONS- Adjustment of pH: no- Photoperiod: 16 h light/ 8 h darkEFFECT PARAMETERS MEASURED: Mortality, every 24 hRANGE-FINDING STUDY: no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
29 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 95% CL: 21-40
Details on results:
N/A
Results with reference substance (positive control):
N/A
Reported statistics and error estimates:
The LC50 values and associated 95% confidence intervals were estimated using the trimmed Spearman-Karber Method or the Binomial Probability Method. EC values and associated 95% confidence intervals were estimated using Probit. All statistics except Spearman-Karber were conducted with SAS 8.01. Statistical significance was established at p<0.05.

N/A

Validity criteria fulfilled:
yes
Conclusions:
The 96 hr LC50 of dodecyl sulfate (C12-alkyl sulfate) to fathead minnows was 29 mg/L, based on measured concentration.
Executive summary:

The acute effect of dodecyl sulfate (C12 -alkyl sulfate) on Fathead minnows was evaluated in a continuous flow-through system. Nominal test concentrations were 0, 3, 6, 12, 24, and 48 mg/L. Measured concentrations were 0, 2.0, 4.8, 10, 21, and 40 mg/L. Measured concentrations were 67 -88% of nominal, and test results are based on measured concentrations.

There were two replicates per test concentration, and the test began with 11 -week old fish. Mortality was monitored daily. Results are based on survival.

The 96 hr LC50 of dodecyl sulfate to Fathead minnows was 29 mg/L, based on measured concentrations (21 -40, 95% CL).

Endpoint:
short-term toxicity to fish
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:
yes
Vehicle:
no
Test organisms (species):
Cyprinodon variegatus
Test type:
static
Water media type:
brackish water
Limit test:
no
Total exposure duration:
96 h
Salinity:
10 ‰
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
4.1 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 3.83-4.47 (95% C.L.)

Most mortality was observed within first 48 h of exposure. Significant decay of test substance took place within 2 hours, all test substance was decayed after 48 h.

Description of key information

48h LC50 (Cyprinus carpio pre-larvae, mortality) = 13 mg/L (nominal concentration, Japanese Industrial Standard JIS K0102)
96h LC50 (Cyprinodon variegates) = 4.1 mg/L (measured concentration, marine water, ASTM E-35 1980)

Key value for chemical safety assessment

LC50 for freshwater fish:
13 mg/L
LC50 for marine water fish:
4.1 mg/L

Additional information

Since no reliable short-term fish test 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). Toxicity of alkyl sulfates is dependent on the carbon chain length.

In the key, non-GLP study performed according to Japanese Industrial Standard JIS K0102, 1-week old carp pre-larvae (Cyprinus carpio) were exposed to C10AS Na for 48 hours under static conditions (Kikuchi et al., 1976a). Based on pre-larvae mortality, the LC50 value was 13 mg/L (nominal concentrations in agreement with the measured ones). Since the obtained value was the most critical, it is considered as a reliable short-term LC50 value for fish.

The same authors provide supporting information on Carp egg hatching rate influenced by C10AS Na (Kikuchi et al., 1976b). Fish eggs were exposed for 96 hours to the test concentrations up to 100 mg/L (nominal concentrations in agreement with the measured ones). The study followed Japanese Industrial Standard JIS K0102. Inhibition of hatching rate could not be calculated because hatching rate was higher at 70 mg/L (ca. 40%) than at 50 mg/L (ca. 12%). No hatching at 100 mg/L was observed. Hatching rate in the control group was 87.3%.

Another supporting, non-GLP study performed according to ISO 7346-1 guidance is available (BASF, 2001). Mortality of zebrafish (Danio rerio) was determined after 24, 48, 72 and 96 hours of exposure to five test concentrations up to 1000 mg/L of product containing 30% of active ingredient and 70% water (nominal concentrations). Analytical monitoring was not performed. The results showed that the 96-hour LC50 value was 177 mg a.i./L (nominal concentration).

Toxic effects of C12AS Na (CAS 151-21-3) to fathead minnow (Pimephales promelas) were studied in a non-GLP test performed similar to OECD guideline 203 (P&G, 2004). Fish were exposed in a flow-through system to five test concentrations up to 48 mg/L of nominal concentration, corresponding to 40 mg/L of measured concentration. Mortality of fish was evaluated every 24 hours. The test substance was determined to have an 96-hour LC50 of 29 mg/L (measured concentration). Moreover, the short term effects of C12AS Na (CAS 151-21-3) were studied on the marine sheepshead minnow Cyprinodon variegatus (Roberts et al., 1982). This non-GLP test was performed according to ASTM E-35 (1980) method. Fish were exposed to five test concentrations in brackish water (salinity 10 ‰) under static conditions. The 96h LC50 value of 4.1 mg/L was determined (measured concentration).

Due to structural and property similarities with the tested category members, it can be concluded that the above results apply also to C9-12AS Na. The LC50 value to freshwater fish is assumed to be 13 mg/L and to marine fish 4.1 mg/L.