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Long-term toxicity to fish

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Endpoint:
fish short-term toxicity test on embryo and sac-fry stages
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
01 Jun 2000- 11 Sep 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Please refer to the Category Approach Justification provided in Section 13
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
Deviations:
no
GLP compliance:
no
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Water samples were collected from all test concentrations on days 0, 1, and 4, and then approximately every 4 days thereafter.
- 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: A concentrated stock solution was prepared, which was then dispersed by the the exposure system. 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: No
Test organisms (species):
Pimephales promelas
Details on test organisms:
Acute Exposures:

TEST ORGANISM
- Common name: Fathead minnow
- Source: In-house cultures or Aquatic Research Organisms, Hampton, NH
- Age at study initiation: 12 weeks
- Length at study initiation: avg length 34 +/- 3mm
- Weight at study initiation: wet weight 0.25 +/- 0.069 g
- Method of breeding: In-house culture

FEEDING DURING TEST
- Food type: not fed during 96 h tests

Chronic Exposures:

TEST ORGANISM
- Common name: Fathead minnow
- Source: In-house cultures or Aquatic Research Organisms, Hampton, NH

METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS
- Numbers of parental fish (i.e. of females used to provide required number of eggs): no data
- Method of collection of fertilised eggs: no data
- Subsequent handling of eggs: Tests were initiated with 22-24 eggs per replicate, and thinned when eyed to no more than 16 organisms per replicate.

POST-HATCH FEEDING
- Start date: no data
- Type/source of feed: brine shrimp nauplii, then Tetra Min fish food
- Amount given: in excess
- Frequency of feeding: Daily
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Remarks on exposure duration:
The study (45133) included both 96 hr acute and 28 day chronic results. Acute and chronic results are detailed in separate robust summaries.
Hardness:
Chronic test - 165-184 mg/L. (Acute test - 200 mg/L)
Test temperature:
Chronic test - 23.5-26.5 deg C. (Acute test -22.2-22.7 deg C)
pH:
Chronic test - 7.70-7.95. (Acute test - 8.13-8.14)
Dissolved oxygen:
Chronic test - 7.6-7.8 mg/L. (Acute test - 7.6 mg/L)
Nominal and measured concentrations:
For the Chronic test, Nominal test concentrations were: 0, 0.20, 0.29, 0.41, 0.58, and 0.83 mg a.i./L. Measured concentrations were 0, 0.18, 0.29, 0.42, 0.55, and 0.80 mg/L. Measured concentrations were 90-102% of nominal. Results are based on measured concentrations.

For the Acute test, Nominal test concentrations were: 0, 0.75, 1.5, 3.0, 6.0, and 12 mg a.i./L. Measured concentrations were 0, 0.64, 1.6, 3.3, 6.6, and 13 mg/L. Measured concentrations were 85-110% of nominal. Results are based on measured concentrations.
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: open
- Material: 1 or 2 L beakers depending on size of fish, 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, depending on test
- No. of fertilized eggs/embryos per vessel: 22-24 eggs initially per replicate for chronic tests, thinned when eyed to no more than 16 per replicate. (10 fish per replicate for acute tests)
- No. of vessels per concentration (replicates): 4 for chronic test (2 for acute test)
- No. of vessels per control (replicates): 4 for chronic test (2 for acute test)
- Biomass loading rate: not specified

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory blended water (a mixture of well water and deionized water)
- Total organic carbon: N/A
- Particulate matter: N/A
- Metals: N/A
- Pesticides: N/A
- Chlorine: N/A
- Alkalinity: Chronic test - 107-113 mg/L CaCO3 mg/L. (Acute test - 140-144 mg/L CaCO3)
- Ca/mg ratio: N/A
- Conductivity: Chronic test - 380-400 umhos/cm. (Acute test - 440 umhos/cm)
- Culture medium different from test medium: no
- Intervals of water quality measurement: Daily

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light/ 8 h dark

EFFECT PARAMETERS MEASURED: Mortality, daily

RANGE-FINDING STUDY: no
Reference substance (positive control):
no
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
0.18 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
28 d
Dose descriptor:
EC10
Effect conc.:
0.28 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 95% CI 0.065-0.38 mg/L
Duration:
28 d
Dose descriptor:
other: EC20
Effect conc.:
0.4 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 95% CI 0.26- 0.49 mg/L
Duration:
28 d
Dose descriptor:
EC50
Effect conc.:
0.63 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 95% CI 0.53-0.79 mg/L
Details on results:
The 96 hour LC50 (acute test) was 1.7 mg/L (1.5-2.1).
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. Differences between replicates for exposure concentration and growth data were analyzed using ANOVA with Dunnett's Multiple Range Test. ANOVA with the Wilcoxon Two Sample Test or Dunnett's were used for survival hypothesis testing and growth analysis. 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 28 day EC20 of C14E2S (tetradecyl dioxyethylene sulfate, AES) to fathead minnows was 0.40 mg/L, based on measured concentrations. The 28 day NOEC was 0.18 mg/L. Both results are based on survival.
Executive summary:

The 28 -day chronic toxicity of C14E2S (tetradecyl dioxyethylene sulfate, AES) to Fathead minnows was determined in a flow-through early life-stage test. Nominal test concentrations were 0, 0.20, 0.29, 0.41, 0.58, and 0.83 mg a.i./L. Measured concentrations were 90 -102% of nominal, and results are based on measured concentrations.

There were four replicates, each containing about 15 fish, for each test concentration. Chronic exposures were initiated with 24 eggs per replicate, which were thinned when eyed. Mortality was monitored daily. Water samples were taken on days 0, 1, and 4, and then every 4 days to the end of the 33 day chronic test.

The 28 -day EC20 of C14E2S to the Fathead minnow was 0.40 mg/L (0.26 -0.49). The 28 day NOEC was 0.18 mg/L.

Endpoint:
fish, juvenile growth test
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 Apr - 23 Sep 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Please refer to the Category Approach Justification provided in Section 13
Qualifier:
according to
Guideline:
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
Version / remarks:
additionally, the growth parameters weight and length of the test fish were determined at the start and the end of the test (orientated on the OECD Draft Guideline: Proposal for: "Fish, juvenile growth test - 28 days", March 1992
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 215 (Fish, Juvenile Growth Test)
GLP compliance:
yes (incl. certificate)
Remarks:
Hessisches Ministerium für Umwelt, Energie, Jugend, Familie und Gesundheit
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solutionwas prepared for each test concentration every 3 to 5 days. The test substance was homogenized by intensive mixing. Then an aderquate amount of the homogenized test substance was weighed into deoinized water, wich was sterilized and adjusted to a pH of approx. pH . Stock solutions were prepared with nominal concentrations of 1.6 and 16.0 g test substance/L and continuously mixed during the test period.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: rainbow trout
- Source: Forellenhof Fredelsloh, 37186 Moringen, Germany
- Weight at study initiation (range): 1.6 - 2.4 g (first experiment); 1.0 - 1.5 g (second experiment)

FEEDING DURING TEST
- Food type: commercial trout food (Alleinfutter für Forellenbrut, Aminostrat (extr.); Kraftfutterwerk Wesel GmbH, 46483 Wesel, germany
- Amount: 4% dry weight releated to the mean initial fish wet weight
- Frequency: daily
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Hardness:
210 - 230 mg/L as CaCO3
Test temperature:
13.2 - 16.8 °C
pH:
7.4 - 7.9
Dissolved oxygen:
7.1 - 10.6 mg/L
Nominal and measured concentrations:
Nominal test concentrations of the first experiment: control, 0.63, 2.0, 6.3, 20 mg/L
Nominal test concentrations of the second experiment: control, 0.063, 0.2 mg/L
Since in the first experiment the growth of the surviving fish in the lowest test concentration was statistically significantly lower than in the control, the NOEC could not determined. Therefore, a second experiment was performed with the next two lower test concentrations
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, fill volume: one glass-aquarium, 0.54 x 0.29 x 0.395 m, 48 L test medium
- Aeration: slightly (from Day 24 until the end in experiment one, from Day 14 onwards in experiment two)
- Renewal rate of test solution (frequency/flow rate): 20 dosages per hour, 50 to 1000 µlm per dossage
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water of the community 64380 Rossdorf, Germany. before use the total hardness was reduced in the laboratories of RCC and the water was filtered through an activated carbon filter
- Alkalinity: 4.5 - 4.7 mmol/L
- Intervals of water quality measurement: pH, dissolved oxygen and behaviour of the test substance three times per week

OTHER TEST CONDITIONS
- Photoperiod: 16 h light per day
- Light intensity: approx. 50 - 300 Lux

EFFECT PARAMETERS MEASURED: mortality, symptoms of intoxication once each working-day, body length and weight at the start and the end of the test.

RANGE-FINDING STUDY
- Test concentrations:
- Results used to determine the conditions for the definitive study: LC50 = ca. 18 mg/L, LC0 = 10 mg/L and LC100 = 32 mg/L
Reference substance (positive control):
no
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
0.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality and sublethal effects
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
0.14 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
other: mortality and sublethal effects
Endpoint:
fish, juvenile growth test
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to the Category Approach Justification provided in Section 13
Reason / purpose:
read-across source
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
0.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality and sublethal effects
Remarks on result:
other:
Remarks:
Source, key, 68891-38-3, 1995
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
0.14 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
other: mortality and sublethal effects
Remarks on result:
other:
Remarks:
Source, key, 68891-38-3, 1995

Description of key information

NOEC (28 d) for Oncorhynchus mykiss = 0.14 mg/L (measured) related to mortality and sublethal effects (similar to OECD 215)

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater fish:
0.14 mg/L

Additional information

Data on long-term toxic effects to fish are not required for the registered tonnage band. However, read across studies from a comparable AES (C12 -14, 2EO) Na (CAS 68891-38-3) and the pure AES homologue (C14, 2EO) Na (CAS 27731-62-0) are available.

To determine the toxic effect of the AES (C12-14, 2EO) Na a study similar to OECD guideline 215 was performed (Tegewa, 1995). In this test juvenile individuals of rainbow trout (Oncorhynchus mykiss) were exposed to different concentrations of AES (C12 -14, 2EO) Na under flow-through conditions. Mortality and growth were determined over 28 days. Related to mortality and sublethal effects a NOEC of 0.14 mg/L (measured) was determined.

This result is supported by a non-GLP study carried out similar to OECD guideline 210, eggs of fathead minnow (Pimephales promelas) were exposed to the pure AES homologue (C14, 2EO) Na (P&G, 2004). Under flow-through conditions a NOEC (28 d) of 0.18 mg a.i./L (measured) was determined. The NOEC based on mortality.