Registration Dossier

Administrative data

Endpoint:
fish, juvenile growth test
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
Principles of method if other than guideline:
Additionally the growth parameters weight and lenght of the test fish were determined at the start and end of the test (oriantated on the OECD draft guideline: Proposal for : "Fish, juvenile growth test-28 days", March 1992)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material: Alkansulfonate -Na
- Analytical purity: 61 % related on total sulfonate (56 % related on monosulfonate)
- Batch No. E 11 A 03673

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test substance was homogenized by intesive stirring. Then an adequate amount of the homogenized test substance was weighted into test water for the preparation of a stock solutions, all stock solutions were kept under refrigeration to reduce the biological degradation.
Just before the start of the test, adequate volumes of the stock solutions were mixed directly into the test water and the test water were intensively mixed. Then the dosing system and water flow were started.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: rainbow trout
- Strain: Oncorhynchus mykiss Walbaum 1792
- Source: The fish were obtained from Forellenhof Fredelsloh, D-37186 Moringen
- Weight at study initiation: 1.2-1.3 g (first experiment); 2.7 g (second experiment)

FEEDING DURING TEST
- Food type: commercial trout diet (Alleinfutter für Forellenbrut, Aminostart (extr.); Kraftfutterwerke Wesel GmbH)
- Amount: 4% dry weight related to the mean initial fish wet weight, weekly increased during the test by 25 % related to the initial food ration of the week before.
- Frequency: Daily (five portions during the light phase)

Study design

Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d

Test conditions

Hardness:
220-230 mg/L CaCO3 ( first and second experiment)
Test temperature:
13.9-16.8 °C
pH:
7.4-7.8
Dissolved oxygen:
7.8-9.6 mg/L
Nominal and measured concentrations:
Nominal concentrations: Control, 0.063, 0.2, 0.63, 2.0, 6.3, 20.0 mg/L
Measured concentrations: Control, 0.042, 0.14, 0.48, 1.4, 4.7, 17.8 mg/L (approximately 72 % or nominal values)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, fill volume: glass aquaria, 54 × 29 × 39 cm, 48 L test medium
- Type of flow-through: 16 L per hour
- Renewal rate of test solution: eightfold volume exchange per day.
- 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 D-64380 Rossdorf. Before use in the test the total hardness was reduced and the water was filtered through an activated carbon filter.
- Intervals of water quality measurement: three times a week

OTHER TEST CONDITIONS
- Photoperiod: 16/8 hours light-dark cycle
- Light intensity: 50-300 lux

EFFECT PARAMETERS MEASURED: mortality and symptoms (every working day)

Results and discussion

Effect concentrationsopen allclose all
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
0.85 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 61% a.i. in test mat.
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
1.4 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Executive summary:

The toxic effect of the test substance to rainbow trout was investigated in a 28-day flow-through test according to the OECD guideline no. 204. In addition, the fish weight and length at the start and the end of the test were determined (corresponding to OECD draft guideline: Proposal for: "Fish, juvenile growth test - 28 days", March 1992). The test was performed in compliance with GLP.

The nominal test concentrations in a first experiment were 0.063, 0.20, 0.63, 2.0 and 6.3 mg/L and a control. In a second experiment the next higher concentration of nominal 20 mg/L and a control were tested for the determination of a lethal test substance concentration.

The measured test substance concentrations in the analysed test media decreased during the test period from 83–107 % of the nominal values at the start of the test down to 59–69 % of the nominal concentrations after 28 days. this decrease of the actual test concentrations was obviously caused by biological degradation of the test substance. The biological results were related to the nominal as well to the mean test substance concentrations.

The highest concentration tested without observed toxic effects (NOEC) is 2.0 mg/L nominal (mean measured: 1.4 mg/L). The lowest concentration tested with sublethal effects (LOEC) is 6.3 mg/L nominal (mean measured: 4.7 mg/L).

At the test concentrations of 20 mg/L (nominal) all fish were dead after 24 hours. This test concentration was the lowest lethal concentration (LLC) after 28 days, and due to the steep concentration-effect relationship also the 24-hour LC100.