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Diss Factsheets

Administrative data

short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to OECD- and EEC-Guideline under GLP

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:

Test material

Constituent 1
Details on test material:
Identity: TKA 40270 (CGPS 345)
Batch no.: Lot 02243FC7, Op. 1/07
Purity: Confidential information (see Analytical Certificate No. 38291-1)
Expiration date: 01-Oct-2012
Solubility in water: <0.21 mg/L
Aggregate state / physical form at room temperature: Liquid
Color: Colorless to yellow
Storage conditions: Storage at under 18 °C may lead to partial solidification. To reliquify, heat contents to 25-35 °C.Protect from light. (At RCC: At room temperature at about 20 °C, away
from direct sunlight.)

Sampling and analysis

Analytical monitoring:
Details on sampling:
- Concentrations: The measured test item concentrations were 0.57 and 0.42 mg/L
- Sampling method: Standard Solution for Sample Quantification (acetonitrile/water (v/v; 1/1))
- Sample storage conditions before analysis: No

Test solutions

Details on test solutions:
After the 96-hour stirring period, the dispersion of the test item was filtered through a membrane filter (Schleicher & Schuell, Type NC45, pore size
0.45 µm). The undiluted filtrate of the supersaturated stock dispersion with the maximum concentration of dissolved test item was used as the
single concentrated test medium.
The preparation of the test media was performed as far as possible in the dark to avoid photolytic degradation of the test item.
The test method was based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
- Common name: Zebra fish (Brachydanio rerio)
- Strain: Brachydanio rerio
- Source: the fish were raised in the RCC laboratories without any medication
- Feeding during test
- Food type: Tetra Min® Hauptfutter, supplied by TETRA-Werke, 49304 Melle / Germany.

From the acclimated test fish batch, 10 fish were measured at the start of the test. The mean body length of the fish was 3.2 ± 0.13 cm (Mean ± SD),
the mean body wet weight was 0.23 ± 0.02 g (Mean ± SD).
The test method and the test species are recommended by the international test guidelines

Study design

Test type:
Water media type:
brackish water
Total exposure duration:
96 h
Post exposure observation period:
96 hours

Test conditions

125 mg/L as CaCO3
Test temperature:
Dissolved oxygen:
7.8 mg/L; higher than 60% oxygen saturation
Nominal and measured concentrations:
Mean measured concentration: 0.31 mg/L
Details on test conditions:
During this semi-static test, the surviving fish were daily transferred into a clean test vessel with freshly prepared test medium of the corresponding concentration.
Test duration: 96 hours
Water temperature: 21-22 °C during the test period (Table 5)
Light conditions: Since the test item is not stable under light conditions, the test was performed as far as possible in the dark to avoid photolytic degradation of the test item. The aquaria were wrapped with black plastic foil.

Results and discussion

Effect concentrationsopen allclose all
96 h
Dose descriptor:
Effect conc.:
> 100 mg/L
Nominal / measured:
Conc. based on:
other: loading rate
Basis for effect:
mortality (fish)
96 h
Dose descriptor:
Effect conc.:
>= 100 mg/L
Nominal / measured:
Conc. based on:
other: loading rate
Basis for effect:
other: behaviour, mobiliy, morphology
Details on results:
In the control and at the loading rate of 100 mg/L (mean measured concentration of 0.31 mg/L), no mortality or other visible abnormities were determined during the test period of 96 hours.

Applicant's summary and conclusion

Validity criteria fulfilled:
The test item TKA 40270 (CGPS 345) had no acute toxic effects on the test fish up to its solubility limit in test water under the present conditions of the test.
Executive summary:

The 96-hour NOEC and the 96-hour LC0 of TKA 40270 (CGPS 345) were determined to be at the loading rate of at least 100 mg/L (mean measured test item concentration of 0.31 mg/L). The 96-hour NOEC and the 96-hour LC0 might even be higher but loading rates higher than 100 mg/L (equivalent to the mean measured concentration of 0.31 mg/L) were not tested in accordance with the test guidelines. The 96-hour LOEC (lowest concentration with toxic effects), the 96-hour LC50 and the 96-hour LC100 were clearly higher than the loading rate of 100 mg/L (mean measured concentration of 0.31 mg/L). These values could not be quantified due to the absence of toxicity of TKA 40270 (CGPS 345) at the highest concentration which could be dissolved in the test water at the loading rate of 100 mg/L.