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Ecotoxicological information

Short-term toxicity to fish

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Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
The test item was used as analytical standard.
Vehicle:
not specified
Details on test solutions:
None
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebrafish
- Source: Zoohaus Schaub, CH-4410 Liestal, Switzerland.
- Length at study initiation (length definition, mean, range and SD):3.0 ±0.1 cm
- Weight at study initiation (mean and range, SD):0.23 ± 0.05 g
- Food type: During holding and acclimatization until one day before the start of the test, the fish were fed with a commercial fish diet (TETRAMIN Hauptfutter, supplied by TETRA Werke, D-49304 Melle, Germany).

ACCLIMATION
- Acclimation period: They were acclimated for one week prior to the test start to the test water and temperature.
- Health during acclimation (any mortality observed): During holding and acclimatization, no fish died in the test fish batch and all fish were healthy.
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
None
Hardness:
2.5 mmol/l (= 250 mg/l) as CaC03
Test temperature:
21-22 °C during the test period
pH:
7.8 to 8.0
Dissolved oxygen:
7.9 mg/l or higher
Salinity:
No data
Nominal and measured concentrations:
Nominal concentration: 100 mg/l
Details on test conditions:
TEST MEDIUM / WATER PARAMETERS
- Alkalinity: 0.8 mmol/l
- Ca/mg ratio:4 :1 (based on molarity)
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 0.003 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
The 96-hour NOEC and the 96-hour LC0 might even be higher but concentrations of the test item above the maximum concentration which could be dissolved or very finely dispersed in the test water were not tested, according to the guidelines.
Results with reference substance (positive control):
None
Reported statistics and error estimates:
None
Sublethal observations / clinical signs:

None

Validity criteria fulfilled:
yes
Conclusions:
The 96-hour NOEC (highest concentration tested without toxic effects after the exposure period of 96 hours), and the 96-hour LC0 of FAT 60253/A to zebrafish were determined to be at least 0.0030 mg/l (loading rate of 100 mg/l).
Executive summary:

The acute toxicity of the test item FAT 60253/A to zebrafish (Brachydanio rerio) was determined in a 96-hour semi-static test with a daily test medium renewal according to the Commission Directive 92/69/EEC, Annex Part C.1 dated December 29, 1992, and the OECD Guideline for Testing of Chemicals No. 203, adopted July 17, 1992. Due to the very low water solubility of the test item, supersaturated stock dispersions of the test item with a loading rate of nominal 100mg/l were continuously stirred at room temperature in the dark over 7 days. Then, the dispersions were filtered. These filtrates were freshly prepared at each test medium renewal during this semi-static test. The undiluted filtrate with the maximum concentration of dissolved and very finely dispersed test item was used as the only test medium. Additionally, a control was tested in parallel. The analytically determined test item concentration in the samples from the freshly prepared test medium (the undiluted filtrate of the supersaturated dispersion) amounted to 0.0039 and 0.0029 mg/l at the start of the test. After the test medium renewal period of one day, the measured concentrations of FAT 60'253/A slightly decreased to 0.0035 and 0.0018 mg/l. This slight decrease of the measured test item concentrations might have been caused by a precipitation of the finely dispersed test item, or due to a loss by adsorption onto the glass surfaces. All biological results are related to the mean measured test item concentration of 0.0030 mg/l (calculated as the average over all measurements in the undiluted filtrate during the test period). In the control and in the undiluted filtrate, no mortality or other signs of intoxication were determined at the test fish during the test period of 96 hours. Therefore, the 96-hour NOEC (highest concentration tested without toxic effects after the exposure period of 96 hours), and the 96-hour LC0 of FAT 60'253/A to zebra fish were determined to be at least 0.0030 mg/l (loading rate of 100 mg/l). The 96-hour NOEC and the 96-hour LC0 might even be higher but concentrations of the test item above the maximum concentration which could be dissolved or very finely dispersed in the test water were not tested, according to the guidelines. The 96-hour LOEC (lowest concentration with toxic effects), the 96-hour LC50 and the 96-hour LC100 were clearly higher than the solubility limit of the test item in the test water. These values could not be quantified, since the test item had no toxic effect up to the highest concentration, which could be dissolved and very finely dispersed in the test water.

Description of key information

The 96-hour NOEC (highest concentration tested without toxic effects after the exposure period of 96 hours), and the 96-hour LC0 of FAT 60253/A to zebrafish were determined to be at least 0.0030 mg/l (loading rate of 100 mg/l).

Key value for chemical safety assessment

Additional information

The acute toxicity of the test item FAT 60253/A to zebra fish (Brachydanio rerio) was determined in a 96-hour semi-static test with a daily test medium renewal according to the Commission Directive 92/69/EEC, Annex Part C.1 dated December 29, 1992, and the OECD Guideline for Testing of Chemicals No. 203, adopted July 17, 1992.


Due to the very low water solubility of the test item, supersaturated stock dispersions of the test item with a loading rate of nominal 100 mg/l were continuously stirred at room temperature in the dark over 7 days. Then, the dispersions were filtered. These filtrates were freshly prepared at each test medium renewal during this semi-static test. The undiluted filtrate with the maximum concentration of dissolved and very finely dispersed test item was used as the only test medium. Additionally, a control was tested in parallel.


The analytically determined test item concentration in the samples from the freshly prepared test medium (the undiluted filtrate of the supersaturated dispersion) amounted to 0.0039 and 0.0029 mg/l at the start of the test. After the test medium renewal period of one day, the measured concentrations of FAT 60253/A slightly decreased to 0.0035 and 0.0018 mg/l. This slight decrease of the measured test item concentrations might have been caused by a precipitation of the finely dispersed test item, or due to a loss by adsorption onto the glass surfaces. All biological results are related to the mean measured test item concentration of 0.0030 mg/l (calculated as the average over all measurements in the undiluted filtrate during the test period). In the control and in the undiluted filtrate, no mortality or other signs of intoxication were determined at the test fish during the test period of 96 hours. Therefore, the 96-hour NOEC (highest concentration tested without toxic effects after the exposure period of 96 hours), and the 96-hour LC0 of FAT 60'253/A to zebrafish were determined to be at least 0.0030 mg/l (loading rate of 100 mg/l). The 96-hour NOEC and the 96-hour LC0 might even be higher but concentrations of the test item above the maximum concentration which could be dissolved or very finely dispersed in the test water were not tested, according to the guidelines. The 96-hour LOEC (lowest concentration with toxic effects), the 96-hour LC50 and the 96-hour LC100 were clearly higher than the solubility limit of the test item in the test water. These values could not be quantified, since the test item had no toxic effect up to the highest concentration, which could be dissolved and very finely dispersed in the test water.