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Ecotoxicological information

Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January - February 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
Annex V, C1
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
For the aquatic toxicity studies, the test item content of the saturated test medium was determined at the start of the study and after 48 h of exposure using the method of chemical analysis as mentioned below. All samples were concentrated 200 times using solid phase extraction leading to a minimal detectable concentration of 5 µg/l.
Vehicle:
yes
Details on test solutions:
Considering the poor solubility of the test item in water several attempts were made to achieve a homogeneous suspension of the substance in tap water using a solvent. Initially, stock solutions were made up with dimethylsulphoxide (DMSO). The concentrations of P5367 in DMSO were 5 mg/0.1 ml and 88 mg/0.1 ml (stock A and stock B respectively). From these stock solutions 0.1 ml was added to 1 litre tap water. Sonication of the test medium with 5 mg P5367 per litre water resulted in a suspension, but within 24 hours the formation of needle-like particles was observed. Addition of 0.1 ml of stock B resulted in the appearance of a clump of P5367 which could not be dispersed by ultra sonication, and thus was not used for the exposure of fish.
Additionally the test substance P5367 as such was mixed with tap water in a concentration of 10 mg and 20 mg/l. Ultra sonication of these stock
solutions resulted into a suspension consisting of suspended macroscopic particles, but also floating and precipitated particles. The different test media were formulated with these stock solutions. All solutions were prepared within 4 h before the start of the exposures.
Test organisms (species):
Poecilia reticulata
Details on test organisms:
Five fish (length: 1-3 cm) were exposed for 96 h in 1000 ml all glass test vessels. Per test vessel, 10 fish were used.

TEST ORGANISM
- Common name: Guppy (Poecilia reticulata)
- Source: breeded in-house
- Age at study initiation: 4-18 months
- Length at study initiation: 1-3 cm
- Method of breeding: A population of 75 female and 25 male Poecilia reticulata aged 4 to 18 months were reared in all glass aquaria, bonded with silicone rubber, with a volume of 100 l. The room was illuminated for 14 hours a day. The temperature of the water within the aquaria was kept on 23 + 2°C. The aquaria used were provided with vertical grids with a mesh width of 4 by 4 mm, placed in such a way that the volume ratio between the compartment only accessible to the young fish and the compartment the adult fish are kept in was about 2:1. The Standard Water (DSW) contained in the aquaria was filtered continuously (4 l/min.) over synthetic fiber wool (Perlon) and active carbon, while washed fine gravel covered the bottom of the aquaria. The water was aerated continuously and filters and water were replaced once a month if necessary.

FEEDING DURING TEST
- Food type: Tetramin and Tetraphyl: 1:1
- Frequency: once a day
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
None
Hardness:
11.7° DH
Test temperature:
21-22°C
pH:
8.2 +/- 0.2
Dissolved oxygen:
7.0 -8.0 mg/l O2 (= > 60% of the air saturation value)
Salinity:
Freshwater used
Nominal and measured concentrations:
- Range-Finding Test: 0; 0.01; 0.1; 1.0 and 5.0 mg/l
- Main Test: 0 and 1.0 mg/l

Details on test conditions:
See explanations under "test solutions" and "results".
Reference substance (positive control):
yes
Remarks:
Pentachlorphenol was used was used as a reference substance at concentrations of 0.32, 0.56, 1.0 and 1.8 mg/l.; periodical control of sensitivity of fish
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 0.02 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL could not be calculated
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 0.02 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL could not be calculated
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 0.02 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL could not be calculated
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 0.02 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL could not be calculated
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
0.02 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% CL could no be calculated
Details on results:
The maximum soluble concentration (MSC) of P5367 in Milli-Q water was estimated to be 20 ug/l, using HPLC. In an experiment for analysis of the solubility of P5367 in tap water, methanol was used as a vehiculum to suspend 20 ug and 40 ug in 1 liter water respectively. These suspensions were kept in the dark during 24 hours. Then samples were taken to measure the dissolved amount of P5367. It appeared that no dissolved P5367 could be detected. In two seperate pilot tests with P5367 no effects were observed at suspensions of up to 0.1 mg/l. Exposure of fish to a suspension of 1 mg/l resulted in significant mortality. This concentration was tested again in the final test and this result did not appear to be reproducable. From the test media used in final test samples were taken at t = 0 and t = 48 h to measure the amount of dissolved test substance. In these samples no significant concentrations of P5367 could be detected.
It was also tried to dissolve P5367 in tap water using DMSO as a vehiculum. Mixing 5 mg of P5367 in 0.1 ml DMSO with 1 liter water resulted in a cloudy suspension. Within 24 hours the formation of needles with a length of up to a few millimeters was observed. A high rate of mortality (8 out of 10) was seen when fish were exposed in such a suspension for 96 hours. Higher concentration could not be tested since in that case the test substance could not be dispersed by ultra sonication.
It can be concluded that P5367 hardly dissolves in water and appears to be non-toxic to fish when mixed with tap water as such. When added to water, using DMSO as a vehiculum the appearance of needles probably mechanically effects the essential functions of the fish exposed. The mortality during 7 days before the performance of the final experiment with P5367 was less than 5% within the batch of guppies used.
Results with reference substance (positive control):
The results of the periodic positive control experiment indicated that the fish were sensitive.The mortality in the control and the additional control vessels was zero throughout the experiments.
Reported statistics and error estimates:
The probits of the percentages of dead fish and the logarithms of the corresponding concentrations were determined, if possible. Then the LC50 and EC50 values corresponding with the various observation times were calculated with the maximum likelihood estimation method (Finney, 1971). The 96 h concentration response curve concerning either mortality alone or combined with all other effects was plotted and the respective slope was calculated.
Validity criteria fulfilled:
yes
Conclusions:
The LC50 on Poecilia Reticulata (Guppy) was > 1 mg/l (solubility limit of test item incl. solvent), corresponding to > 0.02 mg/l based on the water solubility.
Executive summary:

The study was performed 1987 as GLP-test following EU-testing method C.1 using Poecilia reticulata (Guppy) as test species. The test was performed under semi-static conditions with nominal test item concentrations of 0.01; 0.1; 1.0 and 5.0 mg/l in the range-finding test and 1.0 mg/l in the main study. Due to the very low solubility of the test item, DMSO was added as auxiliary agent to prepare the stock solutions. It was not possible to dissolve the test item at a concentration of 1 mg/l completely, therefore a suspension was tested. There were no effects on fish observed throughout the main study at this nominal concentration, therefore, the LC50 was determined to be above the water solubility of 0.02 mg/l.

Description of key information

The study was performed in 1987 as GLP-test following EU-testing method C.1 using Poecilia reticulata (Guppy) as test species. The test was performed under semi-static conditions with nominal test item concentrations of 0.01, 0.1, 1.0 and 5.0 mg/L in the range-finding test and 1.0 mg/L in the main study. Due to the very low solubility of the test item, DMSO was added as auxiliary agent to prepare the stock solutions. It was not possible to dissolve the test item at a concentration of 1 mg/L completely, therefore a suspension was tested. There were no effects on fish observed throughout the main study at this nominal concentration, therefore, the LC50 was determined to be above the water solubility of 0.02 mg/L. 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
0.02 mg/L

Additional information

Source: GLP-report