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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:
Dec. 04,1996 to Jan. 28, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Swiss GLP
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: WP2/96
- Expiration date of the lot/batch: 11/2004

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Solubility of the test substance in the solvent/vehicle: ca. 50 g/l
Analytical monitoring:
yes
Details on sampling:
All test water samples for the analytical determinations were taken from the fish bath at the beginning, after 48 h and at the end of the experiment. The samples were taken out of the test solutions from the approximate center of the test vessels without mixing the medium. The samples were kept at -18 °C to -25 °C until analysis.
Vehicle:
no
Details on test solutions:
0.5 g test substance was dissolved in 200 ml dechlorinated tap water, was homogenized for 5 minutes by ultrasonic treatment and then added up to 0.5 litre. The test concentration was taken from this stock solution.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
The test organism was the species zebra fish (Brachydanio rend) supplied by Charles River Aquatics; Someren, Netherlands. The quality of the zebra fish was checked with an acclimatization time of 47 days in dechlorinated tap water.
For each concentration, 7 fish were used.
Weight (average): 0.22 g
Length (average): 27 mm
Fish age: 136 days
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
179 mg/I CaCO3
Test temperature:
21.2 – 22.1 °C
pH:
7.9-8.6
Dissolved oxygen:
95-98 %
Salinity:
no data
Nominal and measured concentrations:
nominal: 45, 100 mg/l
measured: 10-70 %
Details on test conditions:
The nominal test concentrations for the main test were chosen as 45 and 100 mg/l. Additionally a blank control without test substance was tested.
12 h light, 12 h dark

The fish were exposed in dechlorinated tap water (carbon filter) in 5 litre glass aquaria with a test volume of 2.88 - 2.96 litre (3.0 litre minus 6x 20 ml for analytical samples). During exposure the fish were kept at actually 21.2 - 22.1 °C, slowly aerated, non feeding.
Reference substance (positive control):
not specified
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
33 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 33 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
33 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
In all test concentrations no mortalities of the Fish was observed after the test period of 96 h. Therefore, only the test concentration of 100 mg/l was analysed and was taken for the determination of the results.
In the test aquaria the test solutions were turbid and a small sediment at the bottom of the test vessels was observed after 24 - 96 h.
During the test the actual test concentration in the analysed test medium was in the range of 10 - 70 % of the nominal values. Therefore, the reported results are related to the actual mean concentrations of the test substance.
In the blank control and in the test concentrations no mortalities and no abnormal behaviour of the test fish was observed during the test period of 96 h.
Results with reference substance (positive control):
no data
Reported statistics and error estimates:
The LC50 value after 96 h could not be calculated, but was higher than 33 mg/l.

Determination of the LC values

Due to the results of a pretest FAT 45176/A was tested in concentrations of 45 and 100 mg test substance/I nominal. Additionally a blank control without test substance was tested.

In all test concentrations no mortalities of the Fish was observed after the test period of 96 h. Therefore, only the test concentration of 100 mg/l was analysed and was taken for the determination of the results.

In the test aquaria the test solutions were turbid and a small sediment at the bottom of the test vessels was observed after 24 - 96 h.

During the test the actual test concentration in the analysed test medium was in the range of 10 - 70 % of the nominal values. Therefore, the reported results are related to the actual mean concentrations of the test substance.

In the blank control and in the test concentrations no mortalities and no abnormal behaviour of the test fish was observed during the test period of 96 h.

Validity criteria fulfilled:
yes
Conclusions:
The NOEC and the LC50 value of FAT 45176/A after 96 h was determined to be 33 mg/l.
Executive summary:

FAT 45176/A was tested for its acute toxicity to Zebra fish in a 96 h static test according to OECD 203 and EU C.1 guideline. The study was performed in compliance with the OECD Guideline for Testing of Chemicals, the EEC Guideline and the Procedures and Principles of Good Laboratory Practice.

 

In all test concentrations no mortalities of the Fish was observed after the test period of 96 h. Therefore, only the test concentration of 100 mg/l was analysed and was taken for the determination of the results.

In the test aquaria the test solutions were turbid and a small sediment at the bottom of the test vessels was observed after 24 - 96 h.

During the test the actual test concentration in the analysed test medium was in the range of 10 - 70 % of the nominal values. Therefore, the reported results are related to the actual mean concentrations of the test substance.

In the blank control and in the test concentrations no mortalities and no abnormal behaviour of the test fish was observed during the test period of 96 h.

Therefore, the LC50value is above the water solubility of the test substance in the test medium of 33 mg/L.

In conclusion, the NOEC and the LC0value of FAT 45176/A after 96 h was determined to be 33 mg/l.

Description of key information

The NOEC and the LC50 value of Reactive Orange 136 after 96 h was determined to be 33 mg/l.

Key value for chemical safety assessment

LC50 for freshwater fish:
33 mg/L

Additional information

FAT 45176/A was tested for its acute toxicity to Zebra fish in a 96 h static test according to OECD 203 and EU C.1 guideline. In all test concentrations no mortalities of the Fish was observed after the test period of 96 h. Therefore, only the test concentration of 100 mg/l was analysed and was taken for the determination of the results.

In the test aquaria the test solutions were turbid and a small sediment at the bottom of the test vessels was observed after 24 - 96 h.

During the test the actual test concentration in the analysed test medium was in the range of 10 - 70 % of the nominal values. Therefore, the reported results are related to the actual mean concentrations of the test substance.

In the blank control and in the test concentrations no mortalities and no abnormal behaviour of the test fish was observed during the test period of 96 h.

Therefore, the LC50value is above the water solubility of the test substance in the test medium of 33 mg/L.

In conclusion, the NOEC and the LC0value of FAT 45176/A after 96 h was determined to be 33 mg/l.