Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

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:
24.-28.04.2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
EEC Directive 92/69
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
Identity and concentration of auxiliary solvent for dispersal: reconstituted water
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Species: zebra fish (Danio rerio), originated West-Aquarium
Breeder: in house
Size: 2.0 + 1.0 cm
Body weight per group: 6.0 and 8.1 g

The species is internationally accepted for this type of study.
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
267 mg CaCO3/L
Test temperature:
24 to 26 °C
pH:
7.46 - 7.99
Dissolved oxygen:
> 60 % saturation
Nominal and measured concentrations:
100 mg/L
Reference substance (positive control):
not required
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: >0.0114 mg/L (limit of water solubility)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: >0.0114 mg/L (limit of water solubility)
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: >0.0114 mg/L (limit of water solubility)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: >0.0114 mg/L (limit of water solubility)
Details on results:
No signs of toxicity have been observed throughout the study up to the limit of water solubility (0.0114 mg/L).
Sublethal observations / clinical signs:

After exposure of zebra fish to a saturated aqueous solution of the test item, with a nominal concentration of 100 mg/L for 96 hours, the following results were obtained:

 24h  48 h  72h  96h
 0/10  0/10  0/10  0/10

 

Zebra fish exposed to an aqueous solution, with a nominal concentration of 100 mg test item per liter, were not affected. The analysis revealed, that the solubility the test item in water was < 0.0114 mg/L. Because of this low water solubility and the fact that the study was performed as a limit test, the test material concentrations in the aqueous medium at the start and the end of this study could not be quantified.

For the test material the following LC50values and no effect concentration (EC0) for zebra fish were determined.

24h LC50       > 0.0114 (nominal> 100 mg/L)

48 h LC50         > 0.0114 (nominal> 100 mg/L)

72 h LC50         > 0.0114 (nominal> 100 mg/L)

96 h LC50         > 0.0114 (nominal> 100 mg/L)

EC0                   > 0.0114 (nominal> 100 mg/L)

 

Control

Time

3 h

24 h

48 h

72 h

96 h

Observed fish

10

10

10

10

10

Symptom

No abnormalities detected

10

10

10

10

10

 

 

Test material group

Time

3 h

24 h

48 h

72 h

96 h

Observed fish

10

10

10

10

10

Symptom

No abnormalities detected

10

10

10

10

10

 

In the control and the test material group no clinical findings were observed during the

experimental part.

Control

Time

3 h

24 h

48 h

72 h

96 h

Observed fish

10

10

10

10

10

Symptom

No abnormalities detected

10

10

10

10

10

 

 

Test material group

Time

3 h

24 h

48 h

72 h

96 h

Observed fish

10

10

10

10

10

Symptom

No abnormalities detected

10

10

10

10

10

 

In the control and the test material group no clinical findings were observed during the

experimental part.

 

Mortality

Concentration

24 h

48 h

72 h

96 h

Control

0/10

0/10

0/10

0/10

100

0/10

0/10

0/10

0/10

 

All fish survived the observation period.

 

LC50

 

24 h

48 h

72 h

96 h

Nominal

>100 mg/L

>100 mg/L

>100 mg/L

>100 mg/L

Analytical

>0.0114 mg/L

>0.0114 mg/L

>0.0114 mg/L

>0.0114 mg/L

 

A dose group with nominal 100 mg/L test item (maximal solubility <0.0114 mg/L analytically) revealed no aquatic toxicity in this test system.The analytical 24, 48, 72,and 96 h LC50value exceed the maximal solubility of the test material. No remarkable observations were made concerning the appearance of the solution of the test material preparation. The test medium was a clear preparation and stayed unchanged throughout the study.

Validity criteria fulfilled:
yes
Conclusions:
An aqueous solution of the test material of a nominal concentration of 100 mg/L revealed no aquatic toxicity in the test system. The 96 h LC50 value to zebra fish exceeded the maximal solubility (< 0.0114 mg/I, analytically observed) of the test material in reconstituted water and could thus not be determined.
Executive summary:

Study design

The objective of this aquatic toxicity study in zebra fish (Danio rerio) was to provide information on environmental hazards likely to arise from exposure of the test material and to serve as a basis for classification and labeling purposes. For this purpose, 10 fish (test material group) were exposed over 96 hours, under defined conditions in a limit test. A further 10 fish were used as a control group. The fish were observed for signs of toxicity or death for 96 hours. Zebra fish of the test material group were exposed to a saturated aqueous test material solution of nominal 100 mg/L (limit test) in an open static system. The study was conducted according to Good Laboratory Practice (GLP) and followed the OECD Guidelines for the Testing of Chemicals, No. 203 Fish Acute Toxicity Test.

Results

After exposure of zebra fish to a saturated aqueous solution of test material with a nominal concentration of nominal 100 mg/L for 96 hours, the following results were obtained:

Mortality
24h 48h 72h 96 h
Control Group 0/10 0/10 0/10 0/10
Test material group 0/10 0/10 0/10 0/10


Zebra fish exposed to an aqueous solution, with a nominal concentration of 100 mg test item per liter, were not affected.

The analysis revealed, that the solubility of the test material in water was < 0.0114 mg/L. Because of this low water solubility and the fact that the study was performed as a limit test, the test material concentrations in the aqueous medium at the start and the end of this study could not be quantified.

For the test material, the following LC50 values for zebra fish were determined.

24 h LC50    >    0.0114 mg/L (nominal >    100 mg/L)
48 h LC50    >    0.0114 mg/L (nominal >    100 mg/L)
72 h LC50    >    0.0114 mg/L (nominal >    100 mg/L)
96 h LC50    >    0.0114 mg/L (nominal >    100 mg/L)


Conclusion

An aqueous solution of the test material of a nominal concentration of 100 rng/L revealed no aquatic toxicity in the test system. The 96 h LC50 value to zebra fish exceeded the maximal solubility (< 0.0114 mg/I, analytically observed) of the test material in reconstituted water and could thus not be determined.

Description of key information

An aqueous solution of the test material of a nominal concentration of 100 rng/L revealed no aquatic toxicity in the test system. The 96 h LC50 value to zebra fish exceeded the maximal solubility (< 0.0114 mg/I, analytically observed) of the test material in reconstituted water and could thus not be determined.

Key value for chemical safety assessment

Additional information

The study was conducted according to Good Laboratory Practice (GLP) and followed the OECD Guidelines for the Testing of Chemicals, No. 203 Fish Acute Toxicity Test. Zebra fish exposed to an aqueous solution, with a nominal concentration of 100 mg test item per liter, were not affected. The analysis revealed, that the solubility of the test material in water was < 0.0114 mg/L. The 96 h LC50 value to zebra fish exceeded the maximal solubility (< 0.0114 mg/I, analytically observed) of the test material in reconstituted water and could thus not be determined.