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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:
2004-12-14 to 2005-04-06
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:
1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
Directly after preparation in the laboratory the test media were given to analysis with the following nominal concentrations: 100 mg/L.
These samples were analyzed at the beginning and 96 hours after start of the experimental part. All samples were stored under the same conditions as the vessels with Zebra fish and afterwards sent to analysis.
Vehicle:
no
Details on test solutions:
For the reconstituted water the following chemicals (analytical grade) were dissolved in fully demineralized water:
Macro nutrients (mg/L):
CaCI2x2H20 294.00
Mg5O4x7H20 123.0
Na HCO3 65.0
KCI 5.8

Before the start of the experimental part the reconstituted water for fish was prepared. After preparation the water was aerated for 24 hours before using it.

The proportion of Ca to Mg ions was 4:1 and that of Na to K ions 10:1.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Selection and adaptation

The fish were acclimatized to the conditions of the laboratory for more than 14 days and were held in reconstituted water for at least 7 days before testing. During the acclimatization, until one day before the experimental part, the fish were fed with flakes (Tetra Min® diet; Tetra GmbH, Melle). Furthermore, the fish were fed with daphnia, or artemia, or frozen mosquitolarva daily. During the week before testing, the mortality of the test fish batch was lower than 5 %. At the start of the test, 10 fish per group were randomly introduced into aquaria filled with test medium or reconstituted water, respectively.

Assignment:
A total of 24 zebra fish was used in this study.
Pretest: 4 zebra fish Control group: 10 fish
Test material group: 10 fish.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
about 267 mg CaCO3
Test temperature:
23-24 °C
pH:
7.34 to 7.97
Dissolved oxygen:
The dissolved oxygen concentrations were > 60 % oxygen saturation throughout the study.
Nominal and measured concentrations:
nominal 100 mg/L (103.8 mg/L measured)
Details on test conditions:
Environmental conditions
During the study, the zebra fish were kept in all-glass aquaria. The study was located in an air-conditioned room. Lighting was controlled by a timer provide a 12 hours light - 12 hours dark regime. The Danio rerio were not fed during the study.

Preparation
Before exposure of the fish, the test medium (reconstituted water and test material) was freshly prepared. Therefore, the calibrated flask with test material and vehicle, reconstituted water, was shaken. The solution was used for the study.

Administration
At the start of the experimental phase, 10 zebra fish per group were introduced into an aquarium (all-glass) with about 9 liters of reconstituted water (control group) or test medium (test material group). The aquaria were labeled to assure an unequivocal identification.

Observation schedule
The behavior and general condition of all fish were checked immediately after the introduction into the test medium or reconstituted water, after three hours, and then daily.

Laboratory tests
Dissolved oxygen (02) concentration in percent and pH values were measured in the control and test material groups at the beginning and at the end of the exposure period.
During the experimental part, the temperature was registered in the control vessel with an electronic thermometer containing a maximum and minimum memory display.

Analysis
The limit of quantification of the analytical method was 0.5 mg/L. Samples were taken after preparation of the test medium and at the end of the experimental part.
Reference substance (positive control):
no
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
EC0
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Results with reference substance (positive control):
not applicable
Validity criteria fulfilled:
yes
Conclusions:
An aqueous solution of the test item, corresponding to a nominal or analytical concentration of 100 mg/L, revealed no aquatic toxicity in this test system. The 96 hours LC50 to Danio rerio was > 100 mg/L, (limit test) and could not be determined in this test.
Executive summary:

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 measured 100 mg/L (limit test) in an open static system. The limit of quantification of the analytical method was 0.5 mg/L. 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. The analytically determined concentration was at the start about 95 % and at the end 104 % of the nominal concentration. The test material concentration could be maintained at > 80 % of the initial concentration and the nominal concentration is regarded as equivalent to the analytical concentration.
After exposure of zebra fish to an aqueous solution of the test item, with a nominal or analytical concentration of 100 mglL for 96 hours, no signs of toxicity could be observed and no fish died. The following results were obtained:

Mortality
24h 48h 72h 96 h
Control Group 0/10 0/10 0/10 0/10
Test item 100 mg/L 0/10 0/10 0/10 0/10


Zebra fish exposed to an aqueous preparation of the test item, with a nominal concentration of 100 mg/L were not affected.

The solubility of the test item in water is < 0.02 mg/L. Due to 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 were not quantified.

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

24, 48, 72 and 96 h LC50    >    100 mg/L

An aqueous solution of the test item, corresponding to a nominal or analytical concentration of 100 mg/L, revealed no aquatic toxicity in this test system. The 96 hours LC50 to Danio rerio was > 100 mg/L, (limit test) and could not be determined in this test.

Description of key information

Short term toxicity to fish was assessed in an OECD TG 203 compliant study and 96h-LC50 was greater than 100 mg/L (reference 6.1.1-1).

Key value for chemical safety assessment

Additional information

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 measured 100 mg/L (limit test) in an open static system. The limit of quantification of the analytical method was 0.5 mg/L. 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. The analytically determined concentration was at the start about 95 % and at the end 104 % of the nominal concentration. The test material concentration could be maintained at > 80 % of the initial concentration and the nominal concentration is regarded as equivalent to the analytical concentration.
After exposure of zebra fish to an aqueous solution of the test item, with a nominal or analytical concentration of 100 mglL for 96 hours, no signs of toxicity could be observed and no fish died. The following results were obtained:

Mortality
24h 48h 72h 96 h
Control Group 0/10 0/10 0/10 0/10
Test item 100 mg/L 0/10 0/10 0/10 0/10


Zebra fish exposed to an aqueous preparation of the test item, with a nominal concentration of 100 mg/L were not affected. The solubility of the test item in water is < 0.02 mg/L. Due to 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 were not quantified. For the test material, the following LC50 values for zebra fish were determined:

24, 48, 72 and 96 h LC50    >    100 mg/L

An aqueous solution of the test item, corresponding to a nominal or analytical concentration of 100 mg/L, revealed no aquatic toxicity in this test system. The 96 hours LC50 to Danio rerio was > 100 mg/L, (limit test) and could not be determined in this test.