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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:
Aug 28 - Dec 11, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The study was conducted for a registration in non-EU.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
Council Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and the council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
A preparation with a test item concentration of 100 mg/L was freshly prepared.
For that purpose, the test item was weighed in a calibrated flask and vehicle was added. The preparation was stirred with a magnetic stirrer for 24 hours. Then the formulation was passed through a filter membrane (pore size: 0.2 µm). The filtrate was used for the study. The pH was not adjusted.
Analytical monitoring:
no
Remarks:
The test item concentration was not quantified at the start and the end of this study. Because of the low water solubility of a comparable chemical, the compound cannot be detected with standard analytical methods.
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A preparation with a test item concentration of 100 mg/L was freshly prepared.
For that purpose, the test item was weighed in a calibrated flask and vehicle was added. The preparation was stirred with a magnetic stirrer for 24 hours. Then the formulation was passed through a filter membrane (pore size: 0.2 µm). The filtrate was used for the study. The pH was not adjusted.
- Controls: reconstituted water
- Chemical name of vehicle: OECD 203 Medium
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish (Danio rerio)
- Strain: West-Aquarium
- Source: Institute of Toxicology, Merck KGaA
- Age at study initiation (mean and range, SD):
- Length at study initiation: 2.7-2.9 cm
- Weight at study initiation:: 0.2 -0.4 g (control group) and 0.2 -0.4 g (test material group)


ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation:
- Feeding frequency during acclimation: 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.
- Health during acclimation (any mortality observed): no mortality observed


FEEDING DURING TEST
The zebrafish were not fed during the study.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
no
Hardness:
about 228 mg/L CaCO3
Test temperature:
23 to 24°C
pH:
7.49-7.95
Dissolved oxygen:
75.6 - 93.3%
Salinity:
no data
Conductivity:
710 µS/cm (vehicle)
Nominal and measured concentrations:
Nominal Concentration: 100 mg/L
Details on test conditions:

TEST SYSTEM
- Test vessel: 10L glass aquarium
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass, 10L, no headspace, about 10L
- Aeration: none
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water (OECD 203 Medium)
- Ca/Mg ratio: 4 : 1
- Culture medium different from test medium: no
- Intervals of water quality measurement: daily

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12 hours light - 12 hours dark regime
- Light intensity: no data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality and Clinical Symptoms (daily)

TEST CONCENTRATIONS
- Range finding study:
- Test concentrations: 0 mg/L and 100 mg/L (nominal)
- Results used to determine the conditions for the definitive study: no mortality observed
Reference substance (positive control):
no
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: > 1.6281 × 10-6 mg/L
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: > 1.6281 × 10-6 mg/L
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: > 1.6281 × 10-6 mg/L
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: > 1.6281 × 10-6 mg/L
Details on results:
A saturated aqueous solution of the test material of nominal 100 mg/L revealed no aquatic toxicity in the test system. The 96 h LC50 value to zebrafish exceeded the maximal solubility of 1.6281 × 10-6 mg/L of the test material in reconstituted water and, thus, could not be determined in this test.

The 96h EC50 exceeded the water solubility of 1.6281 × 10-6 mg/L (nominal >100 mg/L) and, thus, could not be determined in this study.

- Behavioural abnormalities: no
- Observations on body length and weight: none
- Other biological observations: none
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: yes
Validity criteria fulfilled:
yes
Conclusions:
A saturated aqueous solution of the test material of nominal 100 mg/L revealed no aquatic toxicity in the test system. The 96 h LC50 value to zebrafish exceeded the maximal solubility of 1.6281 × 10-6 mg/L of the test material in reconstituted water and, thus, could not be determined in this test.
Executive summary:

Objective

The objective of this study was to determine the acute toxicity of the test material in the zebrafish (Daniorerio).

Study design

For this purpose, 10 fish (test material group) and further 10 fish (control group) were exposed over 96 hours, under defined conditions in a limit test. The fish were observed for signs of toxicity or death for 96 hours.Zebra fish of the test material groupwere exposed to a saturated aqueous test material solution of nominal 100 mg/L (limit test) in an open static system.

Results

The zebrafishexposed to an aqueous solution, with a nominal concentration of 100 mg/L were not affected.

The test material concentration in the aqueous medium was not quantified at the start and the end of this study due to the low water solubility (1.6281 × 10 -6 mg/L). The water solubility was determined for a structurally related chemical, within the scope of another study. Because of the low water solubility, the compound cannot be detected with standard analytical methods. The development of an analytical method with a sufficiently low detection and quantification limit is complex. Due to the absence of any adverse effects at the saturation concentration, the study was performed without analytical concentration verification.

For the test material, the following LC50values forzebrafishwere determined.

24 h LC50      nominal > 100 mg/L(>1.6281 × 10-6 mg/L)

48 h LC50      nominal > 100 mg/L(>1.6281 × 10-6 mg/L)

72 h LC50      nominal > 100 mg/L(>1.6281 × 10-6 mg/L)

96 h LC50      nominal > 100 mg/L (> 01.6281 × 10-6 mg/L)


Conclusion

A saturated aqueous solution of the test material of nominal 100 mg/L revealed no aquatic toxicity in the test system. The 96 h LC50 value to zebrafish exceeded the maximal solubility of 1.6281 × 10-6 mg/L of the test material in reconstituted water and, thus, could not be determined in this test.

Description of key information

OECD 203: EC50 (96 h) > 100 mg/L (nominal); no adverse effects were seen up to the limit of water solubility (1.6281 × 10-6 mg/L)

Key value for chemical safety assessment

Additional information