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Ecotoxicological information

Short-term toxicity to fish

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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 July 2016 - 28 October 2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Exposure concentrations were not analytically verified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to
Guideline:
other: OECD 23 (OECD series on testing and assessment guidance document on aquatic toxicity testing of difficult substances and mixtures.)
Version / remarks:
2000
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: orange powder
- Storage condition of test material: room temperature
Specific details on test material used for the study:
Solubility in water: < 1 mg/L (see section 4.8 for details)

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
REPARATION AND APPLICATION OF TEST SOLUTION
- Method: WAFs were prepared seperately for each test concentration and stirred for 7 days. At the end of the stirring period, the magnetic stirrers were stopped and the test substance was allowed to settle. WAF solutions were filtered (0.45 µm). The filtered WAF solutions were transferred to the glass aquaria for the final study.
- Controls: medium without test item
- Evidence of undissolved material: not indicated

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebrafish
- Strain: not indicated
- Source: registered animal facility (no further details provided)
- Age at study initiation: not indicated
- Weight at study initiation: mean weight of 0.229 g for individual fish
- Length at study initiation: not indicated, however the weight of the fish corresponds to the length-range prescribed by OECD 203 (2.0 +/- 1.0 cm)
- Method of breeding: not indicated

ACCLIMATION
- Acclimation period: 10 days
- Acclimation conditions: same as test
- Type and amount of food during acclimation: not indicated
- Health during acclimation: no mortalities or other indications of disease were observed

FEEDING DURING TEST: no

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no

Test conditions

Hardness:
272.46 mg CaCO3/L
Start: 14.00 - 16.00 dH
End: 16.00-16.80 dH
Test temperature:
Start: 24.7 - 25.0 °C
End: 25.4 - 25.7 °C
pH:
Start: 7.5 - 8.1
End: 7.5 - 8.0
Dissolved oxygen:
Start: 96 - 100 %
End: 96 - 98 %
Conductivity:
Start: 730 - 747 µs/cm
End: 758 - 776 µs/cm
Nominal and measured concentrations:
Nominal test concentrations: 62.5, 125, 250, 500 and 1000 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 10 litre, glass aquaria with transparent cover , fill volume: 7 litres
- Aeration: glass pipette
- Renewal rate of test solution: no
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.2 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: not indicated
- Culture medium different from test medium: not indicated
- Intervals of water quality measurement: 24 h

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod:14 hours light, 10 hours dark
- Light intensity: not indicated

EFFECT PARAMETERS MEASURED: mortality after 96 hours. In addition, pH, temperature, oxygen, conductivity and hardness at the start and end of the fish exposure period in all aquaria were measured.

TEST CONCENTRATIONS
- Range finding study: nominal test concentrations were based on a preliminary test, no further details were provided
Reference substance (positive control):
no

Results and discussion

Effect concentrations
Key result
Duration:
96 h
Dose descriptor:
LC50
Remarks on result:
other: The 96-h LC50 was determined to be above the maximum solubility in test media.
Details on results:
- No mortality was observed in any of the tested concentrations.
- No behavioural, biological or other abnormalities were observed
- Effect concentrations exceeding solubility of substance in test medium: yes

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
For details on validity criteria see 'Overall Remarks' section
Conclusions:
No mortality at any of the tested concentrations was observed, therefore the 96h-LC50 was determined to be above the maximum solubility of the test substance in test media. The test substance is concluded not to be acute toxic to fish at its maximum solubility in test media.
Executive summary:

In a 96 -h acute toxicity study conducted according to OECD guideline 203 and GLP principles, zebrafish (Danio rerio) were exposed to the test substance under static conditions at the following nominal concentrations: 0 (blank-control), 62.5, 125, 250, 500 and 1000 mg/L. Since the test substance was insoluble, WAFs were prepared individually for each concentration. The WAFs were stirred for 7 days and subsequently filtered (0.45 µm). No analysis was conducted to determine actual exposure concentrations.

For each concentration and control group, 7 carps were exposed to the test substance during the test period in all-glass aquaria with a transparent cover. During the test period, test conditions remained stable.

No mortality was observed at any of the tested concentrations. Therefore, the 96h-LC50 was determined to be above the maximum solubility of the test substance in test media. The test substance is concluded not to be acute toxic to fish at its maximum solubility in test media. However, since no analysis was conducted and the test item is known to be insoluble in water, the actual exposure concentrations are unknown.