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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 January 2017 - 02 February 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Batch/Lot Number: 150205
Description: Blue powder
Purity1: As a UVCB, purity is considered as 100%
Expiry date: 05 February 2019
Storage condition: Controlled room temperature (15-25°C, below 70 RH%)
Analytical monitoring:
yes
Details on sampling:
A saturated test item solution (nominal loading rate of 100 mg/L) was prepared by dispersing/dissolving the amount of test item into the test medium (ISO Medium) two days before the start of the experiment. This solution was shaken for about 24 hours at approximately 30°C and then equilibrated for about 24 hours at approximately 20°C. The non-dissolved test material was removed by filtration through a fine (0.22 μm) filter to give the nominal loading rate of 100 mg/L.
The sample was homogenized by shaking manually. An aliquot of 2 ml of the sample containing the test item was diluted to 10 mL with nitric acid (1:10). Tha same procedure was used for each sample.
Vehicle:
no
Details on test solutions:
A saturated test item solution (nominal loading rate of 100 mg/L) was prepared by dispersing/dissolving the amount of test item into the test medium (ISO Medium) two days before the start of the experiment. This solution was shaken for about 24 hours at approximately 30°C and then equilibrated for about 24 hours at approximately 20°C. The non-dissolved test material was removed by filtration through a fine (0.22 μm) filter to give the nominal loading rate of 100 mg/L.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Feeding during test: no

ACCLIMATION
- Acclimation period: none
Test type:
semi-static
Water media type:
other: Reconstituted water (ISO medium, according to OECD 202)
Limit test:
yes
Total exposure duration:
48 h
Hardness:
248 mg/L (as CaCO3)
Test temperature:
test vessels: 20.2 – 20.5°C
climate chamber: 19.8 and 20.7°C
pH:
7.25 – 7.49
Dissolved oxygen:
8.2 – 8.9 mg/L
Nominal and measured concentrations:
100 mg/L nominal loading rate WAF
Details on test conditions:
TEST SYSTEM
- Test vessel: glass
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: glass beaker
- Renewal rate of test solution (frequency/flow rate): 24 hours
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hour light and 8-hour dark cycle


RANGE-FINDING STUDY
- Test concentrations: 100, 10 and 1 mg/L nominal loading rates WAFs
- Results used to determine the conditions for the definitive study: toxic response was not observed during the preliminary concentration rangefinding test, a Limit Test was carried out using only one test concentration at 100 mg/L nominal loading rate WAF and one control group in a semi-static system.
Reference substance (positive control):
yes
Key result
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EL100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
NOELR
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
LOELR
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Details on results:
There was no immobilization in the control group and the dissolved oxygen concentration at the end of the test in control and test vessels was more than 3 mg/L.
Results with reference substance (positive control):
The 24-hour EC50 values of Potassium dichromate were within the range 0.6 – 2.1 mg/L (ISO Guideline No. 6341
The 24h EC50: 0.93 mg/L, (95 % confidence limits: 0.86 – 0.99 mg/L).
In addition to immobility, no abnormal behaviour or appearance of test animals was detected.
Reported statistics and error estimates:
No statistical analysis was performed because of the lack of toxic effects.
The EL50, NOELR, LOELR and EL100 values were determined directly from the raw data.
Validity criteria fulfilled:
yes
Conclusions:
Acute toxicity of the test item was assessed with Acute immobilisation test on Daphnia magna, over an exposure period of 48 hours in a semi-static system.
All validity criteria were met during this study.
Under the conditions of this Daphnia magna acute immobilisation study the observed endpoints for the effect of B440 were the followings:
The 24h and 48h EL50 value: > 100 mg/L nominal loading rate WAF
The 48h EL100 value: > 100 mg/L nominal loading rate WAF
The 48h No-Observed Effect Loading Rate (NOELR): 100 mg/L nominal loading rate WAF
The 48h Lowest Observed Effect Loading Rate (LOELR): > 100 mg/L nominal loading rate WAF

Description of key information

The 24h and 48h EL50 value: > 100 mg/L nominal loading rate WAF

The 48h EL100 value: > 100 mg/L nominal loading rate WAF

The 48h No-Observed Effect Loading Rate (NOELR): 100 mg/L nominal loading rate WAF

The 48h Lowest Observed Effect Loading Rate (LOELR): > 100 mg/L nominal loading rate WAF

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

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