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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:
2020-04-30 to 2020-10-06
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)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:provided by sponsor/91112Y
- Expiration date of the lot/batch:12 March 2021

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:At room temperature

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid:a suspension of the test item in n-hexane
Analytical monitoring:
yes
Details on sampling:
- Concentrations:
- Sampling method:
Control-start:;
100mg/L start;

Control-end:;
100mg/L end;

- Sample storage conditions before analysis:kept below -15℃
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:Saturated test item solution was prepared by dispersing/dissolving the amount of test item into the test medium (ISO Medium) two days before the start of the treatments.

- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)):nominal loading rate of 100.0 mg/L

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia
- Strain/clone: Daphnia magna
- Age at study initiation :They were less than 24 h old at the beginning of the test
- Stage and instar at study initiation:
- breeding: The Daphnia are bred in Ecotoxicological Laboratory of Charles River Laboratories Hungary Kft.
- Source: István Szent University, 2100 Gödöllő, Páter Károly u. 1, Hungary

ACCLIMATION
- Acclimation period:There was no acclimatization because the water used was similar to the culture water.

-The animals were not fed during the test.
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
The reconstituted water (ISO medium) had a total hardness of 247 mg/L (as CaCO3).
Test temperature:
The water temperature was measured at the start and at the end of the renewal periods in one control test vessel. The test temperature was in the range of 19.9 – 20.8°C measured in the test vessels.
The additionally measured temperature in the climate chamber was between 19.4 – 21.3°C.
pH:
The pH of the test solution was not adjusted and not varied by more than 1.5 units in any one test. The pH was measured at the start and at the end of the renewal periods in one test vessel both in the control and test item group and was in the range of 7.71 – 8.06.
Dissolved oxygen:
The dissolved oxygen concentration was measured in the control and in the test concentration in one replicate at the start and at the end of the renewal periods and was in the range of 7.3 – 8.6 mg/L.
Nominal and measured concentrations:
100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:glass beaker
- Volume of solution:(~40 mL test solution/flask; 8 mL test solution/animal
- No. of organisms per vessel:5
- No. of vessels per concentration (replicates):4
- No. of vessels per control (replicates):4
- The frequency of the water renewal periods was 24 hours.


OTHER TEST CONDITIONS
- Adjustment of pH:The pH of the test solution was not adjusted and not varied by more than 1.5 units in any one test.
- Light intensity:The test was carried out in 16-hour light and 8-hour dark cycle.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
The immobility of the Daphnia was determined by visual observation 24 and 48 hours after the start of the test. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker are considered to be immobile.
The number of immobilised animals and the percentage of immobility were determined at 24 and 48 hours.


RANGE-FINDING STUDY
- Test concentrations: 0.1.1,10,100 mg/L nominal loading rate WAF
- Results used to determine the conditions for the definitive study:No any visible abnormalities in appearance or behaviour was observed during the preliminary test.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
48 h
Dose descriptor:
LOELR
Remarks:
(Lowest Observed Effect Loading Rate) the lowest loading rate of the test item at which a significant immobilization is observed relative to the control
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOELR
Remarks:
(No Observed Effect Loading Rate) the highest loading rate of the test item at which no significant immobilization is observed relative to the control
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EL50
Remarks:
the calculated loading rate of test item which results in a 50 % immobilization of the daphnids within a stated exposure period
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EL50
Remarks:
the calculated loading rate of test item which results in a 50 % immobilization of the daphnids within a stated exposure period
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC100
Remarks:
the calculated loading rate of test item which results in a 100 % immobilization of the daphnids within a stated exposure period
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: none
- Mortality of control:none
- Immobilisation of control: none

In addition to immobility, no abnormal behaviour or appearance of test animals was detected.
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- ECx:The 24h EC50: 0.87 mg/L, (95 % confidence limits: 0.70 – 0.99 mg/L)

Table : Immobilisation of the test animals

Test Group Number  of animals Number of immobilised animals
24h 48h
Control 5 0 0
0 0
0 0
0 0
100.0 mg/L nominal loading rate 5 0 0
0 0
1 1
0 0

Table : Summary of endpoints

 

Parameter 24 h EL50 [mg/L] 48 h EL50 [mg/L] 48h EL100 [mg/L] 48h NOELR [mg/L] 48h LOELR [mg/L]
nominal loading rate (WAF) > 100.0 mg/L > 100.0 mg/L > 100.0 mg/L 100.0 mg/L > 100.0 mg/L
Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of this Daphnia magna acute immobilisation study the observed endpoints for the effect of the test item were the following:48 h EL50 > 100.0 mg/L.
Executive summary:

The 48-hr acute toxicity of the test item to Daphnia was studied under semi-static conditions. Test species were exposed to control, and test chemical at nominal concentration of 100mg/L for 48 hr immobilisation effects were observed daily.  The 48- hour EL50was >100 mgL.  The 48h-hrNOELbased on immobilization effects was 100 mg//L. 

 

Based on the results of this study, the test item would be not classified to Daphnia in accordance with the classification system of CLP.

 

Results Synopsis

Test Organism Age : less than 24h old

 

Test Type : semi-static

48 h- EL50:  >100 mg/L   

                    

48h- NOELR:  100 mg/L 

Description of key information

48h-EL50 >100 mg/L, 48-NOELR :100 mg/L (Daphnia magna ,OECD202, GLP )


Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC50
Remarks:
the calculated loading rate of test item which results in a 50 % immobilization of the daphnids within a stated exposure period
Effect concentration:
> 100 mg/L

Additional information