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Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
See "attached justification".
Reason / purpose:
read-across source
Related information:
Composition 1
Test material information:
Composition 1
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
>= 105.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Read across from analogue substance.
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 105.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Read across from analogue substance.
Details on results:
The results of the read-across approach from the experimental data obtained for the supporting substance are expressed as the estimated toxicity based on molecular weights. No other adaptation is necessary.
Validity criteria fulfilled:
yes
Conclusions:
Based on the available information for the read-across approach, the target substance has a 48h-EC50 > 105.5 mg/L and a NOEC ≥ 105.5 mg/L in daphnia.
Executive summary:

An acute immobilisation test on Daphnia magna was performed on the analogue substance naringin in accordance with OECD Guideline 202 / EU method C.2, under GLP conditions. Based on the results obtained in a preliminary range-finding test, a Limit Test was carried out using only one test concentration (100 mg/L) and one control group in a static system. Test concentrations were analytically determined (validated method) at the beginning and at the end of the test and did not deviate more than 20%. Twenty animals, divided into four groups (glass beaker) of five animals each were exposed to the test item or the control for 48 h. Positive controls (potassium dichromate) are performed at least twice a year to ensure the quality of the results. All validity criteria were met. The 48h-EC50 was determined to be higher than 100 mg/L and the 48h-NOEC was determined to be 100 mg/L, both based on mobility. Based on the available information for the read-across approach, the target substance has a 48h-EC50 > 105.5 mg/L and a NOEC ≥ 105.5 mg/L in daphnia.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 18th to July 20th, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 016G050
- Expiration date of the lot/batch: 21/07/2016
- Purity test date: 21/07/2016

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled room temperature (15-25°C, below 70 RH%), protected from light and humidity.
- Stability under test conditions: stable during test period.
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0(control) and 100 mg/L
- Sampling method: Samples were taken from the test solution and from the control solution at the beginning and at the end of the test. The samples were properly diluted and analyzed by a HPLC-UV/Vis detection method.
- Sample storage conditions before analysis: The test solution was continuously stirred until sampling in order to ensure its homogeneity during analytical sampling.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solution with a nominal concentration of 100 mg/L was prepared with direct addition of the test item, mixed into the test medium (ISO Medium) using ultrasonic bath (11 minutes). As a Limit test was carried out, further dilution of stock solution was not performed.
- Controls: The dilution water (ISO-medium) was used without addition of the test item.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Source: István Szent University, 2100 Gödöllő, Páter Károly u.1, Hungary
- Age of the animals: less than 24 h old at the beginning of the test
- Feeding during test: no

ACCLIMATION
- Acclimation period: There was no acclimation because the culturing conditions were the same as in the test.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
245 mg/L (as CaCO3)
Test temperature:
20.3 – 20.5ºC
pH:
7.75 – 7.89
Dissolved oxygen:
7.4 – 8.4 mg/L
Nominal and measured concentrations:
- Nominal concentrations: 0 (control), 100 mg/L.
- Measured concentrations: 0 (control), 99.4 mg/L (at the start of test); 101 mg/L (at the end of test).
Details on test conditions:
TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: glass beaker, 50 mL size, 40 mL fill volume.
- Aeration: no.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water (ISO medium, according to OECD 202)
- Culture medium different from test medium: no.

OTHER TEST CONDITIONS
- Adjustment of pH: no.
- Photoperiod: 16-hour light and 8-hour dark cycle
- Light intensity: not specified.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
The immobility or mortality 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 were considered to be immobile.

RANGE-FINDING STUDY
- Test concentrations: 0 (control), 0.1, 1, 10, 100 mg/L.
- Results used to determine the conditions for the definitive study: Because toxic response was not observed during the preliminary concentration range-finding test, a Limit Test was carried out using only one test concentration (100 mg/L) and one control group in a static system.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions.
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: No abnormal behaviour, appearance or any other effect on test animals were detected.
- Mortality of control: 0/20
- Other adverse effects control: no.
- Abnormal responses: no.
- 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: no.
Results with reference substance (positive control):
- Results with reference substance valid? yes
- The date of the last study (Study Code: 17/058-023DA) with reference item Potassium dichromate (batch no.: A0345704) is: 08 - 09 March 2017.
- Relevant effect levels: The 24h EC50: 0.64 mg/L, (95 % confidence limits: 0.59 – 0.68 mg/L).
Reported statistics and error estimates:
No statistical analysis was performed because of the lack of toxic effects. The EC50, NOEC, LOEC and EC100 values were determined directly from the raw data.

Table 2. Number and % of immobilised animals.

Test Group

Number of

treated animals

Number of immobilised animals

24 hours

48 hours

number

percent

number

percent

Control

20

0

0

0

0

100 mg/L

20

0

0

0

0

Table 3. Temperature measured in the test vessels (ºC)

Test group

Replicate

Measuring

0 h

24 h

48 h

Control

1

20.5

20.3

20.4

2

20.5

20.3

20.4

3

20.5

20.3

20.4

4

20.5

20.3

20.4

100 mg/L
(nominal)

1

20.5

20.3

20.4

2

20.5

20.3

20.4

3

20.5

20.3

20.4

4

20.5

20.3

20.4

 

Table 4. Oxygen concentrationmeasured in the test vessels (mg/L)

Test group

Replicate

Measuring

0 h

48 h

Control

1

8.4

8.3

2

8.4

8.2

3

8.4

8.3

4

8.4

8.3

100 mg/L
(nominal)

1

7.4

8.2

2

7.4

8.3

3

7.4

8.3

4

7.4

8.2

 

Table 5. pH measured in the test vessels

Test group

Replicate

Measuring

0 h

48 h

Control

1

7.75

7.80

2

7.75

7.82

3

7.75

7.83

4

7.75

7.83

100 mg/L
(nominal)

1

7.78

7.87

2

7.78

7.88

3

7.78

7.88

4

7.78

7.89

 

Table 6. Immobilisation of the test animals (detailed results).

Test group

Number of
animals

Number of immobilised animals

24 h

48 h

Control

5

0

0

5

0

0

5

0

0

5

0

0

100 mg/L
(nominal)

5

0

0

5

0

0

5

0

0

5

0

0

Validity criteria fulfilled:
yes
Remarks:
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.
Conclusions:
The 48h-EC50 of the test item in Daphnia magna was found to be higher tan 100 mg/L and the NOEC was 100 mg/L, both based on mobility.
Executive summary:

An acute immobilisation test on Daphnia magna was performed in accordance with OECD Guideline 202 / EU method C.2, under GLP conditions. Based on the results obtained in a preliminary range-finding test, a Limit Test was carried out using only one test concentration (100 mg/L) and one control group in a static system. Test concentrations were analytically determined (validated method) at the beginning and at the end of the test and did not deviate more than 20%. Twenty animals, divided into four groups (glass beaker) of five animals each were exposed to the test item or the control for 48 h. Positive controls (potassium dichromate) are performed at least twice a year to ensure the quality of the results. All validity criteria were met. The 48h-EC50 was determined to be higher than 100 mg/L and the 48h-NOEC was determined to be 100 mg/L, both based on mobility.

Description of key information

Key study. Study on the analogue substance naringin, according to OECD TG 202 / EU Method C.2 (GLP study). The 48h-EC50 in Daphnids was determined to be higher than 100 mg/L and the 48h-NOEC was determined to be 100 mg/L, both based on mobility. Based on the available information for the read-across approach, the target substance has a 48h-EC50 > 105.5 mg/L and a NOEC ≥ 105.5 mg/L in daphnia.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
100 mg/L

Additional information

An acute immobilisation test on Daphnia magna was performed in accordance with OECD Guideline 202 / EU method C.2, under GLP conditions. Based on the results obtained in a preliminary range-finding test, a Limit Test was carried out using only one test concentration (100 mg/L) and one control group in a static system. Four groups of five daphnids each were exposed to the test item or the control for 48 h. All validity criteria were met. The 48h-EC50 of the test item was determined to be higher than 100 mg/L and the 48h-NOEC was determined to be 100 mg/L, both based on mobility. Based on the available information for the read-across approach, the target substance has a 48h-EC50 > 105.5 mg/L and a NOEC ≥ 105.5 mg/L in daphnia.