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Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method C.20 (Daphnia magna Reproduction Test)
Version / remarks:
(2008)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Version / remarks:
(2012)
Deviations:
not applicable
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on sampling:
Sampling schedule:
- Control : on day 0, 5, 7, 12, 14 and 19 in the freshly prepared media on day 3, 7, 10, 14, 17 and 21 in the old media
- Test concentrations : 0.316, 1.0, 3.16 and 10 mg/L on day 0, 5, 7, 12, 14 and 19 in the freshly prepared media on day 3, 7, 10, 14, 17 and 21 in the old media

All samples were diluted 1:1 with acetonitrile and were frozen in falcon tubes at -18°C until analysis
Vehicle:
no
Details on test solutions:
Pre-treatment of test item:
- 50 mg of the test item were added to 5 litres of dilution water, treated for 1 hour in an ultrasonic bath and stirred for 24 h on a magnetic stirrer
- Undissolved particles of the test item were removed by filtration using a folded filter (pore size 7-12 μm)
- The pH ranged between 7.9 and 8.0
- Appropriate amounts of the stock solution were diluted with dilution water to a volume of 100 mL per replicate
Test organisms (species):
Daphnia magna
Details on test organisms:
- Name : Daphnia magna STRAUS, parthenogenetic females
- Source : Strain of Bundesgesundheitsamt Berlin
- Maintenance and Acclimatisation : A population of parthenogenetic females of synchronized age structure has been maintained for more than 20 years in the test facility under constant temperature conditions (20 +/- 2 °C) at a 16 : 8 hour light-dark photoperiod (light intensity: < 20 μE x m-2 x s-1). The culture water (so-called 'M4 medium') was partly renewed once a week. The Daphnia were exclusively fed unicellular green algae (Desmodesmus subspicatus) 'ad libitum'. Mortalities of parent Daphnia during the culture period were recorded daily in a semi-quantitative way. The neonates were separated from their parent Daphnia by filtration prior to the acute test.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Hardness:
14.6 to 15.1 °dH measured on day 3, 7, and 14 days
Test temperature:
20.0-20.7 °C measured on day 3, 7, and 14 days
pH:
7.9 - 8.1 measured on day 3, 7, and 14 days
Dissolved oxygen:
8.4-8.9 mg O2/L measured on day 3, 7, and 14 days
Salinity:
n.a.
Conductivity:
No data
Nominal and measured concentrations:
Nominal concentrations (mg/L) and analytical values (time-weighted mean) :
- 0.316 mg/L (0.0021 mg/L); 1.0 mg/L (0.0068 mg/L); 3.16 mg/L (0.187 mg/L) and 10 mg/L (0.553 mg/L)

Details on test conditions:
Exposure conditions
- Test vessels: 150 mL glass beakers covered with watch glasses, holding 1 neonate in 100 mL test medium
- Experimental design: 4 test concentrations plus 1 control; 1 neonate per vessel, 10 replicates per concentration/control
- Renewal of the test media : Monday, Wednesday, Friday
- Method of initiation- : neonates were placed in prepared media
- Photoperiod: 16 h light : 8 h dark
- Light intensity: not exceeding 15-20 μE x m-2 x s-1
- Temperature of incubation unit: 19.2 to 19.8 °C
- Aeration: none
- Test item concentration: 0.316, 1.0, 3.16 and 10 mg/L
- Food source and feeding rate: Desmodesmus subspicatus; day 0-7: 0.1 mg C / Daphnia / day and day 8-21: 0.2 mg C / Daphnia / day
-Criteria of effects : The criterion of adverse effects used in this study was the item-induced inhibitory effect on the parthenogenetic reproduction rate and the mobility behaviour/mortality rate of parent Daphnia, all effects being assessed at least three times a week.
Reference substance (positive control):
no
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 0.553 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: 10 mg/L (Nominal concentration)
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 0.553 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: 10 mg/L (Nominal concentration)
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 0.553 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 10 mg/L (Nominal concentration)
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
> 0.553 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 10 mg/L (Nominal concentration)
Details on results:
Effective concentrations ranged from 5.8 % to 11.4 % of the nominal values in the freshly prepared media and from 1.8 % to 9.9 % in the media after 48 hours, or 72 hours of exposure.

1st brood on day : 7
Validity criteria fulfilled:
yes
Remarks:
(- The mortality rate in the controls did not exceed 20 % by the end of the test. - The dissolved oxygen concentration remained above 3 mg/L throughout the exposure period.)
Conclusions:
After 21 days of exposure no toxic effects against daphnia were observed at a test concentration of nominally higher than 10 mg/L, corresponding to a time-weighted mean measured concentration of 0.553 mg/L, which reflects the maximum water solubility under exposure conditions.
Executive summary:

A study was performed to assess the effects of Solvent Violet 59 on the reproductive output of parthenogenetic Daphnia magna STRAUS under semi-static conditions. The study was conducted in accordance with Council Regulation (EC) No 440/2008, Method C.20 'Daphnia magna Reproduction Test'' (2008), which equals in all relevant parts to the OECD Test guideline 211 (Daphnia magna Reproduction Test; adopted: Oct. 02, 2012). Young female Daphnia, aged less than 24 hours at the start of the test, were exposed to a range of concentrations, nominally 0.316, 1.0, 3.16 and 10 mg/L of Solvent Violet 59 dissolved in water. Auxiliaries used to prepare the test media were an ultrasonic bath, a magnetic stirrer and folded filters. After a 21d-exposure period, the total number of living offspring produced per parent animal which did not die accidentally or inadvertently during the test was assessed. In addition, the reproduction was calculated based on the production of living offspring by the surviving parent organism. The reproductive output of the Daphnia exposed to the test item was compared to that of the control in order to determine the Lowest Observed Effect Concentration (LOEC) and the No Observed Effect Concentration (NOEC) according to Williams Multiple Sequential t-Test Procedure. Additionally, the survival of the parent Daphnia and the time to production of first brood was determined. After 21 days of exposure no toxic effects against daphnia were observed at a test concentration of nominally higher than 10 mg/L, corresponding to a time-weighted mean measured concentration of 0.553 mg/L, which reflects the maximum water solubility under exposure conditions. The results are expressed in terms of time-weighted mean measured and nominal concentrations. Effective concentrations ranged from 5.8 % to 11.4 % of the nominal values in the freshly prepared media and from 1.8 % to 9.9 % in the media after 48 hours, or 72 hours of exposure.

Description of key information

After 21 days of exposure no toxic effects against daphnia were observed at a test concentration of nominally higher than 10 mg/L, corresponding to a time-weighted mean measured concentration of 0.553 mg/L, which reflects the maximum water solubility under exposure conditions.

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater invertebrates:
0.553 mg/L

Additional information

"Should read: 21 -NOEC > 0.553 mg/L (time weighted mean measured concentration)"