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Diss Factsheets

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.20 (Daphnia magna Reproduction Test)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
Sampling schedule:
- Control: on day 2 and 19 in the old media
- Test concentrations: on day 0 and 16 in the freshly prepared media; on day 2 and 19 in the old media
- Stability of test concentration/s during exposure : Ensured by renewal of test media three times per week and checked by chemical analysis (DOC)

The biological test solutions were routinely measured on the day of sampling. If this was exceptionally not possible, the samples were stored in a refrigerator at 4 °C until the analysis was carried out. The biological test solutions were analysed in the same way as the calibration samples.
Vehicle:
no
Details on test solutions:
- Three times a week direct weighings were prepared to produce the desired test concentrations.
- The test item was weighed out, added to 2 litres of dilution water for each concentration and treated for 24 h on a magnetic stirrer.
- Finally undissolved particles of the test item were removed by filtration using an aseptic filter with a pore size of 0.45 + 0.2 μm (Sartobran 150 Sterile Capsule). The pH was measured and ranged between 7.7 and 8.0.
- For each test item concentration and the control 10 replicates were prepared.
Test organisms (species):
Daphnia magna
Details on test organisms:
- Daphnia magna STRAUS, parthenogenetic females, laboratory bred at CURRENTA, Leverkusen, cloned at the Federal Health Office (BGA), Berlin Germany
- feeding: unicellular green algae (Desmodesmus subspicatus) 'ad libitum'
- separation of neonates from their parent Daphnia: by filtration prior to the acute test.
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
21 d
Hardness:
In the range of 14.8 °dH to 15.6 °dH (concerning the highest test concentration)
Test temperature:
In the range of 20.1 and 20.5 °C (concerning the highest test concentration)
pH:
In the range of 7.9 and 8.3 (concerning the highest test concentration)
Dissolved oxygen:
In the range of 8.2 and 10.0 mg/l (concerning the highest test concentration)
Nominal and measured concentrations:
Water Accommodated Fractions (WAFs) were produced to test the effects at different loading rates and all results are expressed in terms of Effective Loadings (EL). Effective Loadings were below the detection limit of the DOC determination (< 2 mg/L) on 2011-10-19, 2011-10-21 and on 2011-11-04 and between < 2 and 2.11 mg/L DOC on 2011-11-07 according to the semi-static conditions, respectively.
Details on test conditions:
TEST SYSTEM:
- Test vessels: 150 mL glass beakers holding 1 neonate in 100 mL of test medium
- Experimental design: 2 test concentrations plus 1 control, 1 neonate per vessel, 10 replicates per concentration/control
- Renewal of the test media: Monday, Wednesday and Friday
- Method of initiation: neonates were placed in prepared media
- Photoperiod: 16 h light: 8 h dark
- Light intensity: not exceeding 20 μE x m-2 x s-1
- Temperature of incubation unit: 19.6 to 20.4 °C
- Aeration: none
- Test item concentration/s: 3 and 10 mg/L
- Food source and feeding rate: Desmodesmus subspicatus; day 0-7: 0.1 mg C / Daphnia / day; day 8-21: 0.2 mg C / Daphnia / day
Reference substance (positive control):
no
Duration:
21 d
Dose descriptor:
NOELR
Effect conc.:
>= 10 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: according to Williams / Dunnett`s Multiple Sequential t-Test Procedure
Duration:
21 d
Dose descriptor:
LOELR
Effect conc.:
> 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: according to Williams / Dunnett`s Multiple Sequential t-Test Procedure
Duration:
21 d
Dose descriptor:
other: NOEL
Effect conc.:
>= 10 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: according to Williams / Dunnett`s Multiple Sequential t-Test Procedure
Duration:
21 d
Dose descriptor:
other: LOEL
Effect conc.:
> 10 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: according to Williams / Dunnett`s Multiple Sequential t-Test Procedure
Details on results:
No toxic effects on reproduction and mortality against Daphnia were observed up to three-fold of the water solubility (< 0.003 g/L) under exposure conditions.
Validity criteria fulfilled:
yes
Remarks:
- mortality rate in the controls did not exceed 20 % by the end; Living offspring produced per parent Daphnia surviving at the end of the test was ≥ 60 in the controls; Diss. oxygen conc. remained above 3 mg/L throughout the exposure period
Conclusions:
After a 21d-exposure period under semi static conditions no toxic effects on reproduction and mortality against Daphnia were observed up to three-fold of the water solubility (< 0.003 g/L).
Executive summary:

A study was performed to assess the effects of the substance 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. 03, 2008). Young female Daphnia, aged less than 24 hours at the start of the test, were exposed to two concentrations, nominally 3 and 10 mg/L of the test item dissolved in water. Auxiliaries used to prepare the test media were on a magnetic stirrer and an aseptic filter. After a 21d-exposure period, the total number of living offspring produced per parent animal alive at the end of the test was assessed. 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 Loading (LOEL) and the No Observed Effect Loading (NOEL) according to Williams / Dunnett's Multiple Sequential t-Test Procedure. Additionally, the survival of the parent Daphnia and the time to production of first brood was determined.

No toxic effects on reproduction and mortality against Daphnia were observed up to three-fold of the water solubility under exposure conditions. The test item is insoluble or only poorly soluble in water. A suitable selective and sensitive chromatographical method for the determination of the test item in aqueous solutions could not be established. Therefore an accompanying analysis by the means of a chromatographical method cannot be performed. The quantification of the test item was performed by DOC determination.

Description of key information

After a 21d-exposure period under semi static conditions no toxic effects on reproduction and mortality against Daphnia were observed up to three-fold of the water solubility (NOEL > 10 mg/l).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
10 mg/L

Additional information

"Should read: NOEL > 10 mg/L"

A study was performed to assess the effects of the substance 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. 03, 2008). Young female Daphnia, aged less than 24 hours at the start of the test, were exposed to two concentrations, nominally 3 and 10 mg/L of the test item dissolved in water. Auxiliaries used to prepare the test media were on a magnetic stirrer and an aseptic filter. After a 21d-exposure period, the total number of living offspring produced per parent animal alive at the end of the test was assessed. 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 Loading (LOEL) and the No Observed Effect Loading (NOEL) according to Williams / Dunnett's Multiple Sequential t-Test Procedure. Additionally, the survival of the parent Daphnia and the time to production of first brood was determined.

No toxic effects on reproduction and mortality against Daphnia were observed up to three-fold of the water solubility under exposure conditions. The test item is insoluble or only poorly soluble in water. A suitable selective and sensitive chromatographical method for the determination of the test item in aqueous solutions could not be established. Therefore an accompanying analysis by the means of a chromatographical method cannot be performed. The quantification of the test item was performed by DOC determination.