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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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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:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Version / remarks:
2012
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 20150702
- Expiration date of the lot/batch: 12 June 2017
- Purity test date: 1 July 2015

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Stable
Analytical monitoring:
yes
Details on sampling:
The content of the test item in the solutions was measured at the beginning of the experiment in the freshly prepared solutions and after 24 hours in the used solutions. Additionally, the test item concentration was measured on day 7 and on day 14 at medium renewal in the new and the old solutions and on day 20 in the new solution and on day 21 in the old solution.
Vehicle:
no
Details on test solutions:
At the beginning and before each medium renewal (daily), a stock solution containing 10.0 ± 0.5 mg/L test item (range during the study was 10.0 - 10.2 mg/L) in dilution water was prepared. This solution was used as highest test concentration and for preparation of the lower concentrated treatments. It was diluted with dilution water.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magne
- Strain/clone:
- Source: bred in the LAUS GmbH throughout the year, originally obtained from the Umweltbundesamt in Berlin (Germany)
- Age of parental stock (mean and range, SD):
- Feeding during test
- Food type: Desmodesmus subspicatus

ACCLIMATION
- Acclimation period:
- Acclimation conditions (same as test or not):
- Type and amount of food:
- Feeding frequency:
- Health during acclimation (any mortality observed):
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Remarks on exposure duration:
None.
Post exposure observation period:
None.
Hardness:
267-356 mg/L as CaCO3 (min-max)
pH:
7.6-8.4 (min-max)
Dissolved oxygen:
8.1-10.0 (min-max)
Salinity:
Not measured (freshwater)
Conductivity:
Not measured
Nominal and measured concentrations:
Nominal concentrations: 0 ; 0.05 ; 0.15 ; 0.44 ; 1.33 ; 4 mg/L
Measured concentrations (geometric means between fresh and old solutions): 0 ; 0.05 ; 0.07 ; 0.13 ; 0.32 ; 1.79 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 250 mL glass beakers
- Material, size, headspace, fill volume: 80 mL
- Aeration: None
- Renewal rate of test solution (frequency/flow rate): semi-static, daily including week-end periods
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4

OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 16L:8D
- Light intensity: 1000 lx

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2
Reference substance (positive control):
not required
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.32 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
reproduction
Key result
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
0.33 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
reproduction
Results with reference substance (positive control):
Not applicable.
Reported statistics and error estimates:
Calculation of results was performed with the help of validated software (Microsoft Ex-cel®). The estimation of the biological results was accomplished using the software Tox-Rat® Professional, version 3.2.1.

Nominal Concentrations in mg/L

Total Living Offspring

Surviving Parent Animals

Mean Living Offspring per Surviving Parent Animal

Inhibition of Reproduction in %

Blank Control

680

8

85

0

0.05

812

9

90

-6

0.15

624

9

69

18

0.44

642

8

80

6

1.33

785

10

79

8

4

0

9

0

100

Table 1: Results on neonate production and parent mortality per treatment.

Validity criteria fulfilled:
yes
Conclusions:
An OECD 211 study using five concentrations of dimethylsebacate was conducted. The study lasted 21 days. Test item concentrations were monitored. Results were based on geometrical mean concentrations. No parental mortality considered due to the substance was recorded. The EC10 for neonate production was 0.33 mg/L
Executive summary:

An OECD 211 study was performed using five concentrations of dimethylsebacate ranging from 0.05 to 4.0 mg/L. Ten daphnia each were exposed to the test item and the control for 21 days. The offspring of the animals was counted each day. Reproduction in the treatments 0.05 mg/L – 1.33 mg/L was in the same range as in the control whereas in the treatment 4.0 mg/L no reproduction was observed. Significant mortality was not observed, neither of the parent animals nor of the new-born animals.

The content of the test item in the test solutions was determined using GC determination. The test item concentration was measured at the beginning in the freshly prepared solutions and after 24 hours in the used solutions. Additionally, the test item concentration was measured on day 7 and on day 14 at medium renewal in the new and the old solutions and on day 20 in the new solution and on day 21 in the old solution.

The correlation between nominal and measured concentration in the fresh prepared solutions was good. Because the test item is not stable in aqueous medium, only in the highest concentrated treatment test item was detectable in the old solution at every measuring point.

Therefore, the determination of the results was based on the arithmetic mean of the geometric means of the measured concentrations at the start and end of each media renewal period. Because only in the highest concentrated treatment inhibition of reproduction could be observed, only the 2 highest test concentrations were used for statistical evaluation. For treatment 1.33 mg/L only at one sampling point test item was detectable in the old solution. Therefore, the LOD (0.04 mg/L) was used for calculation of the geometric mean. NOEC and EC10 for neonate production were 0.32 and 0.33 mg/L respectively.

 

According to the OECD guideline, the offspring of dead animals must be taken into account if the death is caused by toxicity of the test item. Only inadvertent and/or accidental parental mortality should be excluded from evaluation. Because no toxicity could be observed, the offspring of deceased parent animals was excluded from the calculation of total offspring per treatment.

Description of key information

 An OECD 211 study using five concentrations of dimethylsebacate was conducted. The study lasted 21 days. Test item concentrations were monitored. Results were based on geometrical mean concentrations. No parental mortality considered due to the substance was recorded. The EC10 for neonate production was 0.33 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
0.33 mg/L

Additional information