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EC number: 947-912-3 | CAS number: -
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-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:
- Please refer to the analogue justification attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 56 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: source: source, RA-A, EC 946-056-8, Zschimmer & Schwarz, 2017, D. magna, 21 d, RL1
- Duration:
- 21 d
- Dose descriptor:
- EC10
- Effect conc.:
- > 56 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: source: source, RA-A, EC 946-056-8, Zschimmer & Schwarz, 2017, D. magna, 21 d, RL1
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 Jan 2017 - 09 May 2017
- 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
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: all test concentrations, solvent-controls and stock solutions
- Sampling method: 2 mL samples were taken at the beginning and at the end of four intervals 24 hours (nominal days 0-1, 6-7, 13-14 and 20-21); Stock solutions: on nominal days 0, 6, 13 and 20
- Sample storage conditions before analysis: Samples were stored in a freezer (≤ -15 °C) until analysis - Vehicle:
- yes
- Remarks:
- Dimethylformamide (DMF)
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Stock solutions were prepared in Dimethylformamide at the start of the test and weekly thereafter at a concentration of 100 mg/L. No special treatment other than careful mixing was needed to fully dissolve the test item in the solvent.
- Controls: only medium (test medium without test item)
- Chemical name of vehicle: DMF (99.8%, Merck, Darmstadt, Germany)
- Concentration of vehicle in test medium: 100 µL/L - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Strain/clone: Daphnia magna (Straus, 1820)
- Source: In-house laboratory culture with a known history
- Age of parental stock: parental daphnids greater than two weeks old, maximum age of culture: 4 weeks
- Feeding during test: Twice daily an amount of 0.25 mL of a Chlorella sp. suspension. On weekend days an amount of 0.50 mL was added in one single feed. This daily ration corresponded to 0.2 mg C/Daphnia/day, which is the recommended value for daily feeding per daphnid in the reproduction test according to the OECD Guideline 211
- Food type: a suspension of fresh water algae
- Frequency: daily - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Hardness:
- 161 - 214 mg/L CaCO3 (Control)
161 - 214 mg/L CaCO3 (Solvent control)
161 - 214 mg/L CaCO3 (56 µg/L) - Test temperature:
- 19 - 21 °C (Control)
20 - 21 °C (Solvent control)
20 - 21 °C (test item concentration) - pH:
- 7.6 - 8.3 (Control)
7.6 - 8.3 (Solvent control)
7.6 - 8.3 (test item concentration) - Dissolved oxygen:
- 8.0 - 10 mg/L (Control)
8.1 - 10 mg/L (Solvent control)
8.0 - 10 (test item concentration) - Nominal and measured concentrations:
- Control, 1.0, 3.2, 10, 32 and 100 µg/L (nominal)
Control, 0.19, 0.19, 1.1, 12 and 56 µg/L (average measured) - Details on test conditions:
- TEST SYSTEM
Test vessel:
- Type: open (covered with a Perspex plate)
- Material, size, headspace, fill volume: 60 mL-glass vessels, 50 mL volume
- Renewal rate of test solution: daily
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- No. of vessels per vehicle control (replicates): 10
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M7, as prescribed by Dr. Elendt-Schneider
- Hardness: 180 mg/L expressed as CaCO3
- pH: 7.7 ± 0.3
- Culture medium different from test medium: no
- Intervals of water quality measurement: temperature, oxygen and pH was recorded at test start and just before and after each renewal of the test in one of the vessels; hardness was measured once a week
OTHER TEST CONDITIONS
- Photoperiod: 16 h photoperiod daily
- Light intensity: intensity at the start: 475-579 lux; at the end: 486-586 lux
EFFECT PARAMETERS MEASURED: The number of living, immobile and dead parental daphnids was daily recorded; body length was recorded at test end; number of newborn was recorded daily
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.1
Range finding study
- Test concentrations: 0.0010, 0.010, 0.10 and 1.0 mg/L
- Results used to determine the conditions for the definitive study: Results of the range-finding test are summarized within table 1 in section " Any other information on results incl tables" - Reference substance (positive control):
- no
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 56 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 56 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 21 d
- Dose descriptor:
- EC10
- Effect conc.:
- > 56 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 56 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 56 µg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Details on results:
- - Mortality of control: Two out of the twenty parental daphnids died during the test period in the DMF control, hence mortality did not exceed 20%
- Other: All biologicala nd analytical results are summarized within the tables 2-5 in section "Any other information on results incl. tables" - Reported statistics and error estimates:
- Following statistical procedures were used to determine the NOEC for reproduction and growth:
Data distribution: Shapiro-Wilk´s Test ; Homogeneity of variance: Levene´s Test (with Residuals); Differences between two controls: Student-t test; Differencesbetween treatments and the (pooled) control: Williams Multiple Sequential t-test Procedure
Survival: Parental survival was not statistically analysed as the mortality did not exceed 20%.
EC-values for reproduction: No EC10 or EC50 values could be calculated as the observed effects were lower than 10%. All analyses were performed with ToxRat Professional 3.2.1 (ToxRat Solutions® GmbH, Germany).
Referenceopen allclose all
Table 1: Results of the range-finding test: Mortality and reproductive potency
Hexanedioic acid, di-C16-18 alkyl esters Concentration (mg/L) |
Number Daphnia exposed |
Cumulative number of dead/immobile parental daphnids |
||||||
|
|
Day 1-4 |
Day 5 |
Day 6 |
Day 7 |
Day 8 |
Day 9 |
Day 10 |
Blank-control |
5 |
0 |
0 [1] |
0 [5] |
0 [5] |
0 [5] |
0 (13) |
0[2] |
|
5 |
0 |
0 [2] |
0 [4] |
0 [5] |
0 [5] |
0 (12) |
0 [4] |
Acetone-control |
5 |
0 |
0 [1] |
0 [5] |
0 [5] |
0 [5] |
0 (15) |
0 [5] |
|
5 |
0 |
0 [1] |
0 [5] |
0 [5] |
0 [5] |
0 (6) |
0 [5] |
0.0010 |
5 |
0 |
0 [2] |
0 [4] |
0 [4] |
0 [5] |
0 (9) |
0 [5] |
|
5 |
0 |
0 [1] |
0 [4] |
0 [4] |
0 [5] |
0 (8) |
0 [5] |
0.010 |
5 |
0 |
0 [1] |
0 [4] |
0 [5] |
0 [5] |
0 (12) |
0 [5] |
|
5 |
0 |
0 [1] |
0 [4] |
0 [5] |
0 [5] |
0 (14) |
0 [4] |
0.10 |
5 |
0 |
0 [1] |
0 [5] |
0 [5] |
0 [5] |
0 (3) |
0 [5] |
|
5 |
0 |
0 [2] |
0 [5] |
0 [5] |
0 [5](1)1 |
0 (7) |
0 [5] |
1.0 |
5 |
0 |
0 |
0 |
0 [4] |
0 [5] |
0 [5] |
0 [4]2 |
|
5 |
0 |
0 |
0 |
0 [2] |
0 [2] |
0 [4] |
0 [5] |
[ ] number of parents with eggs in their brood pouch, ( ) number of offspring, 1 one immobile offspring, 2 one
Table 2: Main test: Analytical Results: Nominal and mean measured exposure concentrations
Hexanedioic acid, di-C16-18 alkyl esters Nominal concentration (µg/L) |
Mean exposure concentration (µg/L) at day |
Average exposure concentration (µg/L) |
|||
|
0-1 |
6-7 |
13-14 |
20-21 |
|
1.0 |
0.281 |
0.281 |
0.0932 |
0.0932 |
0.19 |
3.2 |
0.281 |
0.281 |
0.0932 |
0.0932 |
0.19 |
10 |
2.5 |
1.3 |
0.48 |
0.26 |
1.1 |
32 |
19 |
16 |
6.5 |
5.1 |
12 |
100 |
78 |
76 |
37 |
32 |
56 |
1 Half of the limit of detection of the analytical method (LOD= 0.568 µg/L)
2 Half of the limit of detection of the analytical method (LOD= 0.185 µg/L)
Table 3: Main test Biological Results: Mortality (immobility) of parental daphnids at the end of the test
Hexanedioic acid, di-C16-18 alkyl esters Average concentration (µg/L) |
Introduced |
Mobile |
Immobile |
% Immobility |
Blank-control |
10 |
10 |
0 |
0 |
DMF-control |
10 |
8 |
2 |
20 |
Pooled control |
20 |
18 |
2 |
10 |
0.19 |
10 |
10 |
0 |
0 |
0.19 |
10 |
10 |
0 |
0 |
1.1 |
10 |
8 |
2 |
20 |
12 |
10 |
8 |
2 |
20 |
56 |
10 |
9 |
1 |
10 |
Table 4: Main test Biological Results: Group mean cumulative number of juveniles per surviving parent and reduction of reproduction at the end of the test
Hexanedioic acid, di-C16-18 alkyl esters Average concentration (µg/L) |
Mean |
Std. Dev. |
n |
%Change1 |
Pooled control |
84.9 |
5.10 |
18 |
|
0.19 |
86.0 |
9.23 |
10 |
-1.3 |
0.19 |
85 (77.0) |
9.37 (27.13) |
9 (10) |
-0.30 (9.3) |
1.1 |
86.1 |
15.43 |
8 |
-1.5 |
12 |
86.6 |
6.44 |
8 |
-2.0 |
56 |
88.9 |
7.59 |
9 |
-4.7 |
1 Negative numbers indicate an increase, () – between brackets values before removal of the outlying replicate are given
Table 5: Main test Biological Results: Incidence of immobilised offspring, offspring trapped at the surface and aborted eggs
Abnormality |
Hexanedioic acid, di-C16-18 alkyl esters; Average concentration (µg/L) |
||||||
|
Blank-control |
DMF-control |
0.19 |
0.19 |
1.1 |
12 |
56 |
Immobile offspring |
5 |
1 |
2 |
2 |
3 |
1 |
5 |
Aborted eggs |
4 |
3 |
2 |
1 |
15 |
14 |
15 |
Table 6: Main test Biological Results: Group mean body lengths (mm) and reduction of growth of parental daphnids at the end of the test.
Hexanedioic acid, di-C16-18 alkyl esters Average concentration (µg/L) |
Mean |
Std. Dev. |
n |
%Change1 |
Pooled control |
4.02 |
0.137 |
18 |
|
0.19 |
3.95 |
0.092 |
10 |
1.8 |
0.19 |
3.90 (3.75) |
0.165 (0.492) |
9 (10) |
3.0 (6.7) |
1.1 |
3.93 |
0.079 |
8 |
2.1 |
12 |
4.06 |
0.164 |
8 |
-1.1 |
56 |
3.94 |
0.150 |
9 |
1.9 |
1 Negative numbers indicate an increase, () – between brackets values before removal of the outlying replicate are given
Description of key information
NOEC (21 d) ≥ 56 µg/L for Daphnia magna (OECD 211); read across
Key value for chemical safety assessment
Additional information
Experimental studies investigating chronic toxic effects of the target substance Fatty acids, C18-unsaturated, 1,6 Hexanediol Diester on Daphnia magna are not available. Thus, in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to the structurally related source substance Hexanedioic acid, di-C16-18 alkyl esters (CAS 92969-90-9) was conducted to fulfill the data requirements according to Annex VII. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment. This read-across is justified in detail within the analogue justification in IUCLID Section 13.
The toxicity of the source substance Hexanedioic acid, di-C16-18 alkyl esters (CAS 92969-90-9) to Daphnia magna was tested under semi-static conditions according to OECD guideline 211 under GLP conditions. D. magna was exposed to nominal concentrations of 1.0, 3.2, 10, 32 and 100 µg/L (0.19, 0.19, 1.1, 12 and 56 µg/L (mean measured concentrations)) for 21 days. Due to the low solubility of the test item dimethylformamide (DMF) was used as a solvent. Due to the decrease of test substance concentration during testing the results were based on average measured concentrations over the 21-day test period. Hexanedioic acid, di-C16-18 alkyl esters did not affect reproduction of Daphnia magna. Thus a NOEC (21 d) ≥ 56 µg/L was determined. Based on the available data for the read across substance and the very low water solubility (<0.57 µg/L at 20°C, pH 6.3) of the target substance a chronic toxicity of Fatty acids, C18-unsaturated, 1,6 Hexanediol Diester is not expected.
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