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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:
2012-04-12 to 2012-09-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP
Qualifier:
according to
Guideline:
EU Method C.20 (Daphnia magna Reproduction Test)
Version / remarks:
30 May 2008
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Version / remarks:
03 October 2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
certificate dated 14 December 2009
Specific details on test material used for the study:
- Name of test material (as cited in study report): Triethyleneglycol dimethacrylate
Analytical monitoring:
yes
Details on sampling:
Duplicate samples from the freshly prepared test media of all test concentrations and the control were taken at the first treatment period (Day 0) and at a treatment period in the second and third week (Days 10 and 19).
For the determination of the stability of the test item under the test conditions and of the maintenance of the test item concentrations during the renewal periods, duplicate samples of the respective aged test media and controls were sampled at Day 3, 12 and 21.
One of these three stability control treatments lasted for 72 hours (weekend), two for 48 hours, corresponding to the different test medium renewal periods.

The concentrations of the test item were measured in all duplicate test medium samples from the three highest test concentrations of nominal 100, 32 and 10 mg test item/L. From the control samples only one of the duplicate samples was analysed from each sampling date.

Storage of Samples:
All samples were stored in a freezer (≤ - 10 °C), protected from light until analysis was performed.

Fortified Samples:
Approximately 50 mg test item were diluted with 50 mL acetonitrile to obtain a stock solution of 1 g test item/L. Appropriate amounts of the stock solution were diluted with test water to obtain fortified samples at concentrations of 5, 30 and 125 mg test item/L. Exact values were documented in the raw data.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Preparation of nominal 100 mg/L test item in water by intense stirring for 20 minutes and short ultrasonic treatment for 2 minutes
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain/clone: Daphnia magna (Straus), clone 5
- Source: in-house laboratory culture
- Age of parental stock: 2.5 to 18.5 hours old
- Feeding during test
- Food type: green algae (Desmodesmus subspicatus), freshly grown in the laboratory
- Amount: algal TOC/daphia: day 0-3: 0.10 mg; day 4-7: 0.15 mg; day 8-20: 0.20 mg
- Frequency: daily

ACCLIMATION
not necessary since the breeding is performed in the same kind of test water
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Test temperature:
19 - 21 °C in the freshly prepared media; 20 - 21 °C in the aged media
pH:
7.7 to 8.1 in the freshly prepared media; 7.8 to 9.1 in the aged media
Dissolved oxygen:
7.9 to 9.1 mg/L in the freshly prepared media; 7.8 to 10.4 mg/L in the aged media
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass beakers of 100 mL volume with approximately 60 mL test medium
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): on days 3, 5, 7, 10, 12, 14, 17 and 19
- 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: reconstituted water, Elendt M4 as recommended in the OECD guideline

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light : 8 h dark.
- Light intensity: 1020 – 1340 lux (measured once during the test)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
The mortality of the test animals and the number of young daphnids were recorded for each day. Dead animals and offspring were removed at the same times.

RANGE-FINDING STUDY
- Test concentrations: 0, 1, 5, 10, 50, 100 mg/L
- Results used to determine the conditions for the definitive study: no immobilisation of daphnia observed at all test concentrations after 48 and 72 h; in control 10% immobilisation after 48 h and 20% immobilisation after 72 h
Reference substance (positive control):
no
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
32 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
51.9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: 95% CL 34.6 - >100 mg/L
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
30.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: 95% CL 8.32 - 43.8 mg/L
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
32 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Reported statistics and error estimates:
Williams-test (one-sided, α = 0.05)

Effects

 

Nominal test item concentration[mg/L]

Control

1

3.2

10

32

100

Number of Live ImmatureDaphniaproduced by each surviving Adult after 21 Days ± SD

131.4±20.4

122.7±21.5

120.8±25.5

120.7
±49.3

114.8±63.1

8.0

Adult mortality after 21 Days [%]

10

0

0

10

0

90

Day of first brood

8

8

8

8

8

14

Apart from mortality and reduced reproduction, the surviving daphnia at the nominal concentration of 100 mg/L was pale in comparison to the control animals and dead offspring were observed during the test.

Validity criteria fulfilled:
yes
Conclusions:
The 21-day-chronic toxicity of TREGDMA (95.8% a.i.) to Daphnia magna was studied under static renewal conditions according to OECD Guideline 211, adopted 03 October 2008, and EU test method C.20, 30 May 2008. Daphnids were exposed to control, and test chemical at nominal concentrations of 1.0, 3.2, 10, 32 and 100 mg/L. The 21 day EC50 based on sublethal effects (reproduction) was 51.9 mg/L (95% CL = 34.6 - >100 mg/L). The 21-day NOEC based on reproduction and adult mortality was 32 mg/L.
Executive summary:

The 21-day-chronic toxicity of TREGDMA (95.8% a.i.) to Daphnia magna was studied under static renewal conditions according to OECD Guideline 211, adopted 03 October 2008, and EU test method C.20, 30 May 2008Daphnids were exposed to control, and test chemical at nominal concentrations of 1.0, 3.2, 10, 32 and 100 mg/L.  The 21 day EC50 based on sublethal effects (reproduction) was 51.9 mg/L (95% CL = 34.6 - >100 mg/L).  The 21-day NOEC based on reproduction and adult mortality was 32 mg/L.  The 21-day EC10 based on reproduction was 30.2 mg/L (95% CL 8.32 - 43.8 mg/L).

Results Synopsis 

Test Organism Age (e.g. 1stinstar): Daphnia magna, 2.5 to 18.5 hours old

Test Type: Static Renewal 

21-d NOEL:  32 mg/L

21 -d LOEC:  100 mg/L                    

21-d EC10: 30.2 mg/L (95% CL 8.32 - 43.8 mg/L)

Endpoint(s) Effected:  reproduction

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Description of key information

The 21 d NOEC of TREGDMA in freshwater invertebrates based on reproduction was 32 mg/L.

Key value for chemical safety assessment

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

Additional information

One long-term study in freshwater invertebrates is available for TREGDMA, which is considered reliable without restriction (Klimisch score 1).

The 21-day-chronic toxicity of TREGDMA (95.8% a.i.) to Daphnia magna was studied under static renewal conditions according to OECD Guideline 211, adopted 03 October 2008, and EU test method C.20, 30 May 2008. Daphnids were exposed to control, and test chemical at nominal concentrations of 1.0, 3.2, 10, 32 and 100 mg/L.  The 21 day EC50 based on sublethal effects (reproduction) was 51.9 mg/L.  The 21-day NOEC based on reproduction and adult mortality was 32 mg/L.  The 21-day EC10 based on reproduction was 30.2 mg/L.

The NOEC is used as key value for chemical safety assessment, as the difference between EC10 and NOEC is negligible.