2,2'-ethylenedioxydiethyl dimethacrylate

Long-term toxicity to aquatic invertebrates

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:

2012-04-12 to 2012-09-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP

Qualifier:

according to guideline

Guideline:

EU Method C.20 (Daphnia magna Reproduction Test)

Version / remarks:

30 May 2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Version / remarks:

03 October 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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 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.  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. 1^stinstar): 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

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

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.