Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
OECD 202, GLP, analytical monitoring.
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
(April 1984)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
Version / remarks:
April 1996
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
31st July 1992
Deviations:
no
Principles of method if other than guideline:
Acute Immobilization Test to Daphnia magna STRAUS to determine the effects of the saturated solution of the test item as a limit concentration after
24 and 48 hours of exposure under static conditions.
The endpoint measured was the EC50 (Median Effective Concentration), a statistically derived concentration which was expected to cause immobility in 50% of the animals. An animal is defined as immobile when it is incapable of swimming (no body movement) within 15 seconds after gentle agitation of the test container.
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Name of test material (as cited in study report): Ethylene Glycol Dimethacrylate (EGDMA; CAS RN: 97-90-5)
Analytical monitoring:
yes
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Strain: (STRAUS (Clone 5)
- Source: CIT
- Age at study initiation (mean and range, SD): 6 to 24 hours
- Length at study initiation (length definition, mean, range and SD): no data
- Weight at study initiation (mean and range, SD): mean weight: no data
- Method of breeding: Laboratory bred
- Feeding during test: daphnids were not fed during the test
- Food type: Scenedesmus subspicatus cultutred at CIT
- Amount: between 0.1 and 0.2 mg of carbon per Daphnia per day with a diet of Scenedesmus subspicatus
- Frequency: at least 5 times per week

ACCLIMATION
- Acclimation period: at least 2 hours in dilution water
- Acclimation conditions (same as test or not): in dilution water (ISO test water, according to OECD 202, Annex 3) of the same quality as used for
the test
- Health during acclimation (any mortality observed): no data
Test type:
static
Limit test:
no
Total exposure duration:
48 h
Hardness:
238 mg/L as CaCO3 (the same value was obtained at T0 and T48 hours in the control)
Test temperature:
19.9 to 21.3 °C
pH:
7.85 to 8.08
Dissolved oxygen:
8.5 to 9.2 mg/L (>= 60% of the air saturation value)
Nominal and measured concentrations:
Preliminary test:
0, 0.025, 0.25, 2.5, 25 and 100 mg/L (nominal)
Main test:
0, 13.2, 19.8, 29.6, 44.4, 66.7 and 100 mg/L
Details on test conditions:
TEST SYSTEM
The test method was adapted to volatile substances.
- Test vessel: closed system; test vessels were sealed and headspace kept at the minimum.
- Type (delete if not applicable):closed
- Aeration: Forced aeration was not used during the test. Test medium was aerated prior to the addition of the test item.
- No. of organisms per vessel: 20 daphnids were tested per concentration (5 per replicate).
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

OTHER TEST CONDITIONS
- Adjustment of pH: no adjustment before addition of animals because the pH range of all test solutions remained within the range of 6.0 to 9.0 after preparation.
- Photoperiod: 16 hours light and 8 hours dark
- Light intensity: no data

TEST CONCENTRATIONS
- Limit test concentration: 0, 100 mg/L (nominal); Results: 0% immobilisation in the control and 100% immobilisation in the limit test solution
- Range finding study
- Test concentrations. 0.025, 0.25, 2.5, 25 and 100 mg/L (nominal); Results: immobilisation was 0%, 0%, 0% and 5% , respectively
- Results used to determine the conditions for the definitive study: all results of the preiminary limit tests and the range-finding test were used.
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
19.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
44.9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% CL: 39.1 - 51.6 mg/L
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks:
concentration resulting in 100% immobilisation
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
13.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
The 24-hour EC50 was not calculated by computer as the spread of immobilization across the concentrations was not sufficient for the software to undertake the calculation. A concentration producing 100% immobilization was not obtained for calculation of this EC50. The 48-hour EC50 was
calculated according to Probit analysis and the confidence interval limits according to Fieller's method.
Results with reference substance (positive control):
No reference substance used.

Immobilization Rates in the Definitive Test after 24 and 48 h of Exposure (n = 20, divided into 4 replicates with 5 daphnids each)

Measured Concentrations in the test solutions were within +/- 20% of the nominal values throughout the test and the control sample from time 0 confirmed that the test item concentration was below the limit of detection. Therefore, toxicity results were based on nominal concentrations.

Nominal
             Mean Measured Concentration (mg/l)
Concentration
(mg/l)
               0 Hour         24 Hours       48 Hours
  0                   BLD  (nc)           ns                  ns
  13.2              12.8  (97)     12.4  (94)     12.1  (92)
  19.8              19.3  (97)     18.9  (95)     18.3  (93)
  29.6              28.6  (97)     27.2  (92)     27.1  (92)
  44.4              43.9  (99)     42.4  (96)     41.8  (94)
  66.7              64.2  (96)     62.7  (94)     61.1  (92)
  100               96.1  (96)     94.9  (95)     93.0  (93)

(#) represent percentages of the nominal concentration
BLD = Below Limit of Detection
nc: not calculated
ns: not sampled

 

 

24 h

48 h

 

Replicates

Replicates

 

1

2

3

4

MV

1

2

3

4

MV

Control

0

0

0

0

0

0

0

0

0

0

Ethylene glycol dimethacrylate

0

13.2 mg/L

19.8 mg/L

29.6 mg/L

44.4 mg/L

66.7 mg/L

100 mg/L

0

0

0

0

0

0

5

0

0

0

0

0

0

4

0

0

0

0

0

0

5

0

0

0

0

0

0

4

0

0

0

0

0

0

4.5

0

0

0

0

3

4

5

0

0

0

1

1

4

5

0

0

1

1

3

5

5

0

0

0

1

1

4

5

0

0

0.25

0.75

2.0

4.25

5.00

MV = Mean value

The highest concentration resulting in no immobilization (NOEC) at 48 hours was 13.2 mg/l.
The lowest concentration resulting in 100% immobilization at 48 hours was
100 mg/l.


The EC50 at each of the observation times was as follows:
Time (h)
      EC50 (mg/l)            95% confidence limits (mg/l)
24
               between 66.7 and 100                   NA
48
                     44.9                                  39.1 - 51.6
NA: Not applicable

Validity criteria fulfilled:
yes
Conclusions:
In this valid guideline study according to OECD 202 (static conditions) the 48 hr EC50 for Daphnia magna (STRAUS Clone 5) of Ethylene glycol dimethacrylate was 44.8 mg/L .
Executive summary:

The 48–hr-acute toxicity of Ethylene glycol dimethacrylate to Daphnia magna straus was studied under static conditions according to OECD 202. Daphnids were exposed to control, 13.2, 19.8, 29.6, 44.4, 66.7 and 100 mg/L (nominal) of the test chemical for 48 hr. 

The concentrations of Ethylene glycol dimethacrylate were analysed by HPLC with UV detection at 200 nm. The recoveries of Ethylene glycol dimethacrylate in the test solutions were determined to be within the acceptable limits.

The water quality parameters (pH and dissolveed oxygen) were measured at 0 and 48 hours and determined to be within the acceptable limits.

The 48– hour EC50was detemined to be 44.9 mg a.i./L.  The 48– hr NOEC based on immobilization/sublethal adverse effects was determined to be 13.2 mg a.i./L. 

This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.

 

Results Synopsis

 

Test Organism Age: Daphnia magna Straus, less than 24 hours old

Test Type: static, no aeration during the test period

 

NOEL:  13.2 mg a.i./L                       

EC50: 44.9 mg a.i./L                       95% C.I.: 39.1 - 51.6 mg a.i./L

Endpoint(s) Effected:  immobilisation

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 acute toxicity of the substance was tested in a 48-h exposure test in Daphnia magna according to OECD guideline 202.

The 48h-EC50 was found to be 44.9 mg/l..

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC50
Effect concentration:
44.9 mg/L

Additional information