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Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 Nov 2017 - 14 Mar 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
2004
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
440/2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom

Test material

Constituent 1
Chemical structure
Reference substance name:
ε-Caprolactone, oligomers, esters with acrylic acid and 2,2,2',2'-tetrakis (hydroxymethyl)-3,3'-oxydipropan-1-ol
EC Number:
500-276-7
EC Name:
ε-Caprolactone, oligomers, esters with acrylic acid and 2,2,2',2'-tetrakis (hydroxymethyl)-3,3'-oxydipropan-1-ol
Cas Number:
89800-10-2
Molecular formula:
{(C10H16O7).(C3H3O)b.[(C6H10O2)m.(C3H3O)a]} (i.e., UVCB substance)
IUPAC Name:
ε-Caprolactone, oligomers, esters with acrylic acid and 2,2,2',2'-tetrakis (hydroxymethyl)-3,3'-oxydipropan-1-ol

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: Samples were taken from the control and each test group; Samples were analysed at the NOEL test item concentration and above
- Sampling method: Samples were taken from the freshly prepared bulk test preparation at 0 and 24 hours and from the old or expired pooled replicates (R1 to R4) at 24 and 48 h.
- Sample storage conditions before analysis: Samples were stored frozen prior to analysis

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Differential loading: 5.0, 16, 50, 160 and 500 mg were each separately added to the surface of 5 L of test water to give the 1.0, 3.2, 10, 32 and 100 mg/L loading rates respectively. The test solutions were stirred by magnetic stirrer for 23 h and was allowed to stand for 1 h. Subsequently the WAFs were filtered through a glass wool plug (2 to 4 cm in length). A wide bore glass tube, covered at one end with Nescofilm was submerged into the vessel, sealed end down, to a depth of approximately 5 cm from the bottom of the vessel. A length of Tygon tubing was inserted into the glass tube and pushed through the Nescofilm seal. A glass wool plug was inserted into the opposite end of the tubing and the WAF removed by mid-depth siphoning (the first 75 to 100 mL discarded) to give the 1.0, 3.2, 10, 32 and 100 mg/L loading rate WAFs.
- Controls: Yes, Medium only
- Evidence of undissolved material: Microscopic observations of the WAFs were performed after filtering and showed no micro-dispersions of test item were present.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Source: In-house laboratory cultures
- Feeding during test: No feeding during the test

ACCLIMATION
- Acclimation conditions: Same
- Type and amount of food: Mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension.
- Feeding frequency: Each culture was fed daily

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: Gravid adults were isolated the day before initiation of the test, such that the young daphnids produced overnight were less than 24 hours old. These young were removed from the cultures and used for testing.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Test temperature:
20 - 21 °C (Control and Test item concentrations)
pH:
7.9 - 8.0 (Control)
7.9 - 8.1 (Test Item Concentrations)
Dissolved oxygen:
8.7 - 8.8 mg O2/L (Control)
8.3 - 8.8 mg O2/L (Test Item Concentrations)
Nominal and measured concentrations:
Control, 1.0, 3.2, 10, 32 and 100 mg/L (nominal loading rate, WAF)
Details on test conditions:
TEST SYSTEM
Test vessel:
- Type: open (covered to reduce evaporation)
- Material, size, headspace, fill volume: 150 mL glass beakers containing 100 mL Elendt M7 medium and 50 mL headspace
- Aeration: No aeration
- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4 according to OECD 202
- pH: 7.9 ±0.3
- Culture medium different from test medium: Same
- Intervals of water quality measurement: The water temperature, pH and dissolved oxygen concentrations were recorded daily throughout the test.

OTHER TEST CONDITIONS
- Photoperiod: 16 h light and 8 h darkness cycle with 20 min dawn and dusk transition periods
- Light intensity: between 806 and 903 lux

EFFECT PARAMETERS MEASURED: Any immobilization or adverse reactions to exposure were recorded at 24 and 48 h after the start of exposure.

RANGE-FINDING STUDY
- Test concentrations: Control, 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: No immobilization was observed at 1.0 mg/L loading rate WAF, however, immobilization was observed at 10 and 100 mg/L loading rate WAF. See detailed information in section "Any other information on results incl tables".
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
93 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: water accomodated fraction
Duration:
48 h
Dose descriptor:
NOELR
Effect conc.:
32 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Water accomodated fraction
Duration:
48 h
Dose descriptor:
LOELR
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Water accomodated fraction
Details on results:
- Observations on body length and weight: at 32 and 100 mg/L decrease of body length and pale
- Mortality of control: No mortality
Results with reference substance (positive control):
The EC50 after 24 h was determined to be at 0.79 mg/L (95% confidential limits: 0.73 - 0.86 mg/L). The results from the positive control with potassium dichromate were within the normal range for this reference item (within the range 0.6 mg/L to 2.1 mg/L).
Reported statistics and error estimates:
The EL50 value at 48 h and the slope of the response curve and its standard error were calculated by Probit analysis using Linear Maximum-Likelihood regression. The LOEL and the NOEL at 24 and 48 h were calculated using the Fisher’s Exact Binomial Test with Bonferroni correction. All results were calculated using the ToxRat Professional computer software package (TOXRAT).

Any other information on results incl. tables

Table 1: Biological Results of the Range finding test: Cumulative Immobilization Data and Observations

Nominal Loading rate

Observations (Initial Population: 5 Per Replicate)

24 Hours

48 Hours

Cumulative Immobilized Daphnia

Observations

Cumulative Immobilized Daphnia

Observations

[mg/L]

Rep1

Rep2

Rep1

Rep2

Rep1

Rep2

Rep1

Rep2

Control

0

0

5 N

5 N

0

0

5 N

5 N

1.0

0

0

5 N

5 N

0

0

5 N

5 N

10

1

1

4 N

4 N

4

5

1 N

AI

100

1

0

4 N

4 N 1 R

5

5

AI

AI

 Rep=Replicate; N=normal; R=Reduced mobility; AI=All daphnids immobilized 

Table 2: Biological Results of Definitive test: Cumulative Immobilization Data and Observations

Nominal Loading Rate

48 Hours

[mg/L]

Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate)

Observations

 

Rep1

Rep2

Rep3

Rep4

Total

%

Rep1

Rep2

Rep3

Rep4

Control

0

0

0

0

0

0

5 N

5 N

5 N

5 N

1.0

1

0

0

0

1

5

4 N

5 N

5 N

5 N

3.2

0

0

0

0

0

0

5 N

5 N

5 N

5 N

10

0

0

0

0

0

0

5 N

5 N

5 N

5 N

32

0

0

0

0

0

0

4 N 1 S

5 N

4 N 1 P

5 N

100

4

2

3

4

13

65

1 R

3 P

2 P

1 S

Rep=Replicate; N=normal; R=Reduced mobility; AI=All daphnids immobilized 

Table 3: Validity criteria

Criterion from the guideline

Outcome

Validity criterion fulfilled

In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized.

0%

Yes

The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels.

>8.5 mg/L

Yes

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
For detailed information see table 3 in section "Any other information on results incl tables".
Conclusions:
The effect of the test item on aquatic invertebrates has been investigated and gave EL50 values of 93 mg/L loading rate WAF. The NOEL was 32 mg/L loading rate WAF.