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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:
2013-01-28 to 2013-03-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Name as cited in the study report: Additin E 459
Other name: Triethylene glycol dimaleate
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
At the time of the testing the CAS Number that was used for Triethylene glycol dimaleate was 66790-57-6
In the course of the project the CAS Number 109828-01-5 was assigned, as this number describes better the structure of the main compound

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Control : at 48 hours
Test concentration/s : at 0 and 48 hours

Test solutions

Vehicle:
no
Details on test solutions:
100.0 mg of the test item were added to 1 litre of dilution water, treated for 60 seconds at 8000 rpm with an ultra turrax and stirred for 24 h on a magnetic stirrer. The pH was measured to be 7.5.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Daphnia magna STRAUS, Strain of Bundesgesundheitsamt Berlin

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
No details available

Test conditions

Hardness:
15.7 °dH
Test temperature:
Nominal: 18 - 22°C
measured 19.9°C (0 h) - 20.4°C (48 h)
pH:
7.5
Dissolved oxygen:
8.6 - 8.7 mg/L
Salinity:
M4 medium according to Elendt
Nominal and measured concentrations:
Nominal 100 mg/L
Measured 102.9 (0 h) and 93.0 (48 h)
Details on test conditions:
The main test was conducted as a static test with the test medium unchanged throughout the duration of the test.
During the test a temperature range of 18 - 22 °C was maintained in the test vessels, with a maximum temperature fluctuation of +/- 1 °C in each individual test. The temperature, the pH and the oxygen values were measured at the beginning and end of the test.
Reference substance (positive control):
no

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
102.88 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
behaviour
Details on results:
No toxic effects against Daphnia were observed at a limit test concentration
of 100 mg/L under exposure conditions.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
No details about statistics and error estimates are available.

Any other information on results incl. tables

Table 1:Control

Abioticparameters

0 h

24 h

48 h

Temperature[°C]

20.0

-----

20.4

Oxygen [mg/L]

8.4

-----

8.6

Oxygen [%saturation]

97

-----

99

pHvalue

7.9

-----

7.9

Immobilisation

0 h

24 h

48 h

Absolute

0

0

0

Cumulative

0

0

0

Cumulative[%]

0

0

0

Abnormalities*

0 h

24 h

48 h

Abnormalcolouration

0/20

0/20

0/20

Abnormalswimmingbehaviour

0/20

0/20

0/20

Chemicalanalysis

0 h

24 h

48 h

HPLCvalue[mg/L]

---

---

< 0.0725

 

Comments: *Daphniawith effects /Daphniamobile

 

Table 2: 100 mg/L

Abioticparameters

0 h

24 h

48 h

Temperature[°C]

19.9

-----

20.4

Oxygen [mg/L]

8.6

-----

8.7

Oxygen [%saturation]

98

-----

99

pHvalue

7.5

-----

7.6

Immobilisation

0 h

24 h

48 h

Absolute

0

0

0

Cumulative

0

0

0

Cumulative[%]

0

0

0

Abnormalities*

0 h

24 h

48 h

Abnormalcolouration

0/20

0/20

0/20

Abnormalswimmingbehaviour

0/20

0/20

0/20

Chemicalanalysis

0 h

24 h

48 h

HPLCvalue[mg/L]

102.87861

---

93.04779

 

Comments: *Daphniawith effects /Daphniamobile

An analysis of theimmobilisationrates gave the following results:

 

Time EC 0              EC 100         EC 50

[h]     [mg/L]          [mg/L]          [mg/L]

 

24         = 100                   > 100 >                100

48         = 100                   > 100                   > 100

 

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
No toxic effects against Daphnia were observed at a limit test concentration
of 100 mg/L under exposure conditions
Executive summary:

A study was performed to assess the acute toxicity of Additin E 459 to Daphnia magna STRAUS under static conditions.

The study was conducted in accordance with the Council Regulation (EC) No 440/2008, Method C.2 ‘Acute toxicity for Daphnia’ (2008) which is equivalent to OECD Guideline for Testing of Chemicals No. 202 'Daphnia sp., Acute Immobilisation Test' (adopted April 13, 2004).

The Daphnia were exposed to a limit test concentration of nominally 100 mg/L of Additin E 459 dissolved in dilution water. Auxiliaries used to prepare the test media were an ultra turrax and a magnetic stirrer.

Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure. The following values were determined:

Time EC 50 [h] [mg/L]

24 > 100

48 > 100

No toxic effects against Daphnia were observed at a limit test concentration

of 100 mg/L under exposure conditions.

The results are expressed in terms of nominal concentrations at 24 h and at 48 h.

Effective concentrations correspond to 102.9 % of nominal values at 0 hours and

to 93.0 % of nominal values at 48 hours.

The hardness of the dilution water used was 15.7 °dH (= 280 mg/L CaCO3).