Bis(2-ethylhexyl) tetrabromophthalate

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

four test concentrations were used (preliminary test)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

yes

Remarks:

four test concentrations were used (preliminary test)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-ethylhexyl) tetrabromophthalate

EC Number:

247-426-5

EC Name:

Bis(2-ethylhexyl) tetrabromophthalate

Cas Number:

26040-51-7

Molecular formula:

C24H34Br4O4

IUPAC Name:

1,2-bis(2-ethylhexyl) 3,4,5,6-tetrabromobenzene-1,2-dicarboxylate

Specific details on test material used for the study:

Purity: > 99.5 % (according to data of the sponsor)

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

no

Details on test solutions:

Study No. 2012/0052/01a
To produce of the different concentrations 0.11, 0.46, 1.05 and 10.6 mg of the test item were added each to 1 litre of dilution water and treated for
60 minutes in an ultrasonic bath and afterwards stirred for 24 hours on a magnetic stirrer. Undissolved particles of the test item were removed by filtration using aseptic filters (Sartobran 150 Sterile capsule) with a pore size of 0.45 + 0.2 μm. The pH was measured by 8.1 and 7.9.
Finally 19 mL of the filtered solution were taken per replicate. 1 mL of dilution water containing 10 daphnids was given to all replicates resulting in the final nominal concentrations. For each test item concentration and the control 2 replicates were prepared.

Study No. 2012/0052/01b
To produce of the different concentrations 0.15, 0.46, 1.05 and 10.5 mg of the test item were added each to 1 litre of dilution water and treated for
60 minutes in an ultrasonic bath and afterwards stirred for 2 hours on a magnetic stirrer. Undissolved particles of the test item were removed by filtration using aseptic filters (Sartobran 150 Sterile capsule) with a pore size of 0.45 + 0.2 μm. The pH was measured by 8.1 and 7.9.
Finally 19 mL of the filtered solution were taken per replicate. 1 mL of dilution water containing 10 daphnids was given to all replicates resulting in the final nominal concentrations. For each test item concentration and the control 2 replicates were prepared.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna STRAUS, parthenogenetic females, Strain of Bundesgesundheitsamt Berlin.
A population of parthenogenetic females of synchronized age structure has been maintained for more than 15 years in the test facility under constant temperature conditions (20 +/- 1 °C) at a 16 : 8 hour light-dark photoperiod (light intensity: < 20 μE x m-2 x s-1). The culture water
(so-called 'M4 medium') was partly renewed once a week. The Daphnia were exclusively fed unicellular green algae (Desmodesmus subspicatus)
'ad libitum'. Mortalities of parent Daphnia during the culture period were recorded daily in a semi-quantitative way. The neonates were separated from their parent Daphnia by filtration prior to the acute test.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Test temperature:

20.9-22.6°C

pH:

7.9-8.1

Dissolved oxygen:

7.9 - 8.6 mg/L

Nominal and measured concentrations:

Study No. 2012/0052/01a
0.1, 0.4, 1 and 10 mg/L nominal


Study No. 2012/0052/01b
0.1, 0.4, 1 and 10 mg/L nominal

Details on test conditions:

PRETREATMENT OF TEST ITEM:
Study No. 2012/0052/01a
-0.11, 0.46, 1.05 and 10.6 mg of the test item added to 1 litre of dilution water
-treated in an ultrasonic bath for 60 minutes
-stirred for 24 hours on a magnetic stirrer
-undissolved particles of the test item were removed by filtration
-19 mL of the solution were taken and diluted with 1 mL of dilution water resulting in final test concentrations of 0.1, 0.4, 1 and 10 mg/L (rounded)
-for each test item concentration and the control two replicates were prepared

Study No. 2012/0052/01b
-0.15, 0.46, 1.05 and 10.5 mg of the test item added to 1 litre of dilution water
-treated in an ultrasonic bath for 60 minutes
-stirred for 2 hours on a magnetic stirrer
-undissolved particles of the test item were removed by filtration
-19 mL of the solution were taken and diluted with 1 mL of dilution water resulting in final test concentrations of 0.1, 0.4, 1 and 10 mg/L (rounded)
-for each test item concentration and the control two replicates were prepared

TEST SYSTEM (both reports):
- Test vessels: 50 mL glass beakers covered with watch glass
- 4 test concentrations plus 1 control
- 10 neonates per vessel, 2 replicates per concentration/control
- Temperature of incubation unit : 20.5 to 20.6 °C
- No feeding during the exposure period
- Photoperiod: 16 h light: 8 h dark
- no aeration
- Method of administration: direct weighing

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

The immobilisation and other abnormalities in the controls did not exceed 10 % by the end of the test. The dissolved oxygen concentration remained above 3 mg/L throughout the exposure period.

Conclusions:

An EC50(48h) > 10 mg/L and an EC0(48h) >= 10 mg/L (nominal) were determined in a study investigating the acute effects of the substance against daphnia. No toxic effect could be observed.

Executive summary:

An EC50(48h) > 10 mg/L and an EC0(48h) >= 10 mg/L (nominal) were determined in a study (OECD 202) investigating the acute effects of the substance against daphnia. No toxic effect could be observed.