Registration Dossier

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 April - 22 May 2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study but the test substance is highly insoluble in water and analytical verification of test concentrations difficult.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes (incl. certificate)
Remarks:
The Department of Health of the Government of the United Kingdom

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Benzene, 1,1 ‘-(1‚2-ethanediyl)bis-, brominated, [CAS No. 1092834-40-6]; product name: SH-1; reaction product of bromine and 1,2-diphenylethane
- Substance type: white powder
- Physical state: solid
- Analytical purity: >99%
- Composition of test material, percentage of components: Penta bromodiphenylethane 0-2%, Hexa bromodiphenylethane 40-80%, Hepta bromodiphenylethane 1-20%, Octa bromodiphenylethane 1-30%, Nona bromodiphenylethane 0-10%, Deca bromodiphenylethane 0-5%
- Lot/batch No.: 20090105
- Expiration date of the lot/batch: 08 January 2011
- Storage condition of test material: room temperature in the dark

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
The concentration and stability of the test material in the test preparations were verifled by chemical analysis at 0 and 48 hours.

Test solutions

Vehicle:
no
Details on test solutions:
The test material was insoluble in water. Pre-study solubility work conducted indicated that it was not possible to obtain a testable solution of the test material using traditional methods of preparation e.g. ultrasonicatiori and high shear mixing. A pre-study media preparation trial indicated that a dissolved test material concentration of approximately 0.0041 mg/l was obtained from a saturated solution method of preparation indicating this to be the limit of water solubility of this material under test conditions.

An amount of test material (550 mg) was dispersed, in duplicate, in 11 litres of reconstituted water with the aid of propeller stirring at approximately 1500 rpm at a temperature of approximately 20°C for 24 hours. After 24 hours the stirring was stopped and any undissolved test material was removed by centrifugation at 10000 g for 30 minutes to give a saturated solution with a 0-Hour measured test concentration of 0.0016 mg/l.


Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain: 1st instar
- Source: derived from in-house laboratory cultures
- Age at study initiation (mean and range, SD): < 24h
- Method of breeding: at 20°C, 16 hours light , 8 hours dark
- Feeding during test
- Food type: suspension of Chlorella
- Frequency: daily

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Test temperature:
20°C ± 1°C; The temperature throughout the test was observed to be slightly in excess of the 20°C ± 1°C range given in the Protocol. This deviation was considered not to have any impact on the outcome or validity of the test as no adverse effects of exposure were observed throughout the test.
Nominal and measured concentrations:
The test concentration of 0.0016 mg/I was the highest attainable test concentration that could be prepared due to the Iimited solubility of the test material in water.


Analysis of the test preparations at 0 hours showed measured test concentrations to range from 0.001 61 mg/l to 0.00167 mg/l.
Analysis of the old or expired test preparations at 48 hours showed a slight decline in measured test concentrations of 0.000514 mg/l to 0.00106 mg/l.

lt was therefore considered justifiable to base the results on the geometric mean measured test concentrations in order to give a “worst case“ analysis of the data. The use of geometric mean measured test concentrations was considered not to have affected the results of the test.

Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 250 mL glass jars containing approx. 250 mL test preparation
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): not renewed
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4


OTHER TEST CONDITIONS
- Photoperiod: 16 hours light, 8 hours dark with 20 min dawn and dusk transition periods


TEST CONCENTRATIONS
- Range finding study: 0.000041, 0.00041 and 0.0041 mg/L. Test material prepared from a saturated solution.

Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 0.001 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
dissolved
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
> 0.001 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
dissolved
Basis for effect:
mobility
Results with reference substance (positive control):
Daphnia magna was exposed to an aqueous solution of the reference material at conceritrations of 0.32, 0.56, 1.0, 1.8 and 3.2 mg/l for 48 hours at a temperature of approximately 20°C under static test conditions. Immobilisation and any adverse reactions to exposure were recorded after 3, 24 and 48 hours.

The 48-Hour EC50 for the reference material to Daphnia magna based on nominal concentrations was 0.71 mg/l with 95% confidence limits of 0.61 — 0.81 mg/l. The No Observed Effeet Concentration was 0.32 mg/l.

Any other information on results incl. tables

The acute toxicity of the test material to the freshwater invertebrate Daphnia magna has been investigated and based on the 0-hour measured test concentration gave a 48-hour EC50 of greater than 0.0016 mg/L. Correspondingly the No Observed Effect Concentration was 0.0016 mg/L.

The 48 -hour EC50 based on the geometric mean measured test concentrations was greater than 0.0011 mg/L and correspondingly the NO Observed Effect Concentration was 0.0011 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of the test material to the freshwater invertebrate Daphnia magna has been investigated and based on the 0-Hour measured test concentration gave a 48-Hour EC50 of greater than 0.0016 mg/l. Correspondingly the No Observed Effect Concentration was 0.0016 mg/l.

The 48-Hour EC50 based on the geometric mean measured test concentrations was greater than 0.0011 mg/l and correspondingly the No Observed Effect Concentration was 0.0011 mg/l.

This study showed that there were no toxic effects at saturation.