1,1'-ethan-1,2-diylbisbenzene, brominated

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 May - 19 June 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes (incl. QA statement)

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 centrifuged and uncentrifuged samples were verified by chemical analysis at 0 (fresh media), 24, 48, 72 (old and fresh media) and 96 hours (old media).

Test solutions

Vehicle:

yes

Details on test solutions:

An amount of test material (100 mg) was dissolved in tetrahydrofuran and the volume adjusted to 25 mL to give a 100 mg/25 mL solvent stock solution. Serial dilutions were prepared from this to give a 0.40 mg/10 mL solvent stock solution. An aliquot (2.0 mL) of the 0.40 mg/25 mL solvent stock solution was dispersed in dechlorinated tap water and stirred with a flat bladed mixer for approximately 1 minute to give the required test concentration. This method of preparation was conducted in duplicate to give replicates R1 and R2.

Each of the stock solutions were inverted several times to ensure adequate mixing and homogeneity.

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source: Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK
- Age at study initiation (mean and range, SD): juvenile
- Method of breeding: maintained in-house since 20 May 2009; in glass fibre tank with a"single-pass" water renewal system
- light: 18 hours light, 8 hours dark, with 20 min dawn and dusk transition periods
- Feeding during test: no; stock fish were fed commercial trout pellets which was discontinued 24 hours prior to the start of the definitive test


ACCLIMATION
- Acclimation period: 03 - 15 June 2009
- Acclimation conditions (same as test or not): yes

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

test water: approx. 140 mg/L as CaCO3

Test temperature:

14 - 15°C

pH:

7.6 - 8.0

Dissolved oxygen:

9.8 - 10.1 mg O2/L

Nominal and measured concentrations:

0.0040 mg/L (nominal)
0.0034 mg/L (time-weighed mean measured)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 20 L glass vessels
- Aeration: via narrow bore glass tubes
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: laboratory water was dechlorinated by passage through an activated carbon filter and partly softened, giving water a total hardness of approx. 140 mg/L as CaCO2. Water was then heated to achieve required temperature.
- Total organic carbon: 1.041 mg/L
- Pesticides: 0
- Chlorine: 0.297 mg/L
- Conductivity: 421.385 µS/cm at 20°C
- Intervals of water quality measurement: reporting period 01 Jan - 31 Dec 2007


OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods for a period of 96 hours.


TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: see "any other information on materials and methods"
- Range finding study
- Test concentrations: single nominal concentration of 0.0040 mg/L (as the results from a Acute Toxicity to Daphnia magna test, Harlan Laboratories Ltd Project Number: 2737/0002)
- Results used to determine the conditions for the definitive study: see "any other information on materials and methods"

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

0.003 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.003 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

no mortalities in 14 fish exposed, no sublethal effects

Any other information on results incl. tables

Sublethal observations / clinical signs:

Current regulatory advice is that in cases where a decline in measured concentrations is observed, time-weighed mean measured concentrations should be used for calculating LC50 values. It was therefore considered justifiable to base the results on the time-weighted mean measured test concentrations in order to give a "worst case" analysis of the data. 0.0034 mg/L was the highest attainable test concentration that could be prepared due to the limited solubility of the test material.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Based on the time-weighted mean measured test concentrations of the centrifuged test media the acute toxicity of the test material to rainbow trout gave a 96-hour LC50 value of greater than 0.0034 mg/L. The No Observed Effect Concentration was 0.0034 mg/L.