6H-Benzofuro[3a,3,2-ef][2]benzazepin-6-one, 1-bromo-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-, (4aR,8aR)-rel-

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:

2001-11-12 to 2002-02-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

439-750-2

EC Name:

-

Cas Number:

183487-56-1

Molecular formula:

Hill formula: C17H19BrClNO3 CAS formula: C17H19BrClNO3

IUPAC Name:

(4aR*,8aR*)-1-bromo-4a,5,9,10,11,12- hexahydro-3-methoxy-11-methyl-6H-ben zofuro[3a,3,2-ef][2]benzazepin-6-one hydrochloride

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: RT002113G3A231
- Expiration date of the lot/batch: 2001-12-01 (retest date)
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature at about 20°C
- Stability under test conditions: Determined in RCC study 825265
- Solubility and stability of the test substance in the solvent/vehicle: in water 120 g/L (non-GLP, sponsor's information; determined in RCC study 825030)

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Sampling method: duplicate samples from each test medium were taken just before the start of the test and at the end of the test. For the 48-hour stability samples the contents of the two respective test beakers were
combined. The samples were acidified to about a pH 4-5 immediately after sampling using a 0.1 M phosphoric acid solution.
- Sample storage conditions before analysis: the sample were analyzed immediately after sampling without prior storage.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: the highest test concentration of nominal 100 mg/L was prepared by dissolving 60 mg test item completely in 600 mL test water by intense stirring for 5 minutes at room temperature. The lower test item concentrations were prepared by diluting this test medium.
- Controls: yes
- Evidence of undissolved material (e.g. precipitate, surface film, etc): all test media were clear solutions throughout the entire test duration.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water-flea
- Source: University of Sheffield/UK in 1992
- Age at study initiation (mean and range, SD): 6-24 hours old and were not first brood progeny
- Method of breeding: the clone is bred in the RCC laboratories in reconstituted water of the quality identical to the water quality used in
the tests (regarding pH, main ions and total hardness) and under temperature and light conditions identical to those of the tests.

ACCLIMATION
- Acclimation period: not relevant

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

250 mg CaCO3/L

Test temperature:

21-22°C

pH:

7.3 - 8.0

Dissolved oxygen:

at least 8.0 mg/L.

Salinity:

not applicable

Nominal and measured concentrations:

Nominal test concentrations: 4.6, 10, 22, 46, 100 mg/L
Mean measured concentrations: 4.5, 9.6, 22, 37, 75 mg/L
The mean measured concentrations (calculated as the average over all measurements per test concentration) ranged from 75 to 79% of nominal.

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beakers
- Aeration: the test water was aerated prior to the start of the study until oxygen saturation was reached
- Material, size, headspace, fill volume: 100 mL glass beakers filled with 50 mL test medium.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: lower than 1 Daphnia per 2 mL test solution

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted test water
- Alkalinity: 0.8 mmol/L
- Ca/mg ratio: 4:1 (based on molarity)
- Culture medium different from test medium: no
- Intervals of water quality measurement: 2 days

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hour light to 8-hour darkness photoperiod (with a 30 minute transition period)
- Light intensity: 200-1200 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobility by visual control after 24 and 48h of exposure

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Range finding study
- Test concentrations: not reported
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

52 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 37-75

Details on results:

- Behavioural abnormalities: no
- Immobility of control: no
- Other adverse effects control: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no.
- The 24-h EC50 = 62 mg/L.
- The 48-h EC100 = 75 mg/L.
- The 48-h NOEC = 37 mg/L.

Results with reference substance (positive control):

- Results with reference substance valid? potassium dichromate is tested as a positive control at least once a year. no information about the result is reported.

Reported statistics and error estimates:

The EC50 values and their 95% confidence interval could not be calculated by Probit analysis or Moving average Interpolation due to the steep concentration-effect relationship. The 48-h EC50 value was determined as the geometric mean value of the 2 consecutive test concentrations with 0% and 100% immobility.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of the test item T002113 to Daphnia magna was determined in a 48-hour static test according to the OECD guideline 202. The geometric mean measured 48-hour EC50 was determined to be 52 mg T002113/Lwith a 95% confidence interval ranging from 37 to 75 mg/L. The results of the test can be considered reliable without restriction.