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:
26 April to 28 April 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study report is conducted to OECD and EEC guidelines and contains a statement of GLP compliance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
84/449/EEC
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:

- Physical state: white powder
- Analytical purity: not known
- Impurities (identity and concentrations): not known
- Composition of test material, percentage of components: not known
- Lot/batch No.: not known
- Expiration date of the lot/batch: not known
- Storage condition of test material: in a glass container at room temperature in the dark
- Other:
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Melting point: 515 to 517.2K
- Boiling point: >538K
- Vapour pressure: <0.00001Pa
- Water solubility (under test conditions): 187 mg/l
- Henry's law constant: Not reported
- log Pow: 2.32 at 18C
- pKa: Not reported
- Stability in water: stable in water
- Stability in light: stable in light
- pH dependance on stability: Not reported


OTHER PROPERTIES (if relevant for this endpoint)
- Results of test for ready biodegradability: 15% biodegradation after 28 days
- Other:

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0.025 - 0.25 μg/mlof test substance in a methanol/ distilled water (50:50) dilution solution.
- Sampling method: 10ml sample made upto volume with methanol/ distilled water (50:50)

Test solutions

Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
2.0 g of test material were stirred into 5L of de-ionised water overnight at room temperature. The saturated solution was then filtered through glass fibre paper and diluted to give the anticipated test concentrations of 0.10 to 18.0 mg/l.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Strain: Straus
- Source: Laboratory culture originating from a strain supplied by IRCHA, France
- Age at study initiation (mean and range, SD): young daphnids produced overnight before the test.
- Valve height at study initiation, for shell deposition study (mean and range, SD): Not reported
- Peripheral shell growth removed prior to test initiation: Not reported
- Method of breeding: Not reported
- Feeding during test: None

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
Not reported

Test conditions

Hardness:
Total Hardness ≈ 350 mg/l as calcium carbonate. Although slightly higher than the recommended range for this test, it is not considered to have had any significant effects on the results of the test.
Test temperature:
21 ±1C
pH:
pH = 8
Dissolved oxygen:
Mean D.O.: 94.58%
Salinity:
Sodium content: 43.8 mg/l
Nominal and measured concentrations:
Nominal test concentrations: 0.10, 0.18, 0.32, 0.56, 1.0, 1.8, 3.2, 5.6, 10 and 18 mg/l
Measured test concentrations: 0.077, 0.50, 0.45, 0.79, 1.6, 2.8, 4.4, 7.5 and 14 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass Jars
- Type (delete if not applicable): not reported
- Material, size, headspace, fill volume: 200ml test solution
- Aeration: None
- No. of organisms per vessel: 20 animals per test vessel
- No. of vessels per concentration (replicates): two
- No. of vessels per control (replicates): two
- Biomass loading rate: 20 ml test solution per organism



TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionised laboratory water
- Total organic carbon: mean 4.52 mg/l
- Particulate matter: No information
- Metals: No information
- Pesticides: No information
- Chlorine: mean 0.09 mg/l
- Alkalinity: mean 215.22 mg/l (calcium carbonate)
- Ca/mg ratio: mean Ca: Mg ratio = 16:1
- Conductivity: mean 905.31
- Culture medium different from test medium: No information
- Intervals of water quality measurement: 3 monthly intervals.


OTHER TEST CONDITIONS
- Adjustment of pH: no adjustment
- Photoperiod: 16 h light : 8 h dark
- Light intensity: no information



EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : 24 and 48 hours


Reference substance (positive control):
no

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.73 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
other: immobilisation
Remarks on result:
other: 95% CL: 0.59 - 0.9 mg/l
Details on results:
- Behavioural abnormalities: None
- Observations on body length and weight: N/A
- Other biological observations: None reported
- Mortality of control: N/A
- Other adverse effects control: None reported
- Abnormal responses: None reported
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None reported
- Effect concentrations exceeding solubility of substance in test medium: None reported
Results with reference substance (positive control):
No positive control data are included
Reported statistics and error estimates:
None reported

Any other information on results incl. tables

 Time (h) EC 50 (mg/l)  95% confidence limits (mg/l) 
24  9.0  6.3 - 13 
48  0.73  0.59 - 0.90 

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 48 hour EC50 of the test substance to Daphnia Magna is 0.73 mg/l.
Executive summary:

The acute toxcity to Daphnia magna study was conducted with Daphnia magna under static conditions and with analysis provided by HPLC with a UV-visible detector. Conducted over a 48 -hour exposure period, the test substance achieved an EC50of 0.73 mg/l. Based on these test results, the susbstance is proposed to be classified as very toxic to aquatic species.