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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
5 September 1995 - 13 October 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The analysis failed to provide evidence of exposure concentrations. However, the test solution was a turbid, white suspension which confirms the exposure to the test substance. Also, the sensitivity of the used batch of Daphnia magna showed to be low. However, based on the complete absence of immobility in the limit test, no different result of the test is expected when a different batch is used.
Qualifier:
according to guideline
Guideline:
other: EEC-Directive 92/69 C.2
Version / remarks:
1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
1984
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Stability under storage conditions: stable
Stability in water: not indicated
Solubility in water: < 2.4 mg/L at 20 °C
Analytical monitoring:
yes
Details on sampling:
No analytical method was available or could be developed for this compound. Therefore, quantitative analyes were performed on Al and Mg. Consequently, no stability of the test substance could be tested. The analyses were performed by: TNO Institute of Environmental Sciences in Delft, the Netherlands

- Concentrations: 0 and 100 mg/L. In addition, a sample from the Cremophor-control was taken for analysis.
- Sampling method: according to schedule below
Frequency: at t=0 and at t=48 h
Volume: 25 mL
- Storage before sampling: samples were stored in a refrigerator until shipment to the TNO laboratories at Delft, the Netherlands. All samples were filtered through a 0.45 µm filter and acidified before storage and subsequent shipment.
Vehicle:
yes
Remarks:
Cremophor EL
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 798.8 mg of test substance was mixed with 801.16 mg Crempohor EL and added to 8 liters of ISO medium, providing a nominal concentration of 100 mg/L. This dispersion was stirred for 66 hours before the start of the exposure.
- Controls: one control containing test medium without test substance or other additives and one control without test substance but with Cremophor EL
- Chemical name of vehicle: Cremophor EL, dispersant
- Concentration of vehicle in test medium: 100 mg/L
- Evidence of undissolved material: yes, the final solution was a turbid, white suspension
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia Magna
- Strain/clone: Straus, 1820
- Age at start of the test: < 24 hours
- Feeding during test: no

ACCLIMATION: no

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: each batch was started with newborn animals, i.e. less than 3 days old, by placing about 250 of them into 10 litres of medium in an all-glass culture vessel.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
250 mg CaCO3/L
Test temperature:
Between 21 and 22 °C throughout the test.
pH:
Between 8.0 and 8.1 throughout the test.
Dissolved oxygen:
Between 9.0 and 9.9 mg O2/L throughout the test.
Nominal and measured concentrations:
Nominal concentrations: 0, 0 (with Cremophor EL) and 100 mg/L
Measured concentration for both controls and 100 mg/L: < 1.52 mg/L. The concentration of test substance was based on the amount of Al calculated as follows: Concentration Al * (588/54)
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 mL, all-glass, open, fill volume: 80 mL
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO, prepared in milli-RO water
- Culture medium different from test medium: yes (M4)

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours, daily

EFFECT PARAMETERS MEASURED: mobility after 24 and 48 hours. In addition, pH and oxygen were measured at the beginning and at the end of the test, for both the treated solution and the controls.Temperature of the medium was measured daily in one control vessel, beginning at the start of the test.

VEHICLE CONTROL PERFORMED: yes

RANGE-FINDING STUDY
- Test concentrations: supersaturated solution of 100 mg/L and a filtrate of a solution of 100 mg/L
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
Potassium dichromate (August 1995)
Key result
Duration:
48 h
Dose descriptor:
EC50
Basis for effect:
mobility
Remarks on result:
other: The 48h-EC50 was above the solubility limit of the test substance in test medium.
Details on results:
- No behavioural, biological or other abnormalities have been observed.
- Effect concentrations exceeding solubility of substance in test medium: yes
Results with reference substance (positive control):
- Results with reference substance valid? Yes
24h-EC50: 1.8 mg/L (estimated)
48h-EC50: 1.1 mg/L (estimated)
- The responses of the reference test are not within the ranges of the expected responses at the different concentrations. Mortality rate at 1.0 mg/L was below the historical response of 40%. Hence, the sensitivity of this batch of Daphnia magna can be considered as being low.

For more details on analytical and final results refer to the attached document. (CRL 137791 - Tables.docx)

Validity criteria fulfilled:
no
Remarks:
Due to low solubility of TS, actual concentrations were not shown to be maintained at more than 80% of the initial concentration.
Conclusions:
Under the conditions of the present study, the 48h-EC50 of Alcamizer 5 was greater than the solubility limit of the test substance in test medium.
Executive summary:

A study was performed to assess the effect of the test substance on the mobility of Daphnia magna after 48 hours. The study was conducted in accordance with OECD 202 and under GLP conditions.

A range-finding test was used to determine the range of concentrations for the final test. Daphnia were exposed for 48 hours to a supersaturated solution of 100 mg/L and a filtrate of a solution of 100 mg/L. No immobility was seen in either of the two solutions tested.

For the final study, an exposure concentration of 100 mg/L and two controls were used. One control contained test medium without test substance or other additives, a second control contained test medium without test substance but with Cremophor EL. 20 Daphnia magna (less than 24 hours old) were exposed to 100 mg/L solution and the controls for 48 hours in all-glass, open vessels. The incidence of immobilisation was recorded for each test and control group at 24 hours and at 48 hours.

Quantative analysis was performed on Al and Mg in samples taken from 0 and 100 mg/L and the Cremophor control to determine the test concentrations. Analysis showed that no levels of Al or Mg higher than those in the controls were found in the 100 mg/L solution. Measured test substance concentrations, based on Al were calculated to be < 1.52 mg/L in both controls and 100 mg/L solution. Water solubility was determined to be < 2.4 mg/L in an earlier study. The 100 mg/L solution was a turbid, white suspension which proved that the Daphnia were exposed to the test substance.

No effects were seen at a nominal concentration of 100 mg/L.

Based on the results with the reference substance, it was shown that the sensitivity of the system was low. However, based on the complete absence of immobility in the limit test, no different result of the test is expected when another batch of Daphnia would be used.

Under the conditions of the present study, the 48h-EC50 of Alcamizer 5 was greater than the solubility limit of the test substance in test medium.

Description of key information

A study was performed to assess the effect of the test substance on the mobility of Daphnia magna after 48 hours. The study was conducted in accordance with OECD 202 and under GLP conditions.

A range-finding test was used to determine the range of concentrations for the final test. Daphnia were exposed for 48 hours to a supersaturated solution of 100 mg/L and a filtrate of a solution of 100 mg/L. No immobility was seen in either of the two solutions tested.

For the final study, an exposure concentration of 100 mg/L and two controls were used. One control contained test medium without test substance or other additives, a second control contained test medium without test substance but with Cremophor EL. 20 Daphnia magna (less than 24 hours old) were exposed to 100 mg/L solution and the controls for 48 hours in all-glass, open vessels. The incidence of immobilisation was recorded for each test and control group at 24 hours and at 48 hours.

Quantative analysis was performed on Al and Mg in samples taken from 0 and 100 mg/L and the Cremophor control to determine the test concentrations. Analysis showed that no levels of Al or Mg higher than those in the controls were found in the 100 mg/L solution. Measured test substance concentrations, based on Al were calculated to be < 1.52 mg/L in both controls and 100 mg/L solution. Water solubility was determined to be < 2.4 mg/L in an earlier study. The 100 mg/L solution was a turbid, white suspension which proved that the Daphnia were exposed to the test substance.

No effects were seen at a nominal concentration of 100 mg/L.

Based on the results with the reference substance, it was shown that the sensitivity of the system was low. However, based on the complete absence of immobility in the limit test, no different result of the test is expected when another batch of Daphnia would be used.

Under the conditions of the present study, the 48h-EC50 of Alcamizer 5 was greater than the solubility limit of the test substance in test medium.

Key value for chemical safety assessment

Additional information