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Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
other: ead-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
From June 27, 1986 to June 28, 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Read-across justification appended to Section 13 of the IUCLID file.
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
(Number of daphnids per concentration were about 20 but not exactly counted, substance concentration was not followed by chemical analysis, duration of test was less than 48 h, control data not reported)
GLP compliance:
no
Remarks:
However, the study adhered to GLP comparable quality conditions
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Chemical name of vehicle: Synthetic mineral water
- Concentration of vehicle in test medium (stock solution and final test solution): Stock solution of 100 mg/L of test medium was prepared from which aliquots of 0.2-2.2 mL were pipetted to the test volume of 20 mL and the test organisms were added.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain: Own breed, strain identical with the strain of the Bundesgesundheitsmnt/Inst. Wasser-Boden-Luft.
- Food type: Chlorella kessleri (not during the test)
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
24 h
Hardness:
about 14 °dH (80 mg Ca and 12.2 Mg mg/L)

Test temperature:
Room temperature (about 20 °C)
Nominal and measured concentrations:
Nominal: 1.0, 1.4, 2.0, 2.8, 4.0, 5.6, 8.0 and 11 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: Glass beakers, covered with glass plates
- Fill volume: 20 mL
- No. of organisms per concentration: 20
- Renewal rate of test solution (frequency/flow rate): Not renewed


TEST MEDIUM:
Following mineral salts were present per litre deionised water:
- 294 mg CaCl2.2H2O
- 123 mg MgSO4.7H2O
- 63 mg NaHCO3
- 5.5 mg KCl



OTHER TEST CONDITIONS
- Photoperiod: About 16 h daily
Reference substance (positive control):
no
Key result
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
3.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
24 h
Dose descriptor:
EC0
Effect conc.:
2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Validity criteria fulfilled:
not specified
Remarks:
(Control data and dissolved O2 not reported )
Conclusions:
Under the study conditions, the nominal 24 h EC50 and EC0 were equivalent to 3.3 and 2.0 mg/L, respectively.
Executive summary:

A study was conducted to evaluate the acute toxicity of the read across substance, amides, C12-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl), to water flea (Daphnia magna) according to OECD Guideline 202. Groups of 20 daphnids were exposed to the test substance in a concentration range of 1 to 11 mg/L for 24 h under static conditions. Immobility was determined at 24 h. No analytical dose verification was conducted. Under the study conditions, the nominal 24 h EC50 and EC0 were equivalent to 3.3 and 2.0 mg/L, respectively (Gode, 2001). 

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
other: ead-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From November 7 to November 17, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Read-across justification appended to Section 13 of the IUCLID file.
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
yes
Remarks:
(no analytical verification of test conc was done)
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
The test solution was prepared in dilution water. The test material was found to be soluble up to 1000 mg/L in water.


Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea
- Strain: Not specified
- Source: Toxicon's Daphnia culture
- Age at study initiation: Newly hatched, 6 to 24 h old
- Weight at study initiation: Not specified
- Length at study initiation: Not specified

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Test temperature:
21±1 °C
pH:
7.8±0.2
Dissolved oxygen:
Not specified, initial oxygen saturation > 90%

Salinity:
250±25 mg CaCO3/L


Nominal and measured concentrations:
Nominal: 0, 1, 2, 4, 8 and 16 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: open
- Material, size, headspace, fill volume: Glass petri dishes with 50 mL solution
- Aeration: The dilution water was initially aerated to an oxygen saturation value of > 90%
- Renewal rate of test solution: Not applicable, static test
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): Two
- No. of vessels per control (replicates): Two


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reverse osmosis water

Composition of dilution water: According to ISO test water composition



OTHER TEST CONDITIONS
- Adjustment of pH: When required, it was done with HCl or NaOH
- Photoperiod: 16 h/8 h light: dark
- Light intensity: Subdued, no oher details


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobilisation in the control and test animals at 24 and 48 h


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
3.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
Control dish: Less than 10% immobility was observed in the control at 24 and 48 h.
Test dish: At 16 and 8 mg/L, 100 % immobilisation was observed.
Oxygen saturation: > 97 % oxygen saturation was maintained at the end 48 h. The pH was maintained around 8.0.
For details please refer to the attached results table in the 'background material' section.
Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of the study, the 48 h EC50 was determined to be 3.2 mg/L (nominal) and the 48 h NOEC was 1.0 mg/L (nominal).
Executive summary:

A study was conducted to determine the acute toxicity of the read across substance, amides, C8-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl), to Daphnia magna according to OECD Guideline 202, in compliance with GLP. The daphnids were exposed to nominal concentrations of 0, 1, 2, 4, 8 and 16 mg/L for 48 h under static conditions. Observations were performed at 0, 24 and 48 h to determine the % immobilised daphnids in the control and test groups. No analytical dose verification was conducted. Under the conditions of the study, the 48 h EC50 was determined to be 3.2 mg/L (nominal) and the 48 h NOEC was 1.0 mg/L (nominal) (Olsson, 1994).

 

Description of key information

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
3.2 mg/L

Additional information

A study was conducted to determine the acute toxicity of the read across substance, amides, C8-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl), to Daphnia magna according to OECD Guideline 202, in compliance with GLP. The daphnids were exposed to nominal concentrations of 0, 1, 2, 4, 8 and 16 mg/L for 48 h under static conditions. Observations were performed at 0, 24 and 48 h to determine the % immobilised daphnids in the control and test groups. No analytical dose verification was conducted. Under the conditions of the study, the 48 h EC50 was determined to be 3.2 mg/L (nominal) and the 48 h NOEC was 1.0 mg/L (nominal) (Olsson, 1994).

A study was conducted to evaluate the acute toxicity of the read across substance, amides, C12-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl), to water flea (Daphnia magna) according to OECD Guideline 202. Groups of 20 daphnids were exposed to the test substance in a concentration range of 1 to 11 mg/L for 24 h under static conditions. Immobility was determined at 24 h. No analytical dose verification was conducted. Under the study conditions, the nominal 24 h EC50 and EC0 were equivalent to 3.3 and 2.0 mg/L, respectively (Gode, 2001).