Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 7 to November 17, 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No analytical dose verification.
Qualifier:
according to guideline
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:
no
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
Post exposure observation period:
none
Hardness:
Not specified
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):
not required
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 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.:
ca. 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
ca. 2 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.

None.

Validity criteria fulfilled:
yes
Remarks:
Both the criteria for dissolved oxygen and control immobility were fulfilled
Conclusions:
Under the study conditions, the nominal 48 h EC50 was determined to be 3.2 mg/L. The nominal 48 h LOEC and NOEC values were 2.0 and 1.0 mg/L, respectively.

Executive summary:

A study was conducted to determine the acute toxicity of the test substance, C8-18 and C18-unsatd. DEA, to Daphnia magna according to OECD Guideline 202, in compliance with GLP. The daphnids were exposed to test substance (directly diluted in test medium) at 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 % of immobilised daphnids in the control and test vessels. No analytical dose verification was conducted. Under the study conditions, the nominal 48 h EC50 was determined to be 3.2 mg/L. The nominal 48 h LOEC and NOEC values were 2.0 and 1.0 mg/L, respectively (Olsson, 1994).

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
November 7 to November 17, 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
KL 2 due to RA and no analytical dose verification.
Justification for type of information:
Refer to the section 13 for details on the category justification.
Qualifier:
according to guideline
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:
no
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
Post exposure observation period:
none
Hardness:
Not specified
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):
not required
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 3.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
ca. 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.:
ca. 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.

None

Validity criteria fulfilled:
yes
Remarks:
Both the criteria for dissolved oxygen and control immobility were fulfilled
Conclusions:
Under the study conditions, the nominal 48 h EC50 was determined to be 3.2 mg/L. The nominal 48 h LOEC and NOEC values were 2.0 and 1.0 mg/L, respectively.
Executive summary:

A study was conducted to determine the acute toxicity of the read across substance, C8-18 and C18-unsatd. DEA, to Daphnia magna according to OECD Guideline 202, in compliance with GLP. The daphnids were exposed to test substance (directly diluted in test medium) at 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 % of immobilised daphnids in the control and test vessels. No analytical dose verification was conducted. Under the study conditions, the nominal 48 h EC50 was determined to be 3.2 mg/L. The nominal 48 h LOEC and NOEC values were 2.0 and 1.0 mg/L, respectively(Olsson, 1994).

Description of key information

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
3.2 mg/L

Additional information

A study was conducted to determine the acute toxicity of the read across substance, C8-18 and C18-unsatd. DEA, to Daphnia magna according to OECD Guideline 202, in compliance with GLP. The daphnids were exposed to test substance (directly diluted in test medium) at 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 % of immobilised daphnids in the control and test vessels. No analytical dose verification was conducted. Under the study conditions, the nominal 48 h EC50 was determined to be 3.2 mg/L. The nominal 48 h LOEC and NOEC values were 2.0 and 1.0 mg/L, respectively (Olsson, 1994).

A study was conducted to evaluate the acute toxicity of the test substance, C12-18 and C18-unsatd. DEA, to Daphnia magna according to OECD Guideline 202 with deviations. Daphnia (20 per dose) were exposed to the test substance (directly diluted in test medium) in a concentration range of 1-11 mg/L for 24 h and immobility was determined at test end. No analytical dose verification was carried out. Under the study conditions, the nominal 24 h EC0, EC50 and EC100 were 2.0, 3.3 and 5.6 mg/L, respectively (Gode, 2001).