Amides, C12-18 and C18-unsatd., N,N-bis(hydroxyethyl)

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

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.

Reason / purpose for cross-reference:

read-across source

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).

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From June 27, 1986 to June 28, 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

No analytical dose verification.

Qualifier:

according to guideline

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:

Pre-GLP, however, the study adhered to GLP comparable quality conditions

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- 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 1°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:

EC0

Effect conc.:

ca. 2 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

ca. 3.3 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Key result

Duration:

24 h

Dose descriptor:

EC100

Effect conc.:

ca. 5.6 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

None.

Validity criteria fulfilled:

not specified

Remarks:

(Control data and dissolved O2 not reported)

Conclusions:

Under the study conditions, the nominal 24 h EC0, EC50 and EC100 were 2.0, 3.3 and 5.6 mg/L, respectively.

Executive summary:

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).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

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).