2,2'-oxydi(ethylamine)

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:

experimental study

Adequacy of study:

key study

Study period:

2011-11-23 - 2012-01-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Well performed study according to OECD guideline 202 and in agreement with GLP requirements. However, since initial pH levels in the test solutions 18-100 mg/L (of which 18 mg/L shows partial mortality) were > 9 (9.2-10), this may have affected the results of the test and therefore the results of this study can be considered reliable, but with restrictions.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

; 10 daphnids in duplicate

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

- Name of test material (as cited in study report): BAEE
- Physical state: liquid
- Analytical purity: 95.9 %
- Lot/batch No.: LL080179
- Expiration date of the lot/batch: not provided
- Storage condition of test material: room temperature in the dark

Analytical monitoring:

yes

Details on sampling:

- At 0 and 48 h duplicate samples (replicates pooled) were taken from the control, 1.0, 3.2, 10, 32 and 100 mg/L test groups for analytical verification of test substance concentrations.
- All samples were stored at approximately - 20 °C before analysis.

Vehicle:

no

Details on test solutions:

- 200 mg of test item was directly dissolved in reconstituted water and the volume adjusted to give the 100 mg/L test concentration.
- Based on this test solution the other test solutions were prepared by serial dilution.
- Each prepared test solution was inverted several times to ensure adequate mixing and homogeneity.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: in-house laboratory culture
- Age at study initiation (mean and range, SD): 1st instar, < 24 h old
- Method of breeding:
* in 150 mL glass beakers containing Elendt M7 medium
* temperature controlled room at approximately 20 °C
* light cycle: 16:8 light:dark with 20 min dusk and dawn periods
* feeding frequency: daily
* food type: mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension
* parthenogenetic reproduction
* gravid adults isolated day before initiation of test; young produced overnight were less than 24 hours old
- Feeding during test: no

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

none

Hardness:

ca. 250 mg CaCO3/L (reconstituted water)

Test temperature:

21-22 °C

pH:

8.0-10 at 0 h
8.1-8.8 after 48 h

Dissolved oxygen:

8.8-9.1 mg O2/L at 0 h
8.5-8.7 after 48 h

Salinity:

Not applicable

Nominal and measured concentrations:

- Nominal concentrations: control, 1.0, 1.8, 3.2, 5.6, 10, 18, 32, 56 and 100 mg/L
- Measured concentrations ranged from 91-110% of nominal

Details on test conditions:

TEST SYSTEM
- Test vessel: beaker/jar
- Type (delete if not applicable): covered to prevent evaporation
- Material, size, headspace, fill volume: glass, 250 mL, with 200 mL fill volume
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionised water
- Reconstituted water was used as test medium (containing CaCl2.2H2O, MgSO4.7H2O, NaHCO3, KCl)
- Intervals of water quality measurement during the test:
* water temperature: daily
* dissolved oxygen and pH: at start and termination of test

OTHER TEST CONDITIONS
- Photoperiod: 16:8 light:dark with 20 minutes for dusk and dawn

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): immobilisation after 24 and 48 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: ca. 1.8
- Range finding study: yes
- Test concentrations during range finding study: 0.10, 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study:
* No significant immobilisation observed at test concentrations of 0.10 and 1.0 mg/L
* 20% immobilisation observed at 1.0 mg/L while 100 % immobilisation observed at 100 mg/L

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

7.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 6.1-9.5 mg/L

Details on results:

- EC50(24h) value is 18 mg/L with 95 % C.I. from 14 to 22 mg/L
- NOEC after 24 and 48 hours is 1.8 mg/L

Results with reference substance (positive control):

- EC50(24h): 1.3 mg/L, 95 % C.I. 1.0-1.8 mg/L
- EC50(48h): 1.1 mg/L, 95 % C.I. 1.0-1.3 mg/L
- The results from the positive control were within the normal range for this reference item.

Reported statistics and error estimates:

EC50 values and associated confidence limits at 24 and 48 hours and the slope of the response curve and its standard error were calculated by the maximum-likelihood probit method (Finney 1971) using the ToxCalc computer software package (ToxCalc 1999).

Validity criteria fulfilled:

yes

Conclusions:

The study reported a 48-h EC50 value of 7.6 mg/L for Daphnia magna for the test substance. Analytical verification of test substance concentrations showed measured concentrations to be close to nominal. Initial pH levels of test solutions 18-100 mg/L were outside the allowed range of 6-9 (> 9). At the end of testing pH levels had returned to normal (8.4-8.8). However, especially with the 18 mg/L test solution showing partial mortality, this may have affected the test results and therefore the results should be considered reliable but with restriction.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Study period:

2009

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

accepted calculation method

Justification for type of information:

QSAR prediction using the most recent version of ECOSAR (2009) - can be used as key information in a weight-of-evidence approach.

Qualifier:

according to guideline

Guideline:

other: ECOSAR v.1.00 (ECOWIN v.1.00)

Principles of method if other than guideline:

QSAR predictions were conducted using ECOSAR v.1.00 (2009) using the QSAR for aliphatic amines

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnid (not specified)

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

181.467 mg/L

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

Validity of EC50 model:
1. Defined endpoint: 48-h LC50 for daphnid.
2. Unambiguous algorithm: linear regression QSAR; Log 48-h LC50 (mmol/L) = -0.5119 (log Kow) - 0.7278
3. Applicability domain: APPLICATION: This SAR may be used to estimate toxicity for aliphatic amines. LIMITATIONS: For aliphatic amines with log Kow values greater than 5.0, a test duration of greater than 48 hours may be required for proper expression of toxicity.  Also, if the acute toxicity value obtained by the use of this equation exceeds the water solubility of the compound (measured or estimated), significant mortalities would not be expected in a saturated solution during an exposure period of 48 hours.
4. Statistical characteristics: The LC50 is in millimoles per liter (mM/L); N = 44 + 15; and the Coefficient of Determination (R2) = 0.554. 

Validity of chronic value model:
1. Defined endpoint: chronic value for daphnid.
2. Unambiguous algorithm: linear regression QSAR; Log ChV (mmol/L) = -0.0977 (log Kow) - 3.7304
3. Applicability domain: APPLICATION: This SAR may be used to estimate toxicity for aliphatic amines. LIMITATIONS: If the log Kow value is greater than 8.0, or if the compound is solid and the ChV exceeds the water solubility by 10X, no effects at saturation are predicted.
4. Statistical characteristics: The ChV is in millimoles per liter (mM/L); N =3; and the Coefficient of Determination (R2) = 0.9538.

Adequacy of prediction: the substance falls within the applicability domains described above and therefore the predicted values can be considered reliable.

Validity criteria fulfilled:

not specified

Conclusions:

QSAR predictions were conducted using the latest version of US EPA's ECOSAR (v.1.00, 2009) using input values of -1.89 for log Kow and 1E+006 mg/L for water solubility in the QSAR for aliphatic amines. The model predicted a 48-h LC50 and a chronic value for daphnid of 181.467 mg/L and 0.030 mg/L, respectively. Because the substance falls within the applicability domain of the models these predicted values can be considered reliable.

Description of key information

The EC50 value of 7.6 mg/L  from the key study is taken for further assessment. 

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

7.6 mg/L

Additional information

The acute toxicity of the test substanc to the waterflea, Daphnia magna, was investigated in a 48-hour static test according to the EEC-Guideline 79/831/EEC method C.2 (Harlan, 2012). Based on nominal concentrations, the 48-hour EC50 was estimated to be 7.6 mg/L.