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Ecotoxicological information

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:
2015-06-03 - 2015-07-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline in compliance with GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material: not applicable
Analytical monitoring:
yes
Details on sampling:
Range-finding study
- Concentrations: A sample of each test concentration (0.1, 1.0, 10, 100 mg/L) was taken for chemical analysis at 0 and 48 hours in order to determine the stability of the test item under test conditions.
- Sample storage conditions before analysis: All samples were stored frozen prior to analysis.

Definitive test
- Concentrations: A sample of each test concentration (100 mg/L) was taken for chemical analysis at 0 and 48 hours in order to determine the stability of the test item under test conditions.
- Sample storage conditions before analysis: The samples were stored frozen prior to analysis.
Vehicle:
no
Details on test solutions:
Range-finding study
A nominal amount of test item (50 mg) was dissolved in test water and the volume adjusted to 500 mL to give the 100 mg/L test concentration from which a series of dilutions was made to give the further test concentrations of 0.10, 1.0 and 10 mg/L. Each prepared concentration was inverted several times to ensure adequate mixing and homogeneity.

Definitive test
A nominal amount of test item (200 mg) was dissolved in test water and the volume adjusted to 2 liters to give the 100 mg/L test concentration. The pH of the 100 mg/L test concentration was determined to be 9.2, which was outside of test guideline criteria of pH 6-9. The pH in the definitive test was therefore adjusted to pH 8.7 prior to a series of dilutions being made to give the further test concentrations of 10, 18, 32 and 56 mg/L.
Each prepared concentration was inverted several times to ensure adequate mixing and homogeneity. The concentration and stability of the test item in the test preparations were verified by chemical analysis at 0 and 48 hours
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia
- Strain and source: 1st instar Daphnia magna derived from in-house laboratory cultures.
- Age at study duration: less than 24 hours
- Feeding during test
- Food type: Each culture was fed daily with a mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension
- Other: The diet and diluent water are considered not to contain any contaminant that would affect the integrity or outcome of the study.

ACCLIMATION
- Acclimation period: yes
- Acclimation conditions (same as test or not): same
- Type and amount of food: see above
- Feeding frequency: see above
- Health during acclimation (any mortality observed): none reported
- Other: Adult daphnia were maintained in 150 mL glass beakers containing Elendt M7 medium (see Appendix 2) in a temperature controlled room at approximately 20 °C. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
not reported
Hardness:
250 mg/L as CaCO3
Test temperature:
21 - 22 °C
pH:
7.3 - 8.7 (*)

* adjusted (recorded as 9.2 before)
Dissolved oxygen:
8.7 - 9.0 mg O2/L
Salinity:
not applicable
Nominal and measured concentrations:
Range-finding test
nominal: 0.10, 1.0, 10 and 100 mg/L

Definitive test
nominal: 10, 18, 32, 56 and 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 150 mL glass jars containing approximately 100 mL of test preparation
- Type (delete if not applicable): open (test vessels were then covered to reduce evaporation)
- Material, size, headspace, fill volume: glass
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): no vehicle used

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted Water - ISO Medium
- CaCl2.2H20: 294 mg/L; MgSO4.7H20: 123 mg/L; NaHCO3: 65 mg/L; KCl: 5.8 mg/L
- The reconstituted water had a pH of 7.8 ± 0.2 adjusted (if necessary) with NaOH or HCl and was aerated until the dissolved oxygen concentration was approximately air-saturation value.

OTHER TEST CONDITIONS
- Adjustment of pH: yes (At 0 hours, the 100 mg/L test concentration pH was recorded at 9.23 and was adjusted to 8.70, within the guideline criteria, using hydrochloric acid.)
- Photoperiod: 16 hours light; 8 hours darkness (20 minute dawn and dusk transition periods)
- Light intensity: 641 - 677 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Trapping and mobility was observed after 24 and 48 hours.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0.10, 1.0, 10 and 100 mg/L (nominal)
- Results used to determine the conditions for the definitive study: results of initial experiment (limit test with 100 mg/L) used
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
Definitive test: A single immobilized daphnia was observed in the 18 mg/L test group, however this was thought to be due to natural causes as no other daphnia were observed to be immobilized or have any sub-lethal effects.
Results with reference substance (positive control):
- Results with reference substance valid?
The results from the positive control with potassium dichromate were within the normal range for this reference item.
- NOEC (48 h) = 0.56 mg/L
Reported statistics and error estimates:
no error estimates reported

Range-finding Test


Cumulative immobilization data and other observations from the exposure of Daphnia magna to the test item during the range-finding test are given in Table 1.


No immobilization was observed at the test concentrations of 0.10, 1.0, 10 and 100 mg/L. The pH of the 100 mg/L test concentration was recorded to be 9.4 and was not adjusted to within guideline criteria, all other pH determinations were within guideline criteria.


Chemical analysis of the test preparations at 0 hours showed measured test concentrations to range from 114 % to 141 % of nominal concentrations. There was no significant change in the measured concentrations at 48 hours indicating that the test item was stable under test conditions. The measured concentration in the 0.10 mg/L test concentration at 0 and 48 hours was outside the acceptable range of 80 - 120 %, this was considered to have had no effect on the study as no immobilization or sub lethal affects were observed at this test concentration.


Based on this information, a single nominal test concentration of four replicates, of 100 mg/L was selected for the initial experiment. This experimental design conforms to a "Limit test" to confirm that at the maximum test concentration given in the OECD/EC Test Guidelines no immobilization or adverse reactions to exposure were observed.


 


Table 1. Cumulative Immobilization Data and Observations in the Range-finding Test























































 Observations (Initial Population: 10 Per Replicate)
Nominal Concentration (mg/L)24 Hours48 Hours
Cumulative Immobilized DaphniaObservationsCumulative Immobilized DaphniaObservations
Control010N010N
0.1007N, 3T010N
1.0010N010N
10010N09 N, 1R
100*010N08N,2R

* pH of the 100 mg/L test concentration recorded as 9.4 at 0 hours


N = No sub-lethal effects observed


T = Trapped at surface


R= Reduced Mobility


 


Initial Experiment


Cumulative immobilization data and other observations from the exposure of Daphnia magna to the test item during the initial experiment are given in Table 2. The pH of the 101.5 mg/L test concentration was recorded as being higher than the guideline criteria (pH = 9.4), however, as no immobilization was expected at this concentration, no adjustment of pH was performed.


Significant immobilization was observed at 101.5 mg/L after 48 hours. As this result was not in line with that expected based on the range-finding test performed, a definitive test was performed with test concentrations of 10, 18, 32, 56 and 100 mg/L. In addition, in order to remove the possibility that the high pH was influencing immobilization at the highest test concentration, in the definitive test the pH of the 100 mg/L test concentration was adjusted to within guideline criteria prior to the addition of the test organisms.


 


Table 2. Cumulative Immobilization Data and Observations in the Initial Test

































































































Test Concentration (mg/L)24 Hours
Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate)Observations
R1R2R3R4Total%R1R2R3R4
Control0000005N5N5N5N
101.5*1000154T5N5N2T, 3N
Test Concentration (mg/L)48 Hours
Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate)Observations
R1R2R3R4Total%R1R2R3R4
Control0010155N5N4N5N
101.553121155A/IIT, 1N1T,3N3N

 


* pH of the 101.5 mg/L test concentration recorded as 9.4 at 0 hours


N= No Abnormalities Detected


T= Trapping at the surface


A/I= All Immobilized


 


Definitive Test


 


Verification of Test Concentrations:


Analysis of the test preparations at 0 and 48 hours showed measured test concentrations to range from 106 % to 118 % of nominal concentration with the exception of the 10 mg/L test concentration at 0 hours which gave a measured concentration of 125 % of nominal. This slightly high measured concentration was considered to have had no effect on the study as no immobilization or sub lethal affects were observed at the 10 mg/L test concentration.


Given that the majority of measured test concentrations were near nominal, it was considered appropriate to base these results on nominal test concentrations only.


 


Immobilization Data:


Cumulative immobilization data and other observations from the exposure of Daphnia magna to the test item during the definitive test are given in Table 3.


A single immobilized daphnia was observed in the 18 mg/L test group, however this was thought to be due to natural causes as no other daphnia were observed to be immobilized or have any sub-lethal effects. The No Observed Effect Concentration after 24 and 48 hours exposure was 100 mg/L.


Examination of the data could not determine why significant immobilization was observed in the initial test but not in the range-finding or definitive tests. However, given that measured concentrations in both the range-finding and definitive tests were shown to be near nominal, it was considered that these tests gave a true representation of toxicity of the test item.


 


Sub-Lethal Effects:


Trapping and reduced mobility was observed in all test concentrations except at 18 mg/L.


 


Table 3. Cumulative Immobilization Data and Observations in the Definitive Test







































































































Nominal Concentration (mg/L)24 Hours
Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate)Observations
R1R2R3R4Total%R1R2R3R4
Control0000005N5N5N5N
100000003N,2T5 N5N5N
180100155N4N5N5N
320000003N,2T4N, 1T5N5N
560000002N, 3T3N,2T5N4N, 1T
1000000001N, 4T1N,4T5T1N,4T

 







































































































Nominal Concentration (mg/L)48 Hours
Cumulative Immobilized Daphnia (Initial Population: 5 Per Replicate)Observations
R1R2R3R4Total%R1R2R3R4
Control0000005N5N5N4N, 1T
100000004N, 1T5N5N5N
180100155N4N5N5N
320000003N,2T4N, IT5N5N
560000002N, 3T3N, 2T4N, 1R4N, 1T
1000000005T1N, 4T5T1N, 4T

R1 - R4 = Replicates 1 to 4


N = No sub-lethal effects observed


R= Reduced Mobility


T= Trapped at the surface

Validity criteria fulfilled:
yes
Remarks:
none of the control daphnids showed immobilization or other signs of disease or stress and the oxygen concentration at the end of the test was equal to or greater than 3 mg/L in the control and test vessels
Conclusions:
EC50 (48 h) > 100 mg/L; NOEC (48 h) = 100 mg/L
Executive summary:

A study according to OECD Guideline 202 was conducted to determine the acute toxicity of the substance butyldiethanolamine (CAS 102-79-4) towards Daphnia magna in compliance with GLP. Following a preliminary range-finding test and initial experiment, twenty daphnids (4 replicates of 5 animals) were exposed to an aqueous solution of the test item at concentrations of 10, 18, 32, 56 and 100 mg/L for 48 hours at a temperature of approximately 21 °C under static test conditions. The numbers of immobilized daphnia were recorded after 24 and 48 hours.


Analysis of the test preparations at 0 and 48 hours showed measured test concentrations to range from 106 % to 125 % of nominal concentration and so the results are based on nominal test concentrations. Exposure of Daphnia magna to the test item gave EC50 values of greater than 100 mg/L. The No Observed Effect Concentration was 100 mg/L. Results with the reference substance potassium dichromate were valid.

Description of key information

Butyldiethanolamine_OECD 202: EC50 (48 h) > 100 mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC50
Effect concentration:
100 mg/L

Additional information

A study (Ladwa, 2015) according to OECD Guideline 202 was conducted to determine the acute toxicity of the substance butyldiethanolamine (CAS 102-79-4) towards Daphnia magna in compliance with GLP. Following a preliminary range-finding test and initial experiment, twenty daphnids (4 replicates of 5 animals) were exposed to an aqueous solution of the test item at concentrations of 10, 18, 32, 56 and 100 mg/L for 48 hours at a temperature of approximately 21 °C under static test conditions. The numbers of immobilized daphnia were recorded after 24 and 48 hours.

Analysis of the test preparations at 0 and 48 hours showed measured test concentrations to range from 106 % to 125% of nominal concentration and so the results are based on nominal test concentrations. Exposure of Daphnia magna to the test item gave EC50 values of greater than 100 mg/L. The No Observed Effect Concentration was 100 mg/L. Results with the reference substance potassium dichromate were valid.