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Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 May 2020 - 18 May 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020
Report date:
2020

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
Adopted April 13, 2004
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-aminoethylamino)ethanol
EC Number:
203-867-5
EC Name:
2-(2-aminoethylamino)ethanol
Cas Number:
111-41-1
Molecular formula:
C4H12N2O
IUPAC Name:
2-[(2-aminoethyl)amino]ethan-1-ol
Test material form:
liquid: viscous
Details on test material:
Physical Description: Colourless viscous liquid

Purity/Composition correction factor: No correction factor require

Storage Conditions: At room temperature protected from light container flushed with nitrogen

Test item handling: Use amber glassware or wrap container in aluminum foil
Specific details on test material used for the study:
The stability of the test substance was determined using Infra Red (CRL study no. 20230572). For the acute daphnia study an infrared absorption spectrum was obtained at the start, during and at the end of the study. All infrared absorption spectra were comparable. From this it could be concluded that the test item was stable during the acute daphnia study.

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Samples for possible analysis were taken from all test concentrations and the control according to the schedule below.
Frequency: at t=0 h and t=48 h
Volume: 2.0 mL from the approximate centre of the test solutions
Storage: Samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the Test Facility.
At the end of the exposure period, the replicates were pooled at each concentration before sampling.
Additionally, reserve samples of 2.0 mL were taken for possible analysis. If not used, these samples were stored in a freezer (≤-15°C) for a maximum of three months after delivery of the draft report, pending on the decision of the sponsor for additional analysis.

Test solutions

Vehicle:
no
Details on test solutions:
The batch of 2-(2-aminoethylamino)ethanol tested was a colourless viscous liquid with a purity of >99% and was completely soluble in test medium at the concentrations tested. No correction was made for the purity/composition of the test item. Due to possible light sensitivity of the test item, preparation of test solutions was performed under dimmed light conditions and glassware used was wrapped in aluminum foil.
Preparation of test solutions started with the highest concentration of 100 mg/L applying 15 minutes of magnetic stirring to accelerate dissolution of the test item in medium. The pH of this solution was adjusted from 9.6 to 8.4 using 1M HCL-solution to lay within the pH-range specified in the OECD Test Guideline 202 (i.e. between 6 and 9). Lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. All test solutions were clear and colorless at the end of the preparation procedure.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Species: Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by a cyclical parthenogenesis under specified breeding conditions.
- Source: In-house laboratory culture with a known history.
- Reason for selection: This system has been selected as an internationally accepted invertebrate species.
- Validity of batch: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20% , presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
- Characteristics: Daphnia, less than 24 hours old, from parental daphnids of more than two weeks old.

BREEDING
- Start of each batch: Approximately 250 newborn daphnids, i.e. less than 3 days old, were placed into 5 litres of medium in an all-glass culture vessel.
- Maximum age of the cultures: 4 weeks
- Renewal of the cultures: After 7 days of cultivation, half of the medium twice a week.
- Temperature of medium: 18-22°C
- Feeding: Daily, a suspension of fresh water algae.
- Culture medium: M7, as described by OECD 211 TG.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Hardness:
180 mg CaCO3 /L
Test temperature:
between 19 and 21°C
pH:
7.6 - 8.4
Dissolved oxygen:
8.9 - 9.7
Nominal and measured concentrations:
Nominal concentrations in combined limit/range-finding test: 0.10, 1.0, 10, and 100 mg/L.
Measured concentrations: The measured concentrations in the highest test group were at the level of nominal at the start and the end of the test, i.e. were at 101 and 97% of the nominal values, respectively. No test item was detected in the control samples.
Based on these results, effect parameters were expressed in terms of analytically confirmed nominal concentrations.
Details on test conditions:
TEST SYSTEM
- Test vessel: 60 mL, all-glass
- Volume of solution: 50 mL
- Aeration: No aeration of the test solutions was applied
- Loading: 5 per vessel containing 50 mL of test solution.
- Number of daphnids: Control and highest concentration: 20 per test group. Lower concentrations: 10 per concentration.
- Feeding: No feeding during the exposure period

TEST MEDIUM / WATER PARAMETERS
- Preparation of the test medium: The following salts (analytical grade) were added to tap water purified by Reverse Osmosis (RO-water, GEON Waterbehandeling, Berkel-Enschot, The Netherlands):
CaCl2.2H2O: 211.5 mg/L
MgSO4.7H2O: 88.8 mg/L
NaHCO3: 46.7 mg/L
KCl: 4.2 mg/L
The hardness of test medium expressed as CaCO3: 180 mg/L with a pH between 6 and 9.
- Culture medium different from test medium: yes


OTHER TEST CONDITIONS
- Adjustment of pH:
Yes the highest concentration of 100 mg/L was adjusted from 9.6 to 8.4 using 1 M HCl-solution
- Photoperiod:
The test was performed in the dark due to the light sensitive nature of the test item.

EFFECT PARAMETERS MEASURED
Immobility (including mortality) were observed at T=24 hours and at 48 hours. The 24h and 48h EC50 were determined

VEHICLE CONTROL PERFORMED: no

Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
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
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
No immobility was observed in the control and at any of the test concentrations throughout the exposure period.
It should be noted that two daphnids in the control, 0.10 mg/L and 100 mg/L test groups were trapped at the surface of the solution after 24 hours of exposure. These daphnids were re-immersed into the solution before immobility was recorded. No daphnids were observed to be trapped after 48 hours.
Reported statistics and error estimates:
No EC50 could be calculated because the test item proved to be non-toxic (EC50 > maximum concentration tested).

Any other information on results incl. tables

Table: Number of Introduced Daphnids and Incidence of Immobility       
 

Time (h)

Replicate

2-(2-aminoethylamino)ethanol; Nominal concentration (mg/L)

Control

0.10

1.0

10

100

0

A

5

5

5

5

5

B

5

5

5

5

5

C

5

 

 

 

5

D

5

 

 

 

5

Total introduced

20

10

10

10

20

24

A

0(1)

0(2)

0

0

0(2)

B

0(1)

0

0

0

0

C

0

 

 

 

0

D

0

 

 

 

0

Total immobilised

0

0

0

0

0

Effect %

0

0

0

0

0

 

 

 

 

 

48

A

0

0

0

0

0

B

0

0

0

0

0

C

0

 

 

 

0

D

0

 

 

 

0

Total immobilised

0

0

0

0

0

Effect %

0

0

0

0

0

( ) - number of daphnids observed trapped at the surface of the test solutions. These organisms were re-immersed into the respective solutions before recording of mobility.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
"See Overall remarks"
Conclusions:
In conclusion, the 48h-EC50 for Daphnia magna exposed to 2-(2-aminoethylamino)ethanol was beyond the range of concentrations tested, i.e. exceeded the regulatory limit concentration of 100 mg/L.
Executive summary:

In a 48h acute toxicity test conducted according to OECD guideline 202 with a 2-(2-aminoethylamino)ethanol, Daphnia magna were exposed to an untreated control, 0.1, 1.0, 10 and 100 mg/L (5 daphnids per vessel, 4 replicates for control and 100 mg/L, 2 replicates for 0.1, 1.0 and 10 mg/L). The measured concentrations in the highest test group were at the level of nominal at the start and the end of the test, i.e. were at 101 and 97% of the nominal values, respectively. Based on these results, effect parameters were expressed in terms of analytically confirmed nominal concentrations.

No immobility was observed in the control or any of the test concentrations throughout the test. In conclusion, the 48h-EC50 for Daphnia magna exposed to 2-(2-aminoethylamino)ethanol was beyond the range of concentrations tested, i.e. exceeded the regulatory limit concentration of 100 mg/L. The study met all validity criteria and is considered to be reliable without restrictions.