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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February - March 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992 version
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Batch number - 1721964
Purity - 99.0%
Physical state - yellow liquid
Analytical monitoring:
yes
Details on sampling:
Water samples were taken from the control and the 54 mg/L test vessel at 0 and 72 hours from fresh media and at 24 and 96 hours from old media for quantitative analysis. The 0, 24 and 72 hour samples were stored frozen prior to analysis.

Duplicate samples and samples at 24 (fresh media), 48 (old and fresh media) and 72 hours (old media) were taken and stored frozen for further analysis if necessary.
Vehicle:
no
Details on test solutions:
A nominal amount of test item (1080 mg) was dissolved in test water and the volume adjusted to 20 liters to give the 54 mg/L test concentration. Prior to exposure of the test organisms, the pH of the test media was checked and adjusted from between 9.2 and 9.4 to between 7.8 and 8.0 using dilute hydrochloric acid.

The test preparation was mixed with a flat bladed stirrer for 1 minute to ensure adequate mixing and homogeneity.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
The test was carried out using juvenile rainbow trout (Oncorhynchus mykiss). Fish were obtained from Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK and maintained in-house since 22 January 2016. Fish were maintained in a glass fibre tank with a "single pass" water renewal system. Fish were acclimatized to test conditions from 15 February 2016 to 22 February 2016. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods.

The water temperature was controlled at 13 °C to 14 °C with dissolved oxygen content of greater than or equal to 9.1 mg O2/L. These parameters were recorded daily. The stock fish were fed commercial trout pellets which was discontinued approximately 24 hours prior to the start of the definitive test. There was no mortality in the 7 days prior to the start of the test and the fish had a mean standard length of 4.9 cm (SD = 0.2) and a mean weight of 0.97 g (SD = 0.11) at the end of the definitive test. Based on the mean weight value this gave a loading rate of 0.34 g bodyweight/litre (static volume).
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
Not applicable
Hardness:
Not reported
Test temperature:
Ranged between 13-14°C during the study
pH:
Ranged between 7.4 and 8.0 during the study
Dissolved oxygen:
Ranged between 7.9 and 11.4 mg oxygen/L during the study
Salinity:
Not required
Conductivity:
Not required
Nominal and measured concentrations:
Nominal exposure concentrations were 0 (control) and 54 mg/L
Measured exposure concentrations were Results of the study were based on the nominal exposure concentration.
Details on test conditions:
In the limit test, 20 litre glass exposure vessels containing 20 litres of test media were used for each control and test concentration. At the start of the test seven fish were placed in each test vessel at random, in the test preparations. The test vessels were then sealed due to the particularly odorous nature of the test item and maintained at 13°C to 14°C in a temperature controlled room with a photoperiod of 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods for a period of 96 hours. The test vessels received no auxiliary aeration. The fish were not individually identified and received no food during exposure.

The control group was maintained under identical conditions but not exposed to the test item.
A semi-static test regime was employed in the test involving a daily renewal of the test preparations to prevent the build-up of nitrogenous waste products.
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 54 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
54 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
There were no mortalities or sub-lethal effects of exposure observed in the 7 fish exposed to a nominal test concentration of 54 mg/L over the 96 hours exposure period. Therefore, the 96 hour LC50 was observed to be >54 mg/L and the corresponding NOEC was 54 mg/L.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
An estimate of the LC50 values was given by inspection of the mortality data.

Analytical results

Nominal concentration (mg/L)

Measured concentration (mg/L)

0 hours (fresh)

24 hours (old)

72 hours (fresh)

96 hours (old)

Control

<LOQ

<LOQ

<LOQ

0.591 / <LOQ*

54

58.8
(109%)

57.9
(107%)

55.2
(102%)

54.2
(100%)

LOQ – Limit of Quantification (0.0046 mg/L)

*duplicate sample, stored frozen prior to analysis
Values in brackets are the percentage of nominal exposure concentration

Validity criteria fulfilled:
yes
Conclusions:
There were no mortalities or sub-lethal effects of exposure observed in the 7 fish exposed to a nominal test concentration of 54 mg/L over the 96 hours exposure period. Therefore, the 96 hour LC50 was observed to be >54 mg/L and the corresponding NOEC was 54 mg/L.
Executive summary:

The effects of 2-[[2-(Dimethylamino)ethyl]methylamino]ethanol [CAS# 2212-32-0] to rainbow trout (Oncorhynchus mykiss) were determined in a 96 hour semi-static study. The study was carried out according to OECD guideline 203 (1992). In this study fish were exposed to the test material over a test period of 96 hours in a limit study with renewal of the test media every 24 hours. The nominal exposure concentrations were 0 (control) and 54 mg/L, corresponding arithmetic mean measured concentrations were 0 and 56.5 mg/L, the results of the study were therefore based on nominal exposure concentrations. After 96 hours there was no mortality in the treated fish, the 96 hour LC50 was therefore observed to be >54 mg/L.  There were no sub- lethal effects therefore the corresponding NOEC was observed to be 54 mg/L.

Description of key information

The 96 hour LC50 of 2-[[2-(Dimethylamino)ethyl]methylamino]ethanol [CAS# 2212-32-0] to rainbow trout was observed to be >54 mg/L and the corresponding NOEC was 54 mg/L.

Key value for chemical safety assessment

LC50 for freshwater fish:
54 mg/L

Additional information

The effects of 2-[[2-(Dimethylamino)ethyl]methylamino]ethanol [CAS# 2212-32-0] to rainbow trout (Oncorhynchus mykiss) were determined in a 96 hour semi-static study. The study was carried out according to OECD guideline 203 (1992). In this study fish were exposed to the test material over a test period of 96 hours in a limit study with renewal of the test media every 24 hours. The nominal exposure concentrations were 0 (control) and 54 mg/L, corresponding arithmetic mean measured concentrations were 0 and 56.5 mg/L, the results of the study were therefore based on nominal exposure concentrations. After 96 hours there was no mortality in the treated fish, the 96 hour LC50 was therefore observed to be >54 mg/L.  There were no sub- lethal effects therefore the corresponding NOEC was observed to be 54 mg/L.