Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Conducted to EPA guidelines. Lacking chemical analysis, further reliable.
Qualifier:
equivalent or similar to
Guideline:
other: U.S EPA- TSCA, 40 CFR Part 797 1400
Version / remarks:
Study was carried out according to internal laboratory procedures based on the EPA guideline.
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
Test solutions were made from 4000mg/L stocks in the definative and 5000mg/L in the range finding study. Dechlorinated tap water was used as dilution water. Specific details on stock preparation were not reported.
Test organisms (species):
Pimephales promelas
Details on test organisms:
Fish used were from an internal culture and were between 47-52 days old. All fish were maintained in holding tanks of between 21-23ºc with a 16 hour Light and 8 hour dark photo period. Fish were fed naupuli and tetramin fish food. All fish were accepted for testing after a two week quarantine period.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
40-65 mg/L as CaCO3
Test temperature:
20 ± 2 °C
pH:
7.0-7.5
Dissolved oxygen:
Maintained in all concentrations >4.3 mg/L in definative test
Salinity:
75-160 µmhos/cm
Nominal and measured concentrations:
Preliminary Nominal Concentrations- 5,10,50,100.1000,5000 mg/L
Definative Test Concentrations-25-150-300-600-1200 mg/L
Details on test conditions:
Test organisms were distributed randomly throughout the test concentrations. Each concentration and the control was tested in duplicate with 10 fish per replicate. Each vessel contained 750 mL.
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
330 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: (280-400 mg/L) 95% CI
Details on results:
The NOEC was observed at 150 mg/L after 96 hours.
Reported statistics and error estimates:
LC50 values were estimated by using Spearman - Karber estimator on the percentage mortality per concentration and control.

Results

Nominal concentration mg/L

% Mortality

0h

24h

48h

72h

96h

Control

0

0

0

-

0

75

0

0

0

-

0

150

0

0

0

-

0

300

0

0

0

-

45

600

0

15

60

-

90

1200

0

95

100

-

100

Validity criteria fulfilled:
yes
Conclusions:
This study can be concluded reliable with restrictions.
Executive summary:

Study was conducted under EPA guidelines and was sufficiently reported all raw data was also included. Oxygen concentration did drop below 60 % which is a common accepted minimum for fish tests. The recommended loading was also exceeded slightly. Whilst not absolutely critical to the validility of the study these factors can increase stress factors on the test animals and influence results. More importantly no analitical conformation of the nominal concentrations took place. These restrictions should be considered when using this data. Further to this the study appeared reliable.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
02 Mar - 10 Mar 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study is complete, was performed under GLP and valid. However no analysis was performed so the actual bio-available fraction is unknown, although the substance is completely soluble at the test concentration. Therefore the use of the data from this study is limited when performing a risk assessment
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Qualifier:
according to
Guideline:
other: S.A.L.M. Kooyman: "Parametric Analysis of mortality rates in bio-assays". Water Research 15(1981)107-119.
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
A stock solution of 26 g/l was prepared by dissolving the test substance in demineralized water containing concentrated HCl.
The presence of the test substance in the test medium caused a change of the pH, which was outside the range that can be supported by the test animal. Therefore, the pH was neutralized both in the stock solution and in the dilution water to a value between 7.0 and 7.3. The chosen test concentrations were prepared by dilution of the stock solution.
Test organisms (species):
Poecilia reticulata
Details on test organisms:
The test organism was Poecilia reticulata (guppy); they were produced in the Akzo Research Laboratories Arnhem, dept. CRL according to Standard Operating Procedures SOP cHi T9 & 42. The size was approximately 2 cm.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
63.7 mg Ca/l, 31.8 mg Mg/l, 16.2°dH
Test temperature:
between 22.5 and 23.5°C
pH:
6.9-8.0
Dissolved oxygen:
7.3-9.0 mg/L
Nominal and measured concentrations:
nominal: 180, 320, 560, 1000, 1800 mg/L
Details on test conditions:
The temperature was kept between 22.5 and 23.5 °C, and the light regime was 12 hours ambient light per day.
The duration of the test was 96 hours.
The test vessels were 2 L glass aquaria, containing 1 L of test medium.
The loading in the test vessels was approximately 0.6 g biomass/L.
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.57 g/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 0.45-0.72 g/L
Details on results:
The results are presented in detail in Annexes I-III. No mortality occurred at 0.18 g/l, and 100% mortality occurred at 1.8 g/l. The LC50-96 h was 0.57 g/l. The 95% confidence limits are 0.45 and 0.72 g/l. The quality criteria of this test have been fulfilled: the mortality in the control was ≤10%, the oxygen concentration was >60% of the air-saturation value throughout the test, and the concentration of TETA in the test medium remained constant.
Reported statistics and error estimates:
The LC50 was determined with an LC5O program of Griffioen (RIZA), based on a model of Kooyman (1981).

Nominal concentration mg/L

Cumulative number of survival

0h

24h

48h

72h

96h

Control

60

58

57

56

54 (3)

180

10

10

10

10

10

320

10

10

9

8

8

560

10

10

9

8

5

1000

10

9

7

5

1 (1)

1800

10

8

0

0

0

( ) means not healthy

Validity criteria fulfilled:
yes
Conclusions:
The LC50 was determined in fish for TETA to be 0.57 g/L after 96 h nominal. The results meet the criteria so the study is valid. However no analysis was performed so the actual bio-available fraction is unknown, although the substance is completely soluble at the test concentration. therefore the use of the data from this study is limited when performing a risk assessment
Executive summary:

Triethylenetetramine (TETA) was tested in an acute toxicity test with guppy (Poecilia reticulata).

The test was performed according to the EEC method, part c.: Methods for the determination of ecotoxicity, C.1. Acute toxicity to fish.

The test was performed as a semi-static test, in which the solution was renewed after 48 hours.

During this time triethylenetetramine is not (bio}degradable. No mortality was observed up to 0.18 g/l. The LC50 was 0.57 g/l, with 95% confidence limits of 0.45 and 0.72 g/l. The quality criteria of this test have been fulfilled: the mortality in the control was <= 10%, the oxygen concentration was >60% of the air-saturation value throughout the test, and the concentration of TETA in the test medium remained constant.

Description of key information

LC50(96 h): 330 mg/L (nominal)

Key value for chemical safety assessment

LC50 for freshwater fish:
330 mg/L

Additional information

Two studies investigating the acute toxicity of the substance to fish are available. A static test following U.S EPA guideline TSCA, 40 CFR Part 797 1400 was conducted with Pimephales promelas (Balk and Meuwsen, 1989). The fish were exposed to nominal test substance concentrations of 5, 10, 50,100, 1000 and 5000 mg/L. At test termination a LC50(96h) of 330 mg/L based on the nominal test substance concentration was determined. The second study was conducted according to EU Method C.1 (Acute Toxicity for Fish) in a semi-static test system (Waggy, 1992). The test species was Poecilia reticulata. The fish were exposed to nominal test substance concentrations of 180, 320, 560, 1000 and 1800 mg/L for 96 hours. The LC50(96h) was 570 mg/L based on the nominal test substance concentration.