Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02-03-1989 to 28-04-1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study is complete, performed under GLP and valid. However no analysis was performed and thus the usability for risk assessment purposes is limited when assessing the bioavailable fraction.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
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{l981)107-119.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- name: tetraethylenepentamine (TEPA)
- molecular weight: 189
- structural formula: H2N-(C2H4NH)4H
- CAS-reg. no.: 112-57-2
- purity: 97.3%
- identified impurities: TETA, PEHA
- appearance: pale yellow liquid
- water solubility: 20°C: completely miscible
- volatility: vapour pressure: <0.01 mbar
- storage: 20-40°C
- CRL code: T88-10-2.9



Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Poecilia reticulata
Details on test organisms:
A stock solution of 25 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.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
68.4 mg Ca/l, 35.7 mg Mg/l, 17.7°dH
Test temperature:
21.7-23.0 C
pH:
7.0-7.7
Dissolved oxygen:
7.1-7.7 mg/L
Nominal and measured concentrations:
nominal: 100, 180, 320, 560, 1000 mg/L
Details on test conditions:
The temperature was kept between 21.7 and 23.0 C, and the light regime was 15 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

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.42 g/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
morphology
Remarks on result:
other: 0.35-0.51 g/L
Details on results:
No significant mortality occurred at 0.32 g/l, and 100% mortality occurred at 1 g/l. The LC50 -96h was 0.42 g/l. The 95% confidence limits are 0.35
and 0.51 g/l.
The quality criteria of this test have been fulfilled: the mortality in the control was 90%, the oxygen concentration was >60% of the air-saturation value throughout the test, and the concentration of TEPA in the test medium remained constant.
An earlier study on the toxicity of TEPA for guppy resulted in an LC50-96 h of 0.32 g/l with 95% confidence limits of 0.28 and 0.37 g/l (Ten Berge and Blok, 1975). These results are confirmed by the present test.
Reported statistics and error estimates:
The LC50 was determined with an LC50 program of Griffioen (RIZA), based on a model of Kooyman (1981).

Any other information on results incl. tables

Nominal concentration mg/L

Cumulative animals surviving

 

0h

24h

48h

72h

96h

Control

30

30

30

30

30

100

10

10

10

10

10

180

10

10

10

10

10

320

10

10

10

10

9

560

10

10

8

4

1

100

10

10

3

0

0

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
No significant mortality occurred at 0.32 g/l, and 100% mortality occurred at 1 g/l. The LC50 -96h was 0.42 g/l. The 95% confidence limits are 0.35 and 0.51 g/l.
The quality criteria of this test have been fulfilled: the mortality in the control was 90%, the oxygen concentration was >60% of the air-saturation value throughout the test, and the concentration of TEPA in the test medium remained constant. The test is valid. Only nominal concentrations were recorded so this is a limitation when using these values in a risk assessment.
Executive summary:

Tetraethylenepentamine (TEPA) 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 tetraethylenepentamine is not (bio)degradable. No significant mortality was observed up to 0.32 g/l nominal. The LC50 was 0.42 g/l, with 95% confidence limits of 0.35 and 0.51 g/l nominal. The study is valid and performed according to GLP.