Amines, polyethylenepoly-, triethylenetetramine fraction

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 Mar - 20 Apr 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Study is complete, was done under GLP and meets all criteria. However the absence of chemical analysis limits the use of the data when performing a risk assessment and assessing the bio-available fraction.

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Qualifier:

according to guideline

Guideline:

other: S.A.L.M. Kooyman. "Parametric analyses 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 27 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 is 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):

Daphnia magna

Details on test organisms:

The test organism was Daphnia magna; they were produced in the Akzo Research Laboratories Arnhem, dept. CRL according to NEN 6503 and Standard Operating Procedures SOP CRL T2. They were less than 24 hours old at the beginning of the test.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

68.6 mg Ca/l, 19.7 mg Mg/l, 14.1°dH

Test temperature:

19.5-20.5 °C

pH:

7.0-7.8

Dissolved oxygen:

7.9-9.1

Nominal and measured concentrations:

nominal: 5.6, 10, 18, 32, 56, 100 mg/L

Details on test conditions:

The temperature was kept between 19.5 and 20.5°C, and the light regime was 16 hours ambient light per day.
The duration of the test was 48 hours.
The test vessels were 400 ml glass beakers, containing 250 ml of test medium. Each beaker contained 5 test animals.

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

31.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% CI: 25.6-37.7 mg/L

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

18 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

The EC50-48 h is 31.1 mg/l. The 95% confidence limits are 25.6 and 37.7 mg/l.
No effect on mobility was observed at 18 mg/l, and 100% immobilisation was observed at 56 mg/l.
The quality criteria of the test have been fulfilled: the immobilization in the control was <10%, the oxygen concentration was >2 mg/l at the end of the test, and the Daphnids in the control group have not been trapped at the surface of the water.

Reported statistics and error estimates:

The EC50 was determined by an LC50 program of Griffioen (RlZA) based on a model of Kooyman (1981).

In an earlier study, the EC50-48 h of triethylenetetramine for Daphnia was found to be 17 mg/L with 95% confidence limits between 14.7 and 19.7 mg/L (Ten Berge and Blok, 1975). The small difference may be related to changes in the production process.

ref: W. Ten Berge and J. Blok, 1975. "Biological properties of poly-ethylene amines". Akzo Report - CRG D75/62.

Validity criteria fulfilled:

yes

Conclusions:

The EC50 for triethylenetetramine was determined in Daphnia magna after 48 h to be 31.1 mg/L nominal. The test is valid and was performed unde GLP. No analysis was performed and this limits the use of the determined endpoints for risk assessment purposes when looking at the bio-available fraction

Executive summary:

Triethylenetetramine (TETA) was tested in an acute toxicity test with the water flea (Daphnia magna). The test was performed according to the EEC method, Methods for the determination of ecotoxicity, C.2. Acute toxicity for Daphnia. The test was carried out as a static test, in which the solution was not renewed. The quality criteria of the test have been fulfilled: the immobilization in the control was <10%, the oxygen concentration was >2 mg/l at the end of the test, and the Daphnids in the control group have not been trapped at the surface of the water.

No effects were observed up to 18 mg/l. The EC50 was 31.1 mg/l, with 95% confidence limits of 25.6 and 37.7 mg/l. Al concentrations were nominal because no analysis was performed, this limits the use of the data when looking at the bio-available fraction

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

Compliant to EPA guidelines. Lacking chemical analysis, apart from these restrictions the study is considered reliable.

Qualifier:

according to guideline

Guideline:

EPA OTS 797.1300 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)

GLP compliance:

yes

Analytical monitoring:

no

Details on test solutions:

Test solutions were made from 1000 mg/L and 1002 mg/L in the range finding and definitive studies. Dechlorinated tap water was used as dilution water. Specific details on stock preparation were not reported.

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna used in this study were obtained from the testing labs culture. This daphnia strain originated from the EPA environmental laboratory in Duluth MN. Cultures were maintained with 16 hour daylight at 21-23 °C in 600 ml glass beakers containing aged dechlorinated water. Daphnia were fed with bakers yeast alfalfa powder trout food and mixed algae cell culture.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

66 mg/L as Ca Co3

Test temperature:

22-24 °C

pH:

>7.2 at all times in all concentrations

Dissolved oxygen:

>7.0 mg/L at all times in all concentrations

Nominal and measured concentrations:

Nominal-4.7, 9.4, 18.8, 37.5, 75.0, 150 mg/L

Details on test conditions:

The daphnia test consisted of 4 replicates with 5 daphnids per replicate. 150 mL vessels were used. Daphnia were <24 hour old when test was started.

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

40 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: (35-50 mg/L) 95% CI

Details on results:

NOEC was found to be 18.8 mg/l.

Results with reference substance (positive control):

Not Reported.

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
Control	0	0	0
4.7	0	0	0
9.4	0	0	0
18.8	0	0	0
37.5	0	5	3
75	0	60	100
150	0	100	100

Validity criteria fulfilled:

yes

Conclusions:

This study can be concluded reliable with restrictions. No analysis was performed appart from that the study can be used for RA purposes.

Executive summary:

Study was conducted under EPA guidelines and was sufficiently reported all raw data was also included. The LC50 was determined to be 40 mg/L. All criteria were met and the study is considered valid. No analysis was performed so all endpoints are based on nominal concentrations.

Description of key information

EC50(48 h): 31.1 mg/L (nominal)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

31.1 mg/L

Additional information

Two reliable studies on the acute toxicity of the substance to aquatic invertebrates are available. The key study was conducted according to EU Method C.2 and GLP (Balk and Meuwsen, 1989). Daphnia magna were exposed to nominal test substance concentrations of 5.6, 10, 18, 32, 56 and 100 mg/L. An EC50(48h) of 31.1 mg/L (nominal) was determined at test termination. The results are supported by a study following EPA OTS 797.1300 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids, Waggy, 1992). The test was conducted with following nominal test substance concentrations: 4.7, 9.4, 18.8, 37.5, 75.0 and 150 mg/L. The determined EC50(48 h) was 40 mg/L (nominal).