Ethylenediamine

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: Provisional Procedure: Extended toxicology test with Daphnia magna, EPA, 1984

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

Samples for chemical analysis taken twice during test.

Test organisms (species):

Daphnia magna

Details on test organisms:

- Feeding during test
- Food type: Dry algae Scenedesmus:
- Frequency: Daily

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Hardness:

16°

Test temperature:

25°C

pH:

Reported as not lower than 7, remaining in neutral to sub-alkaline.

Dissolved oxygen:

Minimum oxygen saturation level 58%.

Nominal and measured concentrations:

0.08 -5 mg/L. No further data on concentration levels tested.

Details on test conditions:

TEST SYSTEM
- Test vessel: Bottle
- Type: closed
- Material, size, headspace, fill volume: Glass bottle, 250 mL
- Renewal rate of test solution: 3 times/week
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Synthetic freshwater (DIN 1982 a, b)
- Culture medium different from test medium: Yes

OTHER TEST CONDITIONS
- Adjustment of pH: No data
- Photoperiod: 9 h per day

EFFECT PARAMETERS MEASURED : Mortality of parent animals, time of appearance of first offspring, reproduction rate

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

0.16 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Reported statistics and error estimates:

No data

Validity criteria fulfilled:

yes

Conclusions:

The 21 d NOEC for reproduction rate in Daphnia magna is 0.16 mg/L.

Executive summary:

A semi-static study was conducted to determine the long-term toxicity of the test substance according to the US EPA provisional procedure for the extended toxicology test with Daphnia magna. The study was performed in 4 vessels per concentration, each containing 5 organisms. Analytical monitoring of the test substance concentrations was performed at the start and the end of the study. The Daphnia were exposed to nominal concentrations in the range of 0.08 -5 mg/L during the 21 d. Under the study conditions, the chronic 21 d NOEC was determined to be 0.16 mg/L based on reproduction rate (Kuhn, 1982).

Reference 2

Endpoint:

long-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:

comparable to guideline study

Remarks:

Note, no analytical monitoring of test substance concentrations were performed.

Qualifier:

according to guideline

Guideline:

EU Method C.20 (Daphnia magna Reproduction Test)

Version / remarks:

draft version

Deviations:

yes

Remarks:

slight deviation in light regime, not expected to influence results

GLP compliance:

yes

Analytical monitoring:

no

Details on test solutions:

For the definitive test a stock solution 1g ethylene diamine/L was prepared in deionized water. pH was adjusted to 7.8 by addition of hydrochloric acid. Test solutions were prepared by diluting in M4 medium.
In a first range finding test test solutions were prepared in natural water.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Source: In house culture
- Age of parental stock: 2 - 4 weeks
- Feeding during test
- Food type: Chlorella pyrenoidosea

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Test temperature:

19.8 - 20.5°C. For some hours the temperature was 21.9°C due to air-conditioning failure.

pH:

Stock solution adjusted to pH 7.8 by addition of HCl. pH 7.7 - 7.9 in fresh solutions, pH 7.5 - 8.3 in old solutions

Dissolved oxygen:

9 - 9.2 mg/L in fresh solutions and 7.5 - 11 mg/L in old solutions.

Nominal and measured concentrations:

0, 0.5, 1, 2, 4 and 8 mg/L nominal concentrations

Details on test conditions:

TEST SYSTEM
- Test vessel: 1 L glass beakers, with 800 mL test medium
- Type: covered with glass plate
- Aeration: No
- Renewal rate of test solution: 3 times/ week
- No. of organisms per vessel: 20 animals per beaker up to Day 5, after that transferred to individual beakers
- No. of vessels per concentration: 20 animals
- No. of vessels per control: 20 animals

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4 medium
- Culture medium different from test medium: No

OTHER TEST CONDITIONS
- Adjustment of pH: Yes, in stock solution.
- Photoperiod: 16 h
- Light intensity: 600 lux

EFFECT PARAMETERS MEASURED :Number of juveniles and mortality of parents were noted on Days 7, 9, 11, 14, 16, 18 and 21.

RANGE-FINDING STUDY
- Test concentrations: 0.15 - 0.54 - 1.94 - 7 - 25.2 mg/L in natural water
- Second range finding test in M4 medium at 2 mg/L and one control.

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Details on results:

At 0.5 and 1 mg/L a stimulation of reproduction was observed. At 4 mg/L a delay in reproduction was observed. No mortality in control and at 0.5 mg/L. Mortality was 10% at 1 and 2 mg/, 20% at 4 mg/L and 85% at 8 mg/L.

Validity criteria fulfilled:

yes

Conclusions:

The NOEC for reproduction rate in a 21 d study with Daphnia magna was 2 mg/L.

Executive summary:

A semi-static study was conducted to determine the long-term toxicity of the test substance to Daphnia magna according to the draft version of EU Method C.20, in compliance with GLP. Based on the results of a range-finding test, the organisms were exposed to nominal concentrations of 0, 0.5, 1, 2, 4 and 8 mg/L during 21 d. Results from chemical analysis were not reported but the test substance was readily soluble in the test medium. The number of juveniles and mortality of parents were measured. Under the study conditions, the 21 day NOEC for reproduction rate was 2 mg/L (Mark, 1991).

Description of key information

The NOEC for reproduction rate in a 21 d study with Daphnia magna was 0.16 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

NOEC

Effect concentration:

0.16 mg/L

Additional information

A semi-static study was conducted to determine the long-term toxicity of the test substance according to the US EPA provisional procedure for the extended toxicology test with Daphnia magna. The study was performed in 4 vessels per concentration, each containing 5 organisms. Analytical monitoring of the test substance concentrations was performed at the start and the end of the study. The Daphnia were exposed to nominal concentrations in the range of 0.08 -5 mg/L during the 21 d. Under the study conditions, the chronic 21 d NOEC was determined to be 0.16 mg/L based on reproduction rate (Kuhn, 1982).

A semi-static study was conducted to determine the long-term toxicity of the test substance to Daphnia magna according to the draft version of EU Method C.20, in compliance with GLP. Based on the results of a range-finding test, the organisms were exposed to nominal concentrations of 0, 0.5, 1, 2, 4 and 8 mg/L during 21 d. Results from chemical analysis were not reported but the test substance was readily soluble in the test medium. The number of juveniles and mortality of parents were measured. Under the study conditions, the 21 day NOEC for reproduction rate was 2 mg/L (Mark, 1991).