Ethylenediamine

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Deviations:

yes

Remarks:

minor deviations not expected to influence results

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

A stock solution of 10.2 g ethylene diamine/l was prepared in deionized water. The solution was neutralised to a pH of 8.2 with 12 M HCl. During the test two stock solutions were used, one from Days 0-21 and another from Days 21 to 28. Test solutions were prepared by diluting with test medium, Dutch Standard Water.

Test organisms (species):

Gasterosteus aculeatus

Details on test organisms:

TEST ORGANISM
- Common name: Three spined strickleback
- Source: RIVM, The Netherlands


METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS
- Numbers of parental fish (i.e. of females used to provide required number of eggs): 1
- Subsequent handling of eggs: Disinfection 0.04% formaldehyde wash, Housing in 50-ml beakers in air-conditioned room, 18-20°C. Eggs and larvae
kept separate except day 0. (deviation from method).

POST-HATCH FEEDING
- Start date: Fourth day after hatching
- Type/source of feed: Artemias, of age <24 h
- Amount given: 50 artemias/day /5 days per week

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

28 d

Hardness:

12°

Test temperature:

18-21°C (minor deviation from guideline, 18-20°C)

pH:

7.4 - 8.2

Dissolved oxygen:

60-100% of air saturation value

Salinity:

Test performed in Dutch Standard Water containing:
100 mg of NaC03/l
20 mg of KHC03/l
200 mg of CaCl 2 ·2 H2O/I
180 mg of MgS04 ·7 H2O/I.

Nominal and measured concentrations:

A preliminary test was performed with the following concentrations: 0-1- 10- 50- 100- 300 mg/l . 10 eggs were used per concentration
On the basis of these results a limit test was performed at 10 mg/l, using 60 eggs.

Details on test conditions:

Test solutions were renewed 3 times per week.

Reference substance (positive control):

no

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Mortality during egg phase: Control 7%, at 10mg/L: 2%.

Development of eggs. Control Normal 56/60, at 10 mg/L 60/60.

Hatching during day 6.

No mortality in larvae phase.

Validity criteria fulfilled:

yes

Conclusions:

Fish chronic NOEC is larger than 10 mg/L.

Executive summary:

A study was conducted to determine the long-term toxicity of the test substance to the early life stages of the fish Gasterosteus aculeatus, according to OECD Guideline 210, in compliance with GLP. The test has been performed in a semi-static condition for a duration of 28 days. On the basis of a preliminary range finding study at nominal concentrations of 0, 1, 10, 50, 100 and 300 mg/L in Dutch Standard Water (10 eggs were used per concentration), the main study was performed as a limit test at 0 or 10 mg/L using 60 eggs. No analytical monitoring of the test substance concentrations were performed. No adverse effects were noted at the limit concentration in the study. Under the study conditions, the chronic NOEC was determined to be >10 mg/L (Mark, 1991).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

NOEC

Effect concentration:

> 10 mg/L

Additional information

A study was conducted to determine the long-term toxicity of the test substance to the early life stages of the fish Gasterosteus aculeatus according to OECD Guideline 210, in compliance with GLP. The test was performed in a semi-static condition for a duration of 28 d. On the basis of a preliminary range finding study at nominal concentrations of 0, 1, 10, 50, 100 and 300 mg/L in Dutch Standard Water (10 eggs were used per concentration), the main study was performed as a limit test at 0 or 10 mg/L using 60 eggs. No analytical monitoring of the test substance concentrations was performed. No adverse effects were noted at the limit concentration in the study. Under the study conditions, the chronic NOEC was determined to be >10 mg/L (Mark, 1991).