Decamethylenediamine

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-10-04 to 2011-10-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline Study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: OECD Series on Testing and Assessment No. 126 “Threshold approach for acute fish toxicity” (May 31st, 2010)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Samples were taken from the test and from the control vessel at the beginning (0h) and at the end (96h) of the exposure period. 3.7 mL sample was pipetted directly from the vessel into a 4 mL brown glass vial with screw cap. The samples were stored in the refrigerator at 5°C ± 3°C until they were sent to the analytical laboratory. Samples were shipped via over-night-express in an isolated box containing cooling elements and arrived safely and cool at the next morning. Analysis was performed in a separate GLP study (Report No. AZB 11-067) at AZ Biopharm, Berlin.

Vehicle:

no

Details on test solutions:

The test item was directly dissolved into synthetic fishwater according to OECD 203. 48.0 mg resp. 48.2 mg 1,10-Decanediamine were weight out into two 5,000 mL beakers. Defined volumes of 3,999.57 mL resp. 4,016.3 mL synthetic fish water were added resulting in a final concentration of 12 mg/L. The solutions were stirred at room temperature for about 45 min using an overhead high-grade stainless steel radial impeller (about 500 rpm). The solutions were colourless and clear. Subsequently 3.500 mL from each beaker were transferred into the test vessel. The control vessel was filled with 7.000 mL synthetic fish water. The vessels were aerated for about 1.5 hours and temperature was adapted before 7 fish each were transferred into the test vessels.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

- fish were healthy and showed no abnormal appearance.
- total length of 3 cm (+/- 1 cm).
- were purchased by Aquarium Dietzenbach Fischzucht, D-63128 Dietzenbach and were held in the Hydrotox lab since 31 May 2011
- After arrival in the lab the fish were held at 21-25°C in synthetic fish water according to OECD 203 with a light/dark cycle of 14:10 hours.
- The aquarium was cleaned at least once in two weeks and the water was changed at least once a week.
- Five days a week the fish were fed twice with commercially available fish feed (TetraMin from TetraWerke, Melle, Germany).
- The water temperature and the appearance of the fish were checked daily.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

22.4 – 23.1°C

pH:

control: 7.9 (96 h) to 8.1 (4h)
treatment: 8.0 (96 h) to 9.1 (4h)

Dissolved oxygen:

8.2-8.3 mg/L

Nominal and measured concentrations:

Nominal: 12 mg/L
Measured: 11.8 mg/L (0h); 11.5 mg/L (96h)

Details on test conditions:

- test vessel (aquarium) with 7 fish and a control vessel with 7 fish
- Vessels were aerated for about 1.5 hours and temperature was adapted before 7 fish each were transferred into the test vessels
- fish were held at 21-25°C in synthetic fish water according to OECD 203 with a light/dark cycle of 14:10 hours
- The pH of the test and the control aquarium was measured and recorded at the beginning and at the end of the test.
- The oxygen concentration (mg/L), the min-max temperatures and the behaviour of the fish were recorded daily
- The concentration for this limit test was chosen according to the OECD Series on Testing and Assessment No. 126 “Threshold approach for acute fish toxicity”. It was the lowest EC50 determined in the algal growth inhibition test.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 12 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

No fish died or showed any abnormal behaviour during the 96 hours exposure period.
The analytical determination of 1,10-Decanediamine resulted in 11.8 mg/L at the start and 11.5 mg/L at the end of the experiment. Therefore the concentration analysed was always > 80% of the nominal concentration.

Results with reference substance (positive control):

No positve control available

Validity criteria fulfilled:

yes

Conclusions:

At the threshold concentration of 12 mg/L (EC50 from alga study) no fish died or showed any abnormal behaviour.

Executive summary:

A limit test with a nominal concentration of 12 mg/L was performed. This concentration was chosen according to the OECD Series on Testing and Assessment No. 126 “Threshold approach for acute fish toxicity”. It was the lowest EC₅₀determined in the algal growth inhibition test.

No fish died or showed any abnormal behaviour during the 96 hours exposure period. Therefore the LC₅₀is > 12 mg/L.

The analytical determination of 1,10-Decanediamine resulted in 11.8 mg/L at the start and 11.5 mg/L at the end of the experiment. Therefore the concentration analysed was always > 80% of the nominal concentration.

Description of key information

A limit test with a nominal concentration of 12 mg/L was performed. This concentration was chosen according to the OECD Series on Testing and Assessment No. 126 “Threshold approach for acute fish toxicity”. It was the lowest EC50 determined in the algal growth inhibition test.
No fish died or showed any abnormal behaviour during the 96 hours exposure period. Therefore, the LC50 is > 12 mg/L.
The analytical determination of decamethylenediamine resulted in 11.8 mg/L at the start and 11.5 mg/L at the end of the experiment. Therefore, the concentration analysed was always > 80% of the nominal concentration.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Remarks:

No effects up to the nominal concentration of the limit test.

Effect concentration:

> 12 mg/L