Dodecamethylenediamine

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07. Nov. - 20. Dec. 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: B1-5-10
- Expiration date of the lot/batch: 31. Jan. 2020
- Purity test date: not stated

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item was stored in the test facility in a closed vessel at room temperature (16.2 –
- Stability under storage conditions: assumed stable, no indication of the contrary
- Stability under test conditions: assumed stable, no indication of the contrary
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium: assumed stable and soluble, no indication of the contrary
- Reactivity of the test substance with the solvent/vehicle /test medium (if applicable): assumed stable, no indication of the contrary

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
Preparation
A saturated solution was prepared. This was done by mixing the real load of 100.8 mg/L
with the corresponding amount of dilution water and shaking vigorously for 23.5 hours. The
resulting solution was filtrated through 0.45 µm PTFE filters. The lower treatments (4.6 / 10
/ 22 / 46 mg/L nominal) were prepared by dilution of this stock solution with dilution water.
The measured concentrations showed, that complete dissolution of the test item was
reached.

Analytical monitoring:

yes

Details on sampling:

The pH, the concentration of dissolved oxygen and the content of the test item in the test
vessels were measured at the beginning and at the end of the test.

Vehicle:

no

Details on test solutions:

A saturated solution was prepared. This was done by mixing the real load of 100.8 mg/L
with the corresponding amount of dilution water and shaking vigorously for 23.5 hours. The
resulting solution was filtrated through 0.45 µm PTFE filters. The lower treatments (4.6 / 10
/ 22 / 46 mg/L nominal) were prepared by dilution of this stock solution with dilution water.
The measured concentrations showed, that complete dissolution of the test item was
reached.

Test organisms (species):

Daphnia magna

Details on test organisms:

Species Daphnia magna
Authority STRAUS
Strain Berlin
Sex female
Age between 0 and 24 hours
Origin Umweltbundesamt Berlin
In-house breeding since 27. September 2007

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Remarks on exposure duration:

according to guideline

Post exposure observation period:

no

Hardness:

356 mg/L CaCO3

Test temperature:

19.1 – 21.2 °C

pH:

7.7

Dissolved oxygen:

8.4 - 8.6 mg/L

Salinity:

not applicable

Conductivity:

not determined

Nominal and measured concentrations:

4.6 / 10 / 22 / 46 / 100 mg/L (nominal concentration)
At the beginning and at the end of the test, the content of the test item in the test solutions
was determined using LC/MS-MS-determination. The measured concentrations lay be-
tween 96 % and 101 % of the nominal concentrations at the beginning of the test and be-
tween 108 % and 118 % of the nominal concentrations at the end of the test. Therefore,
the determination of the biological results was based on the nominal concentration

Details on test conditions:

Date of performance 12. – 14. Nov. 2019
Treatments 4.6 / 10 / 22 / 46 / 100 mg/L (nominal concentration)
The concentrations to be tested are based on the result of
a non-GLP pre-test.
Temperature 19.1 – 21.2 °C
Photo period 16/8 hours, using neon tubes
Duration 48 hours
Observation times 24.5 and 48 hours
Medium renewal none
Test vessels glass beakers, nominal volume 50 mL, tall shape
Replicates (Treatments) 4 vessels, each containing 20 ± 5 mL test solution and 5
daphnia
Replicates (Blank control) 4 vessels, each containing 20 ± 5 mL dilution water and 5
daphnia

Reference substance (positive control):

yes

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

25.19 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

13.21 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

<= 4.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a
current reference study. The 24h-EC50 value was determined as 2.07 mg/L.
The value was within the requested range for the 24h-EC50 between 0.6 - 2.1 mg/L of po-
tassium dichromate K2Cr2O7 as specified in the OECD guideline.

Reported statistics and error estimates:

The estimation of the biological results was accomplished using the software ToxRat®
Professional, version 3.3.0. The details of calculation are stated in the Annex 3: Statistical
calculation using ToxRat® Professional 3.3.0.

Validity criteria fulfilled:

yes

Conclusions:

The following results were determined for the test item 1,12-Diaminododecane (species:
Daphnia magna).
48h-NOEC = < 4.6 mg/L
48h-LOEC = ≤ 4.6 mg/L
24h-EC50 = 25.19 mg/L
48h-EC50 = 13.21 mg/L

Executive summary:

One valid experiment was performed.

The study was performed using 5 concentrations ranging from 4.6 to 100 mg/L nominal

concentration. For each test concentration and the blank control, 20 daphnia were ex-

posed to the test item for 48 hours in a static test system. After 24.5 and 48 hours, the im-

mobilised daphnia were counted.

Five concentrations showed toxicity between 15 and 100% immobilisation. None of the

animals was immobilised in the blank control.

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a

current reference study to assure that the test conditions are reliable.  

At the beginning and at the end of the test, the content of the test item in the test solutions

was determined using LC/MS-MS-determination. The measured concentrations lay be-

tween 96 % and 101 % of the nominal concentrations at the beginning of the test and be-

tween 108 % and 118 % of the nominal concentrations at the end of the test. Therefore,

the determination of the biological results was based on the nominal concentration (see

Guidance Doc. No.23 (§176)).

The following results were determined for the test item 1,12-Diaminododecane (species:

Daphnia magna).

48h-NOEC = < 4.6 mg/L

48h-LOEC = ≤ 4.6 mg/L

24h-EC50 = 25.19 mg/L

48h-EC50 = 13.21 mg/L

Description of key information

The following results were determined for the test item 1,12-Diaminododecane (species:

Daphnia magna).

48h-EC50 = 13.21 mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

13.21 mg/L