N,N-bis[3-(dimethylamino)propyl]-N',N'-dimethylpropane-1,3-diamine

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Once a week, the additional vessels (without test organisms in order to not disturb the TOC analysis) of treatment A, B, C, D, E and NC before and after renewal of the test solutions are sampled: 4 samples of 8 ml per treatment group and time.

Vehicle:

no

Details on test solutions:

The test was performed with Elendt M4 medium according to OECD 202 (2004)
the medium was
aerated for 2.25 – 5 h to achieve oxygen saturation and the pH (7.8 – 8.9), oxygen concentration
(8.2 – 8.9 mg/L) and conductivity (673 – 709 μS/cm) was determined. Solution S23 was added
directly before use of the medium.

Test organisms (species):

Daphnia magna

Details on test organisms:

The test organism Daphnia magna Straus originates from the clone breeding of the Federal Environment Agency, department IV 2.4, Berlin, and has been cultivated at Hydrotox GmbH since October 2012. The daphnids are cultured at 20  2 °C with 16 h light : 8 h dark and placed into fresh Elendt M4 medium twice a week. They are kept at approx. 10 animals / 200 mL and fed on workdays with Desmodesmus subspicatus algae corresponding to 0.1 mg C × daphnid-1 × day-1.
The test organisms used were 1.5 – 23.5 h old at the start of the test.
Quality assurance takes place at regular intervals by testing the sensitivity of the test organisms to the reference item potassium dichromate (Honeywell Speciality Chemicals Seelze GmbH, Seelze, Germany; Lot no.: H1030). The recent quality testing was performed in December 2019 (GLP 1504) with EC50 (24h) = 1.95 mg/L, which is in the declared range of 0.6 – 2.1 mg/L (24 h) according to OECD 202.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Test temperature:

The temperature during the exposure was 20.3 – 21.6 °C (required: 18 – 22 °C, constant within +/- 1 °C).

pH:

The pH was 7.7 – 8.5 in the control and 7.7 – 8.8 in the test item treatments A, B, C and D (recommended: 6 - 9). In treatment group E, in which all animals died before the end of the exposure period without producing offspring, the pH was 8.2 – 9.2.

Dissolved oxygen:

The dissolved oxygen concentration was 7.9 – 8.7 mg/L in the control and 7.9 – 8.7 mg/L in the test item treatment (required: ≥ 3 mg/L).

Conductivity:

A conductivity of 673 – 709 μS/cm was determined.

Nominal and measured concentrations:

Nominal test item concentration: 0; 0.33; 1.0; 3.0; 9.0, 27 mg/mL .
For the measured concentration check Results table in Attached background material.

Details on test conditions:

The test vessels are kept in an incubator (specified temperature 18 – 22 °C, constant within +/- 1 °C per day) with 16 h light : 8 h dark (≤ 20 μE m-2 s-1). The pH and the O2-concentrations were measured at the start (0 d) of the exposure, at each renewal of the test solutions (3×/week) and at the end (21 d) of the exposure. The temperature was measured continuously.

Key result

Duration:

9 d

Dose descriptor:

NOEC

Effect conc.:

9 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Key result

Duration:

9 d

Dose descriptor:

LOEC

Effect conc.:

27 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Key result

Duration:

9 d

Dose descriptor:

EC10

Effect conc.:

13.77 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Key result

Duration:

9 d

Dose descriptor:

EC50

Effect conc.:

15.53 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

As the measured mean TOC concentrations are within ± 20 % of the nominal concentrations, all results are given in relation to the nominal test item concentrations.

Reported statistics and error estimates:

The effect occurrence was calculated on the basis of the biological parameters. With the statistical
software ToxRat Professional (ToxRat Solutions GmbH, Alsdorf, Germany), ECx and LOEC/NOEC
were determined.

Validity criteria fulfilled:

yes

Remarks:

The mortality of the parent animals in the control at the end of the test was 0 % and therefore < 20 %.  The mean number of living offspring produced per surviving parent animal in the control at the end of the test was 86.8 and therefore ≥ 60.

Description of key information

 

The EC10 was determined to be at 13.77 mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

13.77 mg/L

Additional information

A semi-static reproduction test with Daphnia magna was conducted according to OECD 211 (02 October 2012, with TOC analysis to determine the test item exposure concentration) with the substance N,N-bis[3-(dimethylamino)propyl]-N',N'-dimethylpropane-1,3-diamine, CAS 33329-35-0 in order to investigate the chronic effects of the test item on daphnids. In the present study, five nominal concentrations of 0.33 – 27 mg/L test item were used.

The measured geometric mean TOC concentrations in the treatment groups were 102.0 – 102.7 % of the nominal concentrations.

The EC10 was determined to be at 13.77 mg/L, based on the mortalities of the test item treatments