Amines, N-(3-aminopropyl)-N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Justification for type of information:

For details and justification of read-across please refer to the report attached in section 13 of IUCLID.

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.431 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: (0.346 - 0.538)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

1.05 mg/L

Remarks on result:

other: IUCLID4 note: "m" (measured/nominal)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

0.18 mg/L

Remarks on result:

other: IUCLID4 note: "m" (measured/nominal)

Details on results:

The LC50 (96 h) was calculated to be 0.431 mg/L with 95% confidence limits of 0.346 and 0.538 m/L. The highest concentration causing no mortality (no observed effect concentration, NOEC) after 96 h amounted to 0.18 mg/L whereas 0.32 m/L was the lowest tested concentration (LOEC,96 h) at which lethality was observed as compared to the control. The LC100 was 1.05 m/L, which was observed after 29 hours.

Reported statistics and error estimates:

The LC50 was calculated using the computer program Toxcalc v 5.0 applying the trimmed Spearman-Karber method

Sublethal observations / clinical signs:

RESULTS: EXPOSED
- Nominal/measured concentrations: 0, 0.1, 0.18, 0.32, 0.58,1.05 mg/L (nominal)
- Effect data (Mortality):
    24h    48h 72h 96h
Control 0 0 0 0
0.1 0 0 0 0
0.18 0 0 0 0
0.32 0 0 0 1
0.58 0* 1* 5 6
1.05 1** 7
* reduced acitivity
** very reduced activity
For ethical reasons two fish were euthanised at the
concentration of 0.58 ml/L after 53 hours.

The LC50 (96 h) was calculated to be 0.431 mg/L with 95% confidence limits of 0.346 and 0.538 m/L. The highest
concentration causing no mortality (no observed effect concentration, NOEC) after 96 h amounted to 0.18 mg/L
whereas 0.32 m/L was the lowest tested concentration (LOEC,96 h) at which lethality was observed as compared to the
control. The LC100 was 1.05 m/L, which was observed after 29 hours.

- Concentration / response curve: -
- Effect concentration vs. test substance solubility: -
- Other effects: see mortality data * and **
RESULTS: CONTROL
- Number/percentage of animals showing adverse effects: None
- Nature of adverse effects: -

Validity criteria fulfilled:

yes

Conclusions:

Validity criteria can be considered as fulfilled.
Mortality of control animals was <10%, the concentration of dissolved oxygen in all test vessels was > 60% saturation and the concentration of test substance >= 80% of initial concentration during test.
Although quantification of the applied concentrations was not possible due to the absence of a suitable analytical method it was possible to analyze the two stock solutions used to prepare the test concentrations. These analyses showed that the stock solutions were stable even after storage for almost 7 months in the refrigerator. Considering the high water solubility of the test substance and its stability it is reasonable to assume that the actual concentrations were identical to the nominal concentrations during the entire test. A dose-response related increase in mortality was observed. Study peformed according to standard protocol and under GLP.

Executive summary:

The acute toxicity of Triameen Y12D to the fresh water fish Brachydanio rerio (zebra fish) was tested under semi-static conditions in accordance with OECD and EEC guidelines for testing of chemicals. The test was performed in compliance with Good Laboratory Practice (GLP). The fish were exposed to the following nominal test concentrations: 0.1- 0.18 – 0.32 – 0.58 and 1.05 mg/l. The LC₅₀(96 h) was calculated to be 0.43 mg/l with 95% confidence limits of 0.346 and 0.538 mg/l. The highest concentration causing no mortality (no observed effect concentration, NOEC) after 96 h amounted to 0.18 mg/l whereas 0.32 mg/l was the lowest tested concentration (LOEC, 96 h) at which lethality was observed as compared to the control. The LC₁₀₀was 1.05 mg/l, which was observed after 29 hours.

At the concentrations where lethality was established, sublethal effects, such as reduced activity, deviations in the behavior or the appearance of the fish, were observed. For ethical reasons two fish were euthanised at the concentration of 0.58 mg/l after 53 hours.

Quantification of the applied concentrations was not possible due to the absence of a suitable analytical method. The currently available analytical method is capable of analyzing down to only 10 mg/l. Therefore only the two stock solutions used to prepare the test concentrations were analyzed. These analyses showed that the stock solutions were stable even after storage for almost 7 months in the refrigerator. All concentrations mentioned in this report are therefore based on nominal concentrations. Considering the high water solubility of the test substance and its stability it is reasonable to assume that the actual concentrations were identical to the nominal concentrations during the entire test.

This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the attached read-across report (see IUCLID section 13).

Description of key information

No short-term fish data are available for branched triamine C16 -18 but the fish data for the branched triamine C12 will be used as a worst-case.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

431 µg/L

Additional information

No short-term fish data are available for branched triamine C16 -18 but the fish data for the branched triamine C12 will be used as a worst-case. Figures for branched triamine C12 (CAS no 2372-82-9) were obtained by performing ecotoxicity tests in reconstituted lab water and are therefore considered as data obtained under extreme worst-case conditions. From these figures it is clear that fish are clearly less sensitive compared to algae and daphnia.