1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts

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:

12 February, 2018 - 15 February, 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: DSP-001.
- Expiration date of the lot/batch: 15th January 2019.
- Purity test date: 1st May 2018.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark.
- Stability under test conditions: Stable.

Analytical monitoring:

yes

Details on sampling:

Samples were taken from the freshly prepared control and each test group from the bulk test preparation at 0 and 24 hours and from the old test media (pooled replicates) at 24 and 48 hours for quantitative analysis. All samples were stored frozen prior to analysis.

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Waterflea - Daphnia magna.
- Source: In-house laboratory cultures.
- Feeding during test: No food given during exposure.
- Food type: Each culture was fed daily with a mixture of algal suspension (Desmodesmus subspicatus) and Tetramin® flake food suspension. No food given during exposure.

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: Gravid adults were isolated the day before initiation of the test, such that the young daphnids
produced overnight were less than 24 hours old. These young were removed from the cultures and used for testing.

Test type:

semi-static

Water media type:

freshwater

Remarks:

Reconstituted water (Elendt M7 medium)

Limit test:

no

Total exposure duration:

48 h

Test temperature:

21 °C to 22 °C

pH:

7.9 ± 0.3

Details on test conditions:

TEST SYSTEM
- Test vessel: 150 mL glass beakers.
- Aeration: No, vessels were covered.
- No. of organisms per vessel: 5 per concentration (20 total).
- No. of vessels per concentration (replicates): 4.
- No. of vessels per control (replicates): 4.

OTHER TEST CONDITIONS
- Adjustment of pH: None.
- Photoperiod: 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods.
- Light intensity: 200 to 1200 Lux.

EFFECT PARAMETERS MEASURED: At the start and throughout the test all control and test solutions were observed to be clear colorless solutions.

VEHICLE CONTROL PERFORMED: No.

RANGE-FINDING STUDY
An initial range finding test was conducted on the basis that the test item was soluble, however, analysis showed that it was not readily soluble in the media required for the test, therefore a preliminary media preparation trial was conducted. The media preparation trial showed that the test item was soluble using a prolonged stirring method of preparation. The test concentrations to be used in the definitive test were determined by a second range-finding test.
- Test concentrations: 0.10, 1.0, 10 and 100 mg/L.
- Results used to determine the conditions for the definitive study: No immobilization was observed at the test concentrations of 0.10, 1.0 and 10 mg/L, however, 100% immobilization was observed at 100 mg/L. A sub lethal effect was observed in the 10 mg/L test group, this was reduced movement. Based on these results, the following test concentrations were assigned to the definitive test: 1.0, 3.2, 10, 32 and 100 mg/L.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

11 mg/L

Conc. based on:

test mat. (dissolved fraction)

Remarks:

geometric mean measured test concentration

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

26 mg/L

Conc. based on:

test mat. (dissolved fraction)

Remarks:

geometric mean measured test concentration

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

9.2 mg/L

Conc. based on:

test mat. (dissolved fraction)

Remarks:

geometric mean measured test concentration

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: Sub-lethal effects of exposure were observed in the 0.82, 2.7 and 9.2 mg/L test concentrations. These responses were reduced mobility and covered with debris.
- Mortality of control: None observed.

Results with reference substance (positive control):

- Results with reference substance valid?: Yes. The results from the positive control with potassium dichromate were within the normal range for this reference item. The results of the inter laboratory tests and a Technical Corrigendum to ISO 6341 give a 24-Hour EC50 for potassium dichromate within the range 0.6 mg/L to 2.1 mg/L.
- Relevant effect levels:
24 hour NOEC 0.56 mg/L
48 hour NOEC 0.56 mg/L
24 hour LOEC 1.0 mg/L
48 hour LOEC 1.0 mg/L
24 hour EC50 0.79 mg/L
48 hour EC50 0.75 mg/L

Reported statistics and error estimates:

Measured test concentrations were observed to have declined in the majority of samples, therefore, results were based on the geometric mean measured test concentrations.
95% Confidence Limits (mg/L) were not determined due to the nature of the results.

Validity criteria fulfilled:

yes

Remarks:

No more than 10% of the control daphnids show immobilization or other signs of disease or stress. The dissolved oxygen concentration at the end of the test is equal to or greater than 3 mg/L in the control and test vessels.

Conclusions:

Exposure of Daphnia magna to the test item resulted in an EC50 value of 11 mg/L, NOEC value of 9.2 mg/L and LOEC value of 26 mg/L and the substance can be considered non hazardous to aquatic invertebrates.

Executive summary:

A GLP compliant short term toxicity to aquatic invertebrates test was performed on the substance according to OECD Test Guideline 202.

Daphnia magna were exposed to an aqueous solution of the test item at nominal concentrations or 1.0, 3.2, 10, 3.2 and 100 mg/L for a total of 48 hours.

After 24 and 48 hours exposure 100% of the Daphnia magna were observed to be immobilized in the test concentrations of 32 and 100 mg/L.

At the lower concentrations the Daphnia magna were observed to be either normal (24 hours) or normal, exhibited reduced mobility or were covered in debris (48 hours).

No mortality was observed and all validity criteria were met.

Therefore, under the conditions of this test, and considering the substance is readily biodegradable, it was was found to be non hazardous to aquatic invertebrates in accordance with CLP Regulation (EC) 1272/2008.

Description of key information

A GLP compliant short term toxicity to aquatic invertebrates test was performed on the substance according to OECD Test Guideline 202.

Daphnia magna were exposed to an aqueous solution of the test item at nominal concentrations or 1.0, 3.2, 10, 3.2 and 100 mg/L for a total of 48 hours.

After 24 and 48 hours exposure 100% of the Daphnia magna were observed to be immobilized in the test concentrations of 32 and 100 mg/L.

At the lower concentrations the Daphnia magna were observed to be either normal (24 hours) or normal, exhibited reduced mobility or were covered in debris (48 hours).

No mortality was observed and all validity criteria were met.

Therefore, under the conditions of this test, and considering the substance is readily biodegradable, it was was found to be non hazardous to aquatic invertebrates in accordance with CLP Regulation (EC) 1272/2008.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

11 mg/L