1-Propanaminium, 3-amino-N-(2-hydroxyethyl)-N,N-dimethyl-, N-mink-oil acyl derivs., chlorides

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The experimental start date was 04 Apr 2017, and the experimental completion date was 02 Jun 2017.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

Adopted April 13, 2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-Propanaminium, 3-amino-N-(2-hydroxyethyl)-N,N-dimethyl-, N-mink-oil acyl derivs., chlorides

EC Number:

273-222-0

EC Name:

1-Propanaminium, 3-amino-N-(2-hydroxyethyl)-N,N-dimethyl-, N-mink-oil acyl derivs., chlorides

Cas Number:

68953-64-0

Molecular formula:

UVCB: CnHnN2 O2 (Cl)

IUPAC Name:

1-Propanaminium, 3-amino-N-(2-hydroxyethyl)-N,N-dimethyl-, N-mink-oil acyl derivs., chlorides

Test material form:

liquid

Specific details on test material used for the study:

Identification Quaternium-26
Appearance Clear amber to dark amber liquid
Batch 0001954899
Purity/Composition UVCB
Test item storage At room temperature
Stable under storage conditions until 22 December 2017 (retest date)

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Single samples for possible analysis were taken from all test concentrations and the control:
Frequency at t=0 h and t=48 h
Volume 2.0 mL from the approximate centre of the test vessels
Storage Not applicable, samples were transferred to the analytical laboratory at the Test Facility and analysed on the day of sampling.
At the end of the exposure period, the replicates were pooled at each concentration before sampling.

During the combined limit/range finding test, test samples were stored in the freezer (≤ -15°C).
On the day of analysis, the test samples were thawed at room temperature. The samples were diluted in a 1:1 (v:v) ratio with methanol and analyzed. If necessary, the samples were further diluted with 50/50 (v/v) methanol/ISO-medium to obtain concentrations within the alibration range.
During the final test, the samples were analyzed on the day of sampling and were diluted in a 1:1 (v:v) ratio with methanol and analyzed. If necessary, the samples were further diluted with 50/50 (v/v) methanol/ISO-medium to obtain concentrations within the calibration range.

Test solutions

Vehicle:

no

Details on test solutions:

The batch of Quaternium-26 tested was a clear amber to dark amber liquid and completely soluble in test medium at the concentrations tested. A correction was made for the purity/composition of the test item. A correction factor of 1.67 was used. Concentration/doses are expressed as mg Quaternium-26 per litre (mg Q-26/L).
Preparation of test solutions started with the highest concentration of 100 mg Q-26/L applying a period of slow magnetic stirring until the test item was completely dissolved in medium (30-44 min.). Slight foam formation was subsequently observed in all tests. Lower test concentrations were obtained by subsequent dilutions of the highest test concentration in test medium. All test solutions were clear and colorless at the end of the preparation procedure.
Any residual volumes were discarded unless otherwise requested by the Study Director.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Source In-house laboratory culture with a known history.
Reason for selection This system has been selected as an internationally accepted invertebrate species.
Validity of batch Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
Characteristics For the test selection of young daphnids with an age of < 24 hours, from parental daphnids of more than two weeks old.
Breeding: start of each batch with newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 litres of medium in an all-glass culture vessel.
Maximum age of the cultures is 4 weeks
Renewal of the cultures After 7 days of cultivation half of the medium twice a week.
Temperature of medium 18-22°C
Feeding Daily, a suspension of fresh water algae.
Medium M7, as prescribed by Dr. Elendt-Schneider (Elendt, B.-P., 1990: Selenium deficiency in Crustacea. An ultrastructural approach to antennal damage in Daphnia magna Straus. Protoplasma 154, 25-33).
The hardness 180 mg/L expressed as CaCO3 and the pH: 7.7 ± 0.3.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

180 mg/L expressed as CaCO3

Test temperature:

20°C

pH:

8.0-8.2

Dissolved oxygen:

8.9-9.6 mg O2/L

Nominal and measured concentrations:

Nominal: 0.10, 0.18, 0.32, 0.56 and 1.0 mg/L.
Average measured: 0.063, 0.13, 0.26, 0.45 and 0.78 mg/L.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.24 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

act. ingr.

Remarks:

m/z 383.5 and m/z 411.5

Basis for effect:

mobility

Details on results:

24h-EC50 0.27 mg/L with 95% CI: 0.24 – 0.31 mg/L
48h-EC50 0.24 mg/L with 95% CI: 0.21 - 0.26 mg/L

Results with reference substance (positive control):

The actual responses in the reference test with K2Cr2O7 are within the ranges of the expected responses at the different concentrations (i.e., the 48h-EC50 was between 0.3 and 1.0 mg/L).
Hence, the sensitivity of this batch of D. magna was in agreement with the historical data collected at Charles River Den Bosch.
The 24h-EC50 was 0.64 mg/L with a 95% confidence interval between 0.56 and 0.73 mg/L.
The 48h-EC50 was 0.48 mg/L with a 95% confidence interval between 0.43 and 0.53 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In conclusion, the 48h-EC50 for Daphnia magna exposed to Quaternium-26 was 0.24 mg/L based on average exposure concentrations (95% confidence interval between 0.21 and 0.26 mg/L).

Executive summary:

The objectiveof the study was to evaluate Quaternium-26 for its ability to generate acute toxic effects on the mobility of Daphnia magna during an exposure period of 48 hours and, if possible, to determine the EC₅₀ at 24 and 48 hours of exposure. The study procedures described in this report were based on the OECD guideline No. 202, 2004.

The batch of Quaternium-26 tested was a clear amber to dark amber liquid and completely soluble in test medium at the concentrations tested. A correction was made for the purity/composition of the test item. A correction factor of 1.67 was used. Concentration/doses are expressed as mgQuaternium-26per litre (mg Q-26/L). A final test was performed based on the results of a preceding combined limit/range-finding and a subsequent range-finding test.Twenty daphnids per group (5 per replicate, quadruplicate) were exposed to an untreated control and to 0.10, 0.18, 0.32, 0.56 and 1.0 mg Q-26/L. The total exposure period was 48 hours and samples for analytical confirmation of exposure concentrations were taken at the start and at the end of the test. Samples taken from all concentrations were analysed employing two out of several peaks observed in the chromatograms of the test item. The initially measured concentrations according to both peaks were comparable to each other. The concentrations measured according to the peak at m/z 383.5 remained relatively stable throughout the test duration, i.e. were at 84-87% of initial at the end of the test, except for the lowest test concentration which was at 65% of initial after 48 hours. The concentrations measured based on the peak at m/z 411.5 declined to 15-62% of initial at the end of the test. Based on these results, the average exposure concentrations were calculated for both peaks.For the expression of the effect parameters in this study, the geometric mean exposure concentrations were determined. The determined exposure concentrations were 0.063, 0.13, 0.26, 0.45 and 0.78 mg/L in solutions of nominal 0.10, 0.18, 0.32, 0.56 and 1.0 mg Q-26/L, respectively. The study met the acceptability criteria prescribed by the study plan and was considered valid.

In conclusion, the 48h-EC₅₀ for Daphnia magna exposed to Quaternium-26 was 0.24 mg/L based on average exposure concentrations (95% confidence interval between 0.21 and 0.26 mg/L).