N,N'-bis[2-hydroxy-3-(2,2,3,3-tetrafluoropropoxy)propyl]-N,N,N',N'-tetramethylethane-1,2-diaminium dichloride

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study carried out according to OECD Guideline 202

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

The protocol stated culture water will be maintained @20±2 ºC. Two weeks prior to testing the temp of the culture water ranged from 20-23ºC. This temp range was well within the typical temp encountered in the natural environment so no negative impact.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-bis[2-hydroxy-3-(2,2,3,3- tetrafluoropropoxy)propyl]-N,N,N',N'-tetramethylethane-1,2- diaminium dichloride

IUPAC Name:

N,N'-bis[2-hydroxy-3-(2,2,3,3- tetrafluoropropoxy)propyl]-N,N,N',N'-tetramethylethane-1,2- diaminium dichloride

Constituent 2

Reference substance name:

1,1,2,2,17,17,18,18-octafluoro-6,13-dihydroxy-8,8,11,11-tetramethyl-4,15-dioxa-8,11-diazaoctadecane-8,11-diium dichloride

EC Number:

700-737-4

Cas Number:

1220100-43-5

Molecular formula:

C18H34F8N2O4.2Cl

IUPAC Name:

1,1,2,2,17,17,18,18-octafluoro-6,13-dihydroxy-8,8,11,11-tetramethyl-4,15-dioxa-8,11-diazaoctadecane-8,11-diium dichloride

Details on test material:

[14C] Radiolabelled test substance was received and stored frozen in the original container.
Non Radiolabelled test substance was received and stored at room temperature in the original container in a dessicator.

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

At test initiation (0 hour) and test termination (48 hours), triplicate samples were removed from each test solution and the control and samples were analyzed for [14C] residues by liquid scintillation counting (LSC). The highest test solution was also analyzed for distribution of radioactivity by high performance liquid chromatography with radiochemical detection (HPLC/RAM), at each interval. At test initiation, test solution samples were taken from the intermediate vessels prior to division into replicate vessels. At test termination, the replicate solutions from each respective concentration and the control were composited prior to sampling.

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnids were selected as the test organism since they are recommended by U.S. EPA and OECD and are commonly used in acute freshwater invertebrate toxicity tests. The Daphnia magna used in this toxicity test were obtained from laboratory cultures maintained at Smithers Viscient.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

Total hardness as CaCO3: 190 mg/L

Test temperature:

20 to 21 ºC

pH:

pH: 8.0 to 8.1

Dissolved oxygen:

8.5 to 8.6 mg/L

Nominal and measured concentrations:

Nominal test concentrations of 4.3, 9.4, 21, 45 and 100 mg/L were selected for the definitive exposure.
Measured concentrations of 4.1, 9.3, 21, 44 and 100 mg/L were defined by analytical monitoring.

Details on test conditions:

The culture water was prepared by fortifying well water based on the formula for hard water (U.S. EPA, 1975) and filtering it through an Amberlite XAD 7 resin column to remove any potential organic contaminants. For the two weeks prior to testing, this water had a total hardness and a total alkalinity range as calcium carbonate (CaCO3) of 190 mg/L and 96 to 100 mg/L, respectively, and a specific conductivity range of 720 to 850 micromhos per centimeter (µmhos/cm). A pH range of 7.7 to 8.3, a temperature range of 20 to 23 ºC, and a dissolved oxygen concentration range of 6.3 to 9.6 mg/L were measured in the culture solutions during the two weeks prior to test initiation.

The daphnid culture area received a regulated photoperiod of 16 hours of light and 8 hours of darkness. Light at an intensity of 69 to 88 footcandles at the surface of the culture solutions was provided by fluorescent bulbs. Daphnids were fed unicellular green algae, Ankistrodesmus falcatus (4 x 107 cells/mL), in addition to a suspension of YCT (yeast, cereal leaves and flaked fish food). In culture, daphnids were fed various amounts based on their age. Daphnids that were 0 to 6 days old were fed 1.0 mL of algae and 0.5 mL of YCT suspension per vessel per day. Daphnids that were 7 to 10 days old were fed 1.5 mL of algae and 0.5 mL of YCT suspension per vessel per day. Daphnids that were > 10 days old were fed 2.0 mL of algae and 0.5 mL of YCT suspension per vessel per day. Representative samples of the food source were analyzed periodically for the presence of pesticides, PCBs and toxic metals by GeoLabs, Inc., Braintree, Massachusetts. None of these compounds have been detected in the food samples at concentrations considered toxic in any of the samples analyzed, in agreement with ASTM (2002) standard practice. Based on the analysis for pesticides, PCBs and toxic metals, the food sources were considered to be of acceptable quality since all analyte concentrations were below limits of concern.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

33 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 29 to 39 mg/L @ 95 % CL (EC50 value was determined by Trimmed Spearman-Karber)

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

30 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 24 to 36 mg/L @ 95 % CL (EC50 value was determined by Trimmed Spearman-Karber)

Effect concentrations 3

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

9.3 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

EC50 value was determined by Trimmed Spearman-Karber.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Based on mean measured concentrations, the 48-hour EC50 value for Daphnia magna exposed to the test substance was determined by Trimmed Spearman-Kärber to be 30 mg/L with 95% confidence intervals of 24 to 36 mg/L. The highest concentration producing 0% immobilization was 9.3 mg/L and the lowest concentration producing 100% immobilization was > 100 mg/L, the highest concentration tested. The No-Observed-Effect concentration (NOEC) was determined to be 9.3 mg/L.

Executive summary:

The EC50 and NOEC of the test substance to daphnids (Daphnia magna) under static test conditions has been determined in accordance with the OECD guideline 202 under GLP conditions.

The 48 -hour EC50 value for Daphnia magna exposed to the test substance was determined by Trimmed Spearman-Kärber to be 30 mg/L.

The No-Observed-Effect concentration (NOEC) was determined to be 9.3 mg/L.