N,N,N-tributylbutan-1-aminium ({[(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]oct-6-yl]oxy}sulfonyl)oxidanide

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:

5-7 April 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

see below

Principles of method if other than guideline:

Daphnia magna <25 hours old were used for testing. The guideline states that daphnids should be <24 hours old. This deviation is not thought to have affected the outcome of the study.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1192491-61-4

Cas Number:

1192491-61-4

IUPAC Name:

1192491-61-4

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): NXL-104
- Chemical name: Sulfuric acid, mono[(1R,2S,5R)-2-(aminocarbonyl)-7-oxo-1,6-diazabicyclo[3.2.1]oct-6-yl] ester, sodium salt (1:1)
- Molecular formula (if other than submission substance): C7H10N3O6S1 (+ Na)
- Molecular weight (if other than submission substance): ca. 288.23
- Substance type: salt
- Physical state: slightly yellow crystalline powder
- Analytical purity: 99.7%
- Impurities (identity and concentrations): not indicated
- Composition of test material, percentage of components: not indicated
- Purity test date: not indicated
- Lot/batch No.: AFCH005151
- Expiration date of the lot/batch: not indicated
- Stability under test conditions: not indicated
- Storage condition of test material: The sample was stored in a fridge.

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

At the start of the test the excess test solutions were sampled and at the end of the test one replicate of the dilution water control and the 120 mg/L test concentration were sampled.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A primary stock of NXL-104 with a nominal concentration of 120 mg/L was prepared by adding a nominal 0.240 g of test substance to 2000 mL of dilution water. This stock was used directly as the 120 mg/L test solution. The control and 120 mg/L test solution were observed to be clear and colourless.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Source: obtained from continuous laboratory cultures held at Brixham Environmental Laboratory. Parental stock 28 ± 1 days old
- Age at study initiation (mean and range, SD): <25 hours old, obtained from a single culture vessel
- Method of breeding: The stock cultures of D. magna were maintained in a reconstituted water medium, the same as the test dilution water, at a temperature of 20 ± 2°C. The cultures were maintained in 2 L glass vessels with a working volume of 1.6 L. A photoperiod of 16 hours light: 8 hours dark, with 20 minute transition periods was provided. The D. magna cultures were fed on a mixed algae diet of Chlorella vulgaris, strain CCAP 211/12 and Pseudokirchneriella subcapitata, strain CCAP 278/4. The D. magna cultures were fed daily ad libitum depending on age and density of the culture. Culture conditions were such that the D. magna reproduction was by diploid parthenogenesis.
- Feeding during test: none

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

247 mg/L CaCO3

Test temperature:

20.1-20.8 ºC

pH:

7.9 to 8.1

Dissolved oxygen:

8.1 to 9.0 mg/L

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal concentration of 120 mg/L
Measured concentration was 120 mg/L at the start and end of the test

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: Glass beakers of 250 mL nominal capacity, containing 200 mL test solution providing a depth of approximately 60 mm. The beakers were covered with loose fitting glass lids.
- Aeration: No
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt's M4 Daphnia magna medium

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light/8 hours dark, with 20 minute dusk and dawn transition periods
- Light intensity: not indicated

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mobility at 24 and 48 hours

TEST CONCENTRATIONS
Limit test at 120 mg/L

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: analytically confirmed concentration

Details on results:

None of the daphnia observed were immobilised after 24 or 48 hours, and no symptoms of toxicity were observed in this study. There was no immobility observed in the dilution water control.

Any other information on results incl. tables

Validity of the test:

- In the control, < 10% of the daphnia were immobile (i.e. 0%)

- The dissolved oxygen concentration at the end of the test was > 60% of the air saturation value at the used temperature (i.e. > 8.0)

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Based on analytically confirmed nominal concentrations, the 48h-EC50 of the acute toxicity to Daphnia magna was > 120 mg/L.