Potassium carbamoylcarbamate

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-1-16 thru 2012-10-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well conducted study according to OECD Guideline 203 with no deviations.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Remarks:

Only exceptions: Latest water characterizations performed in Feb 2012 not performed according to GLP and test substance was not characterized in accordance with GLP

Test material

Test material information

1

Reference substance name:

Potassium carbamoylcarbamate

EC Number:

247-728-7

EC Name:

Potassium carbamoylcarbamate

Cas Number:

26479-35-6

Molecular formula:

C2H3KN2O3

IUPAC Name:

potassium N-carbamoylcarbamate

Test material form:

solid: particulate/powder

Remarks:

migrated information: particulates

Details on test material:

- Name of test material (as cited in study report):Potassium Allophonate
- Physical state:powder
- Analytical purity:83.8%

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
N/A

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Samples taken from control and each concentration at 0 and 72 hours from fresh solution, and at 24 and 96 hrs from spent solution. A 10ml sample was collected from control and each concentration and a 0.500 ml aliquot was removed. The aliquot was diluted with 80:20 acetonitrile:water to provide final concentrations within the analytical standard concentration range. Potassium allophonate fortified samples for QC prepared at concentrations of 5.75 and 115 a.i./L.

Test solutions

Vehicle:

no

Details on test solutions:

Primary stock solution of 0.10 mg a.i./L prepared by weighing 0.8353 g (approximately 0.7000 g when corrected for purity) into 10L glass jar and bringing volume up to 7000 mL with dilution water. Appropriate volumes of primary stock were added to 3.8 L glass test jars and diluted to 3.0 L with dilution water at concentrations of 6.3, 13, 25, 50 and 100 mg a.i./L.

Test organisms

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM
- Common name: Fathead minnow
- Source: ABC lab (In-house culture)
- Length at study initiation (length definition, mean, range and SD): Range: 12 to 18 mm, Mean: 16 +/- 1.8 mm
- Weight at study initiation (mean and range, SD): Range: 0.0141 to 0.0471 g, Mean: 0.0332 +/- 0.0111 g
- Feeding during test: None

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions: In dilution water at same temperature
- Type of food: brine shrimp, salmon starter, and commercially available fish food
- Feeding frequency: at least once/day until 26 hrs prior to test initiation
- Health during acclimation (any mortality observed): none

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

N/A

Test conditions

Hardness:

146 mg CaCO3/L

Test temperature:

22.9 - 23.8 degree C

pH:

8.2 - 8.4

Dissolved oxygen:

7.7 - 8.1 mg/L fresh solutions, 7.3 - 7.9 mg/L spent solutions

Salinity:

N/A

Nominal and measured concentrations:

Nominal: 6.3, 13, 25, 50 and 100 mg a.i./L
Mean measured: 5.31, 10.5, 25.6, 50.6, and 93.5 mg a.i./L

Details on test conditions:

TEST SYSTEM
- Test vessel:3.8 L glass jars covered with petri dish
- Fill volume: 3.0 L
- Aeration: None
- Renewal rate of test solution (frequency/flow rate): Daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): none
- No. of vessels per control (replicates): none
- No. of vessels per vehicle control (replicates): none
- Biomass loading rate: 0.0775 g fish tissue/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Moderately Hard Freshwater
- Alkalinity:158 mg CaCO3/L
- Conductivity: 348
- Culture medium different from test medium: no
- Intervals of water quality measurement: Total hardness, total alkalinity and conductivity taken at test initiation. Temperature, D. O. and pH measured daily.

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 16-hr daylight photoperiod with 30 minute dawn and dusk periods
- Light intensity: 487 lux

TEST CONCENTRATIONS
- Range finding study: 96-hr static test
- Range Test concentrations: 0.010, 0.10, 1.0, and 10 mg a.i./L
- Results used to determine the conditions for the definitive study: Yes, no mortality or sublethal effects in range finding study

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 93.5 other: mg active ingredient/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

93.5 other: mg active ingredient/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

At test initation, measured concentrations of potassium allophonate were 75 to 116% of nominal concentrations. At 24 hours, measured concentrations of spent solutions were 97 to 114% of nominal concentrations. At 72 hours, measured concentrations in fresh solution were 71 to 108% of the nominal concentrations. At 96 hours, measured concentrations of spent solution were 59 to 85% of nominal concentrations. Arithmatic mean measured conecntrations during the 96 hour exposure were 5.31, 10.5, 25.6, 50.6, and 93.5 mg a.i./L. No mortality or sublethal effects during 96 hour exposure at any concentration.

Results with reference substance (positive control):

N/A

Reported statistics and error estimates:

No statistical analyses based on lack of mortality or sublethal effects.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 96-hour NOEC for potassium allophonate on P. promelas was 93.5 mg a.i./L based on lack of mortality and sublethal effects at all test concentrations. The estimated 24-, 48-, 72- and 96- hour LC50 was >93.5 mg a.i./L, the highest concentration tested.

Executive summary:

N/A