(1R,2R)-1-Amino-2-(difluoromethyl)-N-(1-methylcyclopropylsulfonyl)cyclopropanecarboxamide hydrochloride

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:

14 August to 18 August 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 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(1R,2R)-1-amino-2-difluoromethyl)-N- (1-methylcyclopropylsulfonyl)cyclo propanecarboxyamide hydrochloride

EC Number:

943-460-6

Cas Number:

1360828-80-3

Molecular formula:

C9H15CIF2N203S

IUPAC Name:

(1R,2R)-1-amino-2-difluoromethyl)-N- (1-methylcyclopropylsulfonyl)cyclo propanecarboxyamide hydrochloride

Test material form:

solid: particulate/powder

Details on test material:

White solid

Specific details on test material used for the study:

- Water solubility = 3984.9 mg/L at 20 degrees C

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Based on the results of the preliminary test, the definitive test was carried out at a concentraiton of 100 mg/L. The actual concentraitons of test oslutions were measured by HPLC method.
A concurrent blank contorl was performed in parallel. Seven fish were uesd for the test group and control group.
Bsaed on the results of the preliminary test, a semi-static system renewed at 48 hrs. with solution was used for the definitive test. Dissolved oxygen, pH, and temperature were measured daily during the 96-hour expoure period in the control and test solution.

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

other: Gobiocypris rarus

Details on test organisms:

Gobiocypris rarus is one of the recommended species of MEP, P.R. China Guideline for the Testing of Chemicals No. 203

TEST ORGANISM
- Common name: Rare Minnow
- Source:Institute of Hydrobiology, Chinese Academy of Sciences
- Body length ranges: 3.0 cm ~ 3.3 cm
- Body weight ranges: 0.2042 g ~ 0.3003 g
- Feeding: Brine shrimp twice on weekdays and once on weekends until 24 hours prior to the start of the test.

ACCLIMATION
- Acclimation period: First acclimiation peroid of 12 days (no sign of disease or mortalities and fish were help in water of hte quality used during the test). During the following acclimation period there was no sign of disease or mortalities.
- Light conditions: 12 hours light: 12 hours darkness
-Temperature: 23 +/- 2 degrees Celcius

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

10 to 250 mg/L (as CaCO3)

Test temperature:

23 +/- 2 degrees C. Temperature (in the water bath) was monitored continuously by automatic temperature monitoring system and recorded at 1 hour interval.

pH:

6.0 to 8.5 pH units

Dissolved oxygen:

Not less tan 60% of air stauration value (ASV) during test period and no aeration.

Nominal and measured concentrations:

A preliminary test with the nominal concentration of 50 and 100 mg/L were conducted by directly adding method. The slutions were renewed at 48 hours in preliminary test. The analysis results showed that a solution was stable over 48-hours, therefore, a semi-static system renewed at 48 hours with solution was used in the definitive test.

According to the results of the preliminary test, the defnitive test was carried out at a concentration level of 100 mg/L.

Details on test conditions:

TEST SYSTEM
- Test vessel: cylinder glass bottle
- Test solution volume: 5 L
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: <1.0 g fish/L water

Reference substance (positive control):

yes

Remarks:

Potassium dichromate (2016)

Results and discussion

Effect concentrations

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

During the 96-hour exposure period, no death and visible toxic signs were observed in the control group and test group of 100 mg/L. After 96 hours of exposure, all of the surviving fish were euthanized. The method of euthenasia was to put fish into a 0.5% water solution of ethylene glycol monophenyl ether.

Results with reference substance (positive control):

Potassium dichromate
24-hour LC50: 401.04 mg/L
95% confidence limits: 325.99 mg/L ~ 493.36 mg/L

Any other information on results incl. tables

Sublethal observations / clinical signs:

Results of physiochemical measurementsinthe definitive test:

pH = 7.02 ~ 8.19

Dissolved oxygen = 77.3 ~ 97.2 %ASV

Temperature = 22.1 ~ 22.2 degrees C

Environmental temperature = 21.88 ~ 23.91 degrees C

Toxic Signs in the Definitive Test:

During the 96 -hour exposure period, no death and visible toxic signs were observed in the control group and hte test group of 100 g/mL.

Verification of Test Concentration in the Definitive Test:

The concentrations of the test material were determind in samples of test media by HPLC method. The results showed that for the test solutions of 100 mg/L, the mean determined concentration in fresh media was 81.734 mg/L. The mean determined concentration in old media was 81.529 mg/L. The overall determined concentration was 81.631 mg/L, 81.6% of the nominal concentration. Therefore, all effects were based on the nominal concentration of the test material.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

Mortality in control group at end of test = 0 dead fish. Disolved oxygen concentration in test solutions: 77.3~97.2% ASV

Conclusions:

The concentrations of the test material were determined in samples of test media by HPLC method. The results showed that for the test solutions of 100 mg/L, the mean determined concentration in fresh media was 81.734 mg/L. The mean determined concentration in old media was 81.529 mg/L. The overall determined concentration was 81.631 mg/L, 81.6% of the nominal concentration. Therefore, all effects were based on the nominal concentration of the test item.
Based on the results, the 96-hour LC50 of Difluorosulfonamide HCl to Rare Minnow was greater than the limit concentration of 100 mg/L.