Boronic acid, B-(2-fluoro-3-methoxyphenyl)-

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:

17 July 2018 - 19 July 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Measured concentration

Remarks:

A nominal concentration of 2.0 mg/L recorded a 1.672 mg/L in the measured concentration in the old media (71.8% of nominal, exceeding the ±20% variance for test) All other test recordings the test concentrations were satisfactorily maintained in the range of 80 ~ 120% of nominal concentrations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: MEP, P.R. China, the Guidelines for the Testing of Chemicals, Effects on Biotic Systems (the Second Edition), No. 202 "Daphnia sp., Acute Immobilisation Test". (2013.8)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: European Commission, Health & Consumer Protection Directorate-General, Guidance document on analytical quality control and validation procedures for pesticide residues analysis in food and feed, SANCO/12571/2013, 19 November 2013 rev.0,

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(2-fluoro-3-methoxyphenyl)boronic acid

EC Number:

609-099-0

Cas Number:

352303-67-4

Molecular formula:

FC6H3(OCH3)B(OH)2

IUPAC Name:

(2-fluoro-3-methoxyphenyl)boronic acid

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Lot number: 18051400
Purity: 100.2%
Storage: at room temperature 15 ~ 25 °C
Appearance: Off-white powder

Sampling and analysis

Analytical monitoring:

yes

Remarks:

Method: HPLC/UV

Details on sampling:

Analysis frequency: in 0-hour fresh solution and 48-hour old solution

Test solutions

Vehicle:

no

Details on test solutions:

Method of preparation of stock solution:
A stock solution of 100 mg/L was prepared to dilute test concentrations. A weight of 0.1004 g test item was dissolved in 1000 mL test water by magnetic stirring for 2 hours.

Method of preparation of test solutions:
10.0, 19.0, 36.2, 69.0, 131.3, 250.0 mL of the stock solution of 100 mg/L were pipetted to make up 500 mL with test water. The solutions were mixed thoroughly.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia of stock culture were originally obtained from Applying Chemistry Department Pesticide Environmental Evaluation Laboratory of China Agricultural University. The test Daphnia were derived from a same healthy pre-cultured population (i.e. showing no signs of stress such as high mortality, presence of males and ephippia, delay in the production of the first brood, discoloured animals, etc.). The pre-cultured animals were maintained in culture conditions (light, temperature, and medium) similar to those to be used in the test. The test animals were less than 24 hours old and not the first brood progeny. The batch used for this definitive test was Daphnia C20180717.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

24hr, 48 hr

Test conditions

Hardness:

140 to 250 mg/L (as CaCO3)

Test temperature:

18-22°C, for each test constant within ± 1 °C

pH:

6-9, normally not varying by more than 1.5 units in any one test.

Dissolved oxygen:

not less than 3 mg/L during the test period

Nominal and measured concentrations:

Based on a preliminary test, the test concentrations were used as follows:

Nominal concentrations of 2.0, 3.8, 7.2, 13.8, 26.3 and 50 mg/L with a spacing factor of 1.90.

Measured concentrations: the determined concentrations in fresh media were 1.436, 3.640, 6.086, 12.435, 24.735 and 47.554 mg/L, which were 71.8% ~ 95.8% of nominal concentrations. While the determined concentrations in old media were 1.672, 3.255, 7.012, 13.827, 25.950 and 49.396 mg/L, which were 83.6% ~ 100.2% of nominal concentrations. Except for 2.0 mg/L fresh solution exceeding the range of ±20%, the test concentrations were satisfactorily maintained in the range of 80 ~ 120% of nominal concentration.

Details on test conditions:

Range finding test
In a non-GLP range-finding test (Study Number G1822O005A), the preliminary test was conducted twice, the test concentrations included 0.2, 0.5, 1, 3, 10, 20, 30, 50, 100 mg/L and a concurrent blank control was included. The test solution of 100 mg/L was prepared by dissolving the test item in test water by magnetic stirring for 2 hours, and other solutions were diluted from the test solution of 100 mg/L. The test animals were Daphnia magna and 10 animals were used for each group. The solutions were not changed. According to the results, the EC50 may locate in the range of 1-50 mg/L. According to the results of the range-finding test, the definitive test was carried out at 6 nominal concentrations. The details were as following: Nominal concentrations of 2.0, 3.8, 7.2, 13.8, 26.3 and 50 mg/L with a spacing factor of 1.90. Test solutions were added into 4 test vessels respectively, and each vessel contained about 100 mL of the solution.5 daphnids were placed into each vessel. The test solutions were not renewed during the test.Observation intervals: 24 and 48 hours after exposure.

Each test vessel was checked for immobilised daphnids. In addition to immobility, any abnormal behaviour or appearance was recorded. Those animals that are not able to swim within 15 seconds, after gentle agitation of the test vessel were considered to be immobilised (even if they can still move their antennae).

Reference substance (positive control):

yes

Remarks:

Potassium Dichromate

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

21.38 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

other: Immobilisation

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

According to the results of test and based on the arithmetic mean concentrations of fresh and old solutions, the 48-hour ECs, of FMPBA to Daphnia magna was calculated by the Trimmed Spearman-Karber (TSK) method (EPA, VERSION 1.5) to be 21.38 mg/L, and 95% confidence limits were 17.69 ~ 25.83 mg/L

Executive summary:

A Daphnia  Acute Immobilisation  study of FMPBA was conducted with Daphnia magna over a 48-hour exposure period. Based on the results of the preliminary test,  the definitive test was carried out at 6 nominal concentrations of 2.0, 3.8, 7.2, 13.8, 26.3 and 50 mg/L with a spacing factor of 1.90. A blank control was performed concurrently. 4 replicates were used for the control and test concentrations with 5 daphnids for each replicate. The test was performed with a static water system and the test solutions were not renewed during the test.

The  concentration  of  test  item  was  determined  in  samples  of test  media  by HPLC/UV method.  The results showed that for the test solutions of 2.0, 3.8, 7.2, 13.8, 26.3 and 50 mg/L, the  determined  concentrations  in fresh media  were  1.436,  3.640, 6.086,  12.435,  24.735  and 47.554  mg/L,  which  were  71.8%  ~ 95.8%  of nominal concentrations.  While the determined  concentrations  in old media were  1.672, 3.255, 7.012,  13.827,  25.950  and 49.396  mg/L, which  were  83.6% ~ 100.2%  of nominal concentrations. Except  for 2.0 mg/L  fresh solution  exceeding  the range  of ±20% of nominal  concentration, the test concentrations  were  satisfactorily  maintained  in the range of 80 ~ 120% of nominal concentration.

According to the results of test and based on the aritlnnetic mean concentrations of fresh and old solutions, the 48-hour EC50, of FMPBA to Daphnia magna was calculated by the Trimmed  Spearman-Karber (TSK) method (EPA, VERSION 1.5)  to be 21.38 mg/L, and 95% confidence limits were 17.69 ~ 25.83 mg/L.