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

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:

16 JULY 2018 - 20 JULY 2018

Reliability:

1 (reliable without restriction)

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:

other: MEP, P.R China, the Guideline for the Testing of Chemicals, effects on Biotic Systems (the Second Edition) No. 203 "Fish Acute Toxicity Test". (2013.8)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Remarks:

The study described in this report was conducted in compliance with SEPA, P.R. China, the Guidelines of Chemical Testing Good Laboratory Practices (HJ/T 155-2004).

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:

Purity: 100.2%
Appearance: Off-white powder
Lot number: 18051400
Storage conditions: At room temperature: 15-25C

Sampling and analysis

Analytical monitoring:

yes

Remarks:

The concentration of test item was determined in samples of test media by HPLC/UV method. The test concentrations were satisfactorily maintained in the range of 80 ~ 120% of nominal concentration within the fresh and old media.

Details on sampling:

Frequency: in 0, 48 hour fresh solution and 48, 96 hour old solution.

Test solutions

Vehicle:

no

Details on test solutions:

During the test, two batches of the test solutions were prepared. To prepare each solution, 0.1002 and 0.1000g, 0.1498 and 0.1499g, 0.2237 and 0.2237g, 0.3347 and 0.3348g, 0.5001 and 0.5007g of test item were weighed respectively and dissolved in 10L test water by magnetic stirring for about 2 hours.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Batch number: Zebra fish 20180322
Origin: The fish were reproduced in this facility. Their parental generation was introduced from Hangzhou Hunter Biotechnology Inc.

Acclimation:
From hatching, there were not any signs of disease or significant numbers of mortality. The fish are held in water of the quality and under the illumination conditions identical with those used in the test during the acclimation period.
Light condition: 12 hours light: 12 hours darkness
Temperature: 23±2C
Oxygen concentration: at least 80% of air saturation value (ASV)
Feeding: Twice on weekday and one time on weekend until 24 hours before the test was started.

Test organisms conditions of exposure:
Criterion: loading <1.0 g fish /L water, total length: 2.0±1.0 cm
Results: 5 fish were sampled randomly before the test and determined for body length and weight. The ranges of body length: 2.5cm ~ 2.9cm, the ranges of body weight: 0.2533g ~ 0.2983g
Replicates: One replicate for each test concentrations and the control.
Number of animals/vessel: 7
Control: 7 fish in dilution water (without test item) were tested under the same test conditions as the test replicate.
Feeding of fish: Fish were not feed during the period of the test.
Photoperiod: 12 hours light: 12 hours darkness (cool white fluorescent lighting)
Aeration: No aeration during test
Dissolved oxygen concentration (target): Not less than 60% of air saturation value (ASV) during the test period

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Remarks on exposure duration:

The test fishes were exposed for 96 hours to the test solution, to determine the 96-hour median lethal concentration (LC50) with 95% confidence limit.

Test conditions

Hardness:

10 to 250 mg/L (as CaCO3)

Test temperature:

23.0 ~ 23.3 C

pH:

6.0 to 8.5

Dissolved oxygen:

74.8 ~ 98.2% ASV

Nominal and measured concentrations:

Based on the results from the range finding test, the nominal concentrations for the test solutions were: 10, 15.0, 22.4, 33.4 and 50 mg/L, the measured arithmetic mean determined concentrations in fresh media were 9.727, 14.927, 22.103, 32.832 and 48.649 mg/L, which were 97.3% ~ 99.5% of nominal concentrations.

The measured arithmetic mean determined concentrations in old media were 8.702, 14.554, 21.263, 32.208 and 46.297 mg/L, which were 87.0% ~ 97.0% of nominal concentrations. The test concentrations were satisfactorily maintained in the range of 80 ~ 120% of nominal concentration.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate. Study number: HI183420130.

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

33.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 3

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

14.55 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

According to the results and based on the nominal concentrations, the 96-hours median lethal concentration (LCso) (with 95% confidence limits) of the test item to Zebra fish was calculated by the Trimmed Spearman-Karber (TSK) method (EPA, VERSION 1.5)

Results with reference substance (positive control):

24-hour LC50 381.34 mg/L. 95% confidence limits 334.23 - 435.09 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

According to the results and based on the nominal concentrations, the 96-hours median lethal concentration (LCso) (with 95% confidence limits) of the test item to Zebra fish was calculated by the Trimmed Spearman-Karber (TSK) method (EPA, VERSION 1.5)
and as followed: LC50 of 14.55 mg/L, with a 95% lower confidence of 12.23 mg/L and a 95% upper confidence of 17.31 mg/L. LC0 of 10.00 mg/L. The LC100 of 33.4 mg/L.

Executive summary:

A fish acute toxicity study of FMPBA was conducted with Zebra fish (Danio rerio) over a 96-hour exposure period.

Based on the results of the preliminary test, the definitive test was carried out at 5 nominal concentrations of 10,  15.0, 22.4, 33.4 and 50 mg/L with a spacing factor of 1.5. A blank control was performed concurrently. 7 fish were used for the test groups and the control group. The test was performed with a semi-static system and test solutions were renewed every 48 hours.

During  the  96-hour  exposure  period,  no  death  and  visible  toxic  signs  were observed in the control group, the fish exposed to 10 mg/L test group showed lethargy at 96-hour observation. The  concentration   of test  item  was  detemined   in  samples  of test  media  by HPLC/UV method.

Based on the results from the range finding test, the nominal concentrations for the test solutions were: 10, 15.0, 22.4, 33.4 and 50 mg/L, the measured arithmetic mean determined concentrations in fresh media were 9.727, 14.927, 22.103, 32.832 and 48.649 mg/L, which were 97.3% ~ 99.5% of nominal concentrations.

The measured arithmetic mean determined concentrations in old media were 8.702, 14.554, 21.263, 32.208 and 46.297 mg/L, which were 87.0% ~ 97.0% of nominal concentrations. The test concentrations were satisfactorily maintained in the range of 80 ~ 120% of nominal concentration.

According to the results and based on the nominal concentrations, the 96-hours median lethal concentration (LC50) (with 95% confidence limits) of the test item to Zebra fish were 14.55 mg/L.