Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 October 2018 - 09 November 2018
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019

Materials and methods

Test guidelineopen allclose all
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
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. 211 "Daphnia magna Reproduction Test". (2013.8)
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
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
Appearance: Off white powder
Purity: 100%
Storage: At room temperature 15~25°C


Sampling and analysis

Analytical monitoring:
yes
Remarks:
HPLC
Details on sampling:
The concentrations of test item were determined in samples of test media by HPLC. The concentrations of the test chemical were analysed once a week in fresh and old media (i.e. analyses were made on a sample from the same solution when freshly prepared and at renewal)

Test solutions

Vehicle:
no
Details on test solutions:
Preparation of standard solution

On the first day of analysis batch, a stock solution of test item of 1000 mg/L was prepared with acetonitrile to prepare working standard solution. To prepare the stock solution, a weight of 0.1006 g of test item was dissolved and made up to 100 mL with acetonitrile. The stock solution was stored in a refrigerator (2-8 °C) during the test. The series of working standard solutions at the concentrations of 0.5, 0.7, 1, 2, 5, 10, 20 mg/L were diluted from the stock solution with acetonitrile. The solutions were stored in refrigerator (at 2-8 °C) and used for every batch of sample analysis.

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 the 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, discolored 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.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Post exposure observation period:
Every 24 hours

Test conditions

Hardness:
140 to 250 mg/L (as CaCO)
Test temperature:
18 - 22 C
pH:
6.0 to 8.5
Dissolved oxygen:
not less than 3 mg/L during the test period
Nominal and measured concentrations:
Nominal concentrations: 0.8, 1.3, 2.0, 3.2 and 5 mg/L. The arithmetic mean concentration in fresh media was 0.674, 1.327, 2.004, 3.315 and 4.970 mg/L, which was 84.3% ~ 103.6% of the nominal concentration, the arithmetic mean concentration in old media was 0.736, 1.291, 2.172,
3.302 and 4.938 mg/L, which was 92.0% ~ 108.6% of the nominal concentration. Test concentrations were satisfactorily maintained in the range of 80 ~ 120% of nominal concentration.


Details on test conditions:
Frequency of solution renewal: The test was performed with renewal of the test solutions three times a week, i.e. on every Monday, Wednesday and Friday.
Test vessel: 200 ml glass vessel
Replicates: 10 replicated for test concentrations and the control
Control: 10 daphnids in dilution water (without test item) were tested under the same test condtions as test treatment
Reference substance (positive control):
not specified

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
>= 1.9 - <= 2.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: Mortality of parental animal
Key result
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
>= 2.2 - <= 2.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211}
Remarks on result:
other:
Key result
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
>= 1.5 - <= 1.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211}
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
ca. 2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction: embryo numbers in the brood pouch {for Potamopyrgus, TG 242}
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Time to production of first brood
Key result
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211}
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
ca. 1.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction: embryo numbers in the brood pouch {for Potamopyrgus, TG 242}
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
3.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: time to production of first brood
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
ca. 1.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211}

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
EC10 with 95% confidence limit mg/L: 1.6 (1.5 - 1.7)

EC50 with 95% confidence limit mg/L : 2.2 (2.1~ 2.3)
Executive summary:

A reproduction test with FMPBA was conducted with Daphnia magna over a 21-day exposure period. Based on the results of a preliminary test, the definitive test was conducted with five concentrations of 0.8, 1.3, 2.0, 3.2 and 5 mg/L, concurrently with a blank control group. 10 animals were individually held at each test concentration and control. The semi-static test was performed with renewal of the test solutions three times a week.


During the test, no immobilization or mortality was observed in control group and 0.8 and 1.3 mg/L test groups; no immobilization was observed in 2.0, 3.2 and 5 mg/L test groups, but 3 parental animals died in 2.0 mg/L test group, and 100% mortality occurred in 3.2 and 5 mg/L test groups.


The concentrations oftest item were determined in samples of test media by HPLC. The results showed that for the nominal concentrations of 0.8, 1.3, 2.0, 3.2 and 5 mg/L, the arithmetic mean concentration in fresh media was 84.3% ~ 103.6% of the nominal concentration, the arithmetic mean concentration in old media was 92.0% ~ 108.6% of the nominal concentration (within the accepted range of 80 ~ 120% of the nominal concentrations). 


The 21-day NOEC/LOEC for all the parameters and ECx are as follows, based on


the nominal concentrations:


 









































Parameter NOEC (mg/L)LOEC (mg/L)EC with 95% confidence limits (mg/L)
Total living offspring for each parental animal 1.32.0

EC10: 1.6 (1.5-1.7)


EC50: 2.2 (2.1~ 2.3)


Mortality of parental animal //EC50: 2.2 (1.9 ~ 2.5)
Time to production of first brood3.25.0/
Total broods of each parent 1.32.0/
Body length of living parental animal 0.81.3/