1-[2-fluoro-6-(trifluoromethyl)benzyl]-5-iodo-6-methylpyrimidine-2,4(1H,3H)-dione

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:

26th August 2018 to 7th September 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 203 (Fish, Acute Toxicity 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. 203 "Fish Acute Toxicity Test". (2013.8)

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EC, DG Health and Consumer Protection: Residues: Guidance on analytical quality control & validation procedures for pesticide residue analysis in food & feed SANCO/1257/2013 19/11/13 rev 0

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-5-iodo-6-methyl-1,2,3,4-tetrahydropyrimidine-2,4-dione

EC Number:

687-893-6

Cas Number:

1150560-54-5

Molecular formula:

C13H9F4IN2O2

IUPAC Name:

1-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-5-iodo-6-methyl-1,2,3,4-tetrahydropyrimidine-2,4-dione

Test material form:

solid: particulate/powder

Sampling and analysis

Analytical monitoring:

yes

Remarks:

HPLC/UV

Details on sampling:

Analysis frequency: test and control in 0 and 48 hour fresh solution and 48 and 72 hour old solution

Test solutions

Details on test solutions:

Nominal Concentration: 100mg/L
A weight of 1.0004 and 1.0063g of test item was added to 10L of test water. The solution was stirred using a stirring rate of 400rpm for 24 hours. 5L of solution was filtrated with 0.45 μm membrane.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Zebra fish (Danio rerio) were propagated in the facility with the parents originating from Hangzhou Hunter Biotechnology Inc. . No sign of disease or large mortalities
Acclimatation: Fish held under test conditions
Temperature: 23 ± 2°C
Light: 12 hours light / 12 hours darkness
Body length: 2.0 - 2.2cm
Weight: 0.1923 - 0.2132g
Feeding: Fish were not fed during the period of the test.

Study design

Test type:

semi-static

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

2, 4, 24, 48, 72 and 96 hours

Test conditions

Hardness:

140mg/L (as CaCO3)

Test temperature:

21.2 - 23.1 oC

Dissolved oxygen:

74.6 - 96.2%

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1.295 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Results with reference substance (positive control):

LC50: 359.06mg/L - 95% Confidence Limit (314.71 ~ 409.67 mg/L)

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Based on the measured concentration and test results, the 96 hour LC50 of Methyl Iodouracil to Zebra fish was > 1.295mg/L.

Executive summary:

A fish acute toxicity study of Methyl Iodouracil was conducted with Zebra fish (Danio rerio) over a 96 h exposure period. 

Based on the results of the preliminary test, the definitive test was carried out with a test item concentration of 100 mg/L (nominal concentration). A concurrent blank control was performed in parallel. The solution was filtrated with 0.45 μm membrane.

7 fish were used for the test and control group. 

The test was performed with a semi-static water renewal system (solutions replaced every 48 hours). Dissolved oxygen, pH of the old and new media were measured daily during the 96 h exposure period. Temperature was monitored continuously by an automatic temperature monitoring sytem and recorded.

During the 96 h exposure period no death or visible toxicity signs were observed in either the control group and test group of 100mg/L. 

During the test period, chemical analysis on test item concentration in test media  by HPLC showed that for the test media of 100mg/L the mean measured concentrations of fresh solutiuon was 1.311mg/L and the mean measured  concentrations of old solution was 1.280mg/L. The mean concentration was 1.295mg/L.

Based on the measured concentration and test results, the 96 hour LC₅₀ of Methyl Iodouracil to Zebra fish was > 1.295mg/L.