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EC number: 687-893-6 | CAS number: 1150560-54-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 23rd October 2018 to 14th November 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: China Environmental Press, Guidelines for the Testing of Chemicals no. 211 Daphnia Reproduction Test (version 2. 2013)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Qualifier:
- according to guideline
- Guideline:
- other: EC, DG Health and Consumer Protection: 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
- 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
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Remarks:
- HPLC - UV
- Details on sampling:
- Test group and control group: fresh media and old media once every 7 days
Test solutions
- Details on test solutions:
- Method of preparation of stock solution:
A stock solution of nominal concentration 500 mg/L was prepared with acetonitrile. A weight of 0.10002 g test item was dissolved in acetonitrile to 100 mL
Method of preparation of test solutions:
The stock solution was used to prepare the working standard solutions with acetonitrile of 0.05, 0.1, 0.5, 1.0, 5.0, 10 and 20mg/L
On the last day of analysis, another stock solution was prepared (0.10000g was weighed and dissolved in 100ml of acetonitrile) and diluted to 0.5mg/L with acetonitrile to assess the stability of the stock solution under storage conditions.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Daphnia of stock culture were originally obtained from the College of Applied Chemistry 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, 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 C20181024.
A concentrated living algal suspension of Chlorella sp. and Desmodesmus subspicatus was fed to the Daphnia at a level of 0.1 - 0.2 mg/C/Daphnia/day.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 21 d
- Post exposure observation period:
- Mortality and number of offspring produced were recorded daily.
Other parameters were measured at the end of the test.
Test conditions
- Hardness:
- 180mg/L (as CaCO3)
- Test temperature:
- 19 - 20.5 oC
- pH:
- 7.74 - 8.25
- Dissolved oxygen:
- 9.10 - 9.37mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass beakers
- Fill volume: 200 - 250ml
- Volume of solution: 100ml
- Aeration: none during the test period
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- Frequency of solution renewal: 3 times per week
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: water treated with Aquapro Pure Water System
- Total organic carbon: <2mg/L
- Alkalinity: pH 6.0 - 9.0
OTHER TEST CONDITIONS
- Photoperiod: 16 hours photoperiod daily, 8 hours dark
- Light Intensity: 1145 - 1210 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Daily: Mortality and number of offspring produced
At end of test: Reproductive output per surviving parent and body length of surviving parent.
RANGE-FINDING STUDY
- Test concentrations: 10, 30 and 100mg/L (nominal)
- Results used to determine the conditions for the definitive study: At 10mg/L the number of juveniles from parent animals was significantly different in comparison to the control (p<0.05) whereas there were no surviving juveniles at 30mg/L. Based on the results of the preliminary test the definitive test was conducted with five nominal concentrations of 2.0, 3.9, 7.7, 15 and 30mg/L. - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.373 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks on result:
- other: Total broods
- Key result
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 0.373 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks on result:
- other: Total broods
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.373 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks on result:
- other: Body length of parent
- Key result
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 0.373 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks on result:
- other: Body length of parent
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.373 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks on result:
- other: First Brood Time
- Key result
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 0.373 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks on result:
- other: First Brood Time
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.044 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks on result:
- other: Mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211}
- Key result
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.086 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Remarks on result:
- other: Mortality: Number of living offspring produced per surviving parental animal {for Daphnia magna, TG 211}
- Details on results:
- No deaths of daphnia parents were observed in either the test or control groups.
No immobilisation was observed in either the test or control groups.
First brood began at Day 7 and there was no significant difference between test or control groups.
There was no significant difference between test or control groups for total broods per parent.
The total live offspring for each parent of 2.0 and 3.9mg/L and control. There was extreme significance difference between test groups of 7.7, 15 and 30mg/L and the control group (P<0.01).
For test groups 15 and 30mg/L, dead offspring were observed during the test. No significant difference was reported for body length of parents between test and control groups. - Reported statistics and error estimates:
- Student t-test with 5% significance level
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 21-day No Observed Effect Concentration (NOEC) and the Lowest Observed Effect Concentration (LOEC) based on mean measured concentration were as follows:
First brood time: NOEC mg/L - 0.373 LOEC mg/L - >0.373
Total number of live offspring per parent: NOEC mg/L - 0.044 LOEC mg/L - 0.086
Body length of parents: NOEC mg/L - 0.373 LOEC mg/L - >0.373
Total broods: NOEC mg/L - 0.373 LOEC mg/L - >0.373 - Executive summary:
A study was performed to assess the effect of the test item on the reproduction rate of Daphnia magna over a 21-day exposure period.
Based on the results of the preliminary test, the definitive test was carried out at five nominal concentrations of 2.0, 3.9, 7.7, 15 and 30.0mg/L.
For each group, (test and control) 10 daphnia were individually held (1 per test vessel). The test was performed with the renewal of the test solutions three times per week.
No mortality of parents was reported in either the test group or the control group. No signigficant difference betweeen all test groups and control group was noticed for the first brood time, the body length of the parent and the total broods (p>0.05). The total live offspring for each parent of 7.7, 15 and 30mg/L (nominal concentration) showed extreme significance difference compared to the control group.
During the test period, chemical analysis on test item concentration in test media by HPLC showed that for the test media of 2.0, 3.9, 7.7, 15 and 30.0mg/L, the mean measured concentrations of fresh solutuion was 0.024, 0.045, 0.090, 0.182 and 0.379mg/L. The mean measured concentrations in old solution were 0.024, 0.044, 0.083, 0.178 and 0.367mg/L. The mean concentrations were 0.024, 0.044, 0.086, 0.180 and 0.373mg/L. The mean measured concentrations were maintained within 20% of measured initial concentratiosn throughout the test, so results were based on mean measured concentrations.
The 21-day No Observed Effect Concentration (NOEC) and the Lowest Observed Effect Concentration (LOEC) based on mean measured concentration were as follows:
Parameter NOEC mg/L LOEC mg/L First brood time 0.373 >0.373 Total number of live offspring per parent 0.044 0.086 Body length of parents 0.373 >0.373 Total broods 0.373 >0.373
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