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EC number: 911-418-6 | CAS number: 55965-84-9
- 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
Bioaccumulation: aquatic / sediment
Administrative data
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 305 E (Bioaccumulation: Flow-through Fish Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 165-4 (Laboratory Studies of Pesticide Accumulation in Fish)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Test material form:
- not specified
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Rohm and Haas Company, Batch No.: 902.0002 (14C-CMIT) and JK-30/70 (12C-CMIT)
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: 99.7% (14C-CMIT)
- Specific activity: 41.00 mCi/g
- Locations of the label: 4 and 5 positions
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: All solutions were stored in the freezer until needed.
- Stability under test conditions: 14C-CMIT was stable in the treated aquaria. In all the aquaria samples analyzed the percent 14C-activity present as parent compound ranged from 97.9% to 100%.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final dilution of a dissolved solid, stock liquid or gel: Dosing solutions were initially prepared by dissolving the 14C–CMIT (175.9 mg) into 25 ml of acetone. A stock solution for the proportional diluter associated with the aquarium dosed at 0.010 mg/L was prepared by combining 7.5 ml of 14C CMIT and 162 mg of 12C-CMIT and making up to 25 m with acetone. For the aquarium dosed at 0.12 mg/L, 17.5 ml of 14C-CMIT plus 2430 mg of 12C-CMIT were combined and made up to 50 ml with acetone. 18.30 ml of the 0.010 mg/L stock solution and 35.16 ml of the 0.12 mg/L stock solution were diluted with acetone to a volume of 1500 ml for use in the proportional diluters.
OTHER SPECIFICS: Purity of non-labeled test material (Batch No. JK-30/70) was 99.86% - Radiolabelling:
- yes
Sampling and analysis
- Details on sampling:
- - Sampling intervals/frequency for test organisms: 0, 4 h, and 1, 3, 7, 14, 21, and 28 d
- Sampling intervals/frequency for test medium samples: 0, 4 h, and 1, 3, 7, 14, 21, and 28 d
- Sample storage conditions before analysis: Fish were separately pooled and frozen
- Details on sampling and analysis of test organisms and test media samples (e.g. sample preparation, analytical methods): Frozen fish were homogenized in a blender with dry ice and after the dry ice had sublimed, aliquots were taken and combusted in a sample oxidizer. The trapped 14C was quantitated by liquid scintillation spectrometry. Water samples were radioassayed by liquid scintillation spectrometry.
Test solutions
- Vehicle:
- yes
- Remarks:
- acetone
- Details on preparation of test solutions, spiked fish food or sediment:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Proportional diluter
- Controls: Vehicle control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Acetone
- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)): ca. 0.01% v/v
- Evidence of undissolved material (e.g. precipitate, surface film, etc): Not described
Test organisms
- Test organisms (species):
- Lepomis macrochirus
- Details on test organisms:
- TEST ORGANISM
- Common name: Bluegill sunfish
- Source: Osage Catfisheries, Inc. (Osage Beach, Missouri)
- Age at study initiation (mean and range, SD): < 1 year
- Length at study initiation (lenght definition, mean, range and SD): 51± 3.0 mm
- Weight at study initiation (mean and range, SD): 4.5 ± 0.92 g
- Weight at termination (mean and range, SD): 5.1 ± 1.8 g
- Health status: Test fish were in good health at study initiation
- Feeding during test
- Food type: Salmon Starter
- Amount: ca. 6.3 grams per aquarium per day
- Frequency: Daily
Study design
- Route of exposure:
- aqueous
- Test type:
- flow-through
- Water / sediment media type:
- natural sediment: freshwater
- Total exposure / uptake duration:
- 28 d
- Total depuration duration:
- 14 d
Test conditions
- Hardness:
- 260-282 (as CaCO3)
- Test temperature:
- 20-21°C
- pH:
- 7.5-8.4
- Dissolved oxygen:
- 6.9-8.7 mg/L
- TOC:
- < 1.0 mg/L
- Salinity:
- Not applicable
- Conductivity:
- 440-520 µMhos/cm
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass aquaria
- Material, size, headspace, fill volume: 100L size, filled with 70 mL of well water
- Aeration: Yes
- Type of flow-through (e.g. peristaltic or proportional diluter): Proportional diluter
- Renewal rate of test solution (frequency/flow rate): 6.5-7 volume additions per day
- No. of organisms per vessel: 70
- No. of vessels per concentration (replicates): 1
- No. of vessels per control / vehicle control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Well water
- Holding medium different from test medium: No
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16-hour light : 8 hour dark : 30 minutes transition - Nominal and measured concentrations:
- Nominal: 0.12 mg/L and 0.010 mg/L
Measured: 0.12 ± 0.004 and 0.010 ± 0.0005 mg/L - Reference substance (positive control):
- no
- Details on estimation of bioconcentration:
- BASIS FOR CALCULATION OF BCF
- Estimation software: BIOFAC
- Result based on measured log Pow of: 0.401
Results and discussion
Bioaccumulation factoropen allclose all
- Key result
- Conc. / dose:
- 0.01 mg/L
- Temp.:
- ca. 20 °C
- pH:
- 8
- Type:
- BCF
- Value:
- ca. 54 dimensionless
- Basis:
- whole body w.w.
- Time of plateau:
- 5.2 d
- Calculation basis:
- steady state
- Key result
- Conc. / dose:
- 0.12 mg/L
- Temp.:
- ca. 20 °C
- pH:
- 8
- Type:
- BCF
- Value:
- ca. 41 dimensionless
- Basis:
- whole body w.w.
- Time of plateau:
- 2.1 d
- Calculation basis:
- steady state
Depurationopen allclose all
- Key result
- Elimination:
- yes
- Parameter:
- DT50
- Depuration time (DT):
- 0.64 d
- Remarks on result:
- other: 0.12 mg/L treatment
- Key result
- Elimination:
- yes
- Parameter:
- DT50
- Depuration time (DT):
- 1.6 d
- Remarks on result:
- other: 0.010 mg/L treatment
Rate constantsopen allclose all
- Key result
- Rate constant:
- other: uptake rate constant
- Remarks:
- mg/kg fish/mg/L water/day
- Value:
- 45
- Remarks on result:
- other: 0.12 mg/L treatment
- Key result
- Rate constant:
- other: uptake rate constant
- Remarks:
- mg/kg fish/mg/L water/day
- Value:
- 24
- Remarks on result:
- other: 0.010 mg/L treatment
- Key result
- Rate constant:
- overall depuration rate constant (d-1)
- Value:
- 1.1
- Remarks on result:
- other: 0.12 mg/L treatment
- Key result
- Rate constant:
- overall depuration rate constant (d-1)
- Value:
- 0.44
- Remarks on result:
- other: 0.010 mg/L treatment
- Details on kinetic parameters:
- - Indication of bi- or multiphasic kinetics: No
- Computation / data analysis: The steady-state bioconcentration factor for whole fish was determined using the BIOFAC computer program - Metabolites:
- Metabolites were not isolated or identified. Given the low BCF and the resulting low concentration of metabolites in the tissue this was neither practical nor applicable.
- Results with reference substance (positive control):
- n/a
- Details on results:
- - Mortality of test organisms: The only mortality that occured is in the 0.12 mg/l treated aquarium on days 1, 2 and 5 of the exposure phase; mortality affects 5 fish in total, or 7.1% of the 70 fish added to that aquarium.
- Behavioural abnormalities: Not examined
- Observations on feeding behavior: Not examined
- Observations on body length and weight:
- Reproduction during test period: Not examined
- Other biological observations: No
- Organ specific bioaccumulation: Not examined
- Bound residues forming a plateau: Not examined
- Mortality and/or behavioural abnormalities of control: No
- Loss of test substance during test period: No
- Non-eliminated residues (NER) at the end of elimination phase: 12% and 26% for the 0.12 and 0.010 mg/L treatments, respectively
- Results with vehicle control: No effects - Reported statistics:
- In evaluating the data obtained from the bioconcentration study, a steady-state approach was used. This consists of a two compartment model (water and fish) which is used to describe the movement of the test substance into and out of the test fish. This approach is used to determine the steady-state bioconcentration factor, the uptake rate constant and the depuration rate constant.
Bioconcentration factors for the exposure phase were determined by dividing the test substance tissue concentration for each label by the appropriate test substance concentration in water for that day. The uptake rate constant and depuration rate constant were determined by the Dow BIOFAC computer program. This is a non-linear kinetic modeling program which provides optimal parameter estimates of rate constants by utilizing the actual (observed) bioconcentration study data. The bioconcentration factor at steady-state, the time to reach 90 % of steady-state and the time to reach 50% clearance (depuration) of the test substance were also calculated from the estimated rate constants. A measure of the variability of the estimated parameters was provided by the standard deviation of each estimate. All calculations are based on the values for whole fish analysis.
Any other information on results incl. tables
Uptake Phase Concentration in Water and Whole Fish
Uptake Day |
Concentration based on14C-CMIT Equivalents1 |
|||
Low Dose—0.010 mg/L |
High Dose—0.12 mg/L |
|||
Water (mg/L) |
Fish (mg/kg) |
Water (mg/L) |
Fish (mg/kg) |
|
0 |
0.011 |
|
0.12 |
|
0.17 |
0.011 |
0.14 |
0.12 |
1.3 |
1 |
0.010 |
0.37 |
0.12 |
4.3 |
3 |
0.010 |
0.37 |
0.12 |
4.4 |
7 |
0.0099 |
0.37 |
0.12 |
5.0 |
14 |
0.010 |
0.51 |
0.12 |
5.3 |
21 |
0.010 |
0.46 |
0.12 |
4.0 |
28 |
0.010 |
0.46 |
0.13 |
5.0 |
1 Total14C-residues (parent and metabolites)
Depuration Phase Concentration in Water, Whole Fish and Percent Depuration.
Depuration Day |
Concentration Based on14C-CMIT Equivalents1 |
|||||
|
Low Dose—0.010 mg/L |
High Dose—0.12 mg/L |
||||
|
Water (mg/L) |
Fish (mg/kg) |
Depuration (%) |
Water (mg/L) |
Fish (mg/kg) |
Depuration (%) |
1 |
0.0002 |
0.28 |
39 |
0.0005 |
2.5 |
50 |
3 |
<MLQ2 |
0.19 |
59 |
<MLQ2 |
1.4 |
72 |
7 |
<MLQ |
0.15 |
67 |
<MLQ |
0.82 |
84 |
10 |
<MLQ |
0.11 |
76 |
<MLQ |
0.65 |
87 |
14 |
<MLQ |
0.12 |
74 |
<MLQ |
0.61 |
88 |
1 Total14C-residues (parent and metabolites)
2 MLQ = minimum limit of detection
Characterization of Test Substance in Aquaria, Diluter Stock Solution, and Spiking of Control Aquarium Water.
Uptake Day |
Sample |
Percent14C-CMIT (by HPLC) |
|
|
|
Low Dose (0.010mg/L |
High Dose (0.12 mg/L |
0 |
Aquaria Diluter Stock Spikea |
100 100 100 |
100 100 100 |
14 |
Aquaria Diluter Stock Spikea |
97.9 100 100 |
100 100 100 |
28 |
Aquaria Diluter Stock Spikea |
100
100 |
98.6
100 |
a Water from the Control Aquarium was spiked with 14C-CMIT prior to concentration and HPLC analysis
Water Quality Measurements
Study Day |
Control (0 mg CMIT/L) |
Low Dose (0.010 mg CMIT/L) |
High Dose (0.12 mg CMIT/L) |
||||||
Temp. (°C) |
D.O. (mg/L)1 |
pH |
Temp. (°C) |
D.O. (mg/L)1 |
pH |
Temp. (°C) |
D.O. (mg/L)1 |
pH |
|
0 |
20 |
8.7 |
8.3 |
20 |
8.7 |
8.3 |
20 |
8.7 |
8.2 |
0.17 |
20 |
7.8 |
8.2 |
20 |
8.0 |
8.2 |
20 |
7.7 |
8.1 |
1 |
20 |
7.7 |
8.1 |
20 |
7.8 |
8.1 |
20 |
7.5 |
8.0 |
3 |
21 |
7.4 |
8.1 |
21 |
7.8 |
8.2 |
21 |
7.8 |
8.1 |
7 |
21 |
7.8 |
8.1 |
21 |
8.1 |
8.1 |
21 |
7.6 |
8.0 |
14 |
21 |
7.9 |
8.3 |
21 |
8.1 |
8.4 |
21 |
7.9 |
8.3 |
21 |
21 |
8.0 |
7.5 |
21 |
8.0 |
7.7 |
21 |
6.9 |
7.6 |
28 |
21 |
7.9 |
8.0 |
21 |
8.2 |
8.1 |
21 |
7.9 |
8.0 |
29 |
20 |
8.0 |
8.1 |
20 |
8.3 |
8.2 |
20 |
8.1 |
8.2 |
31 |
21 |
8.0 |
8.1 |
21 |
8.3 |
8.1 |
21 |
8.1 |
8.1 |
35 |
20 |
8.4 |
8.0 |
20 |
8.5 |
8.3 |
20 |
8.3 |
8.2 |
38 |
20 |
8.4 |
8.3 |
20 |
8.5 |
8.2 |
20 |
8.3 |
8.1 |
42 |
20 |
8.4 |
8.1 |
20 |
8.3 |
8.1 |
20 |
8.2 |
8.0 |
1 Dissolved oxygen saturation at 20°C and 21°C are 8.7 mg/L and 8.5 mg/L, respectively.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The study provided fulfills the requirement for CMIT fish bioaccumulation. The Bioconcentration Factor (BCF) of total 14C residues, ≤ 54, is very low; well below regulatory thresholds. Additionally 14C-residues depurate very rapidly. These results were expected given the low log Pow value and the high water solubility of CMIT. At environmentally relevant concentrations, the bioaccumulation of parent compound will be significantly less than the toxicity.
- Executive summary:
U.S. EPA 40 CFR § 158, Pesticide Assessment Guidelines Subdivision N § 165-4 and OECD 305 were followed. Initially Bluegill sunfish were dosed with14C-CMIT at 0.010 mg/L and 0.12 mg/L and water and fish samples taken on Days 0, 0.17, 3, 7, 14, 21, and 28 (uptake phase). On day 28 fish were transferred to water free of the active substance and water and tissue samples taken on Days 29, 32, 35, 38, and 42 (depuration phase). Aliquots of water were quantitated (total14C-residues) by radioassaying. Tissue was pooled, homogenized and aliquots radioassayed for total14C-residues. The study provided fulfills the requirement for CMIT fish bioaccumulation. The Bioconcentration Factor (BCF) of total 14C residues, ≤ 54, is very low; well below regulatory thresholds. Additionally 14C-residues depurate very rapidly. These results were expected given the low log Pow value and the high water solubility of CMIT. At environmentally relevant concentrations, the bioaccumulation of parent compound will be significantly less than the toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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