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EC number: 245-740-7 | CAS number: 23564-05-8
- 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 fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish, juvenile growth test
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1989-06-22 to 1989-07-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0.010, 0.032, 0.10, 0.32 and 1.0 mg/L
- Sample storage conditions before analysis: Test samples were injected directly. - Vehicle:
- yes
- Remarks:
- 1 % Tween 80-dimethylformamide
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
Fresh stock solutions of the test item dissolved in 1 % Tween 80-dimethylformamide were prepared daily for dispensing by the continuous flow apparatus. The solvent stock solutions for the test series were 0.10, 0.32, 1.0, 3.2 and 10 mg/mL. - Test organisms (species):
- Salmo sp.
- Details on test organisms:
- TEST ORGANISM
- Common name: Rainbow Trout
- Strain: Salmo gairdneri
- Source: Belleau Bridge Trout Farm, Lincolnshire, U.K.
- Length at study initiation (length definition, mean, range and SD): 4.4 cm (SD = 0.1 cm)
- Weight at study initiation (mean and range, SD): 2.13 g (SD = 0.18 g)
- Feeding during test: yes
- Food type: Commercial trout pellets daily
ACCLIMATION
- Acclimation period: 7 days prior to test
- Health during acclimation: Approximately 1 % mortality in 7 days prior to the test - Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 28 d
- Hardness:
- 50 mg/L as CaCO3
- Test temperature:
- 14 ± 1 °C
- pH:
- 7.7 - 7.9
- Dissolved oxygen:
- > 9.6 mg O2/L
- Nominal and measured concentrations:
- Nominal Concentration: 0.010, 0.032, 0.10, 0.32 and 1.0 mg/L; The mean percentage of the nominal concentrations obtained from the entire study were near nominal and it is considered, therefore, that the test results should only be determined on the basis of the nominal values and not the measured values.
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass aquaria
- Size of vessel: 20 L
- Material, size, headspace, fill volume: Glass, 20 L
- Aeration: None, the diluent supply only was aerated
- Type of flow-through: peristaltic diluter
- Renewal rate of test solution (frequency/flow rate): Continuous at 59 mL/min
- No. of organisms per vessel: 10 animals per test concentration
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 1.07 g bodyweight/L (static volume), 0.25 g body-weight/L (volume in 24 hours) and 4.25 tank volumes per day.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water, dechlorinated by the addition of sodium thiosulphate.
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h light : 8h dark
EFFECT PARAMETERS MEASURED: Absence of respiratory movement and response to physical stimulation.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2 - Duration:
- 28 d
- Dose descriptor:
- LC50
- Effect conc.:
- 0.6 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Details on results:
- Marked reactions to exposure (other than death) were lethargy and loss of equilibrium. Statistical analysis of the data shows that there were no significant dose related effects on growth in terms of both length and weight (P > 0.05) of the controls and all surviving test groups.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In a prolonged toxicity (28-days) of the test item to Rainbow trout (Salmo gairdneri) according to OECD 204, the LC50 was determined to be 0.60 mg/L and the NOEC was determined to be 0.32 mg/L.
- Executive summary:
In a prolonged toxicity (28-days) of the test item to Rainbow trout (Salmo gairdneri) according to OECD 204 in a flow through test system. Fresh stock solutions of the test item dissolved in 1 % Tween 80-dimethylformamide were prepared daily for dispensing by the continuous flow apparatus. The test concentrations were 0.010, 0.032, 0.10, 0.32 and 1.0 mg/L. To ensure the stability of the test concentrations, continuous renewal of test media and verification by chemical analysis on Days 0, 4, 6, 8, 11, 13, 15, 18, 20, 22, 25 and 28 was carried out. Additional samples were taken on days 5 and 7. The criterion for death was determined by the absence of respiratory movement and response to physical stimulation. The LC50 was determined to be 0.60 mg/L and the NOEC was determined to be 0.32 mg/L.
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-08-07 to 2014-03-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
- Version / remarks:
- Adopted July 17, 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method:
Aliquots of exact 25 µL of both IS solutions (thiophanate-ethyl and carbendazim-D4) were pipetted one by one into 1.8 mL HPLC vials; afterwards analytical sub-samples of 1.5 mL of the pre-diluted water samples were added. After tightly closing and manual shaking aliquots of 1.0 µL (analyte 1, TPM) or 10.0 µL (analyte 2, MBC) of the mixtures were analysed successive by LC-MS/MS using separate methods for the two analytes. Where necessary, sample aliquots less than 1500 µL were diluted with a mixture of acetonitrile/'holding- and dilution-water'/formic acid (500/500/1, v/v/v) in a pre-dilution step. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
Nominal initial test concentrations were 0.125, 0.25, 0.5, 1 and 2 mg test item. Four replicate vessels per test concentrations were installed. The stock solutions for nominal concentrations of 0.125, 0.25 and 0.5 mg/L were prepared by solving 184 mg of the test item with 5000 µL HCl (37 %) in 10 L dilution water under stirring at room temperature for 24 h. HCl was added to the stock solution to prevent formation of carbendazim being the major metabolite of the test item. After 24 h the stock solution was mixed with another 30 L of dilution water. The stock solutions for nominal concentrations of 1000 and 2000 µg/L were prepared by solving 4 times 276 mg of the test item with 2500 µL HCl (37 %) in 20 L dilution water under stirring at room temperature for 24 h. The final test media were prepared using the flow through system, by diluting application solutions with dilution water in the mixing vessels. - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish
- Source: Fraunhofer Institute, Schmallenberg, Germany.
METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS
- Method of collection of fertilised eggs: Eggs were collected in a glass spawning-tray which was placed at the bottom of the holding vessels
- Subsequent handling of eggs: The tray was covered with a stainless steel lattice to prevent adult fish from eating eggs. - Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 35 d
- Test temperature:
- 24.6 – 25.7 °C
- pH:
- 7.9 - 8.4
- Dissolved oxygen:
- 93 – 103 µg/L
- Nominal and measured concentrations:
- Nominal: 125, 250, 500, 1000 and 2000 µg/L
Measured conc: 123, 256, 509, 939 and 1870 µg/L - Details on test conditions:
- TEST SYSTEM
- Emybro cups: glass spawnin-tray
- Test vessel: full glass aquaria
- Material, size, fill volume: glass, 28 L and 24 – 25 L
- No. of fertilized eggs/embryos per vessel: 60
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Purified drinking water was used according to the OECD-Guideline 210
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: light/dark cycle of 12 h/12 h
- Light intensity: 1000 lux
EFFECT PARAMETERS MEASURED: Qualitative observations on hatching and survival were made daily.
VEHICLE CONTROL PERFORMED: dilution water (without addition of test item) was used as a control - Key result
- Duration:
- 35 d
- Dose descriptor:
- EC10
- Effect conc.:
- 0.39 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Post hatch survival
- Remarks on result:
- other: CL: 0.147 - 0.645 mg/L
- Key result
- Duration:
- 35 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.509 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Post hatch survival
- Duration:
- 35 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1.87 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: Hatching success
- Duration:
- 35 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1.87 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- weight
- Duration:
- 35 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1.87 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- length
- Details on results:
- No adverse effect could be observed on the fish larvae concerning the endpoint hatching success. Post hatch survival was inhibited by the test item at mean measured concentrations of > 0.509 mg/L and > 0.256 mg/L after 14 and 21 days, respectively. However, no statistically significant differences to the control were found at these test levels at all later observation dates. After 28 and 35 days the post hatch survival was affected at 0.939 mg/L and 1.870 mg/L.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The toxicity of the test item to fish early life stages was determined according to OECD 210. For this purpose, fertilised eggs of zebrafish (Danio rerio) were exposed to five test item concentrations. Hatch, post hatch survival and growth by means of length and weight measurements were recorded. The NOEC based on the mean measured concentrations, was determined to be 0.509 mg/L, for the endpoint post hatch survival. The respective EC10 value was calculated to be 0.393 mg/L (CL: 0.147 – 0.45 mg/L).
- Executive summary:
The toxicity of the test item to fish early life stages was determined according to OECD 210. For this purpose, freshly fertilised eggs of zebrafish (Danio rerio) (less than 4 hours of age, post fertilisation) were exposed to 0.125, 0.25, 0.5, 1 and 2 mg/L. A dilution water control was run in parallel. Water samples were analysed using LC-MS at an LOQ of 0.05 mg/L. The in-life phase was initiated after groups of 60 fertilised eggs were distributed evenly between four replicate vessels per treatment. Each group of 15 eggs was placed into a fry chamber suspended in each test vessel. After 14, 21, 28 and 35 days post fertilisation (pf), the fish larvae were digitally photographed. Post hatch survival rates were estimated by evaluating photographs using electronically supported counting and analysis. At test end, fish lengths and group dry weights of replicate fish groups were measured.
At test start and weekly thereafter, samples of the test media were taken for chemical analysis. The chemical analyses of the test media revealed mean concentrations for the single test vessels between 81 and 123 % of the nominal concentrations. The effect data evaluation was based on the mean measured concentrations. The mean concentrations per treatment were found to be between 93.5 and 103 % of the nominal values and were calculated to be 0.123, 0.256, 0.509, 0.939 and 1.870 mg/L. In addition to the chemical analysis of the test item, the concentrations of carbendazim in the different treatments were measured. For carbendazim the mean concentrations per treatment were found to be between 6.3 and 21.0 % of the nominal values of carbendazim and were calculated to be 0.0146, 0.0209, 0.0281, 0.0442 and 0.0699 mg/L.
Hatch of the fish larvae was not affected by the test item. The hatching success was > 95 % at all test concentrations of the test item. The evaluation of post hatch survival revealed a significant decrease at 0.939 mg/L and 1.870 mg/L after 28 and 35 days (test end). Statistically significant reduced post hatch survival at the low treatment levels 0.256 mg/L and 0.509 mg/L was only observed after 14 and 21 days pf. The respective rates of post hatch survival thereafter were almost comparable to those of after 21 days pf, but no statistically significant differences to the control were found at all later observation dates. Based on this observation, the decreased survival at 0.256 and 0.509 mg/L would not be considered as biologically relevant.
An EC10 value was calculated for this endpoint. The probit analysis revealed an EC10 of 0.390 mg/L (confidence limits: 0.147 - 0.645 mg/L). Since the fit of the regression curve was based on an effect range limited to a maximum of 33 % compared to control observed at the highest treatment level, the confidence limits were accordingly wide and spanned a range over two test concentrations.
Fish lengths were recorded on day 35 (test end). The single dry weights were calculated by dividing the group dry weights by the number of remaining fish on day 35 pf. Fish lengths and the single dry weights were found to be not significantly inhibited by the test item. It should be noticed, that an increase of both lengths and weights was observed at all treatments of the test item, which was not concentration dependent. The single dry weight was between 1.7 to 2.0 times higher than the single dry weight of the control. The observed increase in growth was not considered as negative effect on the fish. In addition, no abnormality in the fish behaviour was observed.
No adverse effect could be observed on the fish larvae concerning the endpoint hatching success. Post hatch survival was decreased by the test item at mean measured concentrations between 0.939 mg/L and 1.870 mg/L at test end. Lengths and single dry weights were found to be elevated at all investigated test concentrations. However, this was not considered as negative effect on the test organisms.
Thus, the lowest no effect concentration, based on the mean measured concentrations, was determined to be 0.509 mg/L for the endpoint post hatch survival after 35 days. The EC10 for post hatch survival was calculated to be 0.39 mg/L (CL: 0.147 – 0.645 mg/L).
Referenceopen allclose all
The mean percentage of the nominal concentrations obtained from the entire study were near nominal and it is considered, therefore, that the test results should only be determined on the basis of the nominal values and not the measured values.
Table 1: Analytical Measurements
Nominal Concentration (mg/L) |
Mean percentage of nominal concentration |
Control |
- |
0.010 |
136 |
0.032 |
129 |
0.10 |
117 |
0.32 |
94 |
1.00 |
95 |
Table 2: Analytical RESULTS
Sample |
Nominal Concentration (mg/L) |
Concentration found (mg/L) |
Concentration expressed as % of nominal |
||
Day 0 |
Control |
* |
* |
||
|
0.010 |
* |
* |
||
|
0.032 |
* |
* |
||
|
0.10 |
* |
* |
||
|
0.32 |
* |
* |
||
|
1.0 |
* |
* |
||
Day 4 |
Control |
* |
* |
||
|
0.010 |
* |
* |
||
|
0.032 |
* |
* |
||
|
0.10 |
0.0949 |
94.9 |
||
|
0.32 |
0.295 |
92.2 |
||
|
1.0 |
0.915 |
91.5 |
||
Day 5 |
Control |
+ |
|
||
|
0.010 |
0.0178 |
178.0 |
||
|
0.032 |
0.0603 |
188.4 |
||
|
0.10 |
0.222 |
222.0 |
||
|
0.32 |
0.250 |
78.1 |
||
|
1.0 |
0.937 |
93.7 |
||
Day 6 |
Control |
0.00469 |
- |
||
|
0.010 |
0.0118 |
118.0 |
||
|
0.032 |
0.0688 |
215.0 |
||
|
0.10 |
0.218 |
218.0 |
||
|
0.32 |
0.206 |
64.4 |
||
|
1.0 |
0.753 |
75.3 |
||
Day 7 |
Control |
0.00632 |
- |
||
|
0.010 |
0.0313 |
313.0 |
||
|
0.032 |
0.0319 |
99.7 |
||
|
0.10 |
0.128 |
128.0 |
||
|
0.32 |
0.313 |
97.8 |
||
|
1.0 |
1.01 |
101.0 |
||
Day 8 |
Control |
0.00353 |
- |
||
|
0.010 |
0.00980 |
98.0 |
||
|
0.032 |
0.0425 |
132.8 |
||
|
0.10 |
0.114 |
114.0 |
||
|
0.32 |
0.365 |
114.1 |
||
|
1.0 |
1.06 |
106.0 |
||
Day 11 |
Control |
0.00941 |
- |
||
|
0.010 |
0.0118 |
118.0 |
||
|
0.032 |
0.0372 |
116.3 |
||
|
0.10 |
0.115 |
115.0 |
||
|
0.32 |
0.264 |
82.5 |
||
|
1.0 |
0.942 |
94.2 |
||
Day 13 |
Control |
None detected |
- |
||
|
0.010 |
0.00717 |
71.7 |
||
|
0.032 |
0.0407 |
127.2 |
||
|
0.10 |
0.0934 |
93.4 |
||
|
0.32 |
0.335 |
104.7 |
||
|
1.0 |
0.848 |
84.8 |
||
Day 15 |
Control |
0.00445 |
- |
||
|
0.010 |
0.0103 |
103.0 |
||
|
0.032 |
0.0418 |
130.6 |
||
|
0.10 |
0.0817 |
81.7 |
||
|
0.32 |
0.290 |
90.6 |
||
|
1.0 |
0.893 |
89.3 |
||
Day 18 |
Control |
None detected |
- |
||
|
0.010 |
0.00821 |
82.1 |
||
|
0.032 |
0.0220 |
68.8 |
||
|
0.10 |
0.101 |
101.0 |
||
|
0.32 |
0.308 |
96.3 |
||
|
1.0 |
0.945 |
94.5 |
||
Day 20 |
Control |
0.0108 |
- |
||
|
0.010 |
0.0112 |
112.0 |
||
|
0.032 |
0.0348 |
108.8 |
||
|
0.10 |
0.122 |
122.0 |
||
|
0.32 |
0.285 |
89.1 |
||
|
1.0 |
1.07 |
107.0 |
||
Day 22 |
Control |
Interference |
- |
||
|
0.010 |
Interference |
_ |
||
|
0.032 |
Interference |
- |
||
|
0.10 |
0.0630 |
63.0 |
||
|
0.32 |
0.307 |
95.9 |
||
|
1.0 |
1.11 |
111.0 |
||
Day 25 |
Control |
0.000726 |
- |
||
|
0.010 |
0.0145 |
145.0 |
||
|
0.032 |
0.0247 |
77.2 |
||
|
0.10 |
0.0693 |
69.3 |
||
|
0.32 |
0.329 |
102.8 |
||
|
1.0 |
0.757 |
75.7 |
||
Day 28 |
Control |
None detected |
None detected |
||
|
0.010 |
0.0153 |
153.0 |
||
|
0.032 |
0.0484 |
151.3 |
||
|
0.10 |
0.0994 |
99.4 |
||
|
0.32 |
0.341 |
106.6 |
||
|
1.0 |
1.17 |
117.0 |
* A method of analysis was developed prior to the study, but unfortunately when the Day 0 samples were analysed there was unanticipated chromatographic interference. This was not overcome until Day 4 of the study.
+ Lost due to spillage.
Table 1: Measured concentrations of the test item and the residual carbendazim
Nominal concentration |
|
Mean measured concentration |
||||
thiophanate-methyl |
Carbendazim |
thiophanate-methyl |
Carbendazim |
|||
[µg/L] |
[µg/L] |
Replicate |
[µg/L] |
[µg/L] |
[µg/L] |
[µg/L] |
Control |
Control |
A |
< LOQ |
- |
< LOQ |
- |
B |
< LOQ |
- |
< LOQ |
- |
||
C |
< LOQ |
- |
< LOQ |
- |
||
D |
< LOQ |
- |
< LOQ |
- |
||
125 |
70 |
A |
131 |
105 |
14.4 |
20.7 |
B |
130 |
104 |
14.4 |
20.6 |
||
C |
115 |
91.7 |
15.1 |
21.7 |
||
D |
115 |
92.1 |
14.6 |
20.9 |
||
Mean |
123 |
98.1 |
14.6 |
21.0 |
||
SD |
9.1 |
7.2 |
0.3 |
0.5 |
||
250 |
140 |
A |
262 |
105 |
20.3 |
14.6 |
B |
262 |
105 |
20.5 |
14.7 |
||
C |
252 |
101 |
21.7 |
15.5 |
||
D |
250 |
100 |
21.0 |
15.1 |
||
Mean |
256 |
103 |
20.9 |
15.0 |
||
SD |
6.4 |
2.6 |
0.6 |
0.4 |
||
500 |
279 |
A |
475 |
94.9 |
25.3 |
9.1 |
B |
477 |
95.3 |
25.2 |
9.0 |
||
C |
545 |
109 |
31.5 |
11.3 |
||
D |
540 |
108 |
30.2 |
10.8 |
||
Mean |
509 |
102 |
28.1 |
10.0 |
||
SD |
38.9 |
7.8 |
3.3 |
1.2 |
||
1000 |
558 |
A |
905 |
90.5 |
41.9 |
7.5 |
B |
897 |
89.7 |
42.3 |
7.6 |
||
C |
970 |
97.0 |
47.1 |
8.4 |
||
D |
985 |
98.5 |
45.3 |
7.1 |
||
Mean |
939 |
93.9 |
44.2 |
7.9 |
||
SD |
44.5 |
4.4 |
2.5 |
0.4 |
||
2000 |
1117 |
A |
1912 |
95.6 |
73.0 |
6.5 |
B |
1887 |
94.3 |
74.0 |
6.6 |
||
C |
1835 |
91.8 |
66.7 |
6.0 |
||
D |
1845 |
92.2 |
65.9 |
5.9 |
||
Mean |
1870 |
93.5 |
69.9 |
6.3 |
||
SD |
36.0 |
1.8 |
4.2 |
0.4 |
LOQ thiophanate-methyl = 50 µg/L. LOQ carbendazim = 1 µg/L.
Table 2: Early Life stage: Hatch, survival and growth.
|
Nominal concentration of the test substance [µg a.s./L] |
|||||
Control |
125 |
250 |
500 |
1000 |
2000 |
|
Mean measured concentration [µg a.s./L] |
||||||
Control |
123 |
256 |
509 |
939 |
1870 |
|
Number of introduced eggs [n] |
60 |
60 |
60 |
60 |
60 |
60 |
Hatching day 3 pf [%] |
26.7 ± 9.4 |
28.3 ± 6.4 |
28.3 ± 14.8 |
33.3 ± 14.4 |
26.7 ± 21.1 |
16.7 ± 3.8 |
Hatching day 4 pf [%] |
90.0 ± 8.6 |
83.3 ± 15.9 |
86.7 ± 5.4 |
76.7 ± 8.6 |
70.0 ± 12.8 |
78.3 ± 17.5 |
Hatching day 5 pf [%] |
98.3 ± 3.3 |
93.3 ± 5.4 |
98.3 ± 3.3 |
95.0 ± 6.4 |
91.7 ± 12.6 |
96.7 ± 6.7 |
Hatching day 6 pf [%] |
100 ± 0.0 |
100 ± 0.0 |
95.0 ± 10.0 |
100 ± 0.0 |
98.3 ± 3.3 |
100 ± 0.0 |
Hatching day 7 pf [%] |
100 ± 0.0 |
100 ± 0.0 |
100 ± 0.0 |
100 ± 0.0 |
100 ± 0.0 |
100 ± 0.0 |
Post hatch survival day 14 pf [%] |
95.0 ± 3.3 |
90.0 ± 6.7 |
88.3 ± 6.4 |
85.0 ± 6.4*) |
75.0 ± 11.3*) |
70.0 ± 3.8*) |
Post hatch survival day 21 pf [%] |
91.7 ± 6.4 |
85.0 ± 6.4 |
83.3 ± 8.6*) |
83.3 ± 6.7*) |
75.0 ± 11.3*) |
68.3 ± 6.4*) |
Post hatch survival day 28 pf [%] |
90.0 ± 8.6 |
85.0 ± 6.4 |
83.3 ± 8.6 |
81.7 ± 8.4 |
75.0 ± 11.3*) |
68.3 ± 6.4*) |
Post hatch survival day 35 pf [%] |
90.0 ± 8.6 |
85.0 ± 6.4 |
83.3 ± 8.6 |
81.7 ± 8.4 |
73.3 ± 12.4*) |
66.7 ± 5.4*) |
Mean length, day 35 pf [cm] |
1.40 ± 0.04 |
1.54 ± 0.05 |
1.58 ± 0.06 |
1.57 ± 0.09 |
1.55 ± 0.09 |
1.52 ± 0.09 |
Mean group dry weight [mg] |
68.2 ± 9.5 |
108.5 ± 21.9 |
126.1 ± 16.2 |
119.4 ± 30.4 |
103.5 ± 21.0 |
92.4 ± 17.5 |
Mean single dry weight [mg] |
5.0 ± 0.3 |
8.5 ± 1.4 |
10.1 ± 0.7 |
9.8 ± 2.5 |
9.6 ± 2.4 |
9.2 ± 1.6 |
Mean values ± standard deviation are presented. All treatment data was evaluated against the control.
*) statistical significant inhibited compared to control, Williams test, p<0.05, one-sided smaller
Table 3: Analytical and statistical results of the fortification experiments for TPM.
Fortification level (F) |
Analytical results |
Statistical results |
||||||
No. (label) and level |
Analyte conc. |
Dilution factor |
LC-MS/MS quan. data |
Measured analyte conc. |
Recovery |
Mean recovery |
Standard deviation SD |
Relative standard deviation, RSD |
- |
[µg/L] |
- |
[µg/L] |
[µg/L] |
[%] |
[%] |
[%] |
[%] |
F0a - F0b, Blanks |
- |
1 |
n.d. *) |
< LOQ |
- |
- |
- |
- |
1 |
n.d. *) |
< LOQ |
- |
|||||
F1a - F1e, LOQ level |
50.0 |
1 |
46.189 |
46.2 |
92.4 |
86.5 |
3.63 |
4.14 |
1 |
42.353 |
42.4 |
84.7 |
|||||
1 |
43.683 |
43.7 |
87.4 |
|||||
1 |
41.506 |
41.5 |
83.0 |
|||||
1 |
42.550 |
42.6 |
85.1 |
|||||
F2a - F2e, 10 X LOQ level |
500 |
1 |
507.565 |
508 |
101.5 |
102.3 |
0.83 |
0.81 |
1 |
517.529 |
518 |
103.5 |
|||||
1 |
508.120 |
508 |
101.6 |
|||||
1 |
510.671 |
511 |
102.1 |
|||||
1 |
513.549 |
514 |
102.7 |
|||||
F3a - F3e, Residue level |
2000 |
1 |
1945.955 |
1946 |
97.3 |
98.7 |
1.32 |
1.34 |
1 |
1986.852 |
1987 |
99.3 |
|||||
1 |
2011.976 |
2012 |
100.6 |
|||||
1 |
1953.879 |
1954 |
97.7 |
|||||
1 |
1976.278 |
1976 |
98.8 |
|||||
Overall mean (n = 15): |
95.6 |
7.31 |
7.63 |
*) n.d. = not detected
Mass transition used for quantification of TPM: m/z 343.15 — m/z 151.15.
Table 4: Analytical and statistical results of the fortification experiments for MBC
Fortification level (F) |
Analytical results |
Statistical results |
||||||
No. (label) and level |
Analyte conc. |
Dilution factor |
LC-MS/MS quan. data |
Measured analyte conc. |
Recovery |
Mean recovery |
Standard deviation SD |
Relative standard deviation, RSD |
- |
[µg/L] |
- |
[µg/L] |
[µg/L] |
[%] |
[%] |
[%] |
[%] |
F0a - F0b, Blanks |
- |
1 |
n.d. *) |
< LOQ |
- |
- |
- |
- |
1 |
n.d. *) |
< LOQ |
- |
|||||
F1a - F1e, LOQ level |
1.0 |
1 |
0.999 |
0.999 |
99.9 |
94.9 |
3.99 |
4.20 |
1 |
0.974 |
0.974 |
97.4 |
|||||
1 |
0.954 |
0.954 |
95.4 |
|||||
1 |
0.907 |
0.907 |
90.7 |
|||||
1 |
0.911 |
0.911 |
91.1 |
|||||
F2a - F2e, 10 X LOQ level |
10.0 |
1 |
10.048 |
10.0 |
100.5 |
96.1 |
2.58 |
2.69 |
1 |
9.561 |
9.56 |
95.6 |
|||||
1 |
9.376 |
9.38 |
93.6 |
|||||
1 |
9.565 |
9.57 |
95.7 |
|||||
1 |
9.483 |
9.48 |
94.8 |
|||||
F3a - F3e, Residue level |
100 |
1 |
101.043 |
101 |
101.0 |
99.4 |
1.39 |
1.40 |
1 |
100.255 |
100 |
100.3 |
|||||
1 |
98.228 |
98.2 |
98.2 |
|||||
1 |
97.736 |
97.7 |
97.7 |
|||||
1 |
99.771 |
99.8 |
99.8 |
|||||
Overall mean (n = 15) |
96.8 |
3.30 |
3.41 |
*) n.d. = not detected
Mass transition used for quantification of MBC: m/z 192.2 — m/z 160.2.
Validity of the test
All validity criteria for controls mentioned by the OECD guideline were met:
- the dissolved oxygen concentration was between 60 and 100 % throughout the test;
- the water temperature did not differ by more than ± 1.5 °C between successive days at any time during the test and was kept within 25 °C ± 2 °C
- the survival rate (post hatch) in the controls was greater than 70 %.
Table 5: Results of the Fish early life stage toxicity test on TPM: Effect concentrations
Parameter |
NOEC [mg/L] |
EC10 [mg/L] |
CL [mg/L] |
Hatching success |
>1.870 |
- |
- |
Post hatch survival |
0.509 |
0.390 |
0.147 – 0.645 |
Length |
>1.870 |
- |
- |
Weight |
>1.870 |
- |
- |
All values are based on mean measured concentrations of thiophanate-methyl (TPM).
Description of key information
Fish Early Life Stage (FELS) toxicity test (OECD 210)
NOEC = 0.509 mg/L
EC10 = 0.390 mg/L (CL: 0.147 – 0.645 mg/L)
(35-d, EC10 > NOEC based on confidence limit CL: 0.147 – 0.645 mg/L)
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 0.39 mg/L
Additional information
For chronic toxicity to fish, two long-term studies are available: OECD 210 (FELS) and OECD 204 (long-term toxicity to fish). Since OECD 210 covers the life cycle of the fish, this study is the most preferred study by ECHA and will be used for risk assessment in this dossier.
Fish Early Life Stage (FELS) toxicity test
The toxicity of the test item to fish early life stages was determined according to OECD 210. For this purpose, freshly fertilised eggs of zebrafish (Danio rerio) (less than 4 hours of age, post fertilisation) were exposed to 0.125, 0.25, 0.5, 1 and 2 mg/L. the lowest no effect concentration, based on the mean measured concentrations, was determined to be 0.509 mg/L for the endpoint post hatch survival after 35 days. The EC10 for post hatch survival was calculated to be 0.390 mg/L (CL: 0.147 – 0.645 mg/L).
Long-term toxicity to fish
In a prolonged toxicity (28-days) of the test item to Rainbow trout (Salmo gairdneri) according to OECD 204 in a flow through test system. Fresh stock solutions of the test item dissolved in 1 % Tween 80-dimethylformamide were prepared daily for dispensing by the continuous flow apparatus. The test concentrations were 0.010, 0.032, 0.10, 0.32 and 1.0 mg/L. The LC50 was determined to be 0.60 mg/L and the NOEC was determined to be 0.32 mg/L.
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