Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 605-399-0 | CAS number: 165252-70-0
- 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
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28/02/2000 - 31/08/2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1300 (Daphnid Chronic Toxicity Test)
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- Duplicate samples were taken from the freshly prepared test media of all concentrations and the control at days 0, 12 and 16. Additional samples from the old test solution were taken on days 14 and 19. All samples were stored frozen at approximately -20°C until analysis.
- Vehicle:
- no
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Strain / Clone: Daphnia magna Straus, Clone 5
Source: University of Sheffield, UK
Age: < 24 hours
Breeding method: The daphnia were cultured und the same environmental conditions as used in the test
Kind of food: 1:1mixture of green algae (Scenedesmus subspicatus) and fish food suspension (Tetra Min Hauptfutter)
Amount of food: 0.10 – 0.25 mg TOC/daphnia/day
Feeding frequency: each working day
Pretreatment: not reported.
Feeding of animals during test: Yes - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Post exposure observation period:
- none
- Hardness:
- 250 mg/L (as CaCO3)
- Test temperature:
- 20°C
- pH:
- 7.9 - 8.6
- Dissolved oxygen:
- 7.6 - 8.0 mg/L
- Salinity:
- not applicable
- Nominal and measured concentrations:
- See table below
- Reference substance (positive control):
- no
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks:
- mortality and growth
- Details on results:
- The effect of MTI-446 on the survival, reproduction and growth was determined in a 21 day semistatic dose response test. The nominal test concentrations were 6.25, 12.5, 25, 50 and 100 mg/L (See Table :Concentration" below). The measured concentration in the 100 mg/L treatment group ranged from 94 – 96% of nominal. Therefore, all biological results are reported based on nominal concentrations.
The NOEC for survival, reproduction and growth was 100 mg/L, see "effect data" table below.
The body length of each surviving adult at the end of exposure was determined by the use of a binocular. The mean body length of the daphnids in the control was 3.77 ± 0.08 mm. The mean body length in the 6.25, 12.5, 25, 50 and 100 mg/L test item groups were 3.77 ± 0.04, 3.75 ± 0.08, 3.77 ± 0.07, 3.75 ± 0.08 and 3.78 ± 0.05 mm , respectively.
There was not statistically significant effect on the mean body weight length of adult daphnia using a Williams-test (one-sided smaller, α = 0.05) - Results with reference substance (positive control):
- Not applicable
- Reported statistics and error estimates:
- Significant differences in the reproduction rate and the body length of the adult daphnids were evaluated by testing the mean reproduction rate and the mean body length for statistically significant differences to the corresponding control values by the multiple Williams-test after a one-way analysis of variance (ANOVA).
- Validity criteria fulfilled:
- yes
- Conclusions:
- MTI-446 had no toxic effects on survival, reproduction and growth of adult Daphnia magna in a 21 day test.
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 October 2002 - 10 December 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The aquatic species shown to be most sensitive to dinotefuran was the chironomid
(Chironomus riparius) following both acute and chronic exposure. The acute 48 h LC50 was
72.1 μg/l and the 27 d NOEC was 2.54 μg/l. These results are consistent with the opinion
that daphnids (the most usual aquatic invertebrate tested) are not as susceptible to
neonicotinoid insecticides as other invertebrates. Information on endpoints for other
neonicotinoids (e.g. imidacloprid, clothianidin) is available in the EFSA conclusions/Review - Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 219 (draft)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- • 2 samples each of every application solution immediately after application
• Sediment, pore water and overlaying water samples from the 8 and 32 µg/L treatment were taken on day 0, 7 and 27
• Sediment, pore water and overlaying water samples from the control (0 µg/L) were taken on days 0 and 27
• All samples were stored frozen at ~-20°C immediately after sampling until analysis - Vehicle:
- no
- Test organisms (species):
- other aquatic arthropod: Chironomus riparius
- Details on test organisms:
- Species/strain: Chironomus riparius
Age: 2 – 3 days (first instar larvae)
Breeding method: Similar temperature and light conditions and in the same kind of water as used in the test
Kind of food: TetraMin Hauptfutter (TETRA-Werke, D 49304 Melle, Germany)
Amount of food: Day -1 – 5: 23 mg / vessel
Day 7 – 24: 47 mg/vessel
Feeding frequency: 3 times a week
Pretreatment: Finely ground and suspended in test water
Feeding of animals during test: Yes - Test type:
- static
- Water media type:
- other: reconstituted water (M7-medium)
- Limit test:
- no
- Total exposure duration:
- 27 d
- Test temperature:
- 19.4 - 19.8
- pH:
- 7.6 - 8.7
- Dissolved oxygen:
- at least 6.2 mg/L
- Key result
- Duration:
- 27 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 2.88 µg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- other: emergence ratio, development
- Remarks on result:
- other: Based on lowest initial measured conc. in water samples (72%) at lowest conc. measured (8 µg/l). Consequently NOEC is 0.72 x 4 µg/l = 2.88 µg/L
- Details on results:
- Toxic effects of the test item MTI-446 on the development of sediment-dwelling larvae of the midge Chironomus riparius in water-sediment systems were investigated following the Proposal for a BBA-Guideline: "Effects of plant protection products on the development of sediment-dwelling larvae of Chironomus riparius in a water-sediment system" (1995), and the OECD Guidelines for Testing of Chemicals, Proposal for a new Guideline 219, Draft Document: "Chironomid Toxicity Test Using Spiked Water" (2001).
First-instar larvae of Chironomus riparius were exposed for a period of 27 days until full maturation of the larvae to adult midges. The test parameters of the study were the development time/rate of the midges and the emergence ratio as the number of fully emerged male and female midges.
The test item was applied to the water column in static water-sediment systems. The nominal initial test item concentrations in the overlaying water columns were 2, 4, 8, 16 and 32 µg/L MTI-446. A control (water-sediment systems without test item application) was tested in parallel.
The mean analytically measured concentrations of MTI-446 in the water columns one hour after the test item application corresponded to 72 and 76% of the nominal concentrations in the analysed test concentrations of 8 and 32 µg/L. Seven days later the concentrations in the water columns had fallen to 58 and 68%, after 27 days to 56 - 61% of the nominal initial concentrations. In the pore water and sediment, the concentrations of MTI-446 continuously increased during the study period. At the test concentration of nominal 8 µg/L, the concentration in pore water was in maximum 3.5 µg/L, and in the sediment 1.13 µg/kg at study termination on Day 27. At nominal 32 µg/L, maximum 17.1 µg/L were found in the pore water and 5.7 µg/kg in the sediment.
The correct preparation of the application solutions was analytically confirmed. The lower measured values in the water samples one hour after application (72 and 76% of the nominal initial values, i.e. average 74% of nominal) were presumably caused by diffusion and adsorption of MTI-446 into the pore water and sediment. All biological results are therefore reported in terms of the nominal initial concentrations of the test item as well as in terms of the analytically measured concentrations one hour after test item application.
First at the test concentrations of nominal initial 8 and 16 µg/L the mean emergence ratios of the midges (pooled sexes) were statistically significantly reduced compared to the control. At the highest test concentration of nominal initial 32 µg/L no midges emerged.
At the test concentration of nominal initial 16 µg/L the males developed slightly, but statistically significantly, more slowly than in the control. The mean development rate of the females was not statistically significantly reduced at this test concentration. At the highest test concentration of nominal initial 32 µg/I the development rates could not be calculated because no midges emerged.
Thus, the 27-day NOEC of MTI-446 (highest tested concentration without toxic effects) for Chironomus riparius in this water-sediment study was 4 µg/L. Based on the analytically measured initial concentrations in the water columns one hour after application the NOEC corresponds to 3 µg/L. The 27-day LOEC (lowest concentration tested with toxic effects) was 8 µg/L due to the reduced emergence ratio of the larvae. Based on the analytically measured initial concentrations in the water columns the LOEC corresponds to 5.9 pa /L.
Based on nominal concentrations, the 27-day EC10 for the emergence ratio of pooled sexes was calculated to be 4.6 µg/L (95% confidence limits 3.7 — 5.8 µg/L), the calculated 27-day EC50 was 14.5 µg/L (95% confidence limits 11.8 — 17.8 µg/L). The 27-day EC10 or EC50 for the development rate could not be calculated due to low inhibition rates - Reported statistics and error estimates:
- For emergence rate and development rate the arithmetic mean values (mean), standard deviation (SD), minimum and maximum (min/max) were calculated from the four replicates per treatment. The values of the emergence rates and the development rates were normally distributed and were statistically evaluated on significant differences to the control by the multivariate Williams-test after a one-way analysis of variance (ANOVA). Statistical evaluations were done separately for emerged males and females (development rate) and with pooled sexes (emergence rate).
The 27-day EC10 and EC50 and the 95% confidence limits of the emergence rate (pooled sexes) were calculated by Probit analyses. The 27-day ECx values and the 95% confidence limits of the development rate of the midges could not be calculated due to the low inhibitory effect up to the highest test concentration that could be evaluated. - Validity criteria fulfilled:
- yes
- Executive summary:
A clear dose response of the test item for development and emergence rate could be determined.
The 27 day NOEC and the LOEC for development and emergence for Chironomus riparius were 4 and 8 µg/L, respectively.
Based on nominal concentrations, the 27 day EC10 for the emergence rate was calculated to be 4.6 µg/L, the EC50 was calculated to be 14.5 µg/L .
Referenceopen allclose all
Concentration:
Conc 1 |
Conc 2 |
Conc 3 |
Conc 4 |
Conc 5 |
Conc 6 |
Control |
6.25 mg/L |
12.5 mg/L |
25 mg/L |
50 mg/L |
100 mg/L |
Effect data:
Total number of alive, young daphnids per test concentration (cumulative numbers)
Exposure day |
Nominal concentration [mg/L] |
|||||
Control |
6.25 |
12.5 |
25 |
50 |
100 |
|
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
0 |
0 |
0 |
0 |
0 |
0 |
9 |
87 |
92 |
85 |
83 |
84 |
66 |
12 |
306 |
252 |
290 |
264 |
265 |
239 |
14 |
335 |
252 |
314 |
264 |
265 |
244 |
16 |
583 |
467 |
526 |
477 |
516 |
473 |
19 |
722 |
598 |
679 |
602 |
600 |
634 |
21 |
722 |
598 |
679 |
602 |
621 |
653 |
% of control* |
100 |
82.8 |
94.0 |
83.4 |
86.0 |
90.4 |
* based on results of d 21
Number of alive offspring reproduced per surviving adult within 21 days of exposure
Replicate number |
Nominal concentration [mg/L] |
|||||
Control |
6.25 |
12.5 |
25 |
50 |
100 |
|
1 |
80 |
85 |
74 |
81 |
54 |
73 |
2 |
58 |
68 |
59 |
77 |
59 |
74 |
3 |
76 |
66 |
71 |
30 |
64 |
63 |
4 |
80 |
59 |
71 |
71 |
62 |
60 |
5 |
85 |
66 |
67 |
35 |
75 |
59 |
6 |
63 |
72 |
79 |
71 |
66 |
75 |
7 |
81 |
* |
69 |
73 |
73 |
79 |
8 |
63 |
77 |
69 |
79 |
56 |
72 |
9 |
74 |
45 |
51 |
55 |
44 |
55 |
10 |
62 |
58 |
69 |
30 |
68 |
43 |
mean |
72.2 |
66.2 |
67.9 |
60.2 |
62.1 |
65.3 |
±SD |
9.8 |
11.6 |
7.8 |
21.0 |
9.3 |
11.2 |
n |
10 |
9 |
10 |
10 |
10 |
10 |
CV % |
13.5 |
17.5 |
11.5 |
34.8 |
15.0 |
17.2 |
Mean in % |
100 |
91.7 |
94.0 |
83.4 |
86.0 |
90.4 |
STAT |
- |
n.s. |
n.s. |
n.s. |
n.s. |
n.s. |
CV %: coefficient of variation in %: (SDx/meanx) x 100%
STAT: result of a Williams-test with the mean values of alive offspring (one-sided smaller, α = 0.05)
n.s.:mean value not significantly lower than in the control
*: test animal died throughout the exposure phase
NOECsurvival, reproduction: 100 mg/L
LOECsurvival, reproduction: ≥ 100 mg/L
Nominal and measured concentrations:
Application solutions |
||
Nominal concentration dinotefuran [mg/L] |
Measured concentration dinotefuran [mg/L] |
Measured concentration [%] of nominal |
0.32 |
0.296 |
93 |
0.64 |
0.596 |
93 |
1.28 |
1.19 |
93 |
2.56 |
2.34 |
92 |
5.12 |
4.86 |
95 |
Water samples |
|||
Nominal concentration [µg/L] |
Sampling day [d] |
measured concentration1[µg/L] |
[% nominal] |
0 (control) |
0 |
n.d. |
n.a. |
27 |
n.d. |
n.a. |
|
8 |
0 |
5.73 |
72 |
7 |
4.66 |
58 |
|
27 |
4.50 |
56 |
|
32 |
0 |
24.3 |
76 |
7 |
21.7 |
68 |
|
27 |
19.4 |
61 |
|
Pore water samples |
|||
0 (control) |
0 |
0.286* |
n.a. |
27 |
n.d. |
n.a. |
|
8 |
0 |
0.247 |
n.a. |
7 |
2.53 |
n.a. |
|
27 |
3.50 |
n.a. |
|
32 |
0 |
1.35 |
n.a. |
7 |
10.1 |
n.a. |
|
27 |
17.1 |
n.a. |
|
Sediment samples |
|||
0 (control) |
0 |
n.d. |
n.a. |
27 |
n.d. |
n.a. |
|
8 |
0 |
0.275 |
n.a. |
7 |
0.654 |
n.a. |
|
27 |
1.13 |
n.a. |
|
32 |
0 |
0.263 |
n.a. |
7 |
2.64 |
n.a. |
|
27 |
5.67 |
n.a. |
|
1: corrected for recovery rate of spiked samples *: excluded as outlier because of absence of test item in the corresponding water and sediment samples n.d.: no test item detected n.a.: not applicable |
Table 1:Emergence rate ofChironomus riparius(males and females pooled) after 27 days of exposure
Nominal test item concentration [µg/L] |
||||||
|
Control |
2 |
4 |
8 |
16 |
32 |
sum inserted larvae / treatment |
80 |
80 |
80 |
80 |
80 |
80 |
sum emerged midges / treatment |
76 |
77 |
74 |
69 |
30 |
0 |
% emerged midges / treatment |
95 |
96 |
93 |
86 |
38 |
0 |
emergence rate ERarc |
1.4099 |
1.4016 |
1.2971 |
1.1920 |
0.6545 |
0 |
% of control |
100 |
99.4 |
92.0 |
84.5 |
46.4 |
0 |
STAT |
- |
n.s. |
n.s. |
s |
s |
s |
ERarc: arcsin-transformed emergence rate STAT: results of a Williams t-test (α = 0.05, one-sided smaller) n.s.:mean ERarcnot significantly lower than in the control s:mean ERarcsignificantly lower than in the control |
Table 2: Development rate for males and females
Females |
||||||
Development rate / treatment [day-1) |
Nominal initial test item concentration [µg/L] |
|||||
|
control |
2 |
4 |
8 |
16 |
32 |
Mean |
0.06465 |
0.06283 |
0.06377 |
0.06495 |
0.06325 |
n.a. |
SD |
0.00336 |
0.00189 |
0.00178 |
0.00060 |
0.00209 |
n.a. |
min |
0.06120 |
0.06070 |
0.06190 |
0.06440 |
0.06100 |
n.a. |
max |
0.06810 |
0.06470 |
0.06600 |
0.06580 |
0.06600 |
n.a. |
n |
4 |
4 |
4 |
4 |
4 |
4 |
% of control |
100 |
97.2 |
98.6 |
100.5 |
97.8 |
n.a. |
STAT |
- |
n.s. |
n.s. |
n.s. |
n.s. |
n.a. |
STAT: results of a Williams t-test (α = 0.05, one-sided smaller) n.s.mean ERarcnot significantly lower than in the control: s:mean ERarcsignificantly lower than in the control n.a.: not applicable (no midge emerged) |
||||||
|
||||||
Males |
||||||
Development rate / treatment [day-1) |
Nominal initial test item concentration [µg/L] |
|||||
|
control |
2 |
4 |
8 |
16 |
32 |
Mean |
0.07412 |
0.07360 |
0.07295 |
0.07240 |
0.07085 |
n.a. |
SD |
0.00126 |
0.00226 |
0.00234 |
0.00062 |
0.00413 |
n.a. |
min |
0.07230 |
0.07080 |
0.07120 |
0.07150 |
0.06480 |
n.a. |
max |
0.07510 |
0.07580 |
0.07640 |
0.07290 |
0.07410 |
n.a. |
n |
4 |
4 |
4 |
4 |
4 |
4 |
% of control |
100 |
99.3 |
98.4 |
97.7 |
95.6 |
n.a. |
STAT |
- |
n.s. |
n.s. |
n.s. |
s |
n.a. |
STAT: results of a Williams t-test (α = 0.05, one-sided smaller) n.s.:mean ERarcnot significantly lower than in the control s:mean ERarcsignificantly lower than in the control n.a.: not applicable (no midge emerged) |
Description of key information
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 2.88 µg/L
Additional information
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.