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EC number: 616-995-5 | CAS number: 8018-01-7
- 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
Toxicity to terrestrial arthropods
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to non-target arthropods on inert substrate (NTA other than pollinators)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-11-30 to 2005-01-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 226 (Predatory Mite (Hypoaspis (Geolaelaps) Aculeifer) Reproduction Test in Soil)
- Deviations:
- yes
- Remarks:
- Please refer to section "Principles of method if other than guideline".
- Qualifier:
- according to guideline
- Guideline:
- other: Meeting on coordination of activities in soil mite testing, Bayer Monheim, Germany (Bakker et al., December 2003)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on regulatory testing and risk assessment procedures for plant protection products with non-target arthropods (Candolfi et al., 2001)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other:
- Version / remarks:
- A laboratory test protocol to evaluate effects of plant protection products on mortality and reproduction of the predatory mite Hypoaspis aculeifer Canestrini (Acari: Laelapidae) in standard soil (Bakker et al., 2003)
- Deviations:
- not specified
- Principles of method if other than guideline:
- This study is quite similar to OECD 226 guideline, but differs from the guideline in some ways. Two day old protonymphs were used instead of 28-35 day old adult females, the study duration was 21 days rather than 14 days, the protonymphs were exposed to the contaminated soil for 1.5 hours and then transferred onto a glass plate test system, rather than staying on the soil for the whole duration of the study. These differences should be considered in the context of the risk assessment.
- GLP compliance:
- yes
- Application method:
- mixed into substrate
- Analytical monitoring:
- no
- Vehicle:
- yes
- Remarks:
- Water
- Details on preparation and application of test substrate:
- The test product was stored at room temperature in the dark and all use was registered.
All solutions were prepared with calibrated precision laboratory equipment less than 45 minutes before application. Deionised water was used as solvent for all solutions. The test solutions were prepared as follows:
Dithane M-45:
A stock was obtained by dissolving 0.5005 g product in deionised water up to a total volume of 1000 ml. The final Solutions were obtained as follows:
1.1 mg a.i./kg soil: 1.05 ml stock in deionised water up to a total volume of 100 mL.
2.1 mg a.i./kg soil: 2.05 ml stock in deionised water up to a total volume of 100 mL.
4.3 mg a.i./kg soil: 4.15 ml stock in deionised water up to a total volume of 100 mL.
Toxic reference:
A stock was obtained by dissolving 1.0 mL product in deionised water up to a total volume of 100 mL. The final Solution was obtained by dissolving 1.2 mL stock in deionised water up to a total volume of 100 mL. - Test organisms (species):
- Hypoaspis aculeifer
- Animal group:
- Acari (soil-dwelling predatory mite)
- Details on test organisms:
- - Species: Hypoaspis aculeifer (Acari: Laelapidae)
- Age at test initiation: < 2 day old protonymphs
- Source: from stock culture at test facility
- Feeding: Tyrophagus putrescentiae as prey - Study type:
- laboratory study
- Limit test:
- no
- Total exposure duration:
- 21 d
- Test temperature:
- mortality phase: Mean 22.5°C;
reproduction phase: Mean 22.8°C - pH (if soil or dung study):
- not specified
- Humidity:
- 65 ± 15%
- Photoperiod and lighting:
- held in dark
- Details on test conditions:
- TEST SYSTEM
- Test container:
Mortality phase: Munger cells (EPPO Guideline 142, 1989)
Mating and reproduction phase: Plastic urtits with humidrfied carbon-darkened untreated plaster
- Cohort: Climate box operated at 20 + 2°C, 65 ± 1 5% RH and in the dark (as dark as practically feasible)
- No. of organisms per container (treatment): 20 protonymphs per Munger unit
- No. of replicates per treatment group: 5
- No. of replicates per control: 5
- No. of replicates reference control: 3
SOURCE AND PROPERTIES OF SUBSTRATE: standard soil (OECD, 10% sphagnum), not further specified
OTHER TEST CONDITIONS
- Photoperiod: no photoperiod, 24 h darkness
EFFECT PARAMETERS MEASURED:
- Mortality/escape rate observed after a 21-day exposure period
- Reproduction (fertile eggs/female/7 days) over a 7-day period for surviving females in the deionised water control and the 3 test item rates causing a corrected mortality >50%
VEHICLE CONTROL PERFORMED: yes (with deionised water) - Nominal and measured concentrations:
- Nominal: 1.1, 2.1 and 4.3 mg a.s./kg dry soil (1.3, 2.6, and 5.2 mg product/kg dry soil); no measured concentrations
- Reference substance (positive control):
- yes
- Remarks:
- Perfektion (dimethoate 400 g/L EC); rate: 12 mg a.s./kg dry soil
- Toxic reference:
- reference control performed with dimethoate
- Key result
- Duration:
- 21 d
- Dose descriptor:
- ER50
- Effect conc.:
- > 4.3 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- LR50
- Effect conc.:
- > 4.3 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 2.1 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Details on results:
- The mean measured temperature throughout the mortality phase was 22.5ºC (Standard Deviation: 1.8) and 22.8ºC (SD: 1.8) in the reproduction phase. Mean measured relative humidity during the mortality phase was 67.9% (SD: 7.0) and 69.1% (SD: 6.3) in the reproduction phase.
Mortality was classed as the difference between the number of living mites found at the end of the study and the initial number of mites introduced (i.e. mortality included dead and escaped mites). After the 21 day exposure period, the mortality in the control was 14%. The corrected mortality in the test treatments was 3, 7, and 15% in the 1.1, 2.1 and 4.3 mg a.s./kg dry soil treatments respectively. Only the mortality in the 4.3 mg a.s./kg dry soil treatment was statistically significantly higher (27% uncorrected) than the control. There was an observable dose-response relationship between dosing rate of Dithane M-45 and mortality. The LC50 was determined to be > 4.3 mg a.s./kg dry soil. The toxic reference mortality was 67% (corrected).
Only reproduction data of females retrieved alive after 7 days were included in the analysis. The number of fertile eggs produced per female after 7 days was 17.9, 13.9, 13.8, and 13.5 in the control, and in the 1.1, 2.1, and 4.3 mg a.s./kg dry soil treatments, respectively. None of the test treatment concentrations produced statistically significant drops in reproductive output. The ER50 was determined to be > 4.3 mg a.s./kg dry soil. - Results with reference substance (positive control):
- The toxic reference , dimethoate, caused 67% corrected mortality. This showed that the test animals were sufficiently sensitive and potential adverse effects of exposure to test item residues could be detected with the set-up used in this experiment.
- Reported statistics and error estimates:
- Mortality in the treatment groups was compared pair-wise to the water control using Fisher’s Exact Test. Egg production was compared to the water control using the Mann-Whitney U test.
- Validity criteria fulfilled:
- yes
- Remarks:
- This study adhered to the validity criteria presented in the OECD guideline. The adult mean mortality in the control treatment did not exceed 20%. The mortality in the toxic reference substance was >50%. Females in the control produced > 5 offspring each.
- Conclusions:
- The LR50 of Hypoaspis aculeifer determined in this study was > 4.3 mg a.s./kg dry soil (equivalent to LR50 > 3200 g a.s./ha). Based on reproduction, the ER50 was > 4.3 mg a.s./kg soil dw (equivalent to ER50 > 3200 g a.s./ha). The endpoint for consideration in the risk assessment is NOEC mortality = 2.1 mg/kg soil dw.
- Executive summary:
The toxicity of the Dithane M-45 (active ingredient Mancozeb, purity: 82.3%) to Hypoaspis aculeifer was assessed in a GLP-compliant study similar to OECD TG 226. The test design differed from the guideline by the following: Two day old protonymphs were used instead of 28-35 day old adult females, the study duration was 21 days rather than 14 days, the protonymphs were exposed to the contaminated soil for 1.5 hours and then transferred onto a glass plate test system, rather than staying on the soil for the whole duration of the study. Solutions of the test item were mixed homogeneously through standard soil (OECD) to give 3 nominal rates, viz. 1.1, 2.1 and 4.3 mg a.i./kg dry soil. The control was treated with deionised water. Dimethoate at a rate of 12 mg a.i./kg dry soil was used as toxic reference. The bioassay was initiated within 1.5 hours after application by confining 20 protonymphs of Hypoaspis aculeifer per Munger unit (inert glass material). Five units were prepared for the water control, 5 units for each test rate of the test item and 3 units for the toxic reference. During the mortality phase, food and water were provided on days 3, 6, 8, 10, 13, 15, and 17. Status of the mites was assessed on day 21 (number of live adults, corpses, and occurrence of offspring). During the reproduction phase, the numbers of juveniles and eggs were counted 5-6 days after the removal of the females after the 7 day laying period. Climatic conditions were measured with a data logger at 15 minute intervals. Control mortality (14%) and reproductive performance (17.9 fertile eggs/female/7 days) in the control treatment met the validation criteria of the study and indicated that test animals were in good condition. The toxic reference, dimethoate, caused 67% corrected mortality. This showed that test animals were sufficiently sensitive and that potential adverse effects of exposure to test item residues could be detected with the set-up used in this experiment. The LR50 of Hypoaspis aculeifer determined in this study was > 4.3 mg a.s./kg dry soil (equivalent to LR50 > 3200 g a.s./ha). Based on reproduction, the ER50 was > 4.3 mg a.s./kg soil dw (equivalent to ER50 > 3200 g a.s./ha). The endpoint for consideration in the risk assessment is NOEC mortality = 2.1 mg/kg soil dw.
Reference
Description of key information
Short-term toxicity to terrestrial arthropods
In accordance with REACH Annex XI a short-term study does not need to be conducted because an appropriate long-term toxicity study on terrestrial arthropods is available. Additional data on short-term toxicity is scientifically not necessary.
Short-term toxicity to terrestrial arthropods
The long-term toxicity to terrestrial arthropods was assessed in a study with Hypoaspis aculeifer similar to OECD TG 225. The 21-day LR50 was determined to be > 4.3 mg a.s./kg dry soil (equivalent to LR50 > 3200 g a.s./ha). Based on reproduction, the ER50 was > 4.3 mg a.s./kg soil dw (equivalent to ER50 > 3200 g a.s./ha). The endpoint for consideration in the risk assessment is NOEC mortality = 2.1 mg/kg soil dw.
Key value for chemical safety assessment
- Long-term EC10, LC10 or NOEC for soil dwelling arthropods:
- 2.1 mg/kg soil dw
Additional information
Key information
Dithane M-45: An extended laboratory limit test to evaluate the effects on survival and reproduction of the predaceous mite Hypoaspis aculeifer Canestrini (Acari: Laelapidae) in artificial soil (OECD) (Loose 2005 ( Doc. No. 835-001, cross reference to Risk Assessment Report according to Regulation (EU) No 1107/2009: 0.3.2.2/09))
The toxicity of the Dithane M-45 (active ingredient Mancozeb, purity: 82.3%) to Hypoaspis aculeifer was assessed in a GLP-compliant study similar to OECD TG 226 (Loose, 2005). The test design differed from the guideline by the following: two day old protonymphs were used instead of 28-35 day old adult females, the study duration was 21 days rather than 14 days, the protonymphs were exposed to the contaminated soil for 1.5 hours and then transferred onto a glass plate test system, rather than staying on the soil for the whole duration of the study. Solutions of the test item were mixed homogeneously through standard soil (OECD) to give 3 nominal rates, viz. 1.1, 2.1 and 4.3 mg a.s./kg dry soil. The control was treated with deionised water. Dimethoate at a rate of 12 mg a.s./kg dry soil was used as toxic reference. The bioassay was initiated within 1.5 hours after application by confining 20 protonymphs of Hypoaspis aculeifer per Munger unit (inert glass material). Five units were prepared for the water control, 5 units for each test rate of the test item and 3 units for the toxic reference. During the mortality phase, food and water were provided on days 3, 6, 8, 10, 13, 15, and 17. Status of the mites was assessed on day 21 (number of live adults, corpses, and occurrence of offspring). During the reproduction phase, the numbers of juveniles and eggs were counted 5-6 days after the removal of the females after the 7 day laying period. Climatic conditions were measured with a data logger at 15 minute intervals. Control mortality (14 %) and reproductive performance (17.9 fertile eggs/female/7 days) in the control treatment met the validation criteria of the study and indicated that test animals were in good condition. The toxic reference, dimethoate, caused 67% corrected mortality. This showed that test animals were sufficiently sensitive and that potential adverse effects of exposure to test item residues could be detected with the set-up used in this experiment. The LR50 of Hypoaspis aculeifer determined in this study was > 4.3 mg a.s./kg dry soil (equivalent to LR50 > 3200 g a.s./ha). Based on reproduction, the ER50 was > 4.3 mg a.s./kg soil dw (equivalent to ER50 > 3200 g a.s./ha). The endpoint for consideration in the risk assessment is NOEC mortality = 2.1 a.s. mg/kg soil dw.
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