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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 230-525-2 | CAS number: 7173-51-5
- 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
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil macroorganisms except arthropods: long-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-01-16 to 2008-07-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
- Version / remarks:
- DIN ISO 11268-2:1998 (E), BBA Guideline
- Deviations:
- yes
- Remarks:
- Fresh Lufa 2.2 was used instead of artificial soil
- Principles of method if other than guideline:
- LUFA 2.2 soil, classified as a loamy sand, was used rather than the soil recommended by the OECD guideline as it is considered a reasonable worst case and this laboratory has experience with this soil. Moreover, the OECD soil contains 20 % kaolinite, a clay type which may influence the test results if used in conjunction with a cationic surfactant. Fresh rather than dried soil was used as this is closer to the soil that would be found in the field and is therefore expected to be more environmentally realistic.
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Vehicle:
- yes
- Details on preparation and application of test substrate:
- - Method of mixing into soil (if used): The necessary amounts of the test item were dispersed in the amount water necessary to adjust a humidity of 50-70% of the maximum water holding capacity. Subsequently, the test medium was thoroughly mixed into the soil with a long handled blender for at least four minutes and filled into the test vessels.
- Control: Fresh LUFA 2.2 standard soil moistened with demineralised water without test or reference item
- Vehicle control: Fresh LUFA 2.2 standard soil mixed with quartz sand and moistened with demineralised water without test or reference item - Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: Eisenia fetida SAVIGNY 1826, subspecies: Eisenia fetida fetida
- Source: Own breeding (Source: Bundesanstalt fuer Verbraucherschutz und Landwirtschaft (BVL), Messeweg 11/12, D-38104 Braunschweig)
- Age at test initiation (mean and range, SD): 9-10-month, not variating more than 1 month
- Weight at test initiation (mean and range, SD): 0.53 +/- 0.04 g
ACCLIMATION
- Acclimation period: 2 days prior to test start
- Acclimation conditions (same as test or not):same as test
- Health during acclimation (any mortality observed): healthy - Study type:
- laboratory study
- Substrate type:
- natural soil
- Limit test:
- no
- Total exposure duration:
- 56 d
- Remarks:
- removement of adults after 28 days
- Test temperature:
- 20 +/- 2 °C
- pH:
- Table 1: pH-Values of the Test Media
Measurement of pH and of test medium was based on mixed samples of all replicates per treatment
and control.
Application rate pH-value
[mg/kg soil DW] day 0 day 56
Control 5.618 6.52
Vehicle Control 5.710 6.72
125 5.773 6.66
250 5.749 6.67
500 5.779 6.72
1000 5.914 6.75 - Moisture:
- Table 1: Moisture of the Test Media
Measurement of moisture content of test medium was based on mixed samples of all replicates per
treatment and control.
Application rate Moisture [%] of dry weight
[mg/kg soil DW] day 0 day 55
Control 24.7 35.6
62.5 24.3 34.3
125 25.3 32.6
250 25.0 31.5
500 23.6 33.8
1000 25.0 32.7 - Details on test conditions:
- TEST SYSTEM
- Test container (material, size): round plastic boxes, ID: 15.0 cm, bottom surface area: 177 cm3, height: 14 cm; transparent and perforated lids enabled sufficient gas exchange and light penetration and prevented the test substrate from drying
- Amount of soil or substrate: 600 g DW
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 8
- No. of replicates per vehicle control: 4
SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Geographic location: Germany / Rheinland Pfalz / Hanhofen, "Grosser Striet", No. 585, owner: Appel, Hanhofen
- Pesticide use history at the collection site: None (former 4 years)
- Collection procedures: Sampling date 2007-10-30, batch F2.24407
- Sampling depth (cm): approximately 20 cm
- Soil texture (if natural soil)
- % sand: 0.63 - 2.0 mm: 0.7 %, 0.2 - 0.63 mm: 44.4 %, 0.063 - 0.2 mm: 35.7 %
- % silt: 0.02 - 0.063 mm: 5.2 %, 0.006 - 0.02 mm: 3.9 %, 0.002 - 0.006 mm: 3.4 %
- % clay: 6.7
- Soil taxonomic classification: loamy sand
- Organic carbon (%): 2.29
- Maximum water holding capacity: 49.7 g/100 g DW
- CEC: 10 mval/100 g
- Pretreatment of soil: Drying (room temperature, until sievable), presieving 10 mm, last sieving 2 mm, moistening at approximately 19 % of water holding capacity
- Storage (condition, duration): 4 - 7 °C for 43 days prior to use
OTHER TEST CONDITIONS
- Photoperiod: 16 h light - 8 h dark
- Light intensity: 400 - 800 lx
EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
Adult mortality, biomass, behaviour and pathological symptoms after 28 days
Reproductive output after 55 days
VEHICLE CONTROL PERFORMED: yes
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Justification for using less concentrations than requested by guideline: Due to the results of the preliminary test no effects were expected.
- Range finding study (NON-GLP)
- Test concentrations: 100 - 500 - 1000 - 2000 mg/kg soil DW
- Results used to determine the conditions for the definitive study: No mortality or significant change of live weight was determined. - Nominal and measured concentrations:
- Nominal application rates: 62.5- 125 - 250 - 500 - 1000 mg/kg soil dry weight (dw)
- Reference substance (positive control):
- yes
- Remarks:
- 1.0 - 2.5 - 5.0 mg Carbendazim/kg soil DW
- Key result
- Duration:
- 56 d
- Dose descriptor:
- NOEC
- Effect conc.:
- ca. 125 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- other: reproduction, mortality, body weight
- Key result
- Duration:
- 28 d
- Dose descriptor:
- EC50
- Effect conc.:
- ca. 509 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- reproduction
- Details on results:
- - Mortality at end of exposure period: No significant mortality (> 10 %) was observed in any of the tested test item and control groups.
- Total mass of adults at beginning of test: 0.49 g (mean)
- Changes in body weigth of live adults (% of initial weight) at end of exposure period:
Control: 11.1 +/- 6.7, 62.5 mg/kg soil: 11.9 +/- 4.9, 125 mg/kg soil DW: 15.4 +/- 4.0, 250 mg/kg soil DW: 8.7 +/- 5.8, 500 mg/kg soil DW: 9.4 +/- 6.7, 1000 mg/kg soil DW: 17.9 +/- 8.5
- No. of offspring produced:
Control: 416 +/- 48.1, 62.6 mg/kg soil DW: 435 +/- 57.9, 125 mg/kg soil DW: 453 +/- 67.6, 250 mg/kg soil DW: 298 +/- 59.7, 500 mg/kg soil DW: 239 +/- 31.5, 1000 mg/kg soil DW: 58 +/- 35.3
- No. of unhatched cocoons: Not determined
- Morphological abnormalities: none
- Behavioural abnormalities: None
- Other biological observations: No significant mortality was observed - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- Relevant effect levels: EC50 (Reproduction) = 1.19 mg/kg - Reported statistics and error estimates:
- One Way Analysis of Variance (ANOVA and Dunnett's Method) was carried out for determination of statistically significant differences between control and vehicle control and further between pooled control and test item concentrations. Prior to Analysis of Variance, a Normality Test and an Equal Variance Test were conducted. P-values for both normality and equal variance test are 0.05. The a-value for ANOVA test (acceptable probability of incorrectly concluding that there is a difference) is a = 0.05.
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the study conditions, the EC50 for reproduction was 509 (95% CI: 412-629) mg/kg soil dw. The NOEC was 125 mg/kg soil dw.
- Executive summary:
The effects of the test substance (40% purity) on mortality, biomass and reproductive potential of the earthworm Eisenia fetida (Savigny) were determined according to the DIN ISO Method 11268-2 and OECD Guideline 222, in compliance with GLP. The study was conducted under static conditions over 8 weeks with concentrations of 62.5, 125, 250, 500 and 1000 mg a.i./kg soil dry weight (dw) applied to natural soil (LUFA 2.2). Forty test organisms, with an individual weight of 0.30 to 0.60 g, were divided into 4 replicate groups of 10 test organisms. After 28 days, no significant mortality and no pathological symptoms or changes in behaviour of the adult earthworms were observed at any of the tested application rates and in the control. The individual body live weights increased in the control as well as in test substance groups, with no significant differences between the groups. After further four weeks, the reproduction rate (average number of juveniles) was 416 in the control and ranged between 58 and 435 in the test substance groups. Compared to the control, reproduction was significantly reduced 250, 500 and 1000 mg a.i./kg soil dw. Under the study conditions, the EC50 for reproduction was 509 (95% CI: 412-629) mg/kg soil dw. The NOEC was 125 mg/kg soil dw (Winkelmann, 2008).
Reference
Adult mortality:
No significant mortality was observed in any of the tested doses of the test item and the control groups.
Behaviour and Pathological Symptoms:
No pathological and behavioural symptoms were found at the tested application rates and control groups.
Live weight:
At test start earthworms had a mean weight of 0.49 g. The body weights of earthworms in tested doses and control groups increased during test period. Effects on body live weights after 28 days were tested for statistical significance by One Way Analysis of Variance (ANOVA). There was no statistically significant difference when compared to the control.
Reproduction rate:
The average number of juveniles of treated groups ranged between 453 and 58 individuals. Mean number of juveniles found in control groups were between 316 and 460. The coefficient of variation calculated for the reproduction of control was lower than 30 %. Statistically significant difference to the control groups was observed for the 250, 500 and 1000 mg/kg dw application rate (ANOVA).
Description of key information
Based on the results of the study, the EC50 and NOEC for reproduction was 509 and 125 mg/kg soil dw respectively.
Key value for chemical safety assessment
- Short-term EC50 or LC50 for soil macroorganisms:
- 509 mg/kg soil dw
- Long-term EC10, LC10 or NOEC for soil macroorganisms:
- 125 mg/kg soil dw
Additional information
The effects of the test substance (40% purity) on mortality, biomass and reproductive potential of the earthworm Eisenia fetida (Savigny) were determined according to the DIN ISO Method 11268-2 and OECD Guideline 222, in compliance with GLP. The study was conducted under static conditions over 8 weeks with concentrations of 62.5, 125, 250, 500 and 1000 mg a.i./kg soil dry weight (dw) applied to natural soil (LUFA 2.2). Forty test organisms, with an individual weight of 0.30 to 0.60 g, were divided into 4 replicate groups of 10 test organisms. After 28 days, no significant mortality and no pathological symptoms or changes in behaviour of the adult earthworms were observed at any of the tested application rates and in the control. The individual body live weights increased in the control as well as in test substance groups, with no significant differences between the groups. After further four weeks, the reproduction rate (average number of juveniles) was 416 in the control and ranged between 58 and 435 in the test substance groups. Compared to the control, reproduction was significantly reduced 250, 500 and 1000 mg a.i./kg soil dw. Under the study conditions, the EC50 for reproduction was 509 (95% CI: 412-629) mg/kg soil dw. The NOEC was 125 mg/kg soil dw (Winkelmann, 2008).
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.