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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 233-226-5 | CAS number: 10094-45-8
- 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
Toxicity to soil microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil microorganisms
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 Dec 2016 - 11 Jan 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 216 (Soil Microorganisms: Nitrogen Transformation Test)
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on preparation and application of test substrate:
- APPLICATION OF TEST SUBSTANCE TO SOIL
- Method: the test item was ground with fine quartz sand and mixed with the sand into the test soil; this spiked sand (or non-treated sand for the control) was mixed into portions of 0.6 kg soil dry weight equivalent and deionised water was added to the soil to adjusted soil moisture to 45% WHCmax; soils were distributed equally to four test vessels which constituted the replicates of the respective treatment.
- Test organisms (inoculum):
- soil
- Total exposure duration:
- 28 d
- Test temperature:
- 19.3 to 20.8 °C
- Moisture:
- 45% WHCmax (adjusted)
- Details on test conditions:
- TEST SYSTEM
- Testing facility: ECT Oekotoxikologie GmbH
- Test container (type, material, size): Glass jars with lids (Model Sturz, volume 0.58 L, Weck GmbH, Germany)
- Amount of soil: 0.6 kg soil dry weight equivalent
- No. of replicates per concentration: 4
- No. of replicates per control: 4
SOIL INCUBATION
- Method: bulk / series of individual subsamples
All test vessels were incubated for 28 days at 19.3 to 20.8 °C in the dark. Test vessels were weighed once per week and weight loss was compensated with deionised water to keep the soil moisture within a range of ± 5 % of the water content at test start.
SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Geographical reference of sampling site (latitude, longitude): Germany, Rhineland-Palatinate, Offenbach, field name „Rechts der Landauer Str.“ field number 826/7
- Supplier: Landwirtschaftliche Untersuchungs- und Forschungsanstalt Speyer,Obere Langgasse 40, D-67346 Speyer, Germany
- History of site: was uncultivated during the last five years
- Treatments with pesticides or fertilizers: has not received pesticides within the last 5 years; in 2014 the sampling location was fertilised three times (Jun, Sep and Dec) with 3500 kg/ha CaO, each, and once (Dec) with 1463 kg/ha MgO
- Depth of sampling: ca. 20 cm
Soil texture:
- % sand: 59.6% ± 1.4%
- % silt: 33.6% ± 0.5%
- % clay: 6.8% ± 1.6%
- Soil taxonomic classification: sandy loam
- Soil classification system: USDA
- pH (in water): 5.9 ± 0.6 (0.01 M CaCl2)
- Initial nitrate concentration for nitrogen transformation test (mg nitrate/kg dry weight): 40.5 ± 1.0 mg kg-1 soil dry weight (mean nitrate concentration of the bulk soil two days prior to lucerne meal amendment), after adding lucerne meal, mean initial nitrate concentration was 53.3 mg kg-1 soil dry weight (control) and 51.7 to 56.3 mg/kg soil dry weight (test item treatments T1 to T5).
- Maximum water holding capacity [g/100 g]: 35.6 ± 1.4
- Cation exchange capacity (mmol/kg): 7.6 ± 0.8 meq/100 g
- Pretreatment of soil: Air drying on 24 Oct 2016; final sieving to 2 mm on 27 Oct 2016
- Storage (condition, duration): soil arrived at the test facility on 08 Nov 2016 and was stored at 16.8 to 21.3 °C in the dark until 13 Dec 2016 (date of test start)
- Initial microbial biomass as % of total organic C: 2.2%
- Microbial Biomass Carbon (Cmic): 146 μg Cmic g-1 soil
DETAILS OF PREINCUBATION OF SOIL: no preincubation
EFFECT PARAMETERS MEASURED: Nitrate of the soil was measured after test item application on day 0, and 28 days after test item application
RANGE-FINDING STUDY: no range-finding test was performed - Nominal and measured concentrations:
- Control, 260, 364, 510, 714 and 1000 mg/kg soil dry weight
- Reference substance (positive control):
- no
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- nitrate formation rate
- Duration:
- 28 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- nitrate formation rate
- Duration:
- 28 d
- Dose descriptor:
- EC25
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- nitrate formation rate
- Duration:
- 28 d
- Dose descriptor:
- EC10
- Effect conc.:
- > 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- nitrate formation rate
- Details on results:
- Due to the lacking of adverse effects of the test item at tested concentrations of up to and including 1000 mg/kg soil dry weight, effective concentrations could not be calculated. Consequently, the EC50, EC25, and EC10 can be considered to be higher than 1000 mg/kg soil dry weight.
- Reported statistics and error estimates:
- Probit Analysis was used to determine the effective concentrations EC10, EC25 and EC50. All statistical tests were performed with the ToxRat® pro statistical software Version 2.10.
- Validity criteria fulfilled:
- yes
Reference
Validity criteria:
The study was valid. Coefficient of variance (CV) between replicate control samples was 1.8 (day 0) and 2.5 (day 28). Hence, variability was always below the critical value of 15 % as required by the OECD test guideline No. 216
Biological Results:
Mean nitrate concentration of the bulk soil as determined two days prior to lucerne meal amendment (day 0) was 40.5 ± 1.0 mg kg-1 soil dw. Adding lucerne meal to the bulk soil on day 0 increased the mean initial nitrate concentration in the test soil to 53.3 mg kg-1 soil dw (control) and 51.7 to 56.3 mg/kg soil dry weight (test item treatments T1 to T5). At the end of the test (day 28) mean nitrate concentration of the control soil had increased to 118.1 mg/kg soil dw (day 28). Nitrate concentration in the test item treated soils ranged from 120.0 mg/kg soil dw to 128.4 mg/kg soil dw. No adverse effects of the test item on nitrate formation were observed. The coefficient of variation within the four replicates of the control was 1.8% on day 0 and 2.5% on day 28. Hence, the validity criterion defined by the OECD Guideline No. 216 was fulfilled as the variability within the control was clearly below 15%.
Table 1: Mean, minimum and maximum nitrate concentration of the untreated soil (control), and coefficient of variance (CV), on day 0 and day 28 after test item application (n = 4).
Time |
NO3 [mg/kg soil dry weight] |
CV [%] |
||
|
Mean |
Min. |
Max. |
|
Day 0 |
53.3 |
52.5 |
54.5 |
1.8 |
Day 28 |
118 |
115 |
122 |
2.5 |
Table 2: Mean nitrate concentration [mg NO3/kg soil dry weight] in soil of the different treatments at starting (day 0) and at the end of the test (day 28). Test item concentration [mg/kg soil dry weight] and treatment code (in brackets).
Measurement time point |
0.0 (BS) |
0.0 (C) |
260 (T1) |
364 (T2) |
510 (T3) |
714 (T4) |
1000 (T5) |
Day 0 |
40.6 |
53.3 |
56.3 |
54.0 |
53.6 |
53.6 |
51.7 |
Day 28 |
n.d. |
118 |
121 |
120 |
128 |
127 |
124 |
Day 28 decrease [%]a |
n.a. |
n.a. |
-2.2 |
-1.6 |
-8.7 |
-7.9 |
-4.6 |
BS = bulk soil without lucerne meal; C = control soil; T1 to T5 = test item treated soil; n.d. = not determined; n.a. = not applicable; a = decrease as percentage related to the control (negative values indicate increase).
Description of key information
EC50 (28 d) ≥1000 mg/kg soil dw (OECD 216)
Due to the lacking of adverse effects of the test item at tested concentrations of up to and including 1000 mg/kg soil dry weight, effective concentrations could not be calculated.
Key value for chemical safety assessment
Additional information
One experimental study is available investigating the potential effects of the test item (CAS 10094-45-8) on the nitrogen transformation (ECT, 2017) by terrestrial microorganisms. The study was performed according to OECD guideline 216 under GLP conditions. Test item was ground with fine quartz sand using a pestle and mortar prior to being mixed together with the sand into the test soil (Lufa standard soil type 2.3). The soil test was amended with ground lucerne grass green meal (5.0 g/kg soil). Test item was tested at five concentrations ranging from 260 mg/kg soil dry weight (T1) to 1000 mg/kg soil dry weight (T5) against an untreated control (C) with four replicates, each. Nitrate of the soil was measured after test item application on day 0 and 28 days after test item application. Due to the lack of a dose-response relationship, effective concentrations could not be calculated. Consequently, the EC50, EC25, and EC10 can be considered to be higher than 1000 mg/kg soil dry weight.
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.