Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 217-496-1 | CAS number: 1873-88-7
- 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
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Toxicity to soil microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil microorganisms
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
Reference
Description of key information
Key value for chemical safety assessment
Additional information
No data are available for the registration substance.
A 28 day EC50 value of >6.5 mg/kg soil dw and an EC10 value of >6.5 mg/kg soil dw (highest nominal concentrations tested) have been reported in an OECD TG 216 (Soil Microorganisms: Nitrogen Transformation Test) for the effects of the structurally related substance L3 on nitrate formation rate of soil microflora. Additionally, a 28 day EC50 value of >8.5 mg/kg soil dw and an EC10 value of >8.5 mg/kg soil dw (highest nominal concentrations tested) have also been reported in an OECD TG 216 study for the effects of the structurally related substance HMDS on nitrate formation rate of soil microflora.
The data indicate that there were no inhibitory effects on the soil micro-organisms. However, analysis of the test substance concentrations in both studies show that test material was lost at the very beginning of the test for HMDS and by day three of the test with L3, with all concentrations below the limit of detection, therefore the micro-organisms would have been exposed to unquantifiable, minimal amounts of the test substance, if any at all. No dose-response relationship was apparent for HMDS, and in view of the <LOQ recoveries of test material, it is not appropriate to ascribe the absence of effects to an absence of toxicity of HMDS.
Apparent significant effects (positive, non-inhibitory) on nitrate concentration and nitrate transformation rate were observed in the study with L3 in the 0.41, 0.81, 1.6, and 3.3 mg/kg treated soils at day 28; replicates at equivalent test concentrations showed good repeatability. No dose-response relationship was apparent, and in view of the <LOQ recoveries of test material, it is not appropriate to ascribe the observed effects to L3.
The results of these tests cannot be used for derivation of PNECs and risk assessment.
L3 and HMDS have very high Henry's Law Constants and losses through volatilisation during test media preparation and within the test system were anticipated. Because of this, measures were taken during the soil micro-organism test to minimise test substance losses.
An initial test was conducted with each substance using a closed bottle system. During this test, nitrate levels decreased significantly in all concentrations, including the control. The report authors explained that this was most likely due to the test vessels being sealed air tight, thus not supplying enough oxygen to allow the nitrifying bacteria to convert the alfalfa nitrogen source to NO3. Thus the study was repeated under a separate protocol, using a different test design.
During the definitive tests, the following measures were taken to prevent loss of test item, while allowing for air exchange:
- The test vessels were sealed with perforated parafilm, which allowed for air exchange and avoided loss in moisture.
- All test substance concentrations were dosed using gastight Hamilton syringes in multiple spots underneath the soil.
- Soil was dosed at ~30% above the calculated maximum sorption concentration to allow for some losses through volatility.
Despite these measures, significant loss of test material was observed at a very early stage in both studies. It may therefore be concluded that the soil micro-organisms were not exposed to adequate concentrations of test substance, and the EC50 and EC10 values determined are not representative of actual exposure of the test organisms to the test substance.
H-L3 has similar physico-chemical and partitioning properties to L3 and HMDS, meaning that similar losses from the test system would be expected under equivalent test conditions. Based on these experimental findings, the registrants consider it is not technically feasible to conduct an OECD TG 216 test for the registration substance on the basis that the test substance is too volatile to maintain adequate concentrations in the test system.
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.
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