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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 443-860-6 | CAS number: 302776-68-7
- 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
Endpoint summary
Administrative data
Description of key information
Additional information
Direct exposure to the terrestrial compartment is not intended. An indirect exposure to the soil compartment via sewage sludge cannot be excluded. Therefore, additional data on terrestrial organisms are provided.
A study on the acute toxicity of the substance to the soil macoorganism Eisenia fetida following OECD guideline 207 resulted in a LC50 >= 1000 mg/kg dw [BAF SE 2011]. Additional studies conducted according to OECD 216 and 217, respectively, investigated long-term effects of the substance on soil microorganisms which also resulted in EC10/EC50 values greater than 1000 mg/kg dw [BASF SE 2012].
Adverse effects of the test substance to terrestrial organisms appeared only with terrestrial plants. A guideline study according to OECD 208 was conducted with three different plant species: Avena sativa, Brassica napus and Vicia sativa. At the end of the exposure period, an EC10 (shoot length) of 15.4 mg/kg soil dw was determined in Brassica napus as the most sensitive endpoint among all observed species and endpoints investigated. The EC10 values for the other two plants species investigated were in fact 148 and 336 mg/kg dw for Vicia sativa and Avena sativa, respectively.
The corresponding EC50 value is 80.4 mg/kg soil dw (based on plant dry weight).
All other EC50 values from other endpoints and species investigated were above this value.
Since the OECD 208 terrestrial plant toxicity study has been carried out in accordance with the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.7. c: Endpoint specific guidance, November 2012, 140ff, Appendix to section R.7.11, Table R.7.11-3 Selected Soil Test Methodologies, which requires a minimum of 3 three test species, the study on Seedling Emerge and Growth (OECD 208) has to be considered as a chronic plant toxicity test and thus the corresponding EC10 value has to be taken into account for the derivation of the PNECsoil.
Based on the available acute data set from three trophic levels (earthworm, soil microflora and terrestrial plants) together with the absence of an experimentally observed bioaccumulation potential (BASF 2006a, 2005a), it is of evidence that terrestrial plants (EC50 of 80.4 mg/kg dw) are the most sensitive taxonomic group at the acute level, whereas both soil microflora organism and earthworm showed no effect at all up to 1000 mg/kg dw (e. g. EC50 is above 1000 mg/kg dw, Table a). Moreover, it can be concluded that terrestrial plants represent the most sensitive taxonomic group in chronic tests too. This was clearly demonstrated by the available chronic toxicity data from the two soil microflora (EC10 >= 1000 mg/kg dw) and the one terrestrial plant study (EC10 of 15.4 mg/kg dw). Thus, taking this information into account, it is very unlikely that an additional chronic toxicity test on earthworm would result in a chronic EC10 value below the value obtained in the toxicity test with terrestrial plants. Therefore, the assessment factor for the derivation of the PNECsoil based on two available chronic toxicity tests (AF of 50) is further lowered down to an assessment factor of 10, which is in accordance with the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, May 2008 (R.10.3.1 Freshwater compartment, p. 17ff, and R.10.6.2. Calculation of PNEC for soil using assessment factors p. 40f).
Table a). Overview on available acute and chronic toxicity data on terrestrial organisms
|
Acute effect level, EC50 [mg/kg dw] |
Chronic effect level, EC10 [mg/kg dw] |
Earthworm |
> 1000 mg/kg dw |
>= 1000 mg/kg dw |
Soil microflora (nitrogen transformation) |
> 1000 mg/kg dw |
>= 1000 mg/kg dw |
Soil microflora (carbon transformation) |
> 1000 mg/kg dw |
>= 1000 mg/kg dw |
Terrestrial plants |
80.4 mg/kg dw |
15.4 mg/kg dw |
In conclusion, the PNECsoil is derived from the terrestrial plant toxicity study with a corresponding EC10 value of 15.4 mg/kg dw by applying an assessment factor of 10.
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.