Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 260-486-7 | CAS number: 56973-85-4
- 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
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The registered substance is not readily biodegradable but disappears totally (100% biodegradation after 28 days, calculated from direct quantitative analysis by GC method) to form two degradation products: succinic acid (degraded and mineralized completely) and 3,3-dimethyl cyclohexanone (called DMCH, which is present at 100% after 28 days). Therefore, the registered substance is not persistent in the environment. In addition, according to a QSAR prediction, the relevant degradation product of the registered substance (DMCH) is not readily biodegradable but achieves > 60% of biodegradation after 60 days. Additionally, the predicted ultimate half life is 19 days, well below the threshold value of 40 days and 60 days for persistence and very persistence. Therefore, it can be concluded that DMCH also is not persistent in the environment.
With measured log Kow values at 4.1 and 2.0 for the registered substance and its relevant degradation product (DMCH), respectively, both substances are not considered bioaccumulable.
Finally, for the registered substance, one long-term aquatic toxicity data is available on algae with an ErC10 value greater than 0.01 mg/L (at 1.7 mg/L). In addition, short-term aquatic toxicity data are available on the three aquatic trophic levels (algae, daphnia, fish) with E(L)C50 values greater than 0.1 mg/L (lowest value at 1.7 mg/L). The registered substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008 and no other evidence of chronic toxicity was observed, as identified by the classification specific target organ toxicity after repeated exposure (STOT RE Category 1 or 2) according to Regulation EC No 1272/2008. Therefore, the registered substance is not toxic.
For its relevant degradation product (DMCH), the estimated acute endpoint values (E(L)C50), determined with a QSAR model, were well greater than 0.1 mg/L (greater than 40 mg/L). Therefore, DMCH is presumably not toxic.
In conclusion, the registered substance and its relevant degradation product does not fulfill any of the PBT or vPvB criteria.
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.
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