Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 943-697-5 | CAS number: -
- 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
Oral LD50 > 10000 mg/kg b.w.
Dermal LD50 > 2500 mg/kg b.w.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Lack of exposure concentrations, only indication of mortality and necropsy findings after exposure time.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
No studies on "Acute toxicity" are available for the Target Substance, therefore information on Similar Substance 01 and 02 have taken into account for the assessment. Details on the similarity between the Target Substance and the Similar Substances are reported in section 3.
Acute toxicity was assessed through oral, dermal, inhalation and intraperitoneal route of exposure.
Acute toxicity: oral
Two studies were considered in order to complete the assessment on Acute oral toxicity: One test was conducted on Similar Substance 01 but limited information is available regarding the method and the experimental results. Therefore, another test conducted on the Similar Substance 02 was considered in order to confirm the results of the first test.
The two results are consistent (LD50 > 10000 mg/kg bw and LD50 > 2000 mg/kg bw) and the substance is expected to have an LD50 > 2000 mg/kg bw.
Acute toxicity: inhalation
In the study conducted on Similar Substace 01, no deaths occurred at the highest exposure time of 8 hours, however, no indication regarding the exposure concentration was present. For this reason, the performed study is not suitable for classification purpose.
Acute toxicity: dermal
Rats were exposed to a single dermal application of the test substance (Similar Substance 01). After 14 days of observation, no deaths occurred and no abnormalities were noted at necropsy.
Other sudies on Similar Substance 01 are available on another route of exposure (intraperitoneal) and were reported in the endpoint nevertheless, no indication on classification can be derived.
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), for both oral and dermal route the substance does not meet the criteria for classification, since the determined LD50 values is above the threshold values of 2000 mg/kg b.w.
Regarding the inhalation route, despite the available study did not reported the actual concentration of the substance in the inhaled air, the negligible vapor pressure of the substance and its physical state does not suggest inhalation route as potential hazard. Furthermore, since the lower range of the particle size distribution is ca. 11 µm, the respirable fraction should be extremely low.
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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