Registration Dossier
Registration Dossier
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EC number: - | 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
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitisation
A GLP-compliant local lymph node assay in mice was performed according to OECD 429 to evaluate the sensitising potential of the test substance (Lütkenhaus, 2012). Based on a preliminary test in two female CBA/CaOlaHsd mice, the test substance at the maximum technical achievable concentration of 25% (w/v) in 4:1 (v/v) acetone/olive oil (AOO) and further dilutions of 12.5 and 6.25% (w/v) in AOO were selected as treatment concentrations for the main study. During the study period, no clinical signs of toxicity were observed and all animals showed the expected weight development compared to control animals. The mean DPM/lymph node for each test group was 598.3, 3960.9, 3446.0 and 3200.7 at concentrations of 0, 6.25, 12.5 and 25% (w/v) of the test substance, respectively. Based on these data, the mean stimulation indices (SI) relative to the negative control were calculated to be 6.6, 5.8 and 5.2 after treatment with 6.25, 12.5 and 25% (w/v) of the test substance, respectively. Since no conventional dose-response-relationship was followed, the EC3 value for the test substance could not be derived by linear extrapolation. The historical positive control p-phenylendiamine (1% in AOO) confirmed the sensitivity and reliability of the experimental technique (SI ≥ 3). Based on the results of this study, the substance is considered to be a skin sensitiser.
Migrated from Short description of key information:
Skin sensitisation (OECD 429): sensitising
Justification for selection of skin sensitisation endpoint:
There is only one study available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VIII of Regulation (EC) No. 1907/2006.
Justification for classification or non-classification
Based on the available data on skin sensitisation, the test substance meets the criteria for classification as skin sensitiser category 1 (H317) according to Regulation (EC) No 1272/2008 and Xi (R43) according to Directive 67/548/EEC.
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