Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 485-390-4 | 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:
- no adverse effect observed (not sensitising)
- Additional information:
For the registered substance, one reliable (Klimisch 1) skin sensitisation study (LLNA) was available.
A LLNA/IMDS was carried out in female NMRI mice after epicutaneous application of a formulation containing 0, 2, 10 or 50% of the registered substance for 3 consecutive days onto both ears of the animals. This study did neither point to a non-specific (irritating) nor to a specific immunostimulating (sensitizing) potential of the substance. This applies to NMRI mice, for weight and cell counts of the draining lymph nodes as well as ear swelling and ear weight indices evaluated after application. In summary, no antigen specific activation of the cells of the immune system via dermal route was determined after application of up to and including 50% of the registered substance by the method used. Therefore, the concentration of 50% turned out to be the NOEL for the parameters investigated in this study with respect to skin sensitization (Bayer, 2006).
These results are supported by a repeated human insult patch test, which was completed by 110 participants. In this study the registered substance did not indicate a clinically significant potential for allergic contact sensitization (see IUCLID section 7.10.4). (CPT, 2007)
Migrated from Short description of key information:
In a GLP-study according to OECD test guideline 429 (LLNA), the registered substance did not induce any skin sensitisation. A repeated human patch insult test with volunteers did not indicate a clinically significant potential for allergic contact sensitization (see IUCLID section 7.10.4).
Justification for classification or non-classification
Based on the results of the skin sensitization studies, the test item is not subjected to classification according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (GHS,CLP).
.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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