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Diss Factsheets
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EC number: 485-420-6 | CAS number: 182918-16-7
- 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
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The allergenic potential of the test item (intermediate) was not determined. There are reliable studies of an analogue substance (final product) available to assess the skin sensitizing potential. The compounds share high similaritiy in structure, are of low water solubility and have a log Pow > 8. The toxicity profile of the analogue as well as of the test item is determined by the main component; the side products are structural analogues of the main product without influence on substance toxicity. The test item as well as the analogue are poorly soluble and have a molecular weight of 494 g/mol and 606 g/mol, respectively, which indicates low skin permeability and low bioavailability. It is, therefore acceptable to derive information on acute toxicity from experimental data of the read across substance.
A detailed risk assessment and read across justification was send to the german chemical agency BAuA in 2007 with the purpose of a national substance notification (VIIA). The read across justification was accepted by the national agency.
Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. The sensitising potential of the test substance was classified according to the grading of Magnusson and Kligman.
No toxic symptoms were evident in the guinea pigs of the control or test group. None of the control and test animals showed skin reactions after the challenge treatment with the test item at 1 % (w/w) in PEG 300.
Migrated from Short description of key information:
The potential for skin sensitization of the test substance was not assessed. Information on sensitization are derived from a strucutral analogue. A Guinea Pig Maximisation Test (GPMT) was performed to examine the sensitizing potential of the substance. As a result, the test material is not a skin-sensitizer (GLP, OECD 406; RCC Ltd, 2002)
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC,as amended for the 30th time in Directive 2008/58/EC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).
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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