Registration Dossier
Registration Dossier
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EC number: 280-734-8 | CAS number: 83763-48-8
- 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
Based on the weight of evidence approach between the three available studies, the regitered substance was classified as Category 1A strong sensitizer H317: "May cause an allergic skin reaction"
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Three studies were available for assessment : One in vivo LLNA and two QSARs
- 25 μl of negative control (DMSO, the vehicle), 0.25, 0.5, 1 and 2% of Lehmann-Blau in DMSO w/v was applied to the surface of the ear of five female CBA/Ca mice per group for three consecutive days. As the positive control, p-phenylenediamine (PPD) in DMSO at the same dilutions was used in parallel. On day 5, the mice received an intravenous injection of 250 μl phosphate buffered saline containing 25 μCi of [H3] methyl thymidine. Approximately 5 hours later, the mice were killed by CO2 inhalation and the draining auricular lymph nodes removed and weighed. After preparing a single cell suspension for each mouse, cells were precipitated and the radioactivity determined. The mean dpm per treated group was determined and the stimulation index (SI) – the test item compared to the concurrent vehicle control – calculated.
No concentration dependent increase in the mean SI values (1.29, 1.03, 1.12, 1.42) could be detected for the 4 consecutive concentrations of Lehmann-Blau in DMSO. The sensitivity of the test system was shown by the positive control, PPD, for which the SI were 5.47, 12.39, 19.12 and 7.07 respectively for the 4 consecutive concentrations. There was no indication of skin sensitisation by Lehmann-Blau at up to 2% in DMSO. An EC3 value could not be calculated.
- A QSAR was performed for the registered item using OECD Toolbox V4.1. This prediction was based on analogy approach with structural similar substances. Using this QSAR, the EC3 value was calculated as lower or equal to 2%. The registered item was defiend as strong sensitizer category 1A H332.
- A second QSAR was performed using VEGA v1.1.3: CAESAR 2.A.6. This perdiction was based on analogy approach with similar susbtances based on similar molecules with experimental values, accuracy of the prediction, concordance with similar molecules, atome centered fragments, model descriptors range check and global AD index. Using this QSAR, the prediction considered the registered item as sensitizer.
Justification for classification or non-classification
Based on the available studies performed in order to assess the skin sensitisation potential of the registered subtance, sensitizing effect cannot be discard. Hence, according the QSAR prediction and the LLNA, the registered substance was considered as sensitzer category 1A H317 "May cause an allergic skin reaction".
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