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Diss Factsheets
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EC number: 946-787-2 | 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
not skin sensitizing
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitization potential of the Target Substance was investigated using a specific QSAR model, developed to predict the skin sensitization potential for dyes. The existing QSAR models have strong limitations to predict ionic complex structures as the organic dyes are, and consequently they provide unreliable results. The QSAR modelling used was developed in accordance with the OECD principles (SKIN SENSITIZATION QSAR MODEL REPORT N. 08).
Based on the estimation, the substance is expected to be not sensitizing. The estimation resulted to be in the applicability domain of the model.
In order to confirm the results obtained by the QSAR prediction, the investigation performed on the analogue substance Similar Substance 01 is used as support of the prediction. Justification for Read Across is given in Section 13 of IUCLID.
The potential of the Similar Substance 01 to cause skin sensitisation reactions following topical application to the skin of CBA/JN mice, was assessed using the LLNA: BrdU-ELISA method, according to the OECD Guideline for testing of chemicals No. 442b. During the preliminary test five concentrations [25 (maximum feasible concentration), 10, 5, 2.5 and 1% w/w in acetone:olive oil 4:1 (v/v)] were tested in the preliminary phase, in order to identify a non toxic and minimally irritant concentration and avoid false positive results. No clinical signs were observed at the tested concentrations. Several animals showed a body weight loss, but not dose correlated. According to the results of the irritation screening, the concentration of 25% w/w was judged to be not irritant. During the Main assay the test item was topically administered at the concentrations of 25, 10 and 5% (w/w), in acetone: olive oil 4:1 (v/v). No mortality nor clinical signs were recorded in any animal. Changes in bodyweight observed during the study were within the expected range for this strain and age of animals. No increase in cell proliferation of draining lymph nodes was observed in any treatment group. The calculated Stimulation Indices (SI) were 1.13, 1.00 and 1.27, respectively at the low, mid- and high dose levels [5, 10 and 25 %, respectively]. No correlation with the doses nor statistical significance was observed. These results indicate that the test item does not elicit any sensitisation response in mice following dermal exposure.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
SKIN SENSITISATION
In the CLP Regulation (EC 1272/2008) a skin sensitizer is defined as “a substance that will lead to an allergic response following skin contact”. A substance classified as skin sensitiser (Category 1) may be allocated to one of the two sub-categories 1A or 1B in accordance with the criteria given in Annex I, Part 3, Table 3.4.2. However, in vitro/in chemico alternatives that have been validated and/or accepted may also be used to make classification decisions.
Based on the results of skin sensitisation, no classification for skin sensitization is warranted under the CLP Regulation (EC 1272/2008).
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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