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EC number: 939-992-3 | CAS number: 1195028-55-7
- 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
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Read-across from experimental results for the same organic structure . This substance has an identical structure of CAS 1195028-55-7 in respect of the anionic components, but containing Na cations instead of a mixture of Na+ and Li+.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reading:
- other:
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- The read-across study supplied supports the feasibility of the approach: see report in the summary endpoint.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The read-across study supplied supports the feasibility of the approach: see report in the summary endpoint.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There are two studies available for this endpoint for source chemical, CAS 1325 -54 -8. This substance is considered as structural analogue to CAS 1195028 -55 -7: has the same organic part but contains only Na+ cations instead of a mixture of Na+ and Li+. The read-across study supplied supports the feasibility of the approach.
Both studies were performed according to Guideline OECD 406 and were GLP compliant. In the study of Hagemann (1993) the test material used for testing was "roh trocken" meaning "crude". The sample tested had a content of 91% of active substance and inside the report it is defined that purity is 27%. In a more recent study done by Arcelin (1995) the test material is described as "gereignit" meaning "purified". The composition of the tested sample is not known.When purified, it is assumed that the purity of the sample will be higher than the one used in Hagemann (1993) test. Under the test conditions of Arcelin (1995), EC 215-397-8 at concentrations of 15% in bi-distilled water is considered to be a non-sensitizer. Similar results were obtained with testing conditions of Hagemann (1993) at concentration 20% in vaseline. There is also one study done with humans in 1972, Shelansky (1972). This is a human repeated insult patch test and the tested material gave a negative result on sensitisation when tested at 4% in 200 individuals covering a wide range of ages. The human patch test does not give any information concerning classification. The source substance with CAS 1325 -54 -8 has a higher purity than the test item used in the Hagemann’s study (27%) and therefore closer to the test substance used in Arcelin’s study. It can be concluded that the source substance 1325-54 -8 is not skin sensitizer. An increase of toxic effects due to the presence of Li+ in the target chemical CAS No 1195028-55-7 is not expected and read across to the source chemical Direct Orange 39 Na salt is regarded as feasible.
Justification for selection of skin sensitisation endpoint:
Read-across study considered relevant and reliable.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
This endpoint is not an information requirement of Annex IX of REACH Regulation.
Justification for classification or non-classification
Based on the above stated assessments of the skin sensitisation potential, the substance is classified as non-sensitising according to Directive 67/548/EEC and according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.
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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