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EC number: 951-477-5 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: HJ/T 153 Appendix 406 Skin Sensitisation Test
- Version / remarks:
- 2004
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The In vivo data was necessary to generate as it is a requirement for performing a substance registration in China under MEP Order 7.
Test material
- Reference substance name:
- Sodium Nickel Manganese Magnesium Titanium Dioxide (Crystal phase: O3/P2/RS)
- EC Number:
- 951-477-5
- Molecular formula:
- Na1-δNivMnwMgxTiyO2, where the ranges are 0 < δ < 0.2, 0.2 < v < 0.4, 0.4 < w < 0.6, 0.02 < x < 0.2, 0.02 < y < 0.2
- IUPAC Name:
- Sodium Nickel Manganese Magnesium Titanium Dioxide (Crystal phase: O3/P2/RS)
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.2 mL solution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- There were no abnormal general findings in the control and treated guinea pigs in test.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.2 mL solution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- There were no abnormal general findings in the control and treated guinea pigs in test.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 mL 3% test solution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- There were no abnormal general findings in the control and treated guinea pigs in test.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 mL 3% test solution
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- There were no abnormal general findings in the control and treated guinea pigs in test.
- Key result
- Group:
- positive control
- Dose level:
- 0.2 mL 2.5% test solution of 2-mercaptobenzothiazole
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The sensitisation incidence of the control group is 0%, and the sensitisation incidence of the treated group is 5%. Therefore, under this test condition, based on these findings and the evaluation system used, TBM-141 is feeble sensitizer.
- Executive summary:
Introduction: The skin sensitisation potential of TBM-141 was determined in guinea pigs following repeated dermal application using the Buehler Method in this study. The study was conducted in compliance with the requirements of “the Guidelines for the Testing of Chemicals-Health Effects” (the second edition).
Method: 0.2 mL 6% test solution was used in induction, and 0.2 mL 3% test solution was used in challenge. 0.2 mL 6% test solution was applied to the shaved left flank every treated guinea pigs (20 animals) once per week during the induction period of three consecutive weeks. The control guinea pigs (10 animals) were handled in same manner, but were not treated with the test chemical in induction. About two weeks following the third induction exposure, 0.2 mL 3% test solution was applied to the shaved right flank of the treated and the control guinea pigs in challenge. Following each induction, the skin reactions were observed and recorded for erythema and edema about 1, 24 and 48 hours after removal of wrappings. Following challenge, the skin reactions were observed and recorded for erythema and edema about 24 and 48 hours after removal of wrappings.
Results: Following induction, there were no visible changes of the control animals, Seventeen animals of the treated group were found slight erythema on test area. Following challenge, there were no visible changes of the control animals, one animals (animal ID: 2716) of the treated group were found discrete erythema on test area, and the other nineteen animals of the treated animals were no visible changes. The sensitisation incidence is 5%.
Conclusion: Under this test condition, based on these findings and the evaluation system used, the sensitisation incidence of TBM-141 is 5%. According to “the Guidelines for the Testing of Chemicals-Health Effects” (the second edition), TBM-141 is feeble sensitizer.
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