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EC number: 610-765-8 | CAS number: 52013-44-2
- 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
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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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Nickel, compound with Titanium (1:1)
- EC Number:
- 610-765-8
- Cas Number:
- 52013-44-2
- Molecular formula:
- NiTi
- IUPAC Name:
- Nickel, compound with Titanium (1:1)
- Details on test material:
- 100% Equiatomic NiTi intermetallic compound
Batch 1048
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Bettinardi - Momo (NO)
- Weight at study initiation: 300-321 g. at the beginning of the test
- Housing: the animals were caged in groups of five in transparent polycarbonate cages.
- Diet (e.g. ad libitum): standard pellet
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod: 12 hrs dark / 12 hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- cotton seed oil
- Remarks:
- and sodium chloride
- Concentration / amount:
- weight/volume ratio of 0.2 g/ml
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Remarks:
- and sodium chloride
- Concentration / amount:
- weight/volume ratio of 0.2 g/ml
- No. of animals per dose:
- Two groups of 10 animals treated with the test substance and 5 animals used as control.
- Details on study design:
- Two extracts were performed by dipping completely the test item in order to reach a weight/volume ration of 0.2 g/ml and incubating it for 72 hours at a temperature of 37°C +/- 1 °C in dynamic control.
Induction phase:
The guinea pigs was treated with 3 (0.1 ml each one) double intradermal injections:
1. 50:50 (v:v) stable emulsion of Freund's complete adjuvant mixed with the solvent
2. the treated animals injected with undiluted extract; the control animals injected with the solvent alone
3. the treated animals injected with undiluted extract, emulsified in a 50:50 (v/v) stable emulsion of Freund's complete adjuvant and the solvent (50%); the control animals injected with an emulsion of the solvent sith adjuvant.
6 days after the beginning of treatment on the all animals, a topical application, with slight massage, of 1 ml of Sodium Lauril Solfatum 10% was performed.
After 47 days from intradermal injections, the extracts of test product were applied (at a dose of 0.5 ml/animal) to the skin of the 10 treated animals for a period of 48 hours. The same treatment was performed on control guinea pigs using only extraction liquid. - Challenge controls:
- Challenge phase:
21 days after the beginning of treatment, the challenge phase was performed applying the extracts of test product (at a dose of 1 ml/animal) on the right side of each animal and about 0.5 ml of the solvent on the left side. The patch was left on for 24 hours.
48 and 72 hours after the beginning of this phase, the tested animals and the control animals were observed.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities were observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No abnormalities were observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
No abnormalities were observed in treated and control animals during the challenge phase.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of obtained results, according to OECD no.406 and interpreted according to Official Journal of the European Union 1272/2008 (CLP), the test item can be considered Not sensitizing.
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