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EC number: 416-390-4 | 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:
- other: GLP Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EEC (Maximisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 416-390-4
- EC Name:
- -
- IUPAC Name:
- Blend of Magneli suboxides of titanium
- Details on test material:
- Black powder, Lot No. Composite 01, Composition : 2% Ti3O5, 49% Ti4O7, 36% Ti5O9, 5% Ti6O11, 8% Ti7O13. The Ebonex Powder used in this experiment differed from the Substance listed in Section 1 in that it contained less Ti4O7 and Ti6O11 and more Ti5O9. It also contained small proportions of Ti3O5, Ti7O13 and Ti8O15. However, the Ebonex Powder used for this study was still a blend of Magneli suboxides of titanium, primarily based upon the same three titanium oxides, Ti4O7, Ti5O9 and Ti6O11 as in the current Ebonex Powder listed in Section 1. As such the results from the Ebonex Powder used in this experiment are considered to be applicable for the current Ebonex Powder as listed in Section 1.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- The animals were in the weight range 301-343 g on arrival and approximately 4-5 weeks of age. They were acclimatised for 12 days prior to starting the experiment. The animals were in the weight range 411-507 g at the start of the experiment. The control group was 5 animals and the test group 10 animals. A vitamin C enriched guinea-pig diet FD1 and drinking water were provided ad libitum. Room temperature was maintained at approximately 21 Centigrade and relative humidity at 30-70% and 12 hours artificial light per day.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- coconut oil
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Induction intradermal injection: 10% w/v in Alembicol D
Induction topical application: 60% w/v in Alembicol D
Concentration of test material and vehicle used for each challenge:
60 and 30% w/v in Alembicol D
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- coconut oil
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
Induction intradermal injection: 10% w/v in Alembicol D
Induction topical application: 60% w/v in Alembicol D
Concentration of test material and vehicle used for each challenge:
60 and 30% w/v in Alembicol D
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- Induction intradermal injections (test animals) - a 40x60 mm area of dorsal skin on the scapular region of the guinea-pig was clipped free of hair with electric clippers. Three pairs of intradermal injections were made into a 20x40 mm area within the clipped area. lnjectables for the test animals were prepared as follows:lnjectables for the test animals were prepared as follows:
1. Freund's complete adjuvant was diluted with an volume of water for irrigation
2. Ebonex Powder, 10% w/v in Alembicol D.
3. Ebonex Powder, 10% w/v in a 50 ; 50 mixture of Freund's complete adjuvant and Alembicol D.
Induction topical application - test animals
The preliminary investigations indicated that the maximum practical concentration of the test substance for topical application (60%) did not produce skin irritation. Therefore, six days after the injections, the same 40 x 60 mm interscapular area was clipped and shaved free of hair and the site was pre-treated by gentle rubbing with 05 mI per site of 10% w/w sodium lauryl sulphate in petrolatum. Twenty-four hours later a 20 X 4() mm patch of Whatman No. 3 paper was saturated with approximately 0.4 m1 of Ebonex Powder, 60% w/v in Alembicol D. The patch was placed on the skin of the test animal,; and covered by a length of impermeable plastic adhesive tape (50 mm width "Blenderm)~ This in turn was firmly secured by elastic adhesive bandage (50 mm width "Elastoplast") wound round the torso of the animal and fixed with "Sleek" impervious plastic adhesive tape. The dressing was left in place for 48 hours.
Induction - control animals
During the induction phase, the control animals were treated similarly to the test animals with the exception that the test substance was omitted from the intradermal injections and topical application. - Challenge controls:
- The control and test animals were challenged topically two weeks after the topical induction application using Ebonex Powder, 60 nad 30 % in Alembicol D.
- Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 60 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 60 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 60 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 60 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 60 %
Signs of irritation during induction:
Slight irritation was seen in test animals receiving Ebonex
Powder, 10% w/v in Alembicol D and slight irritation was
observed in control animals receiving Alembicol D alone.
Evidence of sensitisation of each challenge concentration:
None
Other observations:
None
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: EU
- Conclusions:
- The test substance did not produce eveidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals.
- Executive summary:
The skin sensitisation potential of the test substance was determined in the guinea-pig (10 test animals, 5 controls). the following dose levels were used: Intradermal injection, 10% w/v in Alembicol D; Topical application, 60% w/v in Alembicol D and Challenge application, 60 and 30% w/v in Alembicol D. The test substance did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals.
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