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EC number: 224-699-9 | CAS number: 4454-16-4
- 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
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the effect of the specific CCRI antagonist CP-481715 on the clinical and cellular responses observed following epicutaneous nickel challenge in human subjects
- Author:
- Borregaard J, Skov L, Wang L, Ting N, Wang C, Beck LA, Sonne J, Clucas A.
- Year:
- 2 008
- Bibliographic source:
- Contact Dermatitis 59, 212-19.
Materials and methods
- Type of study / information:
- Phase 1/2 placebo-controlled, randomized, double-blind, parallel group, multi-dose study
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The investigators conducted a phase 1/2 placebo-controlled, randomized, double-blind, parallel group, multi-dose study to evaluate the effects of CP-481715 (a specific CC-chemokine receptor 1 antagonist) on clinical responses and cellular infiltration following Ni challenge in allergic subjects. 40 subjects were randomized to 5 days of treatment in 4 parallel groups (placebo three times daily, placebo once daily, 1000 mg CP-481715 three times daily, 3000 mg CP-481715 once daily). Nickel sulphate patch tests were conducted and biopsies were used to quantify cellular influx into the dermis by immunohistology.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Nickel sulphate
- EC Number:
- 232-104-9
- EC Name:
- Nickel sulphate
- Cas Number:
- 7786-81-4
- Molecular formula:
- H2O4S.Ni
- IUPAC Name:
- Nickel sulfate
- Details on test material:
- - Name of test material (as cited in study report): nickel sulphate
Constituent 1
Results and discussion
Any other information on results incl. tables
EXPOSURE
- Number of measurements: Three Ni sulphate patches applied on the back
of all subjects.
- Other: 24 hours after the first drug administration (placebo three
times daily, placebo once daily, 1000 mg CP-481715 three times daily, or
3000 mg CP-481715 once daily), Ni sulphate patches were applied on all
subjects’ backs and removed 48 hours later.
FINDINGS: Pretreatment with 1000 mg CP-481715 three times daily resulted
in significant, clinical reductions in the visual scores of the nickel
patch test reactions. None of the subjects experienced total inhibition
of the allergic reactions to nickel. No significant change from pooled
placebo was observed for the CP-48l715 3000 mg once daily group for
clinical visual scores. Similarly, pretreatment with 1000 mg CP-481715
three times daily also showed signs of reducing erythema reactions to
nickel when assessed with the chromameter. No significant change
observed in erythema reactions between pooled placebo and the 3000 mg
CP-481715 once daily group. There were no significant differences
observed between either CP-481715 treatment group and pooled placebo for
any of the immunohistological end-points. However, whereas the numbers
of inflammatory cells tended to increase in biopsies after the second
nickel challenge in the placebo groups, the cell counts tended to remain
stable or even decrease for the CP481715
1000 mg three times daily group, particularly for CD4+ and CD8+ cells.
STATISTICAL RESULTS
- Clinical visual scores: Difference in mean change from baseline
(change in area under the curve of patched vs. nonpatched sites) between
treatment with 1000 mg CP-48175 three times daily and pooled placebo:
-50.13 (90% confidence interval -82.17 to -18.09, p =0.01). No
significant change from pooled placebo was observed for the CP-48l715
3000 mg once daily group (P = 0.80).
-Instrumental measurement of erythema: Difference in mean change from
baseline (area under the curve of patched site minus area under the
curve of non-patched site) between treatment with 1000 mg CP-48175 three
times daily and pooled placebo: -186.97 (95% confidence interval -349.01
to -24.92, p=0.06). No significant change from pooled placebo was
observed for the 3000 mg CP-481715 once daily group (P = 0.13).
- Immunohistological cell counts: No significant differences observed
between either CP-481715 treatment group and pooled placebo for any of
the immunohistological end-points (p ≥ 0.13).
Applicant's summary and conclusion
- Conclusions:
- The authors concluded that the blocking of CCR1 only partly inhibited clinical manifestations of allergic contact dermatitis (ACD) as induced by nickel sulphate. Several chemokine receptors are likely relevant for the cellular influx observed in ACD lesions.
- Executive summary:
Study rated by an independent reviewer.
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