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EC number: 235-715-9 | CAS number: 12607-70-4
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Meets generally accepted scientific methods with sufficient documentation. Relevant exposure to submission substance, adequate detail on study methods. (A detailed description of the scoring criteria can be found in the .pdf document attached to the 'Sensitisation Scoring Rationale Document' record at the beginning of Section 7.10.4). (reported T scores and M values may be incorrect (e.g., the T score [i.e., sum of all scored reactions] for the Group I nitrate patients should be 49, but is reported as 94).
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- The influence exerted by cutaneous ligands in subjects reacting to nickel sulfate alone and in those reacting to more transition metals.
- Author:
- Santucci, B., C. Cannistraci, A. Cristaudo, E. Camera, and M. Picardo.
- Year:
- 1 998
- Bibliographic source:
- Exp. Dermatol. 7:162-167.
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No standard guideline followed. Test methods provided in the following sections.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Nickel dichloride
- EC Number:
- 231-743-0
- EC Name:
- Nickel dichloride
- Cas Number:
- 7718-54-9
- Molecular formula:
- Cl2Ni
- IUPAC Name:
- Nickel (II) chloride
- Details on test material:
- - Name of test material (as cited in study report): Nickel chloride hexahydrate
- Molecular formula (if other than submission substance): not different than submission substance
- Molecular weight (if other than submission substance): not different than submission substance
- Smiles notation (if other than submission substance): not different than submission substance
- InChl (if other than submission substance): not different than submission substance
- Structural formula attached as image file (if other than submission substance): not different than submission substance
- Substance type: Pure product
- Physical state: Liquid
- Analytical purity: 98% (BDH) NiCl2, 99% (Erba) NiSO4 hexahydrate, >99 (Aldrich) Nickel nitrate hexahydrate,
>99% (Flutka) nickel acetate tetrahydrate
- Other details on test material not reported or not applicable
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 151
- Other details not reported - Clinical history:
- - History of allergy or casuistics for study subject or populations: no history of atopy
- Other: Test subjects in this study included individuals who previously gave a positive
patch test reaction to nickel sulphate 5% petrolatum (pet) alone, and individuals who gave a positive patch test reaction to nickel sulphate
5% pet + at least one other transition metal (i.e., cobalt chloride 1% pet, palladium chloride 1% pet, or potassium dichloride 0.5% pet).
- Other details not reported - Controls:
- not reported
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
Group I = 71
Group II = 30
Group III = 25
Group IV = 25
- Description of patch: Finn chambers with scanpor tape
- Vehicle / solvent: petrolatum
- Concentrations: Group I and II: nickel chloride (0.1 M, pH 5.3)
Group III and IV: nickel chloride (0.025 M, pH 5.3)
- Volume applied: not reported
- Testing/scoring schedule: read at 48 and 96 hrs
- Removal of test substance: not reported
- Other:
Group I (71 individuals who previously reacted to nickel sulphate alone) and Group II (30 individuals who previously reacted to nickel sulphate
plus other metals) test subjects were contemporaneously re-patch tested to 200 ug Ni2+ contained in 20 mg of nickel sulphate 5% pet,
and to 47 ug Ni2+ contained in 8 ul of 4 aqueous solutions of nickel salts, i.e., nickel sulphate (0.1 M, pH 4.6), nickel chloride (0.1 M, pH 5.3),
nickel nitrate (0.1 M, pH 6.7), and nickel acetate (0.1 M, pH 7.3), respectively.
Group III (25 individuals who had reacted to nickel sulphate alone) and Group IV (25 individuals who had reacted to nickel sulphate plus
other metals) test subjects were re-patch tested respectively to 200 ug Ni2+ contained in 20 mg of nickel sulphate 5% pet, and to 12 ug
Ni2+ contained in 8 ul of 4 aqueous solutions of nickel sulphate (0.025 M, pH 4.6), nickel chloride (0.025 M, pH 5.3), nickel nitrate
(0.025 M (pH 6.7), and nickel acetate (0.025 M, pH 7.3).
The allergens were applied to the backs of the subject individuals via Finn Chambers on Scanpore (for nickel sulphate 5% pet) and A1 tests on
Leucotest (for aqueous nickel solutions) and read at 48 and 96 hours post-application. The aqueous Ni solutions were applied to a circular
area (8 mm diameter) to all subject individuals, arranged in a single horizontal row. The order of the 4 salts were rotated so as not to be in
the same order.
EXAMINATIONS
- Grading/Scoring system: At 48 hours, the contact sites were visually examined and graded in accordance with international standards
- i.e., a ranking/score of 0, +, ++, or +++ was assigned, corresponding to the degree of the reaction.
The total (T) score and the mean (M) value of the reactions to each compound were calculated and reported.
- Statistical analysis: Differences between the mean values of the reactions of each tested compound were evaluated by analysis of variance with
Fisher's F-test.
- Other: none
Results and discussion
- Results of examinations:
- SYMPTOMS/NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
Patch test summary results, by group tested:
Group 1 (n = 71 patients)
200 ug Ni, from sulfate: 71/71 positive reactions (24 patients = 3+; 47 patients = 2+); T score = 166; M value = 2.38
47 ug Ni, from acetate: 45/71 positive reactions (17 patients = 3+; 17 = 2+; 11 = 1+); T score = 50; M value = 0.70
47 ug Ni, from chloride: 32/71 positive reactions (10 patients = 3+; 17 = 2+; 5 = 1+); T score = 69; M value = 0.97
47 ug Ni, from nitrate: 31/71 positive reactions (3 patients = 3+; 12 = 2+; 16 = 1+); T score = 94; M value = 1.32
47 ug Ni, from sulfate: 35/70 positive reactions (7 patients = 3+; 17 = 2+; 11 = 1+); T score = 67; M value = 0.94
Group 2 (n = 30 patients)
200 ug Ni, from sulfate: 30/30 positive reactions (25 patients = 3+; 5 patients = 2+); T score = 85; M value = 2.83
47 ug Ni, from acetate: 25/30 positive reactions (13 patients = 3+; 8 = 2+; 4 = 1+); T score = 59; M value = 1.96
47 ug Ni, from chloride: 30/30 positive reactions (16 patients = 3+; 12 = 2+; 2 = 1+); T score = 74; M value = 2.46
47 ug Ni, from nitrate: 29/30 positive reactions (14 patients = 3+; 14 = 2+; 1 = 1+); T score = 71; M value = 2.36
47 ug Ni, from sulfate: 26/30 positive reactions (10 patients = 3+; 11 = 2+; 5 = 1+); T score = 58; M value = 1.93
Group 3 (n = 25 patients)
200 ug Ni, from sulfate: 25/25 positive reactions (5 patients = 3+; 20 patients = 2+); T score = 55; M value = 2.21
12 ug Ni, from acetate: 3/25 positive reactions (2 patients = 2+; 1 = 1+); T score = 5; M value = 0.20
12 ug Ni, from chloride: 5/25 positive reactions (3 patients = 2+; 2 = 1+); T score = 8; M value = 0.32
12 ug Ni, from nitrate: 5/25 positive reactions (3 patients = 2+, 2 = 1+); T score = 8; M value = 0.32
12 ug Ni, from sulfate: 3/25 positive reactions (3 patients = 2+); T score = 6; M value = 0.24
Group 4 (n = 25 patients)
200 ug Ni, from sulfate: 25/25 positive reactions (19 patients = 3+; 6 patients = 2+); T score = 69; M value = 2.76
12 ug Ni, from acetate: 14/25 positive reactions (5 patients = 3+; 5 = 2+; 4 = 1+); T score = 29; M value = 1.16
12 ug Ni, from chloride: 18/25 positive reactions (6 patients = 3+; 9 = 2+; 3 = 1+); T score = 39; M value = 1.56
12 ug Ni, from nitrate: 18/25 positive reactions (4 patients = 3+; 9 = 2+; 5 = 1+); T score = 35; M value = 1.4
12 ug Ni, from sulfate: 14/25 positive reactions (2 patients = 3+; 5 = 2+; 7 = 1+); T score = 23; M value = 0.92
Applicant's summary and conclusion
- Conclusions:
- Test results demonstrated that subjects allergic to nickel plus other transition metals were more sensitive than those allergic to nickel only.
The authors theorized that, based on a QSAR model, subjects reacting to more metals had a "more uniform availability of cutaneous ligands"
leading to the formation of more immunogenic complexes and a stronger, less specific allergic reaction. - Executive summary:
STUDY RATED BY AN INDEPENDENT REVIEWER.
(A detailed description of the scoring criteria can be found in the .pdf document attached to the 'Sensitisation Scoring Rationale Document' record at the beginning of Section 7.10.4).
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