Registration Dossier
Registration Dossier
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EC number: 227-873-2 | CAS number: 6018-92-4
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication which meets basic scientific principles. Only 5 animals used per group in the GPMT.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of skin sensitization potential of nickel, chromium, titanium and zirconium salts using guinea-pigs and mice.
- Author:
- Ikarashi, Y. et al
- Year:
- 1 996
- Bibliographic source:
- Biomaterials 17: 2103-2108
Materials and methods
- Principles of method if other than guideline:
- Guinea-pig maximization test according to the procedure described by Magnusson and Kligman (1969) with some modification (Nakamura, A. et al., 1994).
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Nickel sulphate
- EC Number:
- 232-104-9
- EC Name:
- Nickel sulphate
- Cas Number:
- 7786-81-4
- IUPAC Name:
- nickel(2+) sulfate
- Details on test material:
- - Name of test material (as cited in study report): nickel sulphate
- Molecular formula (if other than submission substance): NiSO4
- Molecular weight (if other than submission substance): 154.755
- Analytical purity: no data
- Other: Source: Wako Pure Chemical Industries, Ltd. (Osaka, Japan)
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: Japan SLC Inc. (Shizuoka, Japan)
- Weight at study initiation: 350-400 g (guinea-pigs)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Induction: intradermal FCA/saline and epicutaneous petrolatum; Challenge: 30% ethanol
- Concentration / amount:
- Induction: 1% nickel sulphate (intradermal and epicutaneous)
Challenge: 5, 2, 1, 0% nickel sulphate
Rechallenge: 0.5, 0.25% nickel sulphate
Challengeopen allclose all
- Route:
- other: epicutaneous, not further specified
- Vehicle:
- other: Induction: intradermal FCA/saline and epicutaneous petrolatum; Challenge: 30% ethanol
- Concentration / amount:
- Induction: 1% nickel sulphate (intradermal and epicutaneous)
Challenge: 5, 2, 1, 0% nickel sulphate
Rechallenge: 0.5, 0.25% nickel sulphate
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
Preliminary irritation tests were performed to determine suitable concentrations for induction and challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 7 (6 x intradermal and 1 x epicutaneous)
- Exposure period: day 0 to day 9
- Test groups: intradermal: 1% NiSO4 in FCA/saline; epicutaneous: 1% in petrolatum
- Control group: intradermal: FCA/saline; epicutaneous: petrolatum
- Site: shoulder region
- Frequency of applications: 6 x intradermal injections; 1 x epicutaneous (occlusive) 7 days later for 48 hours
- Duration: totally 9 days (occlusive for 48 hours)
- Concentrations: 1% intradermal, 1% epicutaneous
B. CHALLENGE EXPOSURE
- No. of exposures: 1 ( 2 in case of rechallenge)
- Day of challenge: 14 days after induction (and 21 after induction: rechallenge of groups challenged first time with 1 and 0 %)
- Exposure period: 48 h
- Site: flank
- Concentrations: 1st challenge: 5, 2, 1, 0% in 30% ethanol; 2nd challenge 0.5 and 0.25%, respectively (only 1 and 0% 1st challenge groups)
- Evaluation (hr after challenge): 48 - Challenge controls:
- 3 animals per group, groups challenged with 5, 2, 1 and 0%, respectively; rechallenge of 1 and 0% groups with 0.5 and 0.25%, respectively.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 8.04% (recalculated value, equivalent to 5% NiSO4)
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- 3/5 intense; 1/5 moderate; 1/5 slight; 0/5 nothing visible
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 8.04% (recalculated value, equivalent to 5% NiSO4). No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: 3/5 intense; 1/5 moderate; 1/5 slight; 0/5 nothing visible.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3.22% (recalculated value, equivalent to 2% NiSO4)
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Clinical observations:
- 1/5 intense; 2/5 moderate; 1/5 slight; 1/5 nothing visible
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3.22% (recalculated value, equivalent to 2% NiSO4). No with. + reactions: 4.0. Total no. in groups: 5.0. Clinical observations: 1/5 intense; 2/5 moderate; 1/5 slight; 1/5 nothing visible.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.61% (recalculated value, equivalent to 1% NiSO4)
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Clinical observations:
- 1/5 intense; 1/5 moderate; 2/5 slight; 1/5 nothing visible
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.61% (recalculated value, equivalent to 1% NiSO4). No with. + reactions: 4.0. Total no. in groups: 5.0. Clinical observations: 1/5 intense; 1/5 moderate; 2/5 slight; 1/5 nothing visible.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- 5/5 nothing visible
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: 5/5 nothing visible.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.8% (1.61% in 1st challenge (1% NiSO4); recalculated value, equivalent to 0.5% NiSO4)
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- 1/5 slight; 4/5 nothing visible
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 0.8% (1.61% in 1st challenge (1% NiSO4); recalculated value, equivalent to 0.5% NiSO4). No with. + reactions: 1.0. Total no. in groups: 5.0. Clinical observations: 1/5 slight; 4/5 nothing visible.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4% (0% in 1st challenge; recalculated value, equivalent to 0.25% NiSO4)
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Clinical observations:
- 1/5 slight; 4/5 nothing visible
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 0.4% (0% in 1st challenge; recalculated value, equivalent to 0.25% NiSO4). No with. + reactions: 1.0. Total no. in groups: 5.0. Clinical observations: 1/5 slight; 4/5 nothing visible.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 8.04% (recalculated value, equivalent to 5% NiSO4)
- No. with + reactions:
- 1
- Total no. in group:
- 3
- Clinical observations:
- 1/3 moderate; 2/3 nothing visible
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 8.04% (recalculated value, equivalent to 5% NiSO4). No with. + reactions: 1.0. Total no. in groups: 3.0. Clinical observations: 1/3 moderate; 2/3 nothing visible.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3.22% (recalculated value, equivalent to 2% NiSO4)
- No. with + reactions:
- 1
- Total no. in group:
- 3
- Clinical observations:
- 1/3 slight; 2/3 nothing visible
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3.22% (recalculated value, equivalent to 2% NiSO4). No with. + reactions: 1.0. Total no. in groups: 3.0. Clinical observations: 1/3 slight; 2/3 nothing visible.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1.61% (recalculated value, equivalent to 1% NiSO4)
- No. with + reactions:
- 1
- Total no. in group:
- 3
- Clinical observations:
- 1/3 slight; 2/3 nothing visible
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1.61% (recalculated value, equivalent to 1% NiSO4). No with. + reactions: 1.0. Total no. in groups: 3.0. Clinical observations: 1/3 slight; 2/3 nothing visible.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- 3/3 nothing visible
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 3.0. Clinical observations: 3/3 nothing visible.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.8% (1.61% in 1st challenge (1% NiSO4); recalculated value, equivalent to 0.5% NiSO4)
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- 3/3 nothing visible
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.8% (1.61% in 1st challenge (1% NiSO4); recalculated value, equivalent to 0.5% NiSO4). No with. + reactions: 0.0. Total no. in groups: 3.0. Clinical observations: 3/3 nothing visible.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.4% (0% in 1st challenge; recalculated value, equivalent to 0.25% NiSO4)
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- 3/3 nothing visible
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.4% (0% in 1st challenge; recalculated value, equivalent to 0.25% NiSO4). No with. + reactions: 0.0. Total no. in groups: 3.0. Clinical observations: 3/3 nothing visible.
Any other information on results incl. tables
NiSO4 caused positive reactions in the GMPT. All NiSO4 -treated animals showed skin reactions by challenge (mean response = 1.4 at 1% and mean response = 1.6 at 2%). However, as one of the control animals showed a weak reaction at these concentrations, diluted concentrations (0.5 and 0.25%) were rechallenged. With 0.5% NiSO4 (equivalent to 8.04% C6H6O7Ni (nickel citrate)) challenge, 1 of 5 animals (20%) showed positive reactions and mean response was 0.2.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
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