Registration Dossier
Registration Dossier
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EC number: 273-769-5 | CAS number: 69012-72-2 Residue from treatment of calcined zinc ore concentrates with antimony trioxide, zinc dust, lead oxide and copper sulfate. Consists primarily of zinc and a composite of metallics: cobalt, copper and lead.
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January to April 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions
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:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guinea pig mazimization test
- Principles of method if other than guideline:
- According to the Guinea pig mazimization test
- GLP compliance:
- yes
- 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 (NiSO4) 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
- Lot No. JM07021EL
- Storage: room temperature
- Other details not reported or not applicable
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: Charles River Breeding Laboratories, Inc., Wilmington, MA, USA.
- Age at study initiation: young adult
- Weight at study initiation: 345-350 g
- Housing: individually housed in wire mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS: controlled, details not reported
IN-LIFE DATES: not reported
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1 ml of 1.0% w/v NiSO4 in distilled water
0.1 ml of Freunds Complete adjuvant (FCA)
0.1 ml of 1.0% w/w NiSO4 in 50% w/v (FCA)
0.3 ml of 5.0% NiSO4 in distilled water for 48 hours
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1 ml of 1.0% w/v NiSO4 in distilled water
0.1 ml of Freunds Complete adjuvant (FCA)
0.1 ml of 1.0% w/w NiSO4 in 50% w/v (FCA)
0.3 ml of 5.0% NiSO4 in distilled water for 48 hours
- No. of animals per dose:
- 10 per dose
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
0.1 ml of 1.0% w/v NiSO4 in distilled water
0.1 ml of Freunds Complete adjuvant (FCA)
0.1 ml of 1.0% w/w NiSO4 in 50% w/v (FCA)
0.3 ml of 5.0% NiSO4 in distilled water and occluded for 48 hours
B. CHALLENGE EXPOSURE
Challenge performed on both flanks and ventral surface and occluded for 24 hours at concentrations of
0.2 ml of 1.0% w/v NiSO4 in distilled water
Erythema and edema scored according to Draize et al. 1944. - Challenge controls:
- Induction: 0.1 ml of propylene glycol, 0.1 ml of FCA in distilled water, or 0.1 ml of 1.0% w/v proylene glycol in 50% w/v FCA.
Challenge: 0.2 ml of propylene glycol - Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene
Study design: in vivo (LLNA)
- Vehicle:
- not specified
- Concentration:
- not applicable
- No. of animals per dose:
- not applicable
- Details on study design:
- not applicable
- Positive control substance(s):
- not specified
- Statistics:
- Mantel-Haenszel procedure
Results and discussion
- Positive control results:
- 1-chloro-2,4-dinitrobenzene did cause dermal contact sensitization in female albino guinea pigs.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 ml of 1.0% w/v nickel sulfate in distilled water
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 ml of 1.0% w/v nickel sulfate in distilled water. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 ml of 1.0% w/v nickel sulfate in distilled water
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 ml of 1.0% w/v nickel sulfate in distilled water. No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- negative control
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: negative control. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- positive control
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: positive control. No with. + reactions: 6.0. Total no. in groups: 6.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- positive control
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: positive control. No with. + reactions: 6.0. Total no. in groups: 6.0.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: not applicable
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: not applicable
Any other information on results incl. tables
Mean erythema score at 24 and 48 hours for NiSO4 were 1.1 and 1.0, respectively
Applicant's summary and conclusion
- Conclusions:
- Nickel sulfate did cause dermal contact sensitization in female albino guinea pigs.
Mean erythema score at 24 and 48 hours for NiSO4 were 1.1 and 1.0, respectively. - Executive summary:
STUDY RATED BY AN INDEPENDENT REVIEWER.
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