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Toxicological information

Skin sensitisation

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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:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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

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 group
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 group
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.