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Diss Factsheets

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:
comparable to guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1986
Reference Type:
other: ECHA disseminated Dossier
Title:
ECHA disseminated Dossier of Nickel sulfate (CAS 7786-81-4)
Year:
1986
Bibliographic source:
ECHA disseminated Dossier of Nickel sulfate (CAS 7786-81-4), query date 2020-11-24

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Guinea pig maximization test
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The LLNA is not applicable for use in evaluating skin sensitization since this methodology provides false negative results for nickel as a known human skin sensitizer (due to differences in the toll receptors in mice used in the LLNA and humans).

Test material

Constituent 1
Chemical structure
Reference substance name:
Nickel sulphate
EC Number:
232-104-9
EC Name:
Nickel sulphate
Cas Number:
7786-81-4
Molecular formula:
NiSO4
IUPAC Name:
nickel(2+) sulfate

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: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS: controlled, details not reported

Study design: in vivo (non-LLNA)

Induction
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
Challenge
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
Challenge was 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.
No. of animals per dose:
10
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 was 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

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
Key result
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
Key result
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
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
negative control
No. with + reactions:
1
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
negative control
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
positive control
No. with + reactions:
6
Total no. in group:
6
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
positive control
No. with + reactions:
6
Total no. in group:
6

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

Interpretation of results:
other: The test substance did cause dermal contact sensitization in female albino guinea pigs.
Conclusions:
10 of 10 guinea pigs exhibited skin reactions after challenge exposure with the test substance. Therefore the substance was concluded to be sensitising to skin.