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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:
other: Meets generally accepted scientific standards with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
According to the 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 (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)

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:
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

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
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:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
No reliable data with the test substance is available. Data generated with the related substance nickel sulfate is used for endpoint coverage.
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. It is assumed that the test substance is therefore to be classified as skin sensitizing category 1 according to CLP criteria.
Executive summary:

STUDY RATED BY AN INDEPENDENT REVIEWER.