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Diss Factsheets

Administrative data

Description of key information

read across to nickel sulphate (CAS 7786-81-4): skin sensitising cat 1, H317

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to IUCLID section 13 for justification of read across.
Reason / purpose for cross-reference:
read-across source
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
Interpretation of results:
other: The test substance did cause dermal contact sensitization in female albino guinea pigs.
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
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).
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
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
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
Positive control results:
1-chloro-2,4-dinitrobenzene did cause dermal contact sensitization in female albino guinea pigs.

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

Mean erythema score at 24 and 48 hours for NiSO4 were 1.1 and 1.0, respectively.

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.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

No data on the substance itself is available. Therefore, read across to nickel sulfate (CAS 7786-81-4) was applied. Data were obtained from the ECHA disseminated Dossier of the substance.


A Guinea pig maximization test similar to OECD Guideline 406 was conducted with nickel sulfate. 10 female Guinea pigs were therefore tested. 1-chloro-2,4-dinitrobenzene served as positive control. For induction, the animals were exposed to the following concentrations:  0.1 mL of 1.0 % w/v test substance in distilled water, 0.1 mL of Freunds Complete adjuvant (FCA),0.1 mL of 1.0 % w/w test substance in 50% w/v (FCA) and 0.3 mL of 5.0 % test substance in distilled water. The test sites were occluded for 48 hours. Challenge was performed on both flanks and the ventral surface of the animals under occlusion for 24 hours at concentrations of 0.2 mL of 1.0 % w/v NiSO4 in distilled water. As a result, all animals of the test substance group showed skin reactions at the first and second reading. The test substance was concluded to be sensitising to skin.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008


The available data on skin sensitisation are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the available data, the substance is considered to be classified for skin sensitisation, Cat. 1, H317 (may cause an allergic skin reaction) under Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) 2020/1182.