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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Peer reviewed data, acceptable for assessment.

Data source

Reference
Reference Type:
secondary source
Title:
Nickel contact sensitivity in the guinea pig. An efficient open application test method.
Author:
Nielsen GD et al.
Year:
1992
Bibliographic source:
OECD SIDS-Draft (original source: Acta Derm Venereol 72, 45-8)

Materials and methods

Principles of method if other than guideline:
see details in remarks on material and methods
GLP compliance:
not specified
Type of study:
open epicutaneous test

Test material

Constituent 1
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

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
other: lanolin cream (Vaseline, pH 5 SAD cream) or hydroxypropyl cellulose
Concentration / amount:
induction: 0.3%-3% nickel sulphate;
challenge: 2% in water or 1% in petrolatum
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: lanolin cream (Vaseline, pH 5 SAD cream) or hydroxypropyl cellulose
Concentration / amount:
induction: 0.3%-3% nickel sulphate;
challenge: 2% in water or 1% in petrolatum
No. of animals per dose:
no data

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1% in lanolin
No. with + reactions:
8
Total no. in group:
14
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% in lanolin. No with. + reactions: 8.0. Total no. in groups: 14.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1% in lanolin
No. with + reactions:
13
Total no. in group:
14
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% in lanolin . No with. + reactions: 13.0. Total no. in groups: 14.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3% in lanolin
No. with + reactions:
9
Total no. in group:
15
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3% in lanolin. No with. + reactions: 9.0. Total no. in groups: 15.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3% in lanolin
No. with + reactions:
15
Total no. in group:
15
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3% in lanolin . No with. + reactions: 15.0. Total no. in groups: 15.0. Clinical observations: no data.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1% in hydroxypropyl cellulose
No. with + reactions:
8
Total no. in group:
12
Clinical observations:
no data
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% in hydroxypropyl cellulose. No with. + reactions: 8.0. Total no. in groups: 12.0. Clinical observations: no data.
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1% in hydroxypropyl cellulose
No. with + reactions:
9
Total no. in group:
12
Clinical observations:
no data
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% in hydroxypropyl cellulose. No with. + reactions: 9.0. Total no. in groups: 12.0. Clinical observations: no data.

Any other information on results incl. tables

Considering both readings at both challenges concentrations, the frequency of sensitisation was 57-93% (8 /14 to 13/14 animals) in the group treated with 1% in the lanolin cream, 60-100% (9/15 to 15/15 animals) in the group treated with 3% in the lanolin cream, and 67-75% (8/12 to 9/12 animals) in the group treated with 1% in hydroxypropyl cellulose. Rechallenge of initially sensitised animals 10 weeks later confirmed that a lasting contact allergy had been obtained.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information