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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
The chamber scarification test for irritancy
Author:
Frosch PJ, Kligman AM
Year:
1976
Bibliographic source:
Contact Dermatit., 2:314-324

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
In a study performed to develop a new test for skin irritancy, nickel sulphate was included as one of the test agents. A volume of 0.1 ml of nickel sulphate in various concentrations was pipetted on to a disc of two thicknesses of non-woven cotton cloth. The disc was mounted in a chamber designed for use in tests of contact sensitisation, which was sealed to the skin with non-occlusive tape or Dermicel. The advantage of the chamber compared with the use of patches was that there was no loss of test material and uniform contact with the skin. The test subjects were groups of 5-10 light-skinned, young Caucasians. The test material was applied on the mid-volar forearm once daily for 3 days with readings made at 72h, 30 min after removal. The test was conducted on both intact and scarified skin. The reactions were graded on a five-point scale from 0 to 4 (1: erythema, 2: increased erythema, 3: severe erythema with partial confluency with or without other lesions, 4: confluent severe erythema sometimes associated with oedema, necrosis or bulla formation).
GLP compliance:
no

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

Method

Type of population:
general
Subjects:
Five to 10 volunteer, light-skinned, young adult Caucasoids constituted a test panel. For very discriminating work "hyper-reactors" were selected; these persons were especially vulnerable to irritants and could be identified by a simple test, namely, elicitation of a brisk inflammatory reaction (severe erythema with edema and tiny vesicles)
by a 24-hour forearm chamber exposure to 5 % aqueous sodium lauryl sulfate.
Ethical approval:
not specified
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
A volume of 0.1 ml of nickel sulphate in various concentrations was pipetted on to a disc of two thicknesses of non-woven cotton cloth. The disc was mounted in a chamber designed for use in tests of contact sensitisation, which was sealed to the skin with non-occlusive tape or Dermicel. The advantage of the chamber compared with the use of patches was that there was no loss of test material and uniform contact with the skin. The test material was applied on the mid-volar forearm once daily for 3 days with readings made at 72h, 30 min after removal. The test was conducted on both intact and scarified skin.
Examinations:
The reactions were graded on a five-point scale from 0 to 4 (1: erythema, 2: increased erythema, 3: severe erythema with partial confluency with or without other lesions, 4: confluent severe erythema sometimes associated with oedema, necrosis or bulla formation).

Results and discussion

Results of examinations:
The sensitivity of the assay on scarified skin was compared with the sensitivity on normal skin. No details of the results on normal skin are shown. The threshold concentration to produce “just an irritation reaction in 3 days” on normal skin was 20.0% while on scarified skin it was 0.13%. The ratio of threshold concentration on normal skin and threshold concentration on scarified skin was 154. This was the highest ratio among the substances tested, which included surfactants, inorganic salts, antimicrobials, and acids.

Applicant's summary and conclusion

Executive summary:

STUDY RATED BY AN INDEPENDENT REVIEWER

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