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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
JUN 1975 - OCT 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Follow-Up Study of Patients with Contact Dermatitis Caused by Chromates, Nickel, and Cobalt
Author:
A.Dooms-Goossen
Year:
1980
Bibliographic source:
Dermatologie 160: 249-260

Materials and methods

Type of sensitisation studied:
skin
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
- Short description of test conditions: 1,000 patients (396 males and 604 females) were patch tested at our contact allergy unit with the ÏCDRG standard test battery (Trolle Lassen, Denmark) using Silver-Patch® (Van der Bend, The Netherlands), and Tarpal® (Fisch) hypoallergenic tape. The ICDRG guidelines were followed. All test samples were stored in a refrigerator at 4°C to ensure stability.
- Parameters analysed / observed: The patch test results from 1,000 patients tested with the ICDRG standard series are analyzed for positive reactions to potassium dichromate, nickel sulphate, and cobalt chloride.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium dichromate
EC Number:
231-906-6
EC Name:
Potassium dichromate
Cas Number:
7778-50-9
Molecular formula:
Cr2H2O7.2K
IUPAC Name:
sodium dichromate
Details on test material:
Cr (K2Cr2O7)

Method

Type of population:
other: Patients with contact dermatitis
Ethical approval:
not applicable
Subjects:
- Number of subjects exposed: 1000
- Sex: 396 males and 604 females
- Demographic information: 69 (6.9%) suffered fromeczematous lesions only on their feet, 246 (24.6%) patients with eczema only on their hands, 124 were leg ulcer patients
Clinical history:
- Exposure history: 69 (6.9%) suffered fromeczematous lesions only on their feet, 246 (24.6%) patients with eczema only on their hands, 124 were leg ulcer patients; 9 of them reacted to potassium dichromate.

Controls:
none
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Description of patch: Silver-Patch® (Van der Bend, The Netherlands), and Tarpal® (Fisch) hypoallergenic tape.
- Concentrations: 0.5% (ICDRG test)

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 53
- Number of subjects with negative reactions 947

Positive patch test results to metals obtained from 1,000 patients tested with the ICDRG test series shows 25 of male patients and 28 of female patients, total 53 patients (5.3%) had a positive raction to potassium dichromate.
Positive patch test results from 69 patients with foot dermatitis (32 cases were considered allergic contact dermatoses) shows that 13 of patients (18.8%) had a positive reaction to potassium dichromate.
Positive patch test results from patients with hand eczema (109 cases were considered allergic contact dermatoses) shows 25 patients (10.2%) had a positive reaction to potassium dichromate.

Applicant's summary and conclusion

Conclusions:
Positive patch test results to metals obtained from 1,000 patients tested with the ICDRG test series shows 53 of patients (5.3%). Of the 53 patients allergic to potassium dichromate, this allergen was considered relevant to the dermatoses of 46 (87%) of them.
Executive summary:

1,000 patients (396 males and 604 females) were patch tested at contact allergy unit with the ÏCDRG standard test battery1 (Trolle Lassen, Denmark) using Silver-Patch® (Van der Bend, The Netherlands), and Tarpal® (Fisch) hypoallergenic tape. The ICDRG guidelines were followed. Positive patch test results to metals obtained from 1,000 patients tested with the ICDRG test series shows 53 of patients (5.3%). Of the 53 patients allergic to potassium dichromate, this allergen was considered relevant to the dermatoses of 46 (87%) of them.