Chromium trioxide

Sensitisation data (human)

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

Test material information

Constituent 1

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.