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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: human data
Adequacy of study:
supporting study
Reliability:
other: Any kind of reliability rating is not considered to be applicable, since human epidemiological studies, field studies and case reports are not conducted/reported according to standardised guidelines
Rationale for reliability incl. deficiencies:
other: Acceptable publication

Data source

Reference
Reference Type:
publication
Title:
Occupational relevance of positive standard patch-test results in employed persons with an initial report of an occupational skin disease
Author:
Dickel, H. et al.
Year:
2002
Bibliographic source:
Int Arch Occup Environ Health 75: 423 - 434.

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
In this study standard patch-test results of employed persons with an initial report of an occupational skin disease were analysed within 24 occupational groups. One of the tested substances was cobalt chloride (1% concentration in petrolatum).
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): cobalt chloride

Method

Type of population:
occupational
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 4112 cases
- Demographic information: 4112 cases occurred in the 24 occupational groups examined, which were the following groups: assemblers (73 cases), bakers (205 cases), construction and cement workers (195 cases), cooks (147 cases), dental technicians (44 cases), electronics industry (118 cases)
electroplaters (27 cases), florists (45 cases), food-processing industry and butchers (65 cases), hairdressers and barbers (997 cases), health care workers (607 cases), housekeepers, restaurant business, cleaners (288 cases), leather industry and fur processors (37 cases), locksmiths and automobile mechanics (179 cases), machinists (73 cases), mechanics (65 cases), metal processors (177 cases), metal-surface processors (321 cases), painters and varnishers (146 cases), pastry cooks (61 cases), solderers (21 cases), tile setters and terrazzo workers (55 cases), unskilled workers (43 cases) and wood processors (123 cases)
Controls:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

The 21 standard screening tray allergens were obtained, in the majority of cases, from HERMAL Kurt Herrmann, Reinbek, Hamburg, Germany. A few changes were made in the standard patch-test battery over the time period examined, concerning mercapto-mix, mercaptobenzothiazole, paraben-mix and p-phenylenediamine (PPD)-black rubber.


ADMINISTRATION
All employed persons were patch tested on the back by dermatologists using the standard series in accordance with standard methodology (Fischer & Maibach, 1986, Wahlberg, 1992)*. The patients were tested with 1% cobalt chloride in petrolatum. Additionally, specific screening series and less frequent contact agents brought by the employed were tested, depending on their work routines. test sites were on normal skin, free of dermatitis. Patch tests were removed after 24 or 48 hours.

EXAMINATIONS
- Grading/Scoring system: the readings were routinely taken, between days D1 (24 hours) and D4 (96 hours; later readings were taken, to a lesser extent, up to D7 (168 hours). The patch-test results were recorded according to the recommendations of the International Contact Dermatitis Research Group (ICDRG) (Fregert, 1981)* and the German Contact Dermatitis Group (DKG) (Brehler & Hellweg, 1995)*. Each positive reaction was reported, based on the final interpretation, and assessed for its occupational relevance by a government physician who deals with OSDs as described elsewhere (Schmidt, 2000)*. The physician's fundamental knowledge of exposure in the work environment helped in the assessment of the causes of reactions. in the reports all occupationally relevant sensitisation were also clinically relevant.
- Statistical analysis: the statistical analyses were performed with the program package SASTM 6.12 (SAS Institute, Cary, North Carolina, USA).

*References
- Fischer T, Maibach HI (1986) Patch testing in allergic contact dermatitis: an update. Semin Dermatol 5: 214 - 224.
- Wahlberg JE (1992) Patch testing. In: Rycroft RJG, Menné T, Frosch PJ, Benezra C (eds) Textbook of contact dermatitis. Springer, Berlin heidelberg, pp 239 - 268.
- Fregret S (1981) Manual of contact dermatitis. Munksgaard, Copenhagen.
- Brehler R, Hellweg b (1995) Beurteilung von Epikutantestreaktionen nach Empfehlungen der Deutschen Kontaktallergie-Gruppe. Dt Derm 43: 688 - 690.
- Schmidt A, Kühl M, Diepgen TL (2000) (The impact of type.IV allergy on compensation of occupational contact dermatitis). Dermatol Beruf Umwelt 48: 215 - 221.

Results and discussion

Results of examinations:
- of the 4112 cases 554 cases (13.5%) showed a positive reaction to 1% cobalt chloride
- of the 554 cases 94 cases (17%) had an occupational relevance

Any other information on results incl. tables

Table 1: Absolute frequencies of detected (ns) and occupationally relevant sensitisation (ns or s) of cobalt chloride by cases with an initial report of an occupational skin disease within 24 occupational groups

Occupational group

Absolute frequencies

Occupationally relevant sensitisation

assemblers

8

0

bakers

13

0

Construction and cement workers

38

18

Cooks

19

0

Dental technicians

3

1

Electronics industry

20

1

Electroplaters

7

5

Florists

4

0

Food-processing industry and butchers

9

2

Hairdressers and barbers

142

15

Health care workers

100

10

Housekeepers, restaurant business, cleaners

51

4

Leather industry and fur processors

4

2

Locksmiths and automobile mechanics

13

4

Machinists

6

2

Mechanics

7

2

Metal processors

26

4

Metal-surface processors

37

10

Painters and varnishers

14

3

Pastry cooks

4

0

Solderers

6

0

Tile setters and terrazzo workers

9

6

Unskilled workers

6

2

Wood processors

8

3

Total

554

94

Applicant's summary and conclusion

Conclusions:
Of the 4112 cases 554 cases (13.5%) showed a positive reaction to 1% cobalt chloride and of these 554 cases 94 cases (17%) had an occupational relevance.