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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Results of patch testing with a special series of rubber allergens.
Author:
Holness DL and Nethercott JR
Year:
1997
Bibliographic source:
Contact dermatitis, 36, 207-211.

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
no data
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No details

Method

Type of population:
general
Ethical approval:
confirmed, but no further information available
Subjects:
1670 patients were patch tested with the screening tray and 317 of these were also tested with the rubber tray (316 tested with 1% DPG).
Demographic information, including diagnosis, distribution of the eruption, job, past history of atopic disease, length of time of the skin problem, and the use of protective equipment were also used in the analysis.
Clinical history:
no data
Controls:
no data
Route of administration:
dermal
Details on study design:
In each case, the patients were patch tested with either Al-test strips (Imeco AB, Sweden) or Finn Chambers (Epitest Limited OY, Finland). The patch test strips were applied to the subject's back using Scanpor tape (Norgesplaster, Norway) andleft in place for 2 or 3 days. The initial reading took place 30 to 60 min after the patch tests were removed. A second reading was made at 2 or 3 days following the first reading. The scoring methods were those used by the

Results and discussion

Results of examinations:
The purpose of this study was to examine the results of patch testing with the rubber components on a standard screening tray and compare them with the results of testing with a special series of 27 rubber components (rubber tray). 1670 patients were patch tested with the screening tray and 317 of these were also tested with the rubber tray. 4.4% of those tested with DPG had a positive response.

Applicant's summary and conclusion

Conclusions:
4.4% of those tested with DPG had a positive response.
Executive summary:

The purpose of this study was to examine the results of patch testing with the rubber components on a standard screening tray and compare them with the results of testing with a special series of 27 rubber components (rubber tray). 1670 patients were patch tested with the screening tray and 317 of these were also tested with the rubber tray. 4.4% of those tested with DPG had a positive response.