Registration Dossier
Registration Dossier
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EC number: 203-002-1 | CAS number: 102-06-7
Sensitisation data (human)
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:
- 1 997
- 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 substance name:
- 1,3-diphenylguanidine
- EC Number:
- 203-002-1
- EC Name:
- 1,3-diphenylguanidine
- Cas Number:
- 102-06-7
- Molecular formula:
- C13H13N3
- IUPAC Name:
- 1,3-diphenylguanidine
- Details on test material:
- No details
Constituent 1
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.
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