Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
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:
Unnamed
Year:
1986

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline required
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
not specified
Details on test material:
not specified

Method

Type of population:
other: general (patients affected by leg ulcers)
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 25
- Sex: male and female (10 male and 15 female)
- Age: average age 69 years; range 45-87
- Race: not specified
- Demographic information: not specified
- Other: Patients who had lesions for less than 12 months were excluded.

Clinical history:
- History of allergy or casuistics for study subject or populations: patients affected by leg ulcers. The patients studied cannot be considered as "patients at risk of sensitzation" as shown by anamnestic data and patch tests. None had a pre-existing allergie skin reactivity connected with their occupational or other activity
- Symptoms, onset and progress of the disease: 12 patients had varicose, 6 post-phlebitic and 7 both varicose and post-phlebitic ulcers. In 4 cases
the lesions were induced by trauma.
- Exposure history: exposure to creams and ointments
- Aggravating factors both in home and workplace: not specified
- Family history: not specified
- Medical history (for respiratory hypersensitivity): not relevant
- Any other allergic or airway disorders: not specified
- Smoking history: not specified
- Other: not specified
Controls:
not specified
Route of administration:
dermal
Details on study design:
the Authors collected an allergological, family and personal history before patch testing. The GIRDCA series and a vehicle series were used, produced by Lofarma (Milan, ltaly) and by HollisterStier (Spokane, Washington, USA) using Finn Chambers (Norgesplaster A/S Oslo, Norway) as the
test unit.
Patch test evaluation was performed according to Wilkinson et al. (1970).

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: 3 patients resulted positive to vehicle series (Pyrogallol)

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 3
- Number of subjects with negative reactions: not reported
- Number of subjects with equivocal reactions: not reported
- Number of subjects with irritating reactions: not reported

RESULT OF CASE REPORT: see above

OTHER RESULTS: not reported

Applicant's summary and conclusion

Conclusions:
Twenty-five patients (average age 65 years) with leg ulcers were patch tested (Finnchambers) with Pyrogallol. Patch tests were evaluated according to the procedure of Wilkinson et aI. The distribution of leg ulcers was as follows: varicose ulcers (12 patients), postphlebitic ulcers (6 patients), and both varicose and postphlebitic ulcers (7 patients). Patients who had lesions for less than 12 months were excluded. Positive reactions to Pyrogallol were observed in 3 patients.