Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles and considered sufficiently reliable for the purpose of hazard assessment.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1990

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Skin prick test according to Malling (1993) - Commercial and in-house allergenic extracts from Cupressaceae family were used for skin prick testing and specific IgE detection in six groups of subjects exposed to a high concentration of Cupressaceae pollen.
GLP compliance:
no

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 1
- Sex: female
- Age: 40
Clinical history:
- History of allergy or casuistics for study subject or populations:
- Symptoms, onset and progress of the disease:
- Exposure history:
- Aggravating factors both in home and workplace:
- Family history:
- Medical history (for respiratory hypersensitivity):
- Any other allergic or airway disorders:
- Smoking history:
- Other:
Controls:
- Positive and negative controls were histamine solution (10 mg/mL) and 50 % glycerinated solution in water, respectively.
Route of administration:
dermal
Details on study design:
- Skin prick tests were performed according to standard procedure (Malling, 1993).
- Commercial and in-house allergenic extracts were used for skin prick testing and specific IgE detection in six groups of subjects exposed to a high concentration of Cupressaceae pollen.
- Specific IgE detection was performemed according to the procedure (Bousquet et al., 1990; Kleine-Tebbe et al., 1992; Merret et al., 1993; Olivieri et al., 1993; Salkie et al., 1994)
- Patients were asked to avoid antihistamine intake for at least 7 days before testing (8 weeks for astemizole). Test evaluation was done after 15 minutes.

Results and discussion

Results of examinations:
- Positive response: Sensitization effects, 31.5 % of the patients had positive responses to the in-house extract of the test material; 25.9 % had positive responses to the commercial extract.
- Four commercial and two in-house Cupressus sempervirens pollen extracts showed low cutaneous reactivity.
- Positive test results were recorded in 26 % of the 713 subjects tested. C. arizonica in-house pollen extracts gave rise to larger cutaneous reactions. Furthermore, the skin prick test response was positive in a greater number of subjects (38 %) of the same group.
- Six commercial immunoassays were able to detect specific IgE to C. sempervirens in rates ranging from 8.1% to 81.1%. Specific IgE to C. arizonica was detected by means of an in-house immunoenzymatic method in 70.3% of 54 patients with suspected "cypress" allergy, and specific IgE to C. sempervirens was detected in 75.9% of these patients by using a commercial system.
- High rates of cross-reactivity within the Cupressaceae family were recorded with both in vivo and in vitro tests.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Under the test condition, Cupressaceae pollen induced skin sensitization in human.
Executive summary:

Skin prick test was conducted in 713 male and female patients with Cupressaceae pollen.

Sensitization effects were observed: 31.5% of the patients had positive responses to the in-house extract of the test material; 25.9% had positive responses to the commercial extract.

Under the test condition, Cupressaceae pollen induced skin sensitization in human.