Cypress, Cupressus sempervirens, ext.

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

1996

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1996

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

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Cupressaceae pollen

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 713
- Sex: Male and female
- Age: 2-82 years (mean ± SD, 28.5 ± 17.1; median value 26)

Clinical history:

- Patients included were those complaining of symptoms related to upper or lower respiratory tract disorders or conjunctival disease, all suspected of being allergic in nature.

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.