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:
other: Acceptable publication which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Contact allergy: Predictive testing of fragrance ingredients in humans by|Draize and maximization methods
Author:
Marzulli FN and Maibach HI
Year:
1980
Bibliographic source:
Journal of Environmental Pathology and Toxicology 3(5-6): 235-245
Reference Type:
secondary source
Title:
No information
Author:
Marzulli FN and Maibach HI
Year:
2008
Bibliographic source:
RIFM database

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
modified Draize-procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 104
- Age: adult
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive, on the arm or upper back
- Description of patch: covered with a square occlusive Band Aid; no perforations.
- Vehicle / solvent: petrolatum or alcohol
- Concentrations: 10% for induction and challenge
- Volume applied: 0.2 ml or 0.2 g
- Testing/scoring schedule: Induction consisted of the application of 10 patches which remained in place for 48-72 hours each. The rest period was 2 weeks. Challenge consisted of the application of a 72 hour patch on a new skin site with a nonirritating concentration of test material.

EXAMINATIONS
- Grading/Scoring system: The scoring was as follows:
1 = erythema;
2 = erythema and induration;
3 = vesiculation;
4 = bulla formation.
A score of grade 2 or greater is evidence of skin sensitization. The results were reported as response fraction or percent positive
(sensitization index) No further information provided.

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 2/73 in alcohol; 0/104 in petrolatum
- Number of subjects with negative reactions71/73 inalcohol; 104/104 in petrolatum

Applicant's summary and conclusion

Conclusions:
Geraniol at 10% is sensitising when applied with alcohol, but not with petrolatum.