Registration Dossier

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: The method was detailed in the publications Kligman (1966) and Kligman & Epstein (1975). The purity of the test substance was unknown. The study was performed before the GLP standard was established.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Updating the maximization test for identifying contact allergens
Author:
Kligman A.M., Epstein W
Year:
1975
Bibliographic source:
Contact Dermatitis, 1, 231-239
Reference Type:
publication
Title:
Monographs on fragrance raw materials
Author:
Opdyke DL, Letizia C.
Year:
1982
Bibliographic source:
Food Chem Toxicol, 20, 697-701.
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Maximization test on humans: A patch of the materials was applied on 25 healthy adult volunteers to normal sites on the forearms or back for 48
hours under occlusion.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Method

Type of population:
other: Healthy adult volunteers
Subjects:
Details on subjects
- Number of subjects exposed: 25
- Sex: man (11) and woman (14)
- Age: between 18 to 26 years old
- Race: White (22) and black (3)
- Demographic information: no data

Clinical history:
no data
Controls:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: a non woven, highly absorbent, cloth, prepared by Curity under the trade name of Webril.
- Vehicle / solvent: petrolatum
- Concentrations: 2%
- Volume applied: 1 ml
- Testing/scoring schedule: The test substance was applied under occlusion to the volar forearm or back of all subjects for five alternate-day 48 hour periods. The patch site was pre-treated for 24 hours with 2.5% aqueous sodium lauryl sulfate under occlusion.
Following a ten day rest period, a challenge patch of the test material was applied to a different site for a 48-hour period under occlusion.
Prior to challenge, 5 to 10% was applied to test site for one hour before application of test material.
- Removal of test substance: no data

EXAMINATIONS
- Grading/Scoring system: Observations were made immediately after removal of the challenge patch and 24 hours thereafter using the following scale:
- 0 = not sensitized,
- 1 = mild sensitization: mainly erythema and little edema,
- 2 = moderate sensitization: erythema with infiltration, raised, spreading beyond the borders, with or without vesiculation,
- 3 = strong sensitization: large, vesculo-bullous, vividly red, infiltrated plaques.

- Statistical analysis: no data

Results and discussion

Results of examinations:
There were no instances of contact-sensitization from this material on the Maximization Test.

Applicant's summary and conclusion

Conclusions:
Not sensitizing.
Executive summary:

In a study (Kligman, 1978), human were tested in maximization test with Gaiacol.

The test substance was applied under occlusion to the volar forearm or back of all subjects for five alternate-day 48 hour periods. The patch site was pre-treated for 24 hours with 2.5% aqueous sodium lauryl sulfate under occlusion.

Following a ten day rest period, a challenge patch of the test material was applied to a different site for a 48-hour period under occlusion.

Prior to challenge, 5 to 10% was applied to test site for one hour before application of test material.

There was no signs of sensitization with Gaiacol in this study, and Gaiacol could be considered as a non-sensitizer.