Registration Dossier
Registration Dossier
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EC number: 201-964-7 | CAS number: 90-05-1
Sensitisation data (human)
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:
- 1 975
- Bibliographic source:
- Contact Dermatitis, 1, 231-239
- Reference Type:
- publication
- Title:
- Monographs on fragrance raw materials
- Author:
- Opdyke DL, Letizia C.
- Year:
- 1 982
- Bibliographic source:
- Food Chem Toxicol, 20, 697-701.
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
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 substance name:
- Guaiacol
- EC Number:
- 201-964-7
- EC Name:
- Guaiacol
- Cas Number:
- 90-05-1
- Molecular formula:
- C7H8O2
- IUPAC Name:
- Phenol
- Details on test material:
- no data
Constituent 1
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.
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