Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1971
Rationale for reliability incl. deficiencies:
other: No data on ethical approval. Only 25 volunteers were tested, application site was not reported
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Maximisation test in human
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Gund, 2 %, gamma-Undecalactone
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Reception date: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 25
- Sex: male
- Age: 21-58 years
- Race: 2 whites, 23 blacks
- Demographic information: no data
Clinical history:
Healthy adults
Controls:
none
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: no data
- Vehicle / solvent: none
- Concentrations: no data
- Volume applied: no data
- Testing/scoring schedule:
The material was applied to the same site of all subjects for 5 alternate-day 48 hour periods .The patch site was pre-treated for 24 hours with 5.0 % aqueous sodium lauryl sulfate under occlusion. Following a ten-day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by one-hour application of 10 % aqueous sodium lauryl sulfate under occlusion.


EXAMINATIONS
- The challenge site was read on removal of the patch and 24 hours thereafter.
- Grading/Scoring system: no data
- Statistical analysis: none

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: none

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 24 (one subject was not present at the 72 hour challenge reading)
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Any other information on results incl. tables

none

Applicant's summary and conclusion

Conclusions:
Under the conditions employed in this study, there was no evidence of sensitisation to the test material.
Executive summary:

A panel of 25 male and female healthy adult volunteers participated in a maximization test in which γ-Undecalactone (2 %) was applied to the subjects under occlusive patches. During the induction phase patch were applied for five alternate-day 48 hour periods. The patches were removed 24 hours after application. As the test material was not irritating in the pre-test, the patch site was pre-treated for 24 hours with 5.0 % aqueous sodium lauryl sulfate under occlusion. Following a ten-day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by one-hour application of 10 % aqueous sodium lauryl sulfate under occlusion. The challenge site was read on removal of the patch and 24 hours thereafter.

Under the conditions employed in this study, there was no evidence of sensitisation to γ-Undecalactone.