Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1966
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: This study is classified as not reliable because sufficient data on the study design was not available.

Data source

Reference
Reference Type:
publication
Title:
The Identification of Contact Allergens by Human Assay
Author:
Kligman, AM
Year:
1966
Bibliographic source:
The Journal of Investigative Dermatology

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Maximization Test
Deviations:
yes
Remarks:
adopted for human volunteers
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): hexane
- Analytical Purity: assumed to be 100% active ingredients

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 25
- Sex: male
- Age: 18-50
- Race: 90% African-American
- Demographic information: inmates of Holmesburg Prison
Route of administration:
dermal
Details on study design:
TYPE OF TEST USED: patch test


ADMINISTRATION
- Type of application: occlusive
- Description of patch: Webril covered with 3 M Blenderm which is secured with Perforated Band-Aid Clear Tape
- Vehicle / solvent: no solvent was used during induction, during challenge mineral oil or petrolatum was used
- Concentrations: 100 % inducation, 25% challenge
- Volume applied: 1.0 ml inducation, 0.4 ml challenge
- Testing/scoring schedule: skin was scored immediately after each 48 hr exposure

EXAMINATIONS
- Grading/Scoring system: 0-2 positive responses was considered a weak sensitizer, 3-7 positive responses was considered a mild sensitizer, 8-13 positive responses was considered a moderate sensitizer, 14-20 positive responses was considered a strong sensitizer, 21-25 positive responses was considered an extreme sensitizer

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 25

Applicant's summary and conclusion

Conclusions:
The test substance is not sensitizing.
Executive summary:

This study examined the skin sensitization potential of hexane. 1.0 ml of test substance was placed on the extremities of 25 male volunteers, and covered occlusively. The induction patches were left in place for 48 hrs. After a 24 hr interval, the exposure was repeated for another 48 hrs. This was done for a total of 5 exposures. A challenge exposure was then done using a 25% concentration of test substance. The challenge exposure was 48 hrs. No irritation was seen in any of the test subjects. The test substance is not sensitizing.