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: Non GLP, non-guideline, human experimental study, restrictions in design and reporting but otherwise acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
The identification of contact allergens by human assay. III The maximization test: a procedure for screening and rating contact sensitizers.
Author:
Kligman AM
Year:
1966
Bibliographic source:
J Int Dermatol, 47 (5), 393-409.

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 involving topical induction and challenge.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No information

Method

Type of population:
other: prison inmates
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 25
- Sex: male
- Age: 18-50
- Race: 90% of subjects were Negro
Clinical history:
No information
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patches:
Induction patch -non woven, highly absorbent cloth (Webril), 1.5" square, covered with impermeable plastic tape (Blenderm) and held in place with John and Johnson Perforated Band-Aid Clear Tape.
Challenge patch - 1" square Webril, covered with impermeable plastic tape (Blenderm). A single piece of white adhesive was placed over the Blenderm. All held in place with John and Johnson Perforated Band-Aid Clear Tape.
- Vehicle / solvent: mineral oil or petrolatum
- Concentrations: 50% induction, 20% challenge
- Volume applied: induction - 1 mL, challenge - 0.4 mL
- Testing schedule: 5 x 48 hour induction patches with 1 day rest period between exposures applied to same site. Challenge 48 hour occlusive patch.
- Scoring schedule: immediately after removal of 48 hour challenge patch and 2 days later.
- Removal of test substance: no data

EXAMINATIONS
- Grading/Scoring system: positive response was recorded if the treated site was clearly more inflammatory that the control site
- Statistical analysis: none

Results and discussion

Results of examinations:
Sensitisation rate was reported to be 0/25. No information provided on any reactions seen.

Applicant's summary and conclusion

Conclusions:
Benzene is considered not to be a skin sensitiser in humans.
Executive summary:

The sensitisation potential of benzene was assessed in a group of 25 volunteers using five 48 hour topical inductions of 50% benzene to inflamed skin at and a 48 hour topical challenge at 20%. There was no evidence of skin sensitisation in any of the 25 volunteers.

Benzene is considered not to be a skin sensitiser in humans.