Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

sensitisation data (humans)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
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 Type:
The identification of contact allergens by human assay. III The maximization test: a procedure for screening and rating contact sensitizers.
Kligman AM
Bibliographic source:
J Int Dermatol, 47 (5), 393-409.

Materials and methods

Type of sensitisation studied:
Study type:
study with volunteers
Test guideline
no guideline available
Principles of method if other than guideline:
Maximization test involving topical induction and challenge.
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Details on test material:
No information


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

- 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

- 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

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.