Distillates (petroleum), heavy steam-cracked

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

migrated information: read-across based on grouping of substances (category approach)

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

Test material information

Constituent 1

Reference substance name:

Benzene

EC Number:

200-753-7

EC Name:

Benzene

Cas Number:

71-43-2

Molecular formula:

C6H6

IUPAC Name:

benzene

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.