Registration Dossier
Registration Dossier
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EC number: 309-984-9 | CAS number: 101896-26-8 A residue from the distillation of crude benzole to remove benzole fronts. Composed primarily of benzene, toluene and xylenes boiling in the range of approximately 75°C to 200°C (167°F to 392°F).
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles
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:
- 1 966
- Bibliographic source:
- J Invest Dermatol 47(5), 393-409
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- For induction, test substances are repeatedly applied to the skin on the forearm of human subjects. For challenge, a single dose of test substance is epicutaneously applied to the back of test subjects.
- GLP compliance:
- no
- Type of study:
- other: human maximisation test
Test material
- 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:
- - Name of test material (as cited in study report): benzene
- no further information on test substance
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST SUBJECTS: male afro-american healthy adults aged 18 to 50
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil or petrolatum
- Concentration / amount:
- Induction: 50%
Challenge: 20%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil or petrolatum
- Concentration / amount:
- Induction: 50%
Challenge: 20%
- No. of animals per dose:
- 25 human volunteers
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Exposure period: 15 days
- Test groups: 1.0 mL 50% test substance solution on a ca. 4 x 4 cm Webril patch covered by 3 M Blenderm tape completely impermeable
- Control group: no control group
- Site: forearm or calf
- Frequency of applications: every 72 h
- Duration: 48 h
- Concentrations: 50% solution in all induction exposures
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: no data
- Exposure period: 48 h
- Test groups: 0.4 mL of 20% test substance solution on a ca. 2.5 y 2.5 cm Webril patch covered by 3 M Blenderm tape completely impermeable
- Control group: no control group
- Site: back
- Concentrations: 20% test substance concentration in mineral oil or petrolatum
- Evaluation (hr after challenge): immediately after removal of the patch and again in another 2 days - Challenge controls:
- untreated site on the back of test subject
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction 50%, challenge 20%
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction 50%, challenge 20%. No with. + reactions: 0.0. Total no. in groups: 25.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 96
- Group:
- test chemical
- Dose level:
- induction 50%, challenge 20%
- No. with + reactions:
- 0
- Total no. in group:
- 25
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 96.0. Group: test group. Dose level: induction 50%, challenge 20%. No with. + reactions: 0.0. Total no. in groups: 25.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In a human maximisation test according to Kligman, none of the 25 test subjects showed a sensitisation reaction. There was no evidence of a sensitising potential of benzene.
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