Registration Dossier
Registration Dossier
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EC number: 202-849-4 | CAS number: 100-41-4
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- other: publication
- Adequacy of study:
- other information
- Study period:
- 1975
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Report to RIFM
- Author:
- Kligman, A.M.
- Year:
- 1 975
- Bibliographic source:
- Food Cosmet. Toxicol. 13:803-804
- Reference Type:
- secondary source
- Title:
- Fragrance raw material monographs. Ethylbenzene
- Author:
- Opdyke, D.L.J.
- Year:
- 1 975
- Bibliographic source:
- Food Cosmet. Toxicol 13:803-804
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 as cited in Kligman (1966) and Kligman and Epstein (1975).
Ethylbenzene was applied under occlusion to the same site on the volar forearms of all subjects for 5 alternate day 48 hr periods. The patch site was pre-treated for 24 hrs with 5% aqueous solution of sodium lauryl sulfate under occlusion. The challenge sites were read on removal of the patch and 24 hrs later. - GLP compliance:
- not specified
Test material
- Reference substance name:
- Ethylbenzene
- EC Number:
- 202-849-4
- EC Name:
- Ethylbenzene
- Cas Number:
- 100-41-4
- Molecular formula:
- C8H10
- IUPAC Name:
- ethylbenzene
- Details on test material:
- - Name of test material (as cited in study report): Ethylbenzene
Constituent 1
Method
- Type of population:
- not specified
- Ethical approval:
- not specified
- Subjects:
- human volunteers
- Clinical history:
- No data
- Controls:
- No data
- Route of administration:
- dermal
- Details on study design:
- Maximization test as cited in Kligman (1966) and Kligman and Epstein (1975).
Ethylbenzene was applied under occlusion to the same site on the volar forearms of all subjects for 5 alternate day 48 hr periods. The patch site was pre-treated for 24 hrs with 5% aqueous solution of sodium lauryl sulfate under occlusion. The challenge sites were read on removal of the patch and 24 hrs later.
Results and discussion
- Results of examinations:
- Not sensitizing.
No. with positive reactions: 48 and 72 hr readings: 0 out of 25 (test group); dose: 10%
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the study ethylbenzene was not sensitising to human.
- Executive summary:
This maximization test was carried out with ethylbenzene (10% in petrolatum) in 25 human volunteers. There were no sensitisation reactions. No further details are available as this is a reference to unpublished data.
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