Registration Dossier
Registration Dossier
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EC number: 271-233-5 | CAS number: 68526-84-1
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data from secondary literature
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 988
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test material
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Not sensitizing.
- Executive summary:
Human volunteer studies with related alcohols showed little evidence of dermal sensitization. Maximization testing was conducted using five 48-hour covered patch tests over a 10-day period followed by a challenge test 10-14 days after the induction phase. The alcohols tested included 2-ethylhexanol (29 volunteers, 4% 2-ethylhexanol in petrolatum), undecanol (25 volunteers, 4% in petrolatum), and 1-dodecanol (25 volunteers using 4% in petrolatum). Patch tests in eczema patients with 5% and 10% 1-dodecanol in petrolatum showed local reactions in 4/1664 and 15/1664 subjects, respectively. Details on the type of observed skin reactions, which the investigators attributed to a sensitization response, were not provided. As pointed out by BIBRA, interpretation of these results is complicated by the fact that no data are available on the irritancy potential of these concentrations on human skin.
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