Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Data from secondary literature

Data source

Referenceopen allclose all

Reference Type:
secondary source
Reference Type:
secondary source

Materials and methods

Test material

Results and discussion

Applicant's summary and conclusion

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.