Registration Dossier

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:
1988
Reference Type:
secondary source
Title:
Unnamed
Year:
1990

Materials and methods

Type of sensitisation studied:
skin

Test material

Reference
Name:
Unnamed
Type:
Constituent

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 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.