Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1976
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Method not validated and different from today standard methods

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976
Reference Type:
publication
Title:
Unnamed
Year:
1966
Report Date:
1966
Reference Type:
publication
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human skin sensitization test using the maximization method of Kligman (ref.2)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2 ethyl hexanol
- no further information on test substance

Method

Type of population:
other: healthy innate male volunteers
Subjects:
35 test subjects were screened, 29 volunteers completed the study
Controls:
not required
Route of administration:
dermal
Details on study design:
RANGE FINDING TESTS: irritation effects of test substance were tested in a pilot study. Test substance was applied under occlusive conditions to the back of at least 10 test subjects for 24 h and the reaction was rated. If no irritation was observed, the induction sites were pretreated for 24 h with 1.0 mL of a 5% aqueous sodium lauryl sulfate solution on a Webril patch.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5; before the first application, the induction site was pretreated under occlusive conditions for 24 h with 1.0 mL of a 5% aqueous sodium lauryl sulfate solution on a 1.5 x 1.5 inch Webril patch
- Exposure period: 15 days follwed by an 10 to 14 day rest period
- Test groups: 1 test group only
- Control group: no
- Site: inside of forearms
- Frequency of applications: exposure periods of 48 h were follwed by a rest period of 24 h
- Duration: 72 h
- Volume applied: 1.0 mL of test substance
- Concentration 4% in petrolatum

B. CHALLENGE EXPOSURE
- No. of exposures: 1; before the challenge exposure with test substance, the application site is pretreated under occlusive conditions for 30 minuteswith 0.4 mL of a 10% aqueous sodium lauryl sulfate solution on a Webril patch
- Day(s) of challenge: 1
- Exposure period: 48 h
- Test groups: 1 test group only
- Control group: no
- Site: on the back of test subjects
- Volume applied: 0.4 mL
- Concentration 4% in petrolatum
- Evaluation (hr after challenge): immediatly after removal of the patch and after 2 days

Results and discussion

Results of examinations:
2-Ethylhexanol did not produce any reactions that were considered irritant or allergic in the 29 human subjects tested. Under the conditions of the test used, 2-ethanol was not sensitizing.

Applicant's summary and conclusion

Conclusions:
2-Ethylhexanol did not produce any reactions that were considered irritant or allergic in the 29 human subjects tested. Under the conditions of the test used, 2-ethanol was not sensitizing.
Executive summary:

In a dermal sensitization study, the sensitizing potential of 2-ethylhexanol was tested on 29 male human volunteers using the maximization method of Kligman. There was one test group and no controls. For induction, 1.0 mL of the test substance was applied for 48 h under occlusive conditions in 5 alternating repetitions (48 hours occlusive exposure, 24 hours exposure free period). After a rest period of 10 to 14 days, challenge exposure consisted of a single occlusive application of 0.4 mL of 2-ethylhexanol for 48 h. Immediately after removal of the patch and after 48 h, skin reactions were recorded. None of the tested subjects showed any signs of irritation or sensitisation.