Geraniol

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable documented publication which meets basic scientific principles

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Evaluation of a human patch test for the identification and classification of skin irritation potential

Author:

York M, Griffiths HA, Whittle E and Basketter DA

Year:

1996

Bibliographic source:

Contact Dermatitis, 34(2), 204-212

Reference 2

Reference Type:

secondary source

Title:

The classification of skin irritants by human patch test

Author:

Basketter DA, Chamberlain M, Griffiths HA, Rowson M, Whittle E and York M

Year:

1997

Bibliographic source:

Food and Chemical Toxicology 35(8): 845-852

Reference 3

Reference Type:

secondary source

Title:

No information

Author:

York M, Griffiths HA, Whittle E and Basketter DA

Year:

2008

Bibliographic source:

RIFM database

Materials and methods

Endpoint addressed:

skin irritation / corrosion

Principles of method if other than guideline:

closed patch test

Test material

Test material information

Constituent 1

Reference substance name:

Geraniol

EC Number:

203-377-1

EC Name:

Geraniol

Cas Number:

106-24-1

Molecular formula:

C10H18O

IUPAC Name:

3,7-dimethylocta-2,6-dien-1-ol

Method

Details on study design:

- A closed patch test was conducted on about 30 subjects (male and female) per material.
- The subjects were between the ages of 18 and 65 years old.

Details on exposure:

METHOD
- 0.2 ml (0.2 grams for solid test materials) was applied undiluted to a 25 mm Plain Hill Top Chamber containing a Webril pad (moistened for solid test materials).
- Test materials were applied progressively from 15 and 30 minutes through 1, 2, 3 and 4 hours.
- The 15 and 30 minute exposure periods were omitted if the Study Directors were satisfied that excessive reactions would not occur following the 1 hour exposure.
- The upper outer arm was used as the treatment sites.
- 20% sodium dodecyl sulfate (SDS) was used as a positive control

EVALUATION
Reactions were assessed 24, 48 and 72 hours after patch removal according to the following 4 point scale:
0 = no reaction;
+ = weakly positive reaction (usually characterized by mild erythema across most of the treatment site),
++ = moderately positive reaction (usually distinct erythema possibly spreading beyond the treatment site),
+++ = strongly positive reaction (strong, often spreading erythema with oedema).

A volunteer reaction with a +, ++, or +++ reaction at any one of the assessment times was considered to have demonstrated a "positive" irritant reaction and treatment with the material was terminated.
.

Results and discussion

Results:

irritant effects in 2/25 subjects.

Any other information on results incl. tables

Reactions were as follows:

15 min: 0/28

30 min: 0/28

1 h: 0/27

2 h: 0/27

3h: 0/25

4 h: 2/25

Three subjects discontinued the study for non-treatment related reasons.

Applicant's summary and conclusion

Conclusions:

Geraniol at 100% for 4 h showed irritant effects in 2/25 subjects