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Toxicological information

Exposure related observations in humans: other data

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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

Referenceopen allclose all

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 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 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

Reference
Name:
Unnamed
Type:
Constituent

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