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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Constituent 1
Chemical structure
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