Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
As stated in the ECETOC technical report, this study was performed according to OECD guideline 404
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Geraniol
- Analytical purity: 90.7
- Lot/batch No.: 5414003

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100 %
Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
experiment 1: 3
experiment 2: 4
experiment 3: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: experiment 1
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: experiment 1
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
experiment 1
Time point:
other: 24 - 72 h
Score:
3.67
Max. score:
8
Reversibility:
not fully reversible within: 7 d
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.08
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: experiment 2
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.25
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: experiment 2
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
experiment 2
Time point:
other: 24 - 72 h
Score:
3.33
Max. score:
8
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.92
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: experiment 3
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: experiment 3
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
experiment 3
Time point:
other: 24 - 72 h
Score:
2.92
Max. score:
8
Reversibility:
not fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU