Registration Dossier
Registration Dossier
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EC number: 906-125-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- 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:
- publication
- Title:
- Skin Irritation and Corrosion: Reference Chemicals Data Bank
- Author:
- Givaudan-Roure
- Year:
- 1 995
- Bibliographic source:
- ECETOC Technical Report No. 66
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- Geraniol
- EC Number:
- 203-377-1
- EC Name:
- Geraniol
- Cas Number:
- 106-24-1
- Molecular formula:
- C10H18O
- IUPAC Name:
- (2E)-3,7-dimethylocta-2,6-dien-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Geraniol
- Analytical purity: 90.7
- Lot/batch No.: 5414003
Constituent 1
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
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