Registration Dossier
Registration Dossier
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EC number: 204-116-4 | CAS number: 115-95-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study but limited observation period.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Skin irritation and Corrosion: Reference chemical data bank Technical Report No 66.
- Author:
- ECETOC
- Year:
- 1 995
- Bibliographic source:
- Commission of the European Communities, Report EUR 14178 EN
- Reference Type:
- publication
- Title:
- Skin Irritation : Reference Chemicals Data Bank
- Author:
- Bagley DM, et al.
- Year:
- 1 996
- Bibliographic source:
- Toxicology in Vitro, 10, 1-6
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Linalyl acetate
- EC Number:
- 204-116-4
- EC Name:
- Linalyl acetate
- Cas Number:
- 115-95-7
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1,5-dimethyl-1-vinylhex-4-en-1-yl acetate
- Details on test material:
- - Name of test material (as cited in study report): linalyl acetate
- Analytical purity: 96.6%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- Test 1: 3 rabbits
Test 2: 4 rabbits - Details on study design:
- SCORING SYSTEM: Draize score according to OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.88
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days in 2/3 animals
- Remarks on result:
- other: Test 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.78
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days in 2/3 animals
- Remarks on result:
- other: Test 1
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 1-4
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.91
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days in 4/4 animals
- Remarks on result:
- other: Test 2
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1-4
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days in 1/4 animals
- Remarks on result:
- other: Test 2
Any other information on results incl. tables
ECETOC technical report page 152: Test 1
Readings |
Animal |
Exposure period: 4 h |
||
Erythema |
Edema |
Additional findings |
||
1 h |
1 |
0 |
0 |
|
2 |
2 |
2 |
||
3 |
2 |
3 |
||
24 h |
1 |
1 |
2 |
|
2 |
2 |
2 |
||
3 |
2 |
2 |
||
48 h |
1 |
2 |
1 |
|
2 |
2 |
2 |
||
3 |
2 |
2 |
||
72 h |
1 |
2 |
1 |
|
2 |
2 |
2 |
||
3 |
2 |
2 |
||
7 d |
1 |
0 |
0 |
Desquamation (marked) |
2 |
2 |
1 |
Desquamation |
|
3 |
2 |
2 |
Desquamation (marked) |
|
Mean 24 -72 h |
1 |
1.66 |
1.33 |
|
2 |
2 |
2 |
||
3 |
2 |
2 |
||
Mean |
1-3 |
1.88 |
1.78 |
|
ECETOC technical report page 153: Test 2
Readings |
Animal |
Exposure period: 4 h |
||
Erythema |
Edema |
Additional findings |
||
1 h |
1 |
2 |
1 |
|
2 |
1 |
2 |
||
3 |
2 |
2 |
||
4 |
1 |
2 |
||
24 h |
1 |
2 |
1 |
|
2 |
2 |
1 |
||
3 |
2 |
2 |
||
4 |
2 |
1 |
||
48 h |
1 |
2 |
1 |
|
2 |
2 |
1 |
||
3 |
2 |
1 |
||
4 |
2 |
0 |
||
72 h |
1 |
2 |
1 |
|
2 |
2 |
2 |
||
3 |
2 |
1 |
||
4 |
1 |
0 |
||
7 d |
1 |
2 |
1 |
Desquamation |
2 |
1 |
0 |
Desquamation (marked) |
|
3 |
2 |
0 |
||
4 |
1 |
0 |
Desquamation (slight) |
|
Mean 24 -72 h |
1 |
2 |
1 |
|
2 |
2 |
1.33 |
||
3 |
2 |
1.33 |
||
4 |
1.66 |
0.33 |
||
Mean |
1-4 |
1.91 |
1 |
|
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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