Registration Dossier
Registration Dossier
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EC number: 405-040-6 | CAS number: 63500-71-0 CIS/TRANS-TIMO; FLOROL; FLOROSA
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-methylpyran-4-ol
- EC Number:
- 405-040-6
- EC Name:
- A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-methylpyran-4-ol
- Cas Number:
- 63500-71-0
- Molecular formula:
- C10 H20 O2
- IUPAC Name:
- 4-methyl-2-(2-methylpropyl)oxan-4-ol
- Details on test material:
- - Analytical purity: >99%
- Lot/batch No.: S1943401
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0,5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 0,5; 24; 48; 72h
Additional observations on days 5 and 6 - Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24+48+72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24+48+72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24+48+72h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24+48+72h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24+48+72h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24+48+72h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
|
time |
animal 1 |
animal 2 |
animal 3 |
erythema |
24 h |
0 |
1 |
2 |
48 h |
0 |
1 |
2 |
|
72 h |
0 |
0 |
1 |
|
6 d |
0 |
0 |
0 |
|
edema |
24 h |
0 |
1 |
1 |
48 h |
0 |
1 |
1 |
|
72 h |
0 |
0 |
0 |
|
6 d |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Single semi-occlusive application elicited variable skin irritation ranging from no response to transient well defined erythema and very slight oedema. All reactions had resolved by day 6.
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