Registration Dossier
Registration Dossier
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EC number: 226-006-5 | CAS number: 5208-93-5
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)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-methyl-1-(2,6,6-trimethylcyclohex-1-en-1-yl)penta-1,4-dien-3-ol
- EC Number:
- 226-006-5
- EC Name:
- 3-methyl-1-(2,6,6-trimethylcyclohex-1-en-1-yl)penta-1,4-dien-3-ol
- Cas Number:
- 5208-93-5
- Molecular formula:
- C15H24O
- IUPAC Name:
- (4E)-3-methyl-5-(2,6,6-trimethylcyclohex-1-en-1-yl)penta-1,4-dien-3-ol
- Details on test material:
- - Name of test material (as cited in study report): Vinyljonol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.99 kg (mean)
- Housing: single
- Diet: about 130 g per animal per day (Kliba 341)
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml
- Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 15 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: test patches were secured in position with a porous dressing (four layers of absorbent gauze & porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure period with lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline 404/Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24/48/72 hrs
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24/48/72 hrs
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24/48/72 hrs
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24/48/72 hrs
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24/48/72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24/48/72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect
- Other effects:
- no other effects observed
Any other information on results incl. tables
| Exposition: | 4 hrs | |||
| Animal | Reading | Erythema | Edema | Symptoms |
| 1 | 4 hrs | 0 | 0 | |
| 2 | 4 hrs | 2 | 0 | |
| 3 | 4 hrs | 2 | 0 | |
| 1 | 24 hrs | 2 | 1 | |
| 2 | 24 hrs | 1 | 0 | |
| 3 | 24 hrs | 1 | 0 | |
| 1 | 48 hrs | 1 | 0 | |
| 2 | 48 hrs | 1 | 0 | |
| 3 | 48 hrs | 0 | 0 | |
| 1 | 72 hrs | 2 | 1 | |
| 2 | 72 hrs | 1 | 0 | |
| 3 | 72 hrs | 0 | 0 | scaling |
| 1 | 8 d | 1 | 0 | scaling |
| 2 | 8 d | 0 | 0 | |
| 3 | 8 d | 0 | 0 | scaling |
| 1 | 15 d | 0 | 0 | scaling |
| 2 | 15 d | 0 | 0 | |
| 3 | 15 d | 0 | 0 | |
| mean (animal 1-3) | 24/48/72 hrs | 1.0 | 0.2 | |
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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