Registration Dossier
Registration Dossier
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EC number: 208-008-8 | CAS number: 505-32-8
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: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- BASF-Test, no guideline available at that time.
- GLP compliance:
- no
Test material
- Reference substance name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- EC Number:
- 208-008-8
- EC Name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- Cas Number:
- 505-32-8
- Molecular formula:
- C20H40O
- IUPAC Name:
- 3,7,11,15-tetramethylhexadec-1-en-3-ol
- Details on test material:
- - Name of test material (as cited in study report): Isophytol G
- Physical state: fluid
- Analytical purity: ca. 90 %
- Impurities (identity and concentrations): not reported
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data, used animals
- Age at study initiation: no data
- Weight at study initiation: female 2.09 kg, male 2.06 kg
Test system
- Type of coverage:
- occlusive
- 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): not reported
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 1, 5, 15 min, 20 hours
- Observation period:
- 8 days
- Number of animals:
- 2 (1 male, 1 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 1, 5, 15 min, respectively; not washed after 20 hours exposure
SCORING SYSTEM: BASF scheme
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- all animals
- Time point:
- other: 24, 48, 72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Application duration: 1 min
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Application duration: 1 min
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Application duration: 1 min
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Application duration: 1 min
Any other information on results incl. tables
Reported findings in the investigation were converted to Draize scores according to Grundler (1983).
Test substance application: 1 min
| Readings | Animal | Erythema | Edema | Further findings |
| 24h | 1 | 3 | 0 | |
| 2 | 4 | 0 | ||
| 48h | 1 | 3 | 0 | |
| 2 | 4 | 3 | ||
| 72h | 1 | 3 | 3 | |
| 2 | 4 | 3 | ||
| 8d | 1 | 0 | 0 | scaling |
| 2 | 0 | 0 | scaling | |
| Mean (24h-72h) | 1 | 3,0 | 1,0 | |
| 2 | 4,0 | 2,0 |
Test substance application: 5 min
| Readings | Animal | Erythema | Edema | Further findings |
| 24h | 1 | 3 | 0 | |
| 2 | 4 | 0 | ||
| 48h | 1 | 3 | 0 | |
| 2 | 4 | 3 | ||
| 72h | 1 | 3 | 3 | |
| 2 | 4 | 3 | ||
| 8d | 1 | 0 | 0 | scaling |
| 2 | 0 | 0 | scaling | |
| Mean (24h-72h) | 1 | 3,0 | 1,0 | |
| 2 | 4,0 | 2,0 |
Test substance application: 15 min
| Readings | Animal | Erythema | Edema | Further findings |
| 24h | 1 | 3 | 0 | |
| 2 | 4 | 0 | ||
| 48h | 1 | 3 | 0 | |
| 2 | 4 | 3 | ||
| 72h | 1 | 3 | 3 | |
| 2 | 4 | 3 | ||
| 8d | 1 | 0 | 0 | scaling |
| 2 | 0 | 0 | scaling | |
| Mean (24h-72h) | 1 | 3,0 | 1,0 | |
| 2 | 4,0 | 2,0 |
Test substance application: 20h
| Readings | Animal | Erythema | Edema | Further findings |
| 24h | 1 | 3 | 0 | |
| 2 | 4 | 3 | folding of the skin | |
| 48h | 1 | 3 | 2 | |
| 2 | 4 | 3 | folding of the skin | |
| 72h | 1 | 3 | 2 | |
| 2 | 4 | 3 | folding of the skin | |
| 8d | 1 | 1 | 0 | scaling |
| 2 | 3 | 0 | scaling | |
| Mean (24h-72h) | 1 | 3,0 | 1,3 | |
| 2 | 4,0 | 3,0 |
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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