Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 236-770-1 | CAS number: 13477-62-8
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: well-documented, scientifically acceptable study report with deviations from current standard protocols, non-GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive testing; limited observation duration
- GLP compliance:
- no
Test material
- Reference substance name:
- Tetrahydro-2-isobutyl-4-methyl-2H-pyran
- EC Number:
- 236-770-1
- EC Name:
- Tetrahydro-2-isobutyl-4-methyl-2H-pyran
- Cas Number:
- 13477-62-8
- Molecular formula:
- C10H20O
- IUPAC Name:
- 4-methyl-2-(2-methylpropyl)oxane
- Details on test material:
- Name of the test substance used in the study report: Dihydrorosenoxid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: GAUKLER; OFFENBACH, Germany
- Weight at study initiation: 2.11 - 2.54 kg
- Housing: One animal per cage (type: stainless steel with wire mesh walk floors; floor area: 40 x 51 cm)
- Diet : daily approx. 130 g (OVATOR SOLIKANIN 4 MM) per animal
- Water: daily approx. 250 ml tap water per animal
- Acclimation period: at least 8 days before study start
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 8 days
- Number of animals:
- 3 (females)
- Details on study design:
- Clipping of the fur: at least 15 hours before test substance application
Application area: 2.5 x 2.5 cm
Application site: upper third of the back or flanks
Removal of the test substane after the end of the application with Lutrol and Lutrol/water (1:1).
Readings: 30 - 60 min after removal of the test patches and 24 h, 48 h, 72 h and 8 days after start of application
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24 - 72 h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: Scaling at day 8 in 3/3 animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24 - 72 h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Scaling at day 8 in 3/3 animals
Any other information on results incl. tables
| Readings | Animal | Erythema | Edema | Further findings |
| 4h | 1 | 1 | 2 | |
| 2 | 1 | 2 | ||
| 3 | 1 | 2 | ||
| 24h | 1 | 2 | 2 | |
| 2 | 2 | 2 | ||
| 3 | 2 | 2 | ||
| 48h | 1 | 2 | 2 | |
| 2 | 2 | 2 | ||
| 3 | 2 | 2 | ||
| 72h | 1 | 2 | 2 | |
| 2 | 2 | 2 | ||
| 3 | 1 | 1 | ||
| 8d | 1 | 1 | 0 | strong scaling |
| 2 | 1 | 0 | scaling | |
| 3 | 1 | 0 | scaling | |
| Mean (24h-72h) | 1 | 2.0 | 2.0 | |
| 2 | 2.0 | 2.0 | ||
| 3 | 1.7 | 1.7 | ||
| Mean (24h-72h) | all animals | 1.9 | 1.9 |
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
