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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 465-070-0 | CAS number: 518048-03-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 465-070-0
- EC Name:
- -
- Cas Number:
- 518048-03-8
- Molecular formula:
- C16H19FN403
- IUPAC Name:
- 2-(2-aminopropan-2-yl)-N-[(4-fluorophenyl)methyl]-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidine-4-carboxamide
- Details on test material:
- L-000900405-000M004
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Amount / concentration applied:
- 0.5g moistened with 0.5 ml of distilled water to form a pasty consistency.
- Duration of treatment / exposure:
- skin contact = 4 hours
- Observation period:
- Observation periods : 60 minutes - 24 hours - 48 hours - 72 hours
- Number of animals:
- 2 males and 1 female
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: 60 minutes
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: 24 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: 48 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: 72 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 60 minutes
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 24 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 48 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 72 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- other: 60 minutes
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- other: 24 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- other: 48 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- other: 72 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: 60 minutes
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: 24 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: 48 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: 72 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 60 minutes
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 24 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 48 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 72 hours
- Score:
- 0
Any other information on results incl. tables
| edema score | animal#3 female | 60 minutes | 0 |
| 24 hours | 0 | ||
| 48 hours | 0 |
||
| 72 hours | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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.
