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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 616-210-6 | CAS number: 75302-98-6
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)
- Rationale for reliability incl. deficiencies:
- other: Well reported guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 405
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(tert-butoxy)-2-oxoethyl 2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetate
- EC Number:
- 616-210-6
- Cas Number:
- 75302-98-6
- Molecular formula:
- C25 H26 Cl N O6
- IUPAC Name:
- 2-(tert-butoxy)-2-oxoethyl 2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetate
- Details on test material:
- Acemetacin-tert--butylester
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 (two females and one male)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
Results of the study:
| Irritant Effects (Scores) | ||||||||||
| 24 h | 48 h | 72 h | Mean scores | |||||||
| animal | erythema | edema | erythema | edema | erythema | edema | erythema | edema | ||
| 1 (female) | 0 | 0 | 0 | 0 | 0 | 0 | 0.0 | 0.0 | ||
| 2 (male) | 0 | 0 | 0 | 0 | 0 | 0 | 0.0 | 0.0 | ||
| 3 (female) | 0 | 0 | 0 | 0 | 0 | 0 | 0.0 | 0.0 | ||
Applicant's summary and conclusion
- Executive summary:
500 mg of the test substance was semi-occlusively applied to the shaved intact skin of 3 rabbits (two females and one male) for an exposure period of 4 h. Evaluation of skin irritation was made according to Draize.
In this skin irritation study Acemetacin-tert.-butylester was not irritating to the skin.
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.
