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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 805-731-6 | CAS number: 198480-21-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- 1-[4-(2-Azepan-1-yl-ethoxy)-benzyl]-5-(benzyloxy)-2(benzyloxyphenyl)-3-methyl-1H-indole
- Cas Number:
- 198480-21-6
- Molecular formula:
- C44 H46 N2 O3
- IUPAC Name:
- 1-[4-(2-Azepan-1-yl-ethoxy)-benzyl]-5-(benzyloxy)-2(benzyloxyphenyl)-3-methyl-1H-indole
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Details on dermal exposure:
- The test item was diluted in PEG 300 at a concentration of 0.33 g/ml and administered at a volume of 6 ml/kg.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- A group of 5 male and 5 female
- Details on study design:
- The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded togheter with clinical signs at the same time intervals on test day 1. During test days 2-15 it was recorded two times a day.
Body weight were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- Slight erythema and scales on the back were evident in two females and two males between test day two and twelve. All other animals were without clinical signs.
- Body weight:
- The body weight was within the range commonly recorded for this strain and age.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified based on CLP criteria
- Conclusions:
- The median lethal dose of TSE8 after single dermal administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg b.w.
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.
