Registration Dossier
Registration Dossier
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EC number: 926-072-1 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- 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)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-methyl-5-phenylmethoxy-2-(4-phenylmethoxyphenyl)-1H-indole
- EC Number:
- 926-072-1
- Cas Number:
- 198479-63-9
- Molecular formula:
- C29H25NO2
- IUPAC Name:
- 3-methyl-5-phenylmethoxy-2-(4-phenylmethoxyphenyl)-1H-indole
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Description: solid
Batch Number: 0010111968
Purity: 100%
stability of test item: Stable under storage conditions
Stability of test item in vehicle: Unknown, exluded from the statement of compliance
Expiry date: 18-oct-2002
Storage conditions: at room temperature (range of 20±3°C), away from direct sunlight
Safety precautions: Routine hygienic procedures (gloves, goggles, face mask), irritating to eyes, skin and respiratory system.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Duration of exposure:
- 14 days
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred during the study.
- Clinical signs:
- Light scales on the back were observed in a male N. 1 on test days two and three and female N.7 on test day ten. Slight erythema maculate was evident in 3 males on test day 2 and in female N.7 on tets day 2 until test day 5. All other animals were without clinical signs.
- Body weight:
- The body weight of the animals 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:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of TSE 2 after single oral admini stration to rats of both sexes, observed over a period of 14 days is: LD50(rat): greater than 2000 mg/kg bw.
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