Registration Dossier
Registration Dossier
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EC number: 926-072-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
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: 0010211968
Purity: 98.1%
stability of test item: Stable under storage conditions
Expiry date: 03-Mar-2002
Storage conditions: In the original container, at room temperature (range of 17-23°C), away from direct sunlight.
Safety precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
The test item did not elicit any skin reactions at the application site of any animal at anyof the observation times (all scores 0).
No staining by the test item of the treated skin was observed.
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.
The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of April 27, 1993), TSE 2 is considered to be "not irritating" to rabbit skin.
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