Registration Dossier
Registration Dossier
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EC number: 403-830-5 | CAS number: 89331-94-2 B 290; BK 400; CK 34; DIBUTYL-N-102; DX-20; FAT NR. 40391/A; FLUORAN BLACK BD 869; FLUORAN SCHWARZ BD 869; NOIR FLUORANE BD 869; ODB-2; PSD-290; SENOR-2; TG-31; TH-108; WINCON-2
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
Test material
- Reference substance name:
- 6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one
- EC Number:
- 403-830-5
- EC Name:
- 6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one
- Cas Number:
- 89331-94-2
- Molecular formula:
- C35H36N2O3
- IUPAC Name:
- 6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one
Constituent 1
Test animals
- Species:
- other: Rabbit (New Zealand White)
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- Substance moistened with 0.2ml distilled water
- Amount / concentration applied:
- 500mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48 and 72 hours
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24hours
- Score:
- ca. 0
- Remarks on result:
- other: All animals 1, 2 and 3 had zero score
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24hours
- Score:
- ca. 0
- Remarks on result:
- other: All animals 1,2 and 3 had zero score
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48hours
- Score:
- ca. 0
- Remarks on result:
- other: All animals 1,2 and 3 had zero score
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72hours
- Score:
- ca. 0
- Remarks on result:
- other: All animals 1,2 and 3 had zero score
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- ca. 0
- Remarks on result:
- other: All animals 1,2 and 3 had zero score
- Other effects:
- No signs of skin irritation were observed at any time during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- No signs of skin irritation were observed at any time during the study.
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