Registration Dossier
Registration Dossier
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EC number: 207-586-9 | CAS number: 482-89-3
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1981/1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable, well-documented publicationt which meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicology of Indigo - a review
- Author:
- Ferber KH
- Year:
- 1 987
- Bibliographic source:
- J. Environ. Pathol. Toxicol. Oncol. 7, 73 -84 (1987)
Materials and methods
- Principles of method if other than guideline:
- FDRL
- GLP compliance:
- not specified
- Test type:
- standard acute method
Test material
- Reference substance name:
- 2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one
- EC Number:
- 207-586-9
- EC Name:
- 2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one
- Cas Number:
- 482-89-3
- Molecular formula:
- C16H10N2O2
- IUPAC Name:
- 2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Indigo dispersible powder
- Substance type: active ingredient
- Physical state: solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: no data
- Details on inhalation exposure:
- Nominal concentration: 5 mg/l
Time-weighted concentration from breathing zone: 0.76 mg/L (760 mg/m³)
Particle size: 79% <= 10 µm - mean size: 2.1 +/- 2.3 µm
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Time-weighted concentration from breathing zone: 0.76 mg/L (760 mg/m³)
- Duration of exposure:
- 4 h
- Concentrations:
- Nominal concentration: 5 mg/l
Time-weighted concentration from breathing zone: 0.76 mg/L (760 mg/m³) - No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes - Statistics:
- no data
Results and discussion
- Preliminary study:
- NA
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- no deaths
- Clinical signs:
- other: no effects
- Body weight:
- no data
- Gross pathology:
- no effects besides bluish colored lungs
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: US CPSC / US FDA
- Conclusions:
- No significant effects were observed after 4 hours inhalation of nominal concentrations of 5 mg/L of a Indigo dispersible powder aerosol
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