Registration Dossier
Registration Dossier
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EC number: 431-920-4 | CAS number: -
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1981/1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- acceptable, well-documented publicationt which meets basic scientific principles. The registered substance is the reduced form of the test item used in this study. Indigo Vat potassium salt oxidizes rapidly to indigo in the pressence of water and airborne oxygen.
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:
- Indigo
- IUPAC Name:
- Indigo
- Details on test material:
- - Name of test material (as cited in study report): 20% Indigo textile grade
- Molecular formula (if other than submission substance): C16H10N2O2
- Molecular weight (if other than submission substance): 262.2628
- Smiles notation (if other than submission substance): O=C3c4ccccc4NC3=C2Nc1ccccc1C2=O
- InChl (if other than submission substance): InChI=1/C16H10N2O2/c19-15-9-5-1-3-7-11(9)17-13(15)14-16(20)10-6-2-4-8-12(10)18-14/h1-8,17-18H
- Structural formula attached as image file (if other than submission substance): see Fig. 1
- Substance type: preparation
- Physical state: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- NA
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- not specified
- Vehicle:
- other: no data
- Details on inhalation exposure:
- Nominal concentration: 5.3 mg/l
Time-weighted concentration from breathing zone: 0.08 mg/L (80 mg/m³)
Particle size: 74% <= 10 µm - mean size: 4.6 +/- 3.3 µm
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Time-weighted concentration from breathing zone: 0.08 mg/L (80 mg/m³)
- Duration of exposure:
- 4 h
- Concentrations:
- Nominal concentration: 5.3 mg/l
Time-weighted concentration from breathing zone: 0.08 mg/L (80 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:
- > 5.3 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- no deaths
- Clinical signs:
- other: no effects
- Body weight:
- no data
- Gross pathology:
- no effects
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 5.3 mg/L of an 20% indigo textile grade aerosol
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.
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