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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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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:
1987
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

Constituent 1
Chemical structure
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

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