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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

Reference
Name:
Unnamed
Type:
Constituent
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:
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