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Toxicological information

Acute Toxicity: inhalation

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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:
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
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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
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