[[4-[[4-(anilino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]benzenesulphonic acid

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: old study without GLP, but fulfill basically scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

only one concentration: 2.48 mg/L, one hour exposure

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

ALKALINE BLUE GG

IUPAC Name:

ALKALINE BLUE GG

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

The experimental compound, coded CP 1816/346, was supplied by the sponsor. The compound was a fine, bright blue powder, and was assigned an internal Identification number of INHC-062.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Ten (10) male and ten (10) female Sprague-Dawley derived rats, obtained from Charles River Breeding Laboratories, were used for this study. The animals were maintained on Purina cubed diet and tap water ad libitum. The animals were caged in groups of ten(10) and allowed at 1 east seven (7) days to accommodate to the laboratory environment prior to the study.

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

a single one (1) hour exposure to an aerosol of test article at an actual concentration of two (2) milligrams per 1 iter of air.
Aerosol Generation System
An aerosol of the experimental compound was generated by a system shown schematically in Figure 1. 丁his system operates as follows:
The glass flask is periodical1y charged with a fevf grams of the experimental compound. The vibrator maintains a flow of compound to the auger. Thus with the auger turning at a constant speed, powder is delivered at a constant rate to the funnel of the dust ejector assembly. Dry, filtered, compressed air applied to the jet in the dust ejector creates a negative pressure in the funnel which pul 1s dust down into a high velocity air stream. This dust-laden air was then piped to a 56-1 iter all glass exposure chamber.
Determination of Exposure Concentration
Exposure concentration was determined on both a nominal and actual basis. Hominal concentrations were calculated as the ratio of the rate at which the auger delivered compound to the dust ejector (mg/min) to the total air flow through the exposure chamber (L/min).
Actual exposure concentrations were determined by drawing a known volume of chamber air through a pre-weighed glass fiber filter held in an open-face filter holder. The filter was then re-weighed and the aerosol concentration calculated by dividing the filter weight gain by the sample volume. Four (4) such samples were taken during the one-hour exposure.
Evaluation of Aerosol Particle Size
Particle size analysis was conducted utilizing the Andersen Cascade impactor. Pre-weighed glass fiber fi1 ter material, specially cut to fit the impactor, was used for collecting the aerosol on each stage. After sampling, these filters were again weighed. The difference in weight for each stage v/as then used to construct the particle size distribution graph. The aerosol had an Equivalent Aerodynamic Diameter (EAD) of 9.2y with a geometric standard deviation(όg) of 3.56.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

ca. 1 h

Concentrations:

2 mg/L

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

One (1) group of animals consisting of ten (10) male and ten (10) female rats was used for this study. They received a single one (1) hour exposure to an aerosol of test article at an actual concentration of two (2) milligrams per 1 iter of air. A11 animals were held for fourteen (14) days post-exposure for observations of latent effects. All animals were observed during the exposure and then daily during, the post-exposure period for signs.of toxicity. Body weights were recorded prior to exposure and after seven (7) and fourteen (14) days., A11 animal s that died or were sacrificed after the observation period were necropsied. The following tissues were stored in 10% neutral buffered formal in in the event historjntlinlogy might be required.
lungs, heart, liver, atomach, gonads, kidneys, spleen, whole head, intestines

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2 mg/L air (analytical)

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: No apparent signs of toxicity were observed either during the exposure or the fourteen day observation period.

Body weight:

All animals gained weight normally throughout the experiment.

Gross pathology:

This discoloration was the only gross abnormality noted. Al1 other major organs appeared healthy upon inspection.

Other findings:

no data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, the one hour LC50 for test article is considerably greater than 2.48 milligrams per liter of air.

Executive summary:

This study was performed to evaluate the acute inhalation toxicity of test article at an aerosol concentration of 2 milligrams per liter of air. Ten male and ten female rats were exposed for a single one hour aerosol of test article at an acutual concentration of 2.48 milligrams per liter of air. All animals were held for 14 days post-exposure for observations of latent effects. There were no deaths or signs of toxicity during the exposure or the fourteen day observation period. All animals gained weight normal1y throughout the experiment. Upon inspection, the lungs from the majority of male and female rats exhibited a blue/black tint. Therefore, one hour LC50 for test article is estimated to be greater than 2.48 mg/L.