Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with dodecylamine (1:1)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Non-GLP non-guideline study, Substance known to have falsified study reports.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

An acute dust inhalation toxicity study was conducted wherein ten albino rats (5/sex) were exposed to the test substance for a four-hour period in a 70-liter inhalation chamber. The average analytical dust concentration was 179 mg/m³ air. After exposure, all animals were observed for the following 14 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cuprate(2-)

EC Number:

215-537-8

EC Name:

Disodium [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cuprate(2-)

Cas Number:

1330-38-7

IUPAC Name:

1330-38-7

Details on test material:

- Structural formula attached as image file (if other than submission substance): see Fig.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Animals: ARS/Sprague-Dawley, Madison, Wisconsin.
- Age at study initiation: young adult rats
- Weight at study initiation: average body weight of 153 grams
- Fasting: during inhalation exposure
- Housing: housed individually in stock cages
- Diet: Purina Rat Chow, Ralston Purina Company, St. Louis, Missouri.
- Water: ad libitum
- Acclimation period: animals have been under observation for at least five days to insure their general health and suitability for testing

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

not specified

Vehicle:

clean air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume:
Test animals were exposed in a specially constructed Plexiglas inhalation chamber having a capacity of 70 liters.
- Method of holding animals in test chamber:
The chamber was designed so that the animals could be introduced to the test atmosphere after the maximum dust concentration was established. Each animal was caged separately during exposure to minimize filtration of inspired air by animal fur.
- System of generating particulates/aerosols:
Dust was suspended with a specially designed dust feeder capable of producing high concentrations over a long period of time. The test material powder was passed through a high-velocity stream of clean dry air (-40 °C dewpoint). The resulting air and dust mixture was then introduced into the exposure chamber at the top center, dispersed by a baffle plate and exhausted at the bottom of the chamber. Air flow rate through the system (6.4 L/min at 29.92 inches Hg and 25°C) was measured with a rotameter connected upstream of the dust feeder. The rotameter was calibrated with a wet-test meter after the exposure was completed.
- Temperature, humidity, pressure of he test atmasphere: The temperature of the test atmosphere was 23 °C and the pressure was 29.85 inches Hg.

TEST ATMOSPHERE
- Samples taken from breathing zone: yes
The concentration of test material dust present in the exposure chamber was determined by sampling the test atmosphere in the breathing zone of the animals being exposed. The total weight of dust collected on a glass fiber filter* was divided by the total volume of air drawn through the filter during the sampling period. Air flow rate for sampling was regulated by a calibrated limiting orifice. The average concentration of airborne dust, obtained by repeated sampling, was 179 mg/m³ air at 25°C and 29. 92 inches Hg.
* Gelman Instrument Co. , Ann Arbor, Michigan; Type E filter, advertised as 99.7 percent efficient, 0.3 micron DOP aerosol test.

TEST ATMOSPHERE
- Particle size distribution: A sample of airborne dust was collected from the test atmosphere for the purpose of conducting a microscopic determination of particle size distribution. Particles were counted with respect to three size ranges, viz. five microns or smaller, which is considered to be respirable, six to twenty-five microns and larger than twenty-five microns. The smallest particle which can be detected by the light-field technique employed is approximately one micron. The largest particle observed was also recorded.
For particle size distribution data, see any other information on materials and methods incl. tables.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

as described above

Duration of exposure:

4 h

Concentrations:

The average analytical dust concentration was 179 mg/m³ air.

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

The exposure was designed to run for a four-hour period, during which time observations were made with respect to incidence of mortality and reactions displayed. At the end of the exposure period, the rats were returned to their stock cages and observed for the following 14 days. A body weight was determined for each animal prior to inhalation exposure and for each surviving animal at the end of the 14-day observation period. The data were recorded as an index to body weight effects. Gross pathologic examinations were scheduled to be conducted upon all animals which might succumb during the test period and upon those sacrificed at the end of the 14-day observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC0

Effect level:

179 mg/m³ air (analytical)

Based on:

test mat.

Mortality:

There were no deaths during exposure or the 14-day observation period which followed.

Clinical signs:

other: There were no untoward behavioral reactions during exposure or the 14-day observation period which followed.

Body weight:

The average two-week body weight gain was 57 grams which is within the normal limits.

Gross pathology:

Necropsy, performed on all rats at the end of the observation period, revealed minimal to mild focal red discoloration of the lungs in all rats. There were no gross pathologic alterations in any of the other tissues and organs examined.