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Administrative data

acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference Type:
study report

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 403 (Acute Inhalation Toxicity)
not specified
GLP compliance:
Test type:
fixed concentration procedure
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)
EC Number:
EC Name:
Tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)
Cas Number:
Molecular formula:
tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)

Test animals

Details on test animals or test system and environmental conditions:
The test group consisted of five male and five female Sprague- Dawley (CD®) rats obtained from Charles River Breeding Laboratories, Wilmington, Massachusetts on July 8, 1980.
On the day of exposure (Day 0.- July 23, 1980) the pre-exposure body weights were in the ranges 229-252 grams (mates) and 211-222 grams (females).

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Mass median aerodynamic diameter (MMAD):
ca. 5.5 µm
Geometric standard deviation (GSD):
ca. 3.4
Details on inhalation exposure:
The test material was sieved through a 60 mesh sieve to remove large particles and then was press-packed under approximately 200 pounds per square inch (psi) pressure (Carver Laboratory Press) into a large diameter Wright Dust Feeder cylinder. The output of the Wright Dust Feeder (operated at a gear ratio of 1 to 6) with dry air at a flow rate of 15 liters per minute (1pm) was directed, undiluted, into a 100 liter plexiglass chamber which housed the test animals. The exposure lasted 4.0 hours.
The dust feeder cylinder, cutting blade, nozzle, test material, and parafilm were weighed before and after the exposure. The difference in weight represented the total amount of test material delivered into the chamber. The nominal exposure concentration was calculated by dividing the amount of test material delivered by the total air flow through the chamber during the exposure.
Chamber air temperature and relative humidity were monitored at hourly intervals, using a wet bulb/dry bulb hygrometer.
Chamber air samples were drawn at hourly intervals at a rate of 10 liters per minute through a Mi Hi pore fitter holder containing a glass fiber fitter during the exposure. Samples were one minute in duration and, thus, 10 liters in volume. The amount of material collected was determined gravimetrically by weighing the filter paper and holder before and after sampling and dividing the difference in weight by the sample volume.
Additionally, two sets of gravimetric samples were taken from each end of the chamber to determine the distribution of the test material in the exposure chamber.
Particle size distribution samples were taken using a Casella cascade impactor at half-hour intervals throughout the exposure. The distribution was calculated based on the amount of material collected on the impactor stages (glass slides).
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
ca. 4 h
No. of animals per sex per dose:
5 males and 5 females
Control animals:
Details on study design:
The animals were observed for abnormal signs before exposure, every fifteen minutes during the first hour of the exposure period, hourly through termination of the exposure, upon removal from the chamber, hourly for four hours post-exposure, and daily thereafter for 14 days. Individual body weights for all rats were recorded on Day 0 (prior to exposure) and on Days 1, 2, 3, 4, 7, and 14.
On Day 14, all rats were exsanguinated under ethyl ether anesthesia and gross necropsy examinations were performed in the presence of a veterinary pathologist. A thorough examination was made which included scrutiny of the following: nasal passages, trachea, external surfaces, all orifices, cranial cavity, carcass, external and cut surfaces of brain and spinal cord, thoracic cavity, abdominal cavity, pelvic cavity, viscera, and cervical tissues and organs. Samples of the kidneys, liver, lungs and gross lesions were preserved in neutral 10% buffered formalin for possible future histopathology.

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 14.2 mg/L air
Exp. duration:
4 h
Although, small transient weight-losses were seen in most rats, the body weights recovered to pre-exposure values in both sexes by Day 2. Body weight increments in the second week were within the limits of normal expectation, and thus were not indicative of a persistent effect from the exposure
Clinical signs:
other: During the exposure period, most rats huddled in a corner of the chamber. Most rats exhibited labored breathing, excessive lacrimation, excessive salivation, and closed eyes commencing after 15 minutes into the exposure. After removal from the exposure c
Body weight:
Although, small transient weight-losses were seen in most rats, the body weights recovered to pre-exposure values in both sexes by Day 2. Body weight increments in the second week were within the limits of normal expectation, and thus were not indicative of a persistent effect from the exposure.
Gross pathology:
At necropsy, all rats showed foci or areas of lung discoloration. The high incidence of blue and/or green discoloration of lung tissues indicates a residual collection of test material in the lungs. Also noted were 2 rats with discolored cervical lymph nodes and 2 rats with abnormal kidneys. These signs may also have been indications of residual test material effects.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
A four-hour acute inhalation exposure of rats to a dust of Cobalt Phthalocyanine Tetrasulfonate with an average aerodynamic mass median diameter of 5.5 micrometers at a nominal concentration of 14.2 milligrams per liter, and a mean airborne concentration of 0.38 milligrams per liter did not produce mortality. However, during the exposure, some signs of pulmonary irritation were observed. Also, during the 14-day observation period, persistent rales was seen in most rats. Gross abnormalities observed at the necropsy did indicate a residual effect from the test material exposure, especially on the lungs.

Under the tests conditions, the test item do not require classification for acute inhalation toxicity.