[No public or meaningful name is available]

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

fixed concentration procedure

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Trihydrogen [29H,31H-phthalocyaninetrisulphonato(5-)-N29,N30,N31,N32]cobaltate(3-) and [29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt and dihydrogen [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cobaltate(2-) and hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cobaltate(1-)

Molecular formula:

C32H16N8Co(SO3)n with n=0 to 3

IUPAC Name:

Reaction mass of Trihydrogen [29H,31H-phthalocyaninetrisulphonato(5-)-N29,N30,N31,N32]cobaltate(3-) and [29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt and dihydrogen [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cobaltate(2-) and hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cobaltate(1-)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The test group consisted of randomly selected five male and five female Sprague-Dawley derived CD® rats obtained from Charles River Breeding Laboratories, Kingston, New York on May 5, 1981.

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

ca. 4.64 µm

Geometric standard deviation (GSD):

ca. 11.44

Details on inhalation exposure:

The test material was first ground with a mortar and pestle then sieved through a 60 mesh (Tyier equivalent) sieve. The test material was then press-packed into a Wright Oust Feed cylinder using a Carver Laboratory Hydraulic Press at a pressure of 1800-2000 pounds per square inch (psi). The cylinder was mounted on a Wright Dust Feed mechanism. Dry air, at an airflow rate of 15.0 liters per minute (lorn), was delivered to the dust feed mechanism and the test atmosphere was then directed, undiluted, into a 100 liter.
Plexiqlas® chamber housing the test animals. The exposure lasted for four hours.
The dust cylinder, base cap, blade, and test material were weighed before and after the exposure. The difference in weight represented the total amount of test material delivered into the chamber; this, divided by the total volume of air delivered yielded the nominal exposure concentration.
Chamber air samples were drawn at approximately hourly intervals at a rate of 2.9 1pm for 3.0 or 2.0 minutes using a Millipore filter holder and a glass microfibre filter. In addition, a set of gravimetric samples was drawn to determine the distribution of the test material in the chamber. The amount of material collected was determined qravimetrically by weighing the filter holder and filter paper before and after samplinq and dividing the difference in weight by the sample volume (8.7 or 5.8 1).
Particle size distribution samples were taken using a Casella cascade impactor at approximately half-hour intervals throughout the exposure.
The distribution was calculated based on the amount of material collected on the impactor stages (glass slides).
A wet-bulb/dry-bulb hygrometer was used to monitor chamber air temperature and relative humidity which was recorded hourly throughout the exposure.

Duration of exposure:

ca. 4 h

Concentrations:

18.2 mg/l

No. of animals per sex per dose:

5 per sex and per dose

Control animals:

no

Details on study design:

The animals were observed for abnormal signs before exposure, approximately every fifteen minutes during the first hour of the exposure hourly during the remainder of the exposure period, upon removal from the chamber, hourly for four hours post-exposure, and daily thereafter for 14 days. Individual body weights for all rats were scheduled to be recorded on Days 0 (prior to exposure), 1, 2, 4, 7, and 14. On Day 14 (June 5, 1981), all surviving rats were exsanguinated under ethyl ether anesthesia and gross necropsy examinations were performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 18.2 mg/L air

Mortality:

Two animals (#1048M and #1547F) died on Days 2 and 3, respectively, as a result of test material exposure.

Clinical signs:

other: Few rats exhibited lacrimation, mucoid nasal discharge, salivation, rough coat, swollen eyelids, and gasping during the exposure period. These responses commenced after 15 minutes of exposure. After removal from the exposure chamber, some rats exhibited l

Body weight:

Although small, transient weight-losses were seen in most of the eight surviving rats (due to exposure procedure), the body weights recovered to pre-exposure values in most males and a11 females by Day 7. Body weight increments in the second week were within the limits of normal expectation for both sexes.

Gross pathology:

At necropsy, the two rats that died due to exposure, had lunq discoloration. Most of the eiqht surviving rats also had lunq discoloration as well as discoloration of the mucosa of the stomach, esophagus, and qastrointestinal tract. These observations are indicative of exposure related effects.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A four-hour acute inhalation exposure to a dust of Cobalt Phthalocyam'ne Sulfonate at a nominal concentration of 18.2 mq/1 and a mean airborne concentration of 1.05 mg/1 resulted in the death of two animals and caused slight immediate reversible irritation of the ocular and respiratory mucous membranes in the surviving animals.
Post-mortem findings revealed lung discoloration in most rats which indicates a residual effect from exposure.

Under tests conditions, test item do not require classification for acute inhalation toxicity according to GHS criteria.