Reaction product of Chloro[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]aluminium, sulphuric acid and caustic soda

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

Five rats per sex were exposed snout and nostrils only to an aerosol (dust: 1734 mg/m³) for 4 hours, followed by an observation period of 14 days. Inhalation toxicity was tested according to the method of Sachsse et al. (1973, 1976). K. Sachsse, L. Ullmann, G. Voss and R. Hess: Measurement of inhalation toxicity of aerosols in small laboratory animals. In: Proceedings of the Europ. Soc. for the Study of Drug Toxicity. Vol XV, pp. 236-251, Zurich, June 1973. K. Sachsse, L. Ullmann, K. Zbinden: Toxikologische Prufungen von Aerosolen im Tierexperiment: Aus "Chemische Rundschau" 29 (1976), Nr. 38 Seite 1-4.

GLP compliance:

no

Remarks:

Study pre-dates GLP regulations

Test type:

traditional method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts

EC Number:

307-259-1

EC Name:

Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts

Cas Number:

97592-62-6

Molecular formula:

not available

IUPAC Name:

Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts

Test material form:

solid

Specific details on test material used for the study:

- Name of test substance as used in the study report: FAT 60149/B.

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adult
- Weight at study initiation: Mean group weight males: 197-199 g; females 177-188g
- Housing: The males and females were segregated and kept in Macrolon cages, type 4, (10 animals to a cage)
- Diet: ad libitum rat food - NAFAG, Gossau SG, except during inhalation exposure
- Water: ad libitum, except during inhalation exposure
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14 / 10

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

clean air

Remark on MMAD/GSD:

The concentration and the particle size distribution of the aerosol in the vicinity of the animals were monitored at regular intervals throughout the aerosol exposure. The concentration was determined 5 times gravimetrically by sampling the test atmosphere through a selectron filter of 50 mm diameter and with a pore size of 0.2 µm (Schleicher and Schuell, Feldbach, Switzerland) at an air flow rate of 10 1/min. The size distribution of the particles was measured twice with a 4 stage Cascade Impactor with selectron filters of 25 mm diameter and with a pore size of 0.2 µm (Schleicher and Schuell) at an air flow rate of 17.5 L/min.
- Particle size distribution analysis of the chamber airborne particles showed that approximately 20 % were smaller than 7 µm in diameter.

Details on inhalation exposure:

For inhalation the rats were kept in separate PVC tubes positioned radially around the exposure chamber such that snout and nostrils of the animals only were exposed to the aerosol. During the exposure period the following parameters were controlled once at half time of the study inside the inhalation cylinder: temperature (with a Therm 2104 contact thermometer, Ahlborn Messund Regeltechnik, 815 Holzkirchen, Germany), relative humidity (with a VASALA Humidity Indicator HMI 11, Kelag AG, 8057 Zurich, Switzerland) and oxygen content (with a DRAEGER E 15 stationary control system, Draegerwerk AG, Liibeck, Germany) .
The aerosol was generated by injecting the solid test material with the help of a Grafix Exaktomat Injector (Cerutti AG, Bern, Switzerland) into an air stream which was discharged into the exposure chamber at a rate of 20 L/min.

CHAMBER CONDITIONS
- Temperature during the exposure period: 24 °C.
- Relative humidity during the exposure period: 64% for controls and 42% for exposed animals
- Oxygen content (Vol %): 21

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

1734 ± 181 mg/m3

No. of animals per sex per dose:

10

Control animals:

yes

Remarks:

10 males and 10 females exposed to clean air

Details on study design:

After 4 hour inhalation the rats were returned to their cages. Physical condition and incidence of death were monitored throughout an observation period of 14 days.

Statistics:

LC50 including 95 % confidence limits was calculated by the logit model.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1 734 mg/m³ air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality occured at the tested concentration.

Clinical signs:

other: - Exposed: dyspnoea, exophthalmos (moderate), ruffled fur (moderate), ventral body position, curved body position. No symptoms after day 3. - Controls: no symptoms.

Body weight:

- Exposed: pre-test male/female 199/177 g, at day 7 male/female 239/200 g, at day 14 male/female 296/218 g.
- Controls: pre-test male/female 197/188 g, at day 7 male/female 236/213 g, at day 14 male/female 283/235 g.

Gross pathology:

No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met