[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

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1979

Materials and methods

Principles of method if other than guideline:

Nose only exposure of rats to aerosols generated by injecting two different amounts of 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. Exposed animals were then observed for mortality, clinical signs and body weight changes over 14 days observation period. Using the Probit method on the mortality observed, LC50 for the substance was estimated.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromium

EC Number:

271-352-2

EC Name:

[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromium

Cas Number:

68541-72-0

Molecular formula:

C20H13CrN4O5S

IUPAC Name:

[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromium

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Specific details on test material used for the study:

None

Test animals

Species:

rat

Strain:

other: Tif : RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: In house bred
- Housing: Separately, in Macrolon cages, type 4
- Diet: rat food (NAFAG, Gossau SG), ad libitum
- Water: ad libitum
- Acclimatization: minimum of 4 days


ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 10 hours light cycle day

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

not specified

Mass median aerodynamic diameter (MMAD):

> 7 µm

Remark on MMAD/GSD:

Particle size distribution analysis of the chamber airborne particles showed that approximately 40 % 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, Lübeck, Germany).
After a 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.

Preparation of aerosol
The aerosol was generated by injecting two different amounts of 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. The control animals were exposed to filtered air under the same conditions as the animals exposed to the test substance.

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 L/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.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Concentrations:

0, 877 and 1353 mg/m3

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations (mortality and clinical signs): daily
- Frequency of observations (body weight): Day 1 (before exposure), 7 and 14
- Necropsy of survivors performed: yes

Statistics:

None

Results and discussion

Preliminary study:

No data

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1 300 mg/m³ air (nominal)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality observed.

Clinical signs:

other: Dyspnoea, exophthalmos, ruffled fur and curved body position were observed at both doses. The animals exposed to the test material recovered within 4 days. The control rats failed to show any symptoms during the exposure and observation period.

Body weight:

No significant change was seen with body weight and body weight gains of the exposed animals.

Gross pathology:

Partially congested organs were observed.

Other findings:

None

Any other information on results incl. tables

Environmental conditions recorded in the exposure chamber:

- Temperature: 23 - 24 °C

- Relative humidity: 48 - 58 %

- Oxygen content volume : 20 %

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LC50 for FAT 20042/B was estimated to be >1353 mg/m3.

Executive summary:

The acute inhalation toxicity of FAT 20042/B was investigated in a study conducted according to the method of Sachsse et al. (1973, 1976). In this study, groups of young adult rats (each consisting of 10 males and 10 females) were exposed to test concentrations of 0, 877 and 1353 mg/m³. 4 hour inhalation exposure was given to the rats through tubes positioned radially around the exposure chamber such that snout and nostrils of the animals only got exposed. Mortality, clinical signs and body weight changes were monitored throughout an observation period of 14 days and the surviving animals were subjected to the gross necropsy after the completion of observation period. Particle size distribution analysis of the chamber airborne particles showed that approximately 40 % were smaller than 7 µm in diameter. No mortality observed throughout the study. Dyspnoea, exophthalmos, ruffled fur and curved body position were observed at both doses. The animals exposed to the test material recovered within 4 days. The control rats failed to show any symptoms during the exposure and observation period. No significant change was seen with body weight and body weight gains of the exposed animals. Partially congested organs were observed at gross necropsy. based on the findings of the study, the LC50 for FAT 20042/B was estimated to be >1353 mg/m³.