Sodium [3-hydroxy-4-[(1-hydroxy-8-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

not specified

GLP compliance:

no

Remarks:

Study conducted before 1981

Test type:

standard acute method

Limit test:

no

Test material

Test material information

1

Reference substance name:

Acid Blue 158

IUPAC Name:

Acid Blue 158

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin and Kingman Ltd
- Age at study initiation: 7-8 weeks old
- Weight at study initiation: 180-200 g
- Housing: They were caged in groups of five by sex in solid floor polypropylene cages furnished with sterilised sawdust. Sawdust was replaced twice per week
- Diet : free access to mains water and food (Rat ar..d Mouse No. 1 Expanded Diet, BP Nutrition (UK) Ltd., Stepfield, Witham, Essex)
- Acclimation period: 3 days before exposure

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 ± 10 %
- Air changes (per hr): The ventilation system gave 8-10 air changes per hour
- Photoperiod (hrs dark / hrs light): controlled lighting conditions

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: A Timbrell dust generator was used to produce the atmosphere.
- Source and rate of air: 10 l/min

ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 0.86 µm

Analytical verification of test atmosphere concentrations:

yes

Remarks:

by gravimetric analysis

Duration of exposure:

ca. 4 h

Concentrations:

Calculated from compound usage (after exposure): 29.8 mg/l
Calculated from gravimetric analysis: 2.8 mg/l

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed for toxic or pharmacological effects during exposure and subsequently at least twice daily through a 14 days observation period.
- Frequency of weighing: immediately after expasure and an days 1, 3, 7, 10 and 14 after the day of exposure.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC0

Effect level:

ca. 2.8 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Effect levels 2

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2.8 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No deaths occurred during exposure or during the observation period as a result of exposure to the test material. One male treated rat suffocated as a result of turning around in the restraining tube.

Clinical signs:

other: For 1-2 days after exposure, male and female treated rats were hypothermic and lethargic. They bad nasal excretion, laboured and rattling respiration, discoloured faeces and urine and stained and ruffled pelts. The staining of pelts and faeces persisted t

Body weight:

The mean body weights of the male and female control rats throughout the experiment, increase slowly during the first 4 days but thereafter more rapidly.

Gross pathology:

Those dying an the day of exposure also showed staining of the upper respiratory tract, however in the remainder of the rats which survived the observation period, there was a more generalised pulmonary staining.Staining of the renal cortex occurred in four male rats, and staining of the general musculature and testes in one male.

Any other information on results incl. tables

All the treated rats had blue stained pelts.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to the CLP Regulation (EC n. 1272/2008)

Conclusions:

LC50 > 2.8 mg/l

Executive summary:

The study was conducted according to a method similar to OECD Guideline 403. A single maximum concentration of test material (2.8 mg/l calculated from gravimetric analysis; 29.8 mg/l calculated from compound usage) was administered to 20 rats (10 male, 10 female) as a dust by inhalation (nose only) over a period of 4 hours. A further 10 rats (5 male, 5 female) were exposed under similar conditions to an atmosphere of filtered air. The concentration of test material, as measured by gravimetric analysis was 2.8 mg/l. No deaths occurred during exposure or during the observation period as a result of exposure to the test material. For 1-2 days after exposure, male and female treated rats were hypothermic and lethargic. They bad nasal execretion, laboured and rattling respiration, discoloured faeces and urine and stained and ruffled pelts. The staining of pelts and faeces persisted throughout the observation period.

The substance shows a LC50 more than 2.8 mg/l.