Sodium 4(-2-hydroxy-1-naphthylazo)naphthalenesulphonate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1978

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:

1978

Report date:

1978

Materials and methods

Principles of method if other than guideline:

Air in individual inhalation chambers is enriched with test item using 200 l/hour air flow through the test item in a water bath (20 °C). Animals are exposed to the test item at one concentration for various amounts of time (3, 10 and 30 minutes and 1, 3 and 7 days) and monitored for mortality and signs of toxicity for 14 days, then subjected to gross pathology analysis at necropsy.

GLP compliance:

not specified

Test type:

concentration x time method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 4(-2-hydroxy-1-naphthylazo)naphthalenesulphonate

EC Number:

216-760-3

EC Name:

Sodium 4(-2-hydroxy-1-naphthylazo)naphthalenesulphonate

Cas Number:

1658-56-6

Molecular formula:

C20H13N2NaO4S

IUPAC Name:

NA

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma WIGA, Sulzfeld, DE
- Housing: during exposure time: individual inhalation chambers
- Diet: ad libitum; Herilan MRH, supplied by H. Eggersmann KG, Rinteln, DE
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- not specified

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: individual inhalation chambers
- Method of holding animals in test chamber: closure
- Source and rate of air: 200 l/hour
- Temperature: room temperature
- Air in individual inhalation chambers was enriched with test item using 200 l/hour air flow through the test item in a 20 °C water bath

JUSTIFICATION
- Rationale for the selection of the starting concentration: based on the Range-Finding Toxicity Data by Smyth et al. (1962)

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

<= 7 h

Remarks on duration:

6 durations were tested: 3, 10 and 30 minutes and 1, 3 and 7 days

Concentrations:

not specified

No. of animals per sex per dose:

2 animals per duration

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observation: not specified
- Necropsy of survivors performed: yes
- Other examinations performed: mortality and toxic symptoms

Results and discussion

Effect levels

Sex:

not specified

Exp. duration:

7 h

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality was observed.

Clinical signs:

other: No toxic symptoms were observed.

Gross pathology:

No organ abnormalities were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: No mortality or toxic symptoms at durations of exposure ≤ 7 hours.

Conclusions:

No mortality or toxic symptoms at durations of exposure ≤ 7 hours.

Executive summary:

The acute toxicity of the test item by inhalation was evaluated in an experimental study following the Concentration × Time method limit test. Air in individual inhalation chambers was enriched with test item using 200 l/hour air flow through the test item in a 20 °C water bath. 12 Sprague-Dawley rats were exposed to the test item at room temperature for either 3, 10 or 30 minutes or 1, 3 or 7 days (two animals per duration), and monitored for mortality and signs of toxicity for 14 days then subjected to gross pathology analysis at necropsy.

No mortality or toxic symptoms were observed. No organ abnormalities were observed at necropsy. Although it was not possible to observe symptoms, the low volatility of the test item should be taken into account when considering toxicity of the test item.