Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

other: read across from similar substance

Adequacy of study:

key study

Study period:

1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

Reference from study report: OECD Guideline for Testing of Chemicals, 1981

GLP compliance:

yes

Remarks:

GLP declaration

Test type:

traditional method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 6-hydroxy-5-[[4-[[4-(phenylamino)-3-sulphonatophenyl]azo]naphthyl]azo]naphthalene-2-sulphonate

EC Number:

228-412-8

EC Name:

Disodium 6-hydroxy-5-[[4-[[4-(phenylamino)-3-sulphonatophenyl]azo]naphthyl]azo]naphthalene-2-sulphonate

Cas Number:

6262-07-3

Molecular formula:

C32H23N5O7S2.2Na

IUPAC Name:

disodium;(5E)-5-[[4-[(4-anilino-3-sulfonatophenyl)diazenyl]naphthalen-1-yl]hydrazinylidene]-6-oxonaphthalene-2-sulfonate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: VELAZ Praha
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known:
delivered with veterinary attest “QUALITY STATUS” – no parazites, pathogen microorganisms, viruses or mold
- Age at study initiation: 8 weeks
- Weight at study initiation: tested animals; males: 170.8 ± 7.12 g; females: 161.2 ± 4.22 g
- Housing: 5 animals in 1 polypropylene cage T4 type, separated male/female
- Diet (e.g. ad libitum): granulated mixture Altromin 1320 (VELAZ Praha) 12g/animal/day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week as minimum
ENVIRONMENTAL CONDITIONS
Automatically controlled temperature, humidity and lighting
- Temperature (°C): 22±3
- Humidity (%): 40 – 60%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 /12

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

head only

Vehicle:

air

Remark on MMAD/GSD:

Before starting the exposure a particle size of the initial sample was measured microscopically.
The size of the majority of particles was between 2- 4 µm.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

6 h

No. of animals per sex per dose:

5 male/5 female

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
immediately after end of exposure, after 1st and 2nd hour, then daily
body weight was measured immediately before exposure, then on the 7th and 14th day


- Necropsy of survivors performed: yes
- Other examinations performed:
clinical signs, body weight, food and water intake, appearance of hair, skin and visible mucous membranes, somatomotor and mental activity, reaction to stimuli, focusing on sensibility and reactivity, lacrimation, functional assessment of the respiratory, circulatory, digestive and urogenital system

Results and discussion

Effect levels

Key result

Sex:

male/female

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

no

Clinical signs:

other: Health condition clinical detection suggests mechanical irritation due to test substance on exposed mucous membranes of the upper respiratory tract, reduced airway patency and insufficient oxygen supply to vital organs.

Body weight:

see attached document

Gross pathology:

The results of the pathological-anatomical examination revealed a P-deposition of inhaled material particles without local or general response of the organism of animals tested.
Differences depending on the sex of the animals were not recorded. Reactions and autopsy findings were the same.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No toxic effects observed.

Executive summary:

A limit test for acute inhalation toxicity with the tested substancewas conducted. The assay was performed according to OECD methodology No. 403. Experimental animals (10 rats Wistar) were exposed to an aerosol inhalation of the pulverized test substance for 4 hours in the inhalation chamber of "head only" type.

During the exposure and even during the 14 day observation period there was no death among tested animals.

Signs of intoxication were clinically determined and give an evidence of mechanical irritation of dust aerosols on exposed mucous membranes of the upper respiratory tract and decreased airway patency and insufficient oxygen supply to vital organs.

Pathological examination had demonstrated a focal infiltration of pulmonary tissues by test substance particles.

Health condition clinical detection suggests mechanical irritation due to test substance on exposed mucous membranes of the upper respiratory tract, reduced airway patency and insufficient oxygen supply to vital organs.

The results of the pathological-anatomical examination revealed a P-deposition of inhaled material particles without local or general response of the organism of animals tested.

Differences depending on the sex of the animals were not recorded. Reactions and autopsy findings were the same.

Limit test results revealed the P-deposition with test substance particles but showed no adverse effects on the health of experimental animals.