Sodium 3-nitrobenzenesulphonate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Data is from experimental study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

Acute Inhalation Toxicity of test chemical in rat.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 3-nitrobenzenesulphonate

EC Number:

204-857-3

EC Name:

Sodium 3-nitrobenzenesulphonate

Cas Number:

127-68-4

Molecular formula:

C6H5NO5S.Na

IUPAC Name:

sodium 3-nitrobenzenesulphonate

Test material form:

solid

Details on test material:

- Name of test material : Sodium 3-nitrobenzenesulphonate
- Molecular formula : C6H4NNaO5S
- Molecular weight : 225.1556 g/mol
- Smiles notation : c1(cc(ccc1)[N+](=O)[O-])S(=O)(=O)[O-].[Na+]
- InChl : 1S/C6H5NO5S.Na/c8-7(9)5-2-1-3-6(4-5)13(10,11)12;/h1-4H,(H,10,11,12);/q;+1/p-1
- Substance type : Organic
- Physical state : Solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Mean body weight at the beginning of the study: male animals 262 +/- 7.5 g, female animals 185 +/- 3.3 g.
Age of the animals at the beginning of the study: approx . 8- 9 weeks
The animals were identified by color marking on the tail.
The animals were offered KLIBA rat/mouse laboratory diet and drinking water ad libitum during the post-exposure observation period.
The animals were kept in fully air-conditioned rooms in which a temperature in the range 20-24°C and relative humidity in the range 30-70% were regulated by means of a central air-conditioning system.
The animals were housed in groups of five in cages type D III of Becker, without bedding, with a light/dark rhythm of 12 hours.

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

not specified

Remark on MMAD/GSD:

not specified

Details on inhalation exposure:

The animals were restrained in tubes and their snouts projected into the inhalation chamber. The dust aerosol air mixture was generated with a dosing-wheel dust generator and the concentration was adjusted by varying the rotation of the metering disc. Air-flow was 1,500 l/h while the temperature was kept between 19 and 25°C. The limit-test procedure was applied.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Remarks on duration:

not specified

Concentrations:

5.1 mg/L

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

The statistical evaluation of the concentration/effect relationship was carried out on the basis of the binomial test (Wittig, H.: Mathematische Statistik 1974, pp . 32 - 35) in accordance with tables of the BASF Computer Center.

Results and discussion

Preliminary study:

not specified

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.1 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: no mortalities

Mortality:

No mortality was observed in treated rats.

Clinical signs:

other: Clinical examination reveiled 10/10 animals with eyelid closure over the whole course of the exposure period. Temporarily, 4/10 animals showed irregular respiration, 7/10 accelerated respiration, 3/10 intermittent respiration, 3/10 whooping respiration, 7

Body weight:

The body weight gain of male rats in the test group, compared with a historical control collective, was not affected by the substance over the total observation period.
The body weight gain of female rats in the test group, compared with a historical control collective, was slightly retarded in the second week of the observation period.

Gross pathology:

Sacrificed animals (males and females): no pathologic findings noted.

Other findings:

not specified

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

Under the experimental conditions chosen, the combined LC50 for test chemical (aerosol) was >5.1 mg/L. Also, from day 2 of the observation period onward, 10/10 animals were without findings. Hence it is concluded that the chemical is not expected to exhibit acute toxicity by the inhalation route. However, the substance is expected to be an irritant to the respiratory tract at high concentrations.

Executive summary:

Acute Inhalation Toxicity study was conducted according to OECD Guideline 403 (Acute Inhalation Toxicity) by using test chemical in 10 male and female Wistar rats at the concentration of 5.1 mg/L via nose/head only inhalation by aerosol route for 4 hours exposure. The animals were restrained in tubes and their snouts projected into the inhalation chamber. The dust aerosol air mixture was generated with a dosing-wheel dust generator and the concentration was adjusted by varying the rotation of the metering disc. Air-flow was 1,500 l/h while the temperature was kept between 19 and 25°C. The limit-test procedure was applied. Animals were observed for mortality and clinical signs for 14 days. The statistical evaluation of the concentration/effect relationship was carried out on the basis of the binomial test (Wittig, H.: Mathematische Statistik 1974, pp . 32 - 35) in accordance with tables of the BASF Computer Centre. No mortality was observed in treated rats. Clinical examination reviled 10/10 animals with eyelid closure over the whole course of the exposure period. Temporarily, 4/10 animals showed irregular respiration, 7/10 accelerated respiration, 3/10 intermittent respiration, 3/10 whooping respiration, 7/10 shallow respiration, 3/10 salivation, 10/10 restlessness and 10/10 attempts to escape. On day 1 of the post-exposure period, 6/10 animals showed a reddish smear and crusts on their noses and 7/10 animals had fur discoloured with test substance. From day 2 of the observation period onward, 10/10 animals were without findings. Body weight change was observed. In sacrificed animals (males and females) no pathologic findings were noted. Hence, LC50 was considered to be >5.1 mg/L (>5100 mg/m3), when 10 male and female Wistar rats were exposed with test chemical via nose/head only inhalation by aerosol route for 4 hours exposure.