Benzene, bis(1-methylethyl)-, sulfonated, sodium salts

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

April 10 - 24, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline not specified, but with detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline followed

Guideline:

other: no information about guideline available

Deviations:

not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ammonium xylene sulphonate

IUPAC Name:

ammonium xylene sulphonate

Constituent 2

Reference substance name:

Ammonium xylenesulphonate

EC Number:

247-710-9

EC Name:

Ammonium xylenesulphonate

Cas Number:

26447-10-9

IUPAC Name:

ammonium 2,3-dimethylbenzenesulfonate

Details on test material:

- Name of test material (as cited in study report): ammonium xylene sulphonate (AXS)
- Molecular formula (if other than submission substance): no data
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: Sample No. 8694K
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable
- Storage condition of test material: no data
- Other: specific gravity = 1.121 at 25 degrees Centigrade

Test animals

Species:

rat

Strain:

other: albino, COX-SD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Lab Supply Company
- Age at study initiation: no data
- Weight at study initiation: 217 - 240 grams
- Fasting period before study: not fasted
- Housing:individually in metal, wire-bottomed cages elevated above the droppings
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: From: April 10, 1980 To: April 24, 1980

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: DeVilbiss Nebulizer and glass chamber
- Exposure chamber volume: 57 liters
- Method of holding animals in test chamber: none
- Source and rate of air: 24 liters per minute (test sample carried in at an air flow of 3 liter/minute; joined by auxiliary air flow of 21 liter/minute)
- Method of conditioning air: 11 minute period to equilibrium to 99% concentration
- System of generating particulates/aerosols: DeVilbiss Nebulizer
- Method of particle size determination: no data
- Treatment of exhaust air: no data
- Temperature, humidity, pressure in air chamber: no data


TEST ATMOSPHERE
- Brief description of analytical method used: no analytical performed
- Samples taken from breathing zone: no


VEHICLE
- Composition of vehicle (if applicable): no vehicle


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: no data


CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: none provided

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

>= 232 min

Remarks on duration:

plus an 11 minute period to equilibrate to 99% of concentration

Concentrations:

6.41 mg/liter of air

No. of animals per sex per dose:

5 males and 5 females; single dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at regular intervals during the first day and once daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,histopathology, other: behavior and stool
- Upon removal from the chamber, the animals were cleaned with lukewarm water to remove any test material having accumulated on their coats and dried with toweling. Animals were then placed in individual cages.
- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Preliminary study:

none reported

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 6.41 mg/L air (nominal)

Exp. duration:

232 min

Mortality:

No deaths

Clinical signs:

other: One animal displayed a pronounced case of soft stool on Day 6 an returned to normal in two days. Otherwise no gross signs of test compound induced adverse effects were observed in the remaining nine animals

Body weight:

Slight weight gains in two animals at 7 and 14 days. The body weights for the remaining 8 animals showed gains within limits of expectation.

Gross pathology:

Five animals showed slight mottling or slight to moderate congestion of the lungs. The remaining five showed tissues to be not remarkable

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Ammonium xylene sulphonate at 6.41 mg/L did not result in mortality and half of the exposed animals showed only slight to moderate congestion of the lungs.