Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
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:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ammonium xylene sulfonate (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 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 dataENVIRONMENTAL 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 dataTEST ATMOSPHERE- Brief description of analytical method used: no analytical performed- Samples taken from breathing zone: noVEHICLE- Composition of vehicle (if applicable): no vehicleTEST ATMOSPHERE (if not tabulated)- Particle size distribution: no dataCLASS 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
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 6.41 mg/L air (nominal)
Exp. duration:
232 min
Mortality:
No deaths
Clinical signs:
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 sulfonate 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.