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Toxicological information

Acute Toxicity: inhalation

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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:
1987-11-25 to 1989-01-19
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-3 (Acute inhalation toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: diammonium persulfate
- Molecular formula: H2 N2 O8 S2
- Molecular weight: 228.20 g/mol
- Physical state: fine, white powder
- Analytical purity: not stated (assumed as 100 %)
- Purity test date: not stated
- Lot/batch No.: Lot number L 87-
- Expiration date of the lot/batch: not stated
- Stability under test conditions: stable at ambient conditions
- Storage condition of test material: Dry conditions, at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc.; Raleigh, North Carolina
- Age at study initiation: 45 days
- Weight at study initiation: Males: 221.8 - 255.1 g; Females: 161.2 - 193.1 g
- Fasting period before study: not indicated
- Housing: individually in stainless steel wire mesh cages
- Diet: Purina Certified Rodent Laboratory Chow #5002 ad libitum
- Water: tap water through an automatic watering system ad libitum
- Acclimation period: at least two weeks


ENVIRONMENTAL CONDITIONS
- Temperature: 19.4 to 24.4 °C
- Humidity: 48 - 60 % R.H.
- Air changes: not indicated
- Photoperiod: 12 hours dark/12 hours light daily by artificial illumination


Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
The test animals were exposed to ammonium persulfate in a 100-L plexiglass exposure chamber. The chamber was operated in a dynamic mode with a time weighted average (TWA) airflow of 20.7 litres per minute (Lpm). These conditions gave a calculated air change of 12.4 air changes per hour and a T99 value of 22.2 minutes. The airflow rate was monitored at least every 30 minutes using a calibrated Dwyer 0-40 Lpm flow-meter.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetrically by collection of the dust on filters
Duration of exposure:
240 min
Concentrations:
Exposure level: 2.95 mg/L;
No. of animals per sex per dose:
Five animals per sex
Control animals:
no
Details on study design:
The powdered test material was tightly packed in five layers into 3 individual 1-L Spengler dust cups using a Carver Laboratory Press (Model C) at 5000 pounds per square inch (psi) for 30 seconds. Two cups were packed the day prior to exposure and stored overnight in a plastic bag containing a desiccant. The packed cups were mounted individually on the Spengler particulate generator. The speed setting of the particulate generator was initially set at 57.0. House air at a backpressure of 10 psi was directed to a 0-40 Lpm Dwyer Flowmeter and to the dust feeder. The initial air-to-dust feeder rate was 25.3 Lpm. The resultant dust laden airstream was directed from the dust feeder to the inlet of the exposure chamber through a 1/4-inch internal diameter Tygon tubing. The exposure chamber air was exhausted through a HEPA filter.
Following 240 minutes of exposure, the generation was discontinued and clean air was passed through the exposure chamber for an additional 30 minutes to clear the test material from the chamber. Afterwards, the chamber was opened and the animals removed.
Statistics:
Statistical procedures employed in the analysis of particle size data was performed by a computerized particle size distribution analysis (PSDA) program developed for HLA by Beaulogics, Chesterfield, Missouri.
Calculation of TWA exposure levels were performed using a program developed and validated by Hazleton Laboratories America, Inc.

Results and discussion

Preliminary study:
NA
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 2.95 mg/L air (analytical)
Exp. duration:
4 h
Remarks on result:
other: no
Sex:
male/female
Dose descriptor:
LC0
Effect level:
2.95 mg/L air (analytical)
Exp. duration:
4 h
Remarks on result:
other: no
Mortality:
All animals survived to termination of the study. The observation period was 14 days.
Clinical signs:
Crusts (nose, eye(s), mouth), languid behaviour, squinted eye(s), respiratory distress, compound on fur, urine stained fur and increased secretory responses were exhibited by the animals when they were removed from chamber. Many of these findings were not evident at the 60 minute post-exposure observation. During the two-week observation period most animals exhibited crusts; urine stains, rough haircoat, and alopecia were also exhibited. Other findings were considered sporadic.
Body weight:
Except for Test Day 2, body weight gains were exhibited by both sexes throughout the study. On this basis it was concluded that there was no treatment-related effect upon body weight as of Test Day 5.
Gross pathology:
Gross postmortem evaluations revealed one animal with alopecia; the finding was considered sporadic.
Other findings:
NA

Any other information on results incl. tables

The TWA (actual) gravimetric and nominal exposure levels were 2.95 +/- 0.337 and 311.6 mg/L, respectively. A total of 1547.8 g of ammonium persulfate was used during the four-hour exposure. The actual exposure level was considered the maximum attainable exposure level. The difference between actual and nominal exposure levels was attributed to sedimentation and/or impaction of the dust in the exposure chamber.

Particle size distribution measurements indicated the test dust was within the respirable size range of the rats. (considered to be < 10 microns). The percent less than 10 microns was 96.6 to 97.4 and the percent less than 7 microns was 84.6 to 86.

Applicant's summary and conclusion

Interpretation of results:
moderately toxic
Remarks:
Migrated information Criteria used for interpretation of results: US EPA pesticides
Conclusions:
The acute LC50 and LC0 for the 4-hour whole body exposition were greater than 2.95 mg/L and 2.95 mg/L, respectively.
Executive summary:

Diammonium persulfate was tested for acute inhalation toxicity to rats in a study according to guideline EPA OPP 81-3. The acute LC50 and LC0 for the 4-hour whole body exposure were greater than 2.95 mg/L and 2.95 mg/L, respectively. The administered concentration was considered the maximum attainable concentration.