Dipotassium peroxodisulphate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987-11-25 to 1989-01-19

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-3 (Acute inhalation toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diammonium peroxodisulphate

EC Number:

231-786-5

EC Name:

Diammonium peroxodisulphate

Cas Number:

7727-54-0

Molecular formula:

H3N.1/2H2O8S2

IUPAC Name:

diammonium [(sulfonatoperoxy)sulfonyl]oxidanide

Test material form:

solid: crystalline

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system 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

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

>= 2.95 mg/L air (analytical)

Exp. duration:

4 h

Effect levels 2

Sex:

male/female

Dose descriptor:

LC0

Effect level:

2.95 mg/L air (analytical)

Exp. duration:

4 h

Mortality:

All animals survived to termination of the study. The observation period was 14 days.

Clinical signs:

other: 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

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.

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 for-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:

study cannot be used for classification

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.