Diammonium peroxodisulphate

Endpoint summary

Description of key information

Diammonium persulfate was tested for acute toxicity via the oral, dermal and inhalation routes in rats. In an acute oral toxicity study LD50 and LD0 values of 742 mg/kg bw and 300 mg/kg bw, respectively, in the male rat and LD50 value of 700 mg/kg bw in the female rat were determined. In an acute dermal toxicity study LD50 and LD0 values of greater than 2000 mg/kg bw and 2000 mg/kg bw  were determined, respectively. In an acute inhalation toxicity study (whole body exposure) LC50 and LC0 values of greater than 2.95 mg/L and 2.95 mg/L, respectively, were determined. Additional studies were available for substances of the Persulfate Category.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001-05-21 to 2001-10-18

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

August 1998

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

24 February 1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

January 1993

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: Males. 215 - 266 g; Females: 151 - 188 g
- Fasting period before study: overnight prior to dosing
- Housing: individually in stainless steel suspended cages with DACB indirect bedding
- Diet: Purina Rodent Chow 5001 (pellets) ad libitum
- Water: fresh tap water ad libitum
- Acclimation period: minimum of 5 calendar days


ENVIRONMENTAL CONDITIONS
- Temperature: 19.4 - 24.4 °C
- Humidity: 41 - 68 % R.H.
- Air changes (per hr): not stated
- Photoperiod: 12 hours dark/12 hours light

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test material could not be administered undiluted because it was a solid. The highest possible concentration of the test material that could be drawn through a gavage needle was a 50 % (w/v) concentration in tap water; the concentration used in this study was 25 % because using 50 % would result in dose volumes which were too low to administer. The test material was mixed with tap water and then mixed prior to and during dosing on a magnetic stirrer plate. The test material was introduced directly into the stomach of each animal via oral gavage.

Doses:

Males: 300, 500, 660, 750 mg/kg bw
Females: 300, 660, 750 mg/kg bw

No. of animals per sex per dose:

5 males/5 females per dose

Control animals:

not specified

Details on study design:

The rats were fasted overnight prior to dosing. The test material was introduced directly into the stomach of each animal via oral gavage. The animals were dosed at approximately 8:30 a.m.
Clinical signs:
The animals were observed for mortality 0.5, 1, 2, 3, 4, and 6 hours following dosing, and daily thereafter for fourteen days.
Body weights:
Body weights were recorded on days 0, 7 and 14 and prior to necropsy.
Necropsy:
Gross necropsies were performed on all animals upon study completion on day 14 following sacrifice via carbon dioxide inhalation. Any animals not surviving to termination were also necropsied.

Statistics:

The LD50 calculations were performed using a modified Logit-Linear Regression Program written by Jim Gibbons, Texas Instruments Calculator Products Division.

Preliminary study:

No data

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

742 mg/kg bw

95% CL:

>= 237 - <= 1 247

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

700 mg/kg bw

95% CL:

>= 502 - <= 898

Sex:

male

Dose descriptor:

LD0

Effect level:

300 mg/kg bw

Mortality:

All deaths occurred within the first three days post dosing. The mortality data are summarized in sect. "Remarks on results incl. tables".

Clinical signs:

other: The predominant clinical signs were abdominal gripping, abdominogenital staining, ataxia, anorexia, chromodacryorrhea, chromorhinorrhea, diarrhea, decreased feces, decreased locomotion, dehydration, hypothermia, lacrimation, no feces, oral discharge, trem

Gross pathology:

No gross lesions were found during necropsy.

Other findings:

None

Table 1: Mortality data:

Male		Female
Dosage Level (mg/kg)	No. Dead/ No. Dosed	Dosage Level (mg/kg)	No. Dead/ No. Dosed
750	3 / 5	750	3 / 5
660	0 / 5	660	2 / 5
500	2 / 5	500	1 / 5
300	0 / 5

 The LD50 values in mg/kg and the corresponding 95 % confidence limits are as follows:

Male: 742 (237 - 1247);

Female: 700 (502 - 898);

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The oral LD50 and LD0 were determined to be 742 mg/kg bw and 300 mg/kg bw, respectively in male rats and LD50 of 700 mg/kg bw in female rats.

Executive summary:

Diammonium persulfate was tested for acute oral toxicity in the rat in a study according to EPA guideline 870.1100, OECD guideline 401 and EU method B.1. The oral LD50 and LD0 were determined to be 742 mg/kg bw and 300 mg/kg bw, respectively in male rats and LD50 of 700 mg/kg bw in female rats. Therefore, the test substance was considered slightly toxic by oral administration to rat.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

700 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

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)

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

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

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.

Preliminary study:

NA

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

>= 2.95 mg/L air (analytical)

Exp. duration:

4 h

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.

Other findings:

NA

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

2 950 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991-06-27 to 1991-10-31

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Taconic Farms, Germantown, NY
- Age at study initiation: young adult animals
- Weight at study initiation: Males. 252 +/- 12.0 g; Females: 239 +/- 8.8 g
- Fasting period before study: not stated
- Housing: individually in stainless steel suspended cages with DACB cageboard bedding
- Diet: Purina Rodent Chow 5001 (pellets) ad libitum
- Water: fresh tap water ad libitum
- Acclimation period: minimum of 5 calendar days


ENVIRONMENTAL CONDITIONS
- Temperature: 16.1 - 22.2 °C
- Humidity: 42 - 73 % R.H.
- Air changes (per hr): not stated
- Photoperiod: 12 hours dark/12 hours light

Type of coverage:

occlusive

Vehicle:

physiological saline

Details on dermal exposure:

Doses corresponding to a dosage level of 2000 mg/kg bw were individually calculated based on the body weight of each animal on the day of dosing. The test material was weighed onto a 2 x 2 inch gauze pad and moistened with physiological saline. The gauze was positioned on the intact test site and held in place with hypoallergenic tape. The test site was covered with an elastic bandage which was lined with plastic for approximately 24 hours.
The bandages and pads were removed and the test sites were wiped with clean gauze moistened with methanol, then rinsed with tap water approximately twenty-four hours after application.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

The animals were observed for mortality and clinical signs (local irritation excluded) at 0.5, 1, 2, 3, 4, and 6 hours on the day of dosing and twice daily thereafter for 13 days; on day 14 the animals were observed once. A description of the local irritation was recorded on days 1, 3, 7, and 14 of the study. Body weights were taken on the day of dosing and again on days 7 and 14.

Statistics:

NA

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Remarks on result:

other: no

Mortality:

There were no deaths.

Clinical signs:

other: Abdominogenital staining, chromorhinorrhea, chromodacryorrhea and lacrimation were noted during the first 24 hours after dosing. All animals recovered by study day 2 and remained healthy until termination.

Gross pathology:

There were no gross internal lesions observed in any animal at necropsy.

Other findings:

None

Table 1: Local irritation: Dosage level 2000 mg/kg bw

Male
Animal #	Day 1	Day 3	Day 7	Day 14
AC 4877 M	N	N	N	N
AC 4878 M	N	N	N	N
AC 4879 M	Er	N	N	N
AC 4880 M	Er	N	N	N
AC 4881 M	N	N	N	N
Female
AC 4897 F	N	N	N	N
AC 4898 F	N	N	N	N
AC 4899 F	N	N	N	N
AC 4900 F	N	N	N	N
AC 4901 F	N	N	N	N

Er = Erythema

N = normal

Interpretation of results:

GHS criteria not met

Conclusions:

The acute LD50 and LD0 values were greater than 2000 mg/kg bw and 2000 mg/kg bw, respectively, in both male and female rats.

Executive summary:

Diammonium persulfate was tested for acute dermal toxicity to rats in a single dose test according to guideline EPA OPP 81-2. In this test, the acute LD50 and LD0 values were greater than 2000 mg/kg bw and 2000 mg/kg bw, respectively, in both male and female rats. Under the conditions of this study, diammonium persulfate was considered as non-toxic to both male and female rats when topically applied.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Diammonium persulfate was tested for acute toxicity in rats via the oral, dermal and inhalation. Diammonium persulfate was tested for acute oral toxicity according to EU guideline B.1. The LD50 and LD0 were 742 mg/kg bw and 300 mg/kg bw, respectively, in the male rat and LD50 value of 700 mg/kg bw in the female rat. Diammonium persulfate was tested for acute dermal toxicity according to guideline EPA OPP 81-2. LD50 and LD0 values were greater than 2000 mg/kg bw and 2000 mg/kg bw were revealed, respectively. Diammonium persulfate was tested for acute inhalation toxicity study in a whole body exposure according to guideline EPA OPP 81-3. The LC50 and LC0 values were greater than 2.95 mg/L and 2.95 mg/L, respectively.

Of the Persulfate Category, dipotassium persulfate and disodium persulfate were tested for acute oral, acute dermal and acute inhalation toxicity. The LD50 and LD0 values for acute oral toxicity for dipotassium persulfate and disodium persulfate were LD50 of 1130 mg/kg bw for dipotassium persulfate, and LD50 of 895 mg/kg bw and LD0 of 500 mg/kg bw for sodium persulfate. The LD50 and LD0 values for acute dermal toxicity in rats and rabbits were LD50 of greater than 10 000 mg/kg bw for dipotassium and disodium persulfate and LD0 values of 10000 mg/kg bw for both substances. In acute inhalation studies, the LC50 were generally greater than the maximum attainable concentration, > 42900 mg/m³ for dipotassium persulfate and > 5100 mg/m³ for disodium persulfate. LC0 values of 42900 mg/m³ for dipotassium persulfate and 5100 mg/m³ for disodium persulfate were revealed.

For the Persulfate Category worst-case values obtained were considered for safety assessment:

LD50 (oral): 700 mg/kg bw

LD0 (oral): 300 mg/kg bw

LD0 (dermal): 2000 mg/kg bw

LC0 (inhalation): 2950 mg/m³.

Justification for classification or non-classification

The available data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute oral toxicity, the Persulfate Cetegory were classified as acute toxic, cat. 4 H302 (Harmful, if swallowed) according to Regulation (EC) No 1272/2008 (CLP), as amended for the fifteenth time in Regulation (EU) No 2020/1182.