Disodium peroxodisulphate

Endpoint summary

Description of key information

Disodium persulfate was tested for acute toxicity via the oral, dermal and inhalation routes. LD50 values of 930 mg/kg bw and 920 mg/kg bw for male and female, respectively, were determined in an acute oral toxicity study in rats. In a dermal toxicity study LD50 and LD0 values of greater than 10000 mg/kg bw and 10000 mg/kg bw, respectively, were determined. In an inhalation toxicity study with disodium persulfate study LC50 and LC0 values of greater than 5.1 mg/L and 5.1 mg/L, respectively were determined. Additional studies were available for substances of the Persulfate Category, diammonium persulfate and dipotassium persulfate.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: no GLP compliance, no study period.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: own breed
- Age at study initiation: male: 52 days; female: 70 days
- Weight at study initiation: 165 to 185 g
- Housing: individually in Makrolon cages
- Diet (e.g. ad libitum): Altromin
- Water (e.g. ad libitum): tap water, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 0.5 °C
- Humidity (%): 55 ± 5 %:
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

Route of administration:

oral: gavage

Vehicle:

other: Hydroxypropyl-Methylcellulose E 4 M

Details on oral exposure:

Disodium peroxodisulfate was dissolved in 0.8 % aqueous Hydroxypropyl-Methylcellulose E 4 M and applied per gavage in a constant volume of 10 mL/kg bw.

Doses:

215, 464, 562, 681, 825, 1000, 1210, 1470 mg/kg p.o.

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 4 weeks
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, mortalities

Statistics:

According to Litchfield and Wilcoxon.

Sex:

male

Dose descriptor:

LD50

Effect level:

1 200 mg/kg bw

Remarks on result:

other: 24 h

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

930 mg/kg bw

Remarks on result:

other: 14 d

Sex:

female

Dose descriptor:

LD50

Effect level:

1 000 mg/kg bw

Remarks on result:

other: 24 h

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

920 mg/kg bw

Remarks on result:

other: 14 d

Sex:

male

Dose descriptor:

LD0

Effect level:

464 mg/kg bw

Remarks on result:

other: 14 d

Sex:

female

Dose descriptor:

LD0

Effect level:

562 mg/kg bw

Remarks on result:

other: 14 d

Mortality:

See table below at Sect. "Any other information on results"

Clinical signs:

other: Sedation, ataxia, dyspnoea (464 mg/kg), diarrhoea, muscular hypotension, mydriasis (562 mg/kg), reduced feed intake, face-down position (681 mg/kg)

Gross pathology:

Dead animals: liver- and kidney-parenchyma pale, partly sabulous surface structure, distinct haemorrhage and ulceration on gastric wall and intestinal wall, gastric wall and intestinal wall thin-walled, liver tissue green-brown coloured.
surviving animals: without specific pathologic findings; 2 animals liver surface gross structured

Other findings:

no data

Mortality:

Dose [mg/kg p.o.]	24 h		14 d
	Male	Female	Male	Female
215	0	0	0	0
464	0	0	0	0
562	0	0	0	0
681	0	0	1	1
852	3	2	5	5
1000	1	5	2	7
1210	5	7	9	7
1470	7	9	10	10

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

LD50-values of 930 mg/kg bw (males) and 920 mg/kg bw (females) were determined after a 14 days observation period. Corresponding LD0 values of 464 mg/kg in male rats and 562 mg/kg in female rats were revealed. Based on the obtained results disodium persulfate was classified and labelled as toxic cat. 4 H302 (harmful if swallowed) according to Regulation 1272/2008/EC (CLP).

Executive summary:

Disodium persulfate was tested for toxicity by oral application in male and female Sprague Dawley rats. No guideline was specified. Ten male and ten female Sprague-Dawley rats per group were dosed with 215, 464, 562, 681, 825, 1000, 1210 and 1470 mg/kg bw disodium persulfate and were observed for 4 weeks. Clinical signs and mortalities were recorded. All animals were subjected to gross autopsy after termination of the study. No animal died in the lowest dose group (215 mg/kg bw), two rats (one male and one female rat) died in the intermediate dose group (681 mg/kg bw) and all rats died in the highest dose group (1470 mg/kg bw). Death occurred within 60 minutes until 6 days after application. Surviving animals had recovered after 48 hours after application. Clinical signs included sedation, dyspnoea, diarrhoea, muscular hypotension, reduced feed intake and face-down position. LD50-values of 930 mg/kg bw (males) and 920 mg/kg bw (females) were determined after a 14 days observation period and corresponding LD0 values of 464 mg/kg in male rats and 562 mg/kg in female rats were revealed.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

920 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:

1995-09-21 to 1995-12-29

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

EPA OPP 81-3 (Acute inhalation toxicity)

Version / remarks:

(November 1984)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

(May 12, 1981)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Version / remarks:

(29 December 1992)

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, Kingston, NY
- Age at study initiation: approximately 7 and 9 weeks
- Weight at study initiation: males: 216 ± 7.3 g; females 223 ± 8.6 g
- Fasting period before study: no
- Housing: individually in stainless steel suspended cages with Deosorb indirect bedding
- Diet: Purina Laboratory Rodent Chow 5001 ad libitum
- Water: fresh tap water ad libitum
- Acclimation period: 5 days prior to study start

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 20.5 °C on an average
- Humidity: 50 to 56 % R.H
- Air changes not indicated
- Photoperiod: 12 hours fluorescent light/12 hours dark

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

The test animals were exposed to disodium persulfate in a 11 litre ADG nose-only exposure chamber made of anodized aluminium and operated dynamically. The chamber air was exhausted from the bottom of the chamber and passed through an orifice tube system which continuously monitor airflow and then through a commercial filter box. The filter box was connected to a line leading to additional filters and an exhaust fan on the roof. The exhaust operated at a flow rate of 38.6 litres per minute, creating a slight negative pressure in the chamber. The calculated 99 % equilibrium time for the chamber at a flow rate of 38.6 litres per minute was 1.3 minutes (equivalent to 1 "air change" every 17 seconds). This chamber size and airflow rate is considered adequate to maintain the oxygen above 19 %. Chamber airflow measurements were recorded at 30 minute intervals. The entire exposure system and primary exhaust filter were contained in a fume hood.
The exposure was conducted for 4 hours. At the end of the exposure, the chamber was cleared for approximately 30 minutes by drawing room air through it at the same flow rate (38.6 litres per minute) prior to removing the animals.
The test animals were assigned to and housed in individual polycarbonate nose-only tubes during the exposure. The tube position assignment ensured equal distribution of both sexes around the chamber.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

Gravimetric concentration: 5.10 mg/L
Nominal concentration: 19.0 mg/L

No. of animals per sex per dose:

5 males/5 females

Control animals:

no

Details on study design:

The test material was ground using a micro-mill to ensure the test material was respirable as possible to the test species.
The test material was packed into large dust cups and the desiccated overnight. The test atmosphere was generated using a BGI Wright Dust Feeder II. Breathing Grade compressed air was metered to the dust feeder through 1/4 inch Teflon tubing by a Matheson 605 rotameter. The dust feeder back pressure was monitored by a Marshalltown back pressure gauge. The test material was made airborne by compressed air dispersing the material into the exposure chamber. The concentration of the test atmosphere was controlled by the delivery rate setting of the Wright dust feeder.

Statistics:

Particle size distribution was determined by log-probability plotting of the data and subsequent determination of the mass median aerodynamic diameter, geometric standard deviation and other particle size parameters from the data plots. The LC50 and 95 % confidence limits was determined by a suitable logit or probit analysis.

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.1 mg/L air

Exp. duration:

4 h

Sex:

male

Dose descriptor:

LC0

Effect level:

5.1 mg/L air

Exp. duration:

4 h

Mortality:

All animals survived to study termination.

Clinical signs:

other: Clinical signs observed during the study included chromodacryorrhea, chromorhinorrhea, decreased faeces, decreased locomotion, dyspnoea, nasal discharge and oral discharge. All of these signs resolved by day 2 of the observation period.

Body weight:

All animals gained weight during the study.

Gross pathology:

No gross internal lesions were noted during necropsy.

Other findings:

None

The MMAD's ranged from 4.28 to 5.35 micrometers (µm) with a geometric standard deviation ranged from 2.61 to 2.38 µm. The fraction of particles less than or equal to 1 µm in mass aerodynamic diameter, based on the log-probability graphs, ranged from 0 % to 5.6 %. The fraction of particles less than or equal to 10 µm in mass aerodynamic diameter, based on the log probability graphs, ranged from 76.5 to 81.2 %.

Table 1: Particle size analysis:

Sample number: E03C;

Exposure time: 64 minutes;

Percent	Cutoff (microns)
5.6	1.00
15.9	1.64
25.0	2.25
50.0	4.28
81.2	10.00
84.1	11.16
90.5	15.00

 Geometric standard deviation: 2.61;

Table 2: Particle size analysis:

Sample number: E07C;

Exposure time: 190 minutes;

Percent	Cutoff (microns)
-0.5	1.00
15.9	2.25
25.0	2.98
50.0	5.35
76.5	10.00
84.1	12.70
88.3	15.00

 Geometric standard deviation: 2.38

Interpretation of results:

GHS criteria not met

Conclusions:

LC50 and LC0 values of greater than 5.1 mg/L and 5.1 mg/L, respectively, were determined. Thus, the test material was not classified and labelled for acute toxicity via the inhalation route according to Regulation 1272/2008/EC (CLP).

Executive summary:

Disodium persulfate was tested for inhalation toxicity in the rat in a study performed according to EPA OPP 81-3 guideline. A group of five male and five female Sprague Dawley rats was exposed to disodium persulfate for 4 hours at a mean concentration of 5.1 mg/L in a dynamically-operated, nose-only inhalation exposure chamber. Gravimetric airborne test material samples were taken frequently during the exposure. Particle size samples were taken twice during the exposure. Observations for toxicity and mortality were performed frequently during the exposure and upon removal of the rats from the chamber, one hour post-exposure and daily thereafter for 14 days. All animals survived to study termination. Clinical signs observed during the study resolved by day 2 observations. All animals gained weight during the study. No gross internal lesions were noted during necropsy. Under the conditions of the study, LC50 and LC0 values of greater than 5.1 mg/L and 5.1 mg/L, respectively, were determined.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5 100 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

key study

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 000 mg/kg bw

Additional information

Disodium persulfate was tested for acute oral dermal and inhalation toxicity. Disodium persulfate was tested for acute oral toxicity in male and female rats. LD50 values of 930 mg/kg bw and 920 mg/kg bw for male and female rats, respectively, were determined.

In a dermal toxicity non-GLP study in male rabbits the LD50 and LD0 values of greater than 10000 mg/kg bw and 10000 mg/kg bw were determined.

Disodium persulfate was tested in a 4-hour nose-only inhalation study with rats according to EU guideline B.2. The acute LC50 and LC0 values were determined to be greater than 5.1 mg/L and 5.1 mg/L, respectively, for male and female rats.

Of the Persulfate Category, diammonium persulfate and dipotassium persulfate were tested as well for acute oral, acute dermal and acute inhalation toxicity.

For diammonium persulfate and dipotassium persulfate LD50 values of 700 mg/kg bw and 1130 mg/kg bw, respectively, were determined in acute oral toxicity studies. In acute dermal toxicity studies, LD50 and LD0 values of greater than 2000 mg/kg bw and 2000 mg/kg bw, respectively, were determined for diammonium persulfate and LD50 and LD0 of greater than 10000 mg/kg bw and 10000 mg/kg bw, respectively were determined foe dipotassium persulfate. In acute inhalation toxicity studies LC50 and LC0 of greater than 2.95 mg/L and 2.95 mg/L, respectively were determined for diammonium persulfate. LC50 and LC0 values of greater than 42.9 mg/L and 42.9 mg/L, respectively were determined for dipotassium persulfate.

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

LD0 (oral): 300 mg/kg bw

LD0 (dermal): 2000 mg/kg bw

LC0 (inhalation): 2950 mg/m³.

Justification for classification or non-classification

Based on the results obtained, substances of the Persulfate Category were classified and labelled acute toxic, cat. 4 H302 (harmful if swallowed) according to Regulation 1272/2008/EC (CLP), as amended for the fifteenth time in Regulation (EU) 2020/1182.