Disodium peroxodisulphate

Acute Toxicity: oral

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Test animals

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

Administration / exposure

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.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1 200 mg/kg bw

Remarks on result:

other: 24 h

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

930 mg/kg bw

Remarks on result:

other: 14 d

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

1 000 mg/kg bw

Remarks on result:

other: 24 h

Effect levels 4

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

920 mg/kg bw

Remarks on result:

other: 14 d

Effect levels 5

Sex:

male

Dose descriptor:

LD0

Effect level:

464 mg/kg bw

Remarks on result:

other: 14 d

Effect levels 6

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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.