Diammonium peroxodisulphate

Acute Toxicity: oral

Administrative data

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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

August 1998

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

24 February 1987

Deviations:

no

Test guideline 3

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

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 peroxodisulphate

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 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

Administration / exposure

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.

Results and discussion

Preliminary study:

No data

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

742 mg/kg bw

95% CL:

>= 237 - <= 1 247

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

700 mg/kg bw

95% CL:

>= 502 - <= 898

Effect levels 3

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

Any other information on results incl. tables

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);

Applicant's summary and conclusion

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.