Dipotassium peroxodisulphate

Acute Toxicity: dermal

Administrative data

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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

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

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: 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

Administration / exposure

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.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.