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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1991-06-27 to 1991-10-31
Reliability:
1 (reliable without restriction)
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: diammonium persulfate
- Molecular formula: H2 N2 O8 S2
- Molecular weight: 228.20 g/mol
- Physical state: white, crystalline solid
- Analytical purity: 99.0 %
- Purity test date: not stated
- Lot/batch No.: Lot # 105-22
- Expiration date of the lot/batch: not stated
- Stability under test conditions: stable at ambient conditions;
- Storage condition of test material: Dry conditions, at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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.
Statistics:
NA

Results and discussion

Effect levelsopen allclose all
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:
Abdominogenital staining, chromorhinorrhoea, chromodacryorrhoea and lacrimation were noted during the first 24 hours after dosing. All animals recovered by study day 2 and remained healthy until termination.
Body weight:
No test item related findings.
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: 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:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: US EPA pesticides
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.