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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2001-05-21 to 2001-10-18
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:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
August 1998
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
24 February 1987
Deviations:
no
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: ammonium 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 # 10501
- 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: 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 animal not surviving to termination was 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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
742 mg/kg bw
95% CL:
237 - 1 247
Sex:
female
Dose descriptor:
LD50
Effect level:
700 mg/kg bw
95% CL:
502 - 898
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:
The predominant clinical signs were abdominal gripping, abdominogenital staining, ataxia, anorexia, chromodacryorrhoea, chromorhinorrhoea, diarrhoea, decreased faeces, decreased locomotion, dehydration, hypothermia, lacrimation, no feces, oral discharge, tremors and unthriftiness. All rats recovered by study day 8 and remained healthy until termination.
Body weight:
All rats gained weight during the study.
Gross pathology:
No gross lesions were found during necropsy.
Other findings:
None

Any other information on results incl. tables

Table: 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:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: US EPA pesticides
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.