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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to internationally accepted protocol. No deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: tan powder
- Analytical purity: 82.1%
- Reference number: 804-26
- Stability under test conditions: not determined
- Storage condition of test material: 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, New York
- Age at study initiation: no data
- Weight at study initiation: 211 +/- 4.7 g (males), 224 +/- 4.9 g (females)
- Fasting period before study: overnight
- Housing: individually, stainless steel suspended rat cages
- Diet (e.g. ad libitum): Purina Laboratory Rodent Chow 5001, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 66-76°F
- Humidity (%): 24-59%
- Photoperiod (hrs dark / hrs light): 12h fluorescent light, 12h dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25%
- Lot/batch no. (if required): 65084-BAB

DOSE VOLUME APPLIED: 4.1-4.6 mL of corn oil suspension, depending on body weight

TEST MATERIAL ADMINISTRATION
The test material was introduced directly into the stomach by means of a straight, 13 gauge stainless steel dosing needle.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males, 5 females
Control animals:
not specified
Details on study design:
STUDY DESIGN
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

DATA INTERPRETATION
FMC internal guidelines for acute oral toxicity:
LD50 value (mg/kg bw) Toxicity rating
> 5000 Practically non-toxic
500-5000 Slightly toxic
50.0-500 Moderately toxic
<= 50.0 Highly toxic

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the observation period.
Clinical signs:
Abdominogenital staining and diarrhea were noted in several rats shortly after dosing. All rats recovered by day 2 and remained healthy throughout the study.
Body weight:
Male body weights:
Day 0: 211 +/- 4.7
Day 7: 271 +/- 9.3
Day 14: 310 +/- 12.0

Female body weights:
Day 0: 224 +/- 4.9
Day 7: 243 +/- 8.1
Day 14: 256 +/- 9.7
Gross pathology:
There were no gross internal lesions observed in any animal at necropsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: other: FMC internal guidelines
Conclusions:
Under the conditions of this study, the test material is classified as practically non-toxic to both male and female rats.
Executive summary:

5 Male and 5 female Sprague-Dawley rats were orally dosed with Calcium peroxide as a 25% (w/v) suspension in corn oil at a dosage level of 5000 mg/kg bw. Observations for toxicity were conducted at 0.5, 1, 2, 3, 4 and 6 hours on the day of dosing and twice daily thereafter for 13 days. A gross necropsy was performed on all animals.

No deaths occurred during the study. Abdominogenital staining and diarrhea were noted in several rats shortly after dosing. All rats recovered by day 2 and remained healthy throughout the study. There were no gross internal lesions observed in any animal at necropsy.

Under the conditions of this study, the test material is classified as practically non-toxic to both male and female rats. The LD50 is judged to be > 5000 mg/kg to both male and female animals.