Reaction mass of calcium carbonate and calcium dihydroxide and calcium peroxide

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Calcium peroxide

EC Number:

215-139-4

EC Name:

Calcium peroxide

Cas Number:

1305-79-9

Molecular formula:

CaO2

IUPAC Name:

calcium peroxide

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 or test system 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:

other: Abdominogenital staining and diarrhea were noted in several rats shortly after dosing. All rats recovered by day 2 and remained healthy throughout the study.

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.