Reaction mass of calcium dihydroxide and calcium peroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 December 1988 - 05 January 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

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

Constituent 2

Reference substance name:

Calcium dihydroxide

EC Number:

215-137-3

EC Name:

Calcium dihydroxide

Cas Number:

1305-62-0

Molecular formula:

CaH2O2

IUPAC Name:

calcium dihydroxide

Test material form:

solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Tac:N[SD]fBR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Taconic Farms, Germantown, New York (USA)
- Age at study initiation: Young adults
- Weight at study initiation: 204-217 g males, 218-229 g females.
- Fasting period before study: Overnight prior to dosing.
- Housing: Individually housed in stainless steel suspended rat cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9-24.5
- Humidity (%): 24-59
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% w/v

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality and clinical signs: 0.5, 1, 2, 3, 4 and 6 hours on the day of dosing and twice daily thereafter.
Body weights: On the day of dosing and again on days 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

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.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of the test item was determined to be greater than 5000 mg/kg bw to both male and female rats.

Executive summary:

An acute oral toxicity test was performed according to OECD Guideline 401 (GLP study). Ten Sprague-Dawley rats (5 males and 5 females) were orally dosed with test item at a dose level of 5000 mg/kg bw in corn oil. Clinical signs and body weight gains were assessed during the study. Gross necropsy was performed on all animals. There were no deaths. Abdominogenital staining and diarrhea were noted in several rats shortly after dosing. All rats recovered by day 2 and remained healthy throughout the study. All rats gained weight by day 14 of the study. There were no gross internal lesions observed in any animal. Based on these results, the oral LD50 of the test item was determined to be greater than 5000 mg/kg bw to both male and female rats.