Bisisopropyl peroxydicarbonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1961

Report date:

1961

Materials and methods

Principles of method if other than guideline:

Standard acute toxicity study

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bisisopropyl peroxydicarbonate

EC Number:

203-317-4

EC Name:

Bisisopropyl peroxydicarbonate

Cas Number:

105-64-6

Molecular formula:

C8H14O6

IUPAC Name:

2-[({[(propan-2-yloxy)carbonyl]peroxy}carbonyl)oxy]propane

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:
1 to 10 ml

DOSAGE PREPARATION (if unusual):
The diluted isopropyl Percarbonate was prepared by adding the required volume of refrigerated mazola (corn oil) to the calculated weight of the frozen chemical in a beaker previously cooled in a refrigerator. The animals were injected immediately after the crystals had dissolved in the mazola.

Doses:

1000, 2000, 3980 and 7950 mg/kg

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

Following treatment, the rats were observed for 14 days during which period any deaths due primarily to the chemical would be expected to occur. All fatalities were subjected to autopsies to exclude extraneous causes of death. Survivors were sacrificed, weighed, and examined for gross lesions.

Statistics:

The single oral dose LD50, based upon lethal effect during the 14-day observation period, was estimated by Thompson's method of moving averages using the tables of Weil

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

2 140 mg/kg bw

Based on:

act. ingr.

95% CL:

>= 1 380 - <= 3 320

Mortality:

See attached table.

Clinical signs:

other: The general condition and behavior of all of the survivors were good.

Gross pathology:

Upon autopsy, all of the rats which died during the test period revealed distention of the gastrointestinal tract and hyperemia of the intestines. The lungs were normal except for the presence of foci of green coloration. The origin or significance of the pigmentation is unknown, but it was not present in control animals. The gastrointestinal effects were due to the irritating chemical properties of the isopropyl Percarbonate and is typical of shock due to chemicals. The survivors of the observation period showed no gross lesions upon examination after sacrifice.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Executive summary:

The single dose, oral LD50 of pure Isopropyl Percarbonate for male, albino rats is 2140 mg/kg. with 95% confidence limits of 1380 to 3320 mg/kg. Survivors of the exposure exbibited no sign of residual chemical effects.