Bisisopropyl peroxydicarbonate

Endpoint summary

Description of key information

Oral route

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 exhibited no sign of residual chemical effects (McNerney, 1961).

This value is supported by a rat oral LD50 of 2400 mg/kg with a reliability index of 0.8 estimated by the Danish QSAR database.

Inhalation exposure

A 60-minute exposure to the fog and vapors of a 45% solution of bisisopropyl peroxydicarbonate in Soltrol 130 (ca 15 mg/L of bisisopropyl peroxydicarbonate) caused a 50% mortality in a group of six male albino rats, during the exposure and in the 25 minutes after exposure (McNervey, 1961). The apparent cause of death was anoxia due to hemorrhagic pulmonary edema. Pulmonary sequelae that appeared in the 24 hours after the exposure, seemed to disappear in72 hours. Six male albino rats survived an exposure of 30 minutes. Scattered foci of pneumonia existed immediately after exposure, but were resorbed within 24 hours.

A 10-minute exposure did not result in death or grossly significant injury in a group of six albino rats males. All rats exhibited symptoms of respiratory disorders during the exposure, the intensity of the reaction being directly related to the duration of the exposure.

No symptoms of abnormality and histopathological changes in lungs were noted during a 8-hour inhalation exposure to saturated vapor concentration of bisisopropyl peroxydicarbonate and/or its degradation products (Lalich, 1958).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Principles of method if other than guideline:

Standard acute toxicity study

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 140 mg/kg bw

Quality of whole database:

key study

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No classification according to CLP criteria, acute oral cat. 5 according to GHS criteria.