Disodium carbonate, compound with hydrogen peroxide (2:3)

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: see 'Remark'

Remarks:

The study was carried out in accordance with the Health Effects Test Guidelines, U.S. Environmental Protection Agency Office of Pesticides and Toxic Substances (1984) "Acute Exposure Oral Toxicity" and was performed in compliance with the conditions of GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Health Effects Test Guidelines, U.S. Environmental Protection Agency Office of Pesticides and Toxic Substances (1984) "Acute Exposure Oral Toxicity"

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium carbonate, compound with hydrogen peroxide (2:3)

EC Number:

239-707-6

EC Name:

Disodium carbonate, compound with hydrogen peroxide (2:3)

Cas Number:

15630-89-4

Molecular formula:

CH2O3.3/2H2O2.2Na

IUPAC Name:

tetrasodium hydrogen peroxide dicarbonate

Details on test material:

Test substance: as prescribed by 1.1 - 1.4
- Name of test material (as cited in study report): Sodium Percarbonate
- Analytical purity: > 88%

Test animals

Species:

rat

Strain:

other: Crl: CD®BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc., Portage MI
- Age at study initiation: Young adult (approximately 8 weeks old)
- Weight at study initiation: 201 - 282 g
- Acclimation period:at least 7 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

- Doses per time period: single dose
- Volume administered or concentration: An individual dose was calculated for each animal based upon its fasted body weight and administered by
gavage using a dose volume of 10.0 ml/kg

Doses:

700, 1000 and 1500 mg/kg

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

EXAMINATIONS
- Animals were observed for clinical signs and mortality at 1, 2.5 and 4 hours after test material administration. These animals were observed daily
thereafter for 14 days for clinical signs and twice daily for mortality.

Statistics:

The LD50 value for males, females and the sexes combined was determined by a computer program utilizing a Modified Behrens-Reed-Muench Cumulant Method. No other statistical methods were performed.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 034 mg/kg bw

95% CL:

833 - 1 284

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

893 mg/kg bw

95% CL:

663 - 1 202

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

1 164 mg/kg bw

95% CL:

914 - 1 482

Mortality:

Refer to table 1. All mortality occurred within 3 days following test material administration.

Clinical signs:

other: Hypoactivity, ataxia, diarrhea, red-stained face, dyspnea, absence of pain reflex, excessive salivation, brown-stained urogenital area, prostration, and death. Animals surviving until the end of the observation period exhibited weight gain.

Gross pathology:

NECROPSY FINDINGS
Coloration changes in the glandular portion of the stomach. The wall of these stomachs were occasionally thickened as well.

Any other information on results incl. tables

Mortality

Sex	Dose level (mg/kg)	Mortality (number Dead / number dosed)
Male	700	0/5
	1000	1/5
	1500	5/5
Female	700	1/5
	1000	3/5
	1500	5/5

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The estimated oral LD50 was determined to be 1164; 893 and 1034 mg/kg of body weight for males, females and the combined sexes, respectively. All mortality occurred within 3 days of test material administration.

Executive summary:

An acute oral toxicity test was performed with sodium percarbonate following the relevant guideline of the U.S. EPA Office of Pesticides and Toxic Substances (1984). 15 male and 15 female rats were exposed to sodium percarbonate orally via gavage, at doses of 700, 1000 and 1500 mg/kg body weight. The LD 50 was determined to be 1164 (914 -1482) mg/kg bw for males, 893 (663 -1202) mg/kg bw for females, and the combined mortality was 1034 (833 -1284) mg/kb bw. Hypoactivity, ataxia, diarrhea, red-stained face, dyspnea, absence of pain reflex, excessive salivation, brown-stained urogenital area, prostration, and death were observed. Animals surviving until the end of the observation period exhibited weight gain.