Potassium trihydrogen dioxalate

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Altough no specific guideline was followed, the study is well performed and reported. Main focus was on growth and reproduction.

Data source

Reference

Reference Type:

publication

Title:

Effect of dietary ingestion of oxalic acid on growth and reproduction in male and female long-evans rats

Author:

Goldman, M., Doering, G.J., Nelson, R.G.

Year:

1977

Bibliographic source:

Research Communications in Chemical Pathology and Pharmacology, Vol 18, No 2, p 369-372

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Male and female rats received a diet of Purina laboratory chow supplemented with 2.5 and 5.0% oxallic acid for a period of 70 days. Food and water intake was observed daily, and body weight at appropriate intervals. Furthermore, vaginal smears were examined daily, and at necropsy a number of visceral and endocrine tissues were weighed.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Oxalic acid

EC Number:

205-634-3

EC Name:

Oxalic acid

Cas Number:

144-62-7

Molecular formula:

C2H2O4

IUPAC Name:

oxalic acid

Test animals

Species:

rat

Strain:

Long-Evans

Sex:

male/female

Administration / exposure

Route of administration:

oral: feed

Vehicle:

not specified

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

70 days

Frequency of treatment:

via food ad libitum

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
2.5%
Basis:
nominal in diet

Doses / concentrations 2

Remarks:

Doses / Concentrations:
5.0%
Basis:
nominal in diet

No. of animals per sex per dose:

Controls: 12 males, 12 females
2.5%: 11 males, 11 females
5.0%: 9 males, 10 females

Control animals:

yes, concurrent no treatment

Results and discussion

Effect levels

1

Dose descriptor:

dose level: 2.5%

Sex:

male/female

Basis for effect level:

other: Mortality rate was less than 10%, no external untoward effects were observed. In the vaginal smears, some diestrus and persistent vaginal cornification was observed. Histological examinations of ovarian and tested tissue showed abnormalities.

Remarks on result:

not measured/tested

Remarks:

Effect level not specified (migrated information)

2

Dose descriptor:

dose level: 5%

Basis for effect level:

other: Mortality rate was 25%, animals appeared emaciated, stunted, and gaunt with arched backs. Furthermore, growth rates, body weight, visceral, endocrine and accessory reproductive tissue weight were decreased.

Remarks on result:

not measured/tested

Remarks:

Effect level not specified (migrated information)

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Dietary ingestion of 2.5% or 5% oxalic acid over a 2-month interval resulted in marked depression in growth rate, body weight, visceral, endocrine, and accessory reproductive tissue weights, particularly in the highest concentration, under the current test conditions.

Executive summary:

Male and female rats received a diet of Purina laboratory chow supplemented with 2.5 and 5.0% oxallic acid for a period of 70 days. Dietary ingestion of 2.5% or 5% oxalic acid over a 2-month interval resulted in marked depression in growth rate, body weight, visceral, ensocrine, and accessory reproductive tissue weights, particularly in the highest concentration, under the current test conditions.