Citric acid

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP.

Data source

Reference

Reference Type:

publication

Title:

Acute and subacute toxicological studies of TAKEDA - Citric acid in mice and rats

Author:

Yokotani et al.

Year:

1971

Bibliographic source:

J.Takeda Res. Lab. 30 (1) 25-31 (1971)

Materials and methods

Test guideline

Qualifier:

no guideline available

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Citric acid

EC Number:

201-069-1

EC Name:

Citric acid

Cas Number:

77-92-9

Molecular formula:

C6H8O7

IUPAC Name:

2-hydroxypropane-1,2,3-tricarboxylic acid

Details on test material:

- Name of test material (as cited in study report): TAKEDA-citric acid

- Analytical purity: 99.8% citric acid monohydrate, heavy metals and normal paraffins were present at the concentration below 0.001, and below 0.1ppm, respectively.

Test animals

Species:

other: rat (ICR-JCL) and mice (SD-JCL)

Sex:

male

Administration / exposure

Route of administration:

intraperitoneal

Doses:

1250 mg/kg, 1042 mg/kg (other doses administered, but not clear from the report what they were)

No. of animals per sex per dose:

6 males

Control animals:

not specified

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

940 mg/kg bw

Based on:

test mat.

95% CL:

872 - 1 019

Remarks on result:

other: mouse

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

725 mg/kg bw

Based on:

test mat.

95% CL:

690 - 762

Remarks on result:

other: rat

Any other information on results incl. tables

Immediately after administration the animals showed stretching and slow crawling thereafter some laid down on their side. Death of mice given 1250 mg/kg of test compound occurred within 6 to 180 minutes by respiratory and cardiac failures. Some of mice and rats given doses below 1042 mg/kg survived but showed tremor, slight opisthotonus and a slow avoidance reaction to external stimuli within 30 minutes after administration. Some of the animals died by emaciation 2 to 5 days after injection, while others were found to recover within 3 days. At necropsy the surface of the spleen and liver was found to be covered with a thin whitish membrane and there was slight hypertrophy of liver.

Applicant's summary and conclusion

Conclusions:

Acute intraperitoneal LD50 values of 940 in mice and 725 mg/kg in rats (males only) were determined in a reliable study conducted according to an appropriate test protocol. The study was not conducted according to GLP.