3,4,5-trihydroxybenzoic acid

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:

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

Data source

Reference

Reference Type:

publication

Title:

Assessment of the no-observed-adverse-effect level (NOAEL) of gallic acid in mice

Author:

Rajalakshmi K., Devaraj H., Devaraj S. N.

Year:

2001

Bibliographic source:

Food and Chemical Toxicology 39 (2001) 919–922

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Gallic acid, at a dose of 5000 mg/kg body weight, was administered orally to six male and six female mice.
DMSO was used as the vehicle for acute study.
The animals were observed carefully for any signs of morbidity and mortality, immediately after dosing, at 4-h and at 24-h intervals, during the recovery period of 48h, and twice daily for the subsequent 14 days.
After 14 days, the animals were sacrificed under ether anesthesia.
A thorough autopsy was carried out on all the animals.

During autopsy, all organs were observed macroscopically and selected vital organs were excised, blotted and weighed. Tissues were fixed in 10% buffered neutral formalin. Paraffin sections of major organs were prepared and stained with hematoxylin and eosin for histological examination.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,4,5-trihydroxybenzoic acid

EC Number:

205-749-9

EC Name:

3,4,5-trihydroxybenzoic acid

Cas Number:

149-91-7

Molecular formula:

C7H6O5

IUPAC Name:

3,4,5-trihydroxybenzoic acid

Test animals

Species:

mouse

Strain:

Swiss

Sex:

male/female

Details on test animals or test system and environmental conditions:

Strain: Swiss albino mice
Age: 6–8 weeks of age
Weight: 20–25 g

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

DMSO

Doses:

5000 mg/kg

No. of animals per sex per dose:

six male and six female mice.

Control animals:

yes

Details on study design:

The animals were observed carefully for any signs of morbidity and mortality, immediately after dosing, at 4-h and at 24-h intervals, during the recovery period of 48h, and twice daily for the subsequent 14 days.
After 14 days, the animals were sacrificed under ether anesthesia.
A thorough autopsy was carried out on all the animals.

Statistics:

Fischer’s (1950) Student’s t-test used.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

None of the animals showed any visible signs of morbidity and all the animals survived during the experimental period.
A thorough autopsy of the treated animals revealed no treatment-related macroscopic changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item did not induce any toxic effects when administered orally to mice at 5000 mg/kg bw. Under tests conditions and according to GHS criteria, the test item is not acutely toxic (oral).