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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

Constituent 1
Chemical structure
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.
Body weight:
No significant alteration in the mean body weight of the animals before and after the test period, in both the control and gallic acid treated mice.

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).