Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract

Data source

Reference
Reference Type:
publication
Title:
The toxicity of gallic acid, pyrogallol, tannic acid, and Quercus havardi in the rabbit
Author:
Dollahite, J.W.; Pigeon, R.F.; Camp, B.J.
Year:
1962
Bibliographic source:
American Journal of Veterinary Research. 23: 1264-1267

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
- Principle of test: a repeated dose test was performed to rabbit
- Short description of test conditions: no data
- Parameters analysed / observed: mortality and effects related to administration of the substance
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
not specified
Details on test material:
not specified
Specific details on test material used for the study:
no data

Test animals

Species:
rabbit
Strain:
not specified
Details on species / strain selection:
no data
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Details on route of administration:
no data
Vehicle:
not specified
Details on oral exposure:
no data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
10-day exposure
Frequency of treatment:
no data
Doses / concentrationsopen allclose all
Dose / conc.:
500 mg/kg bw/day (nominal)
Dose / conc.:
1 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
total of animals tested: 6
Sex: n.p.
Control animals:
not specified
Details on study design:
observation period n.p.
Positive control:
no data

Results and discussion

Effect levels

Key result
Dose descriptor:
other: repeated-dose LD50
Effect level:
700 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
mortality

Any other information on results incl. tables

A repeated-dose LD50 of 700 mg/kg/day was determined. The following symptoms were observed in some treated rabbits: congestion of the lung; congestion of the liver, with prominent lobules (alternate light and congested areas were observed); congestion and swelling of the kidneys; congestion and enlargement of the spleen; and gastritis, usually with hemorrhages and/or ulcers. A smooth white exudate was induced on the gastric mucosa and there was a varying degree of enteritis in the duodenum and cecum. The doses which caused these effects and the number of animals affected were n.p.

Applicant's summary and conclusion

Conclusions:
In rabbits, a multiple oral dose (LD50) of pyrogallol is 0.7 g/kg per day when administered daily for ten days.