Registration Dossier

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
OECD, 2001: The Organisation for Economic Co-operation and Development (OECD) Guidelines for Testing of Chemicals, OECD 423, Acute Oral Toxicity - Acute Toxic Class Method, adopted by the Council on December 17, 2001.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Test material form:
solid: particulate/powder
Details on test material:
It was manufactured by MOLAR CHEMICALS Ltd.

Test animals

Species:
rat
Strain:
Wistar
Remarks:
RccHan : WIST
Sex:
female
Details on test animals and environmental conditions:
Caging : Polypropylene rat cages covered with stainless steel grid top were used. Autoclaved clean rice husk was used as the bedding material.
Water Bottle : Each cage was supplied with a polypropylene water bottle with a stainless steel nozzle.
Housing : Three rat per cage
Room Sanitation : Daily: 1. Rack was cleaned with cloth, 2. Floor of experimental procedure room was swept, 3. All work tops and the floor were mopped with a disinfectant solution.
Enrichment : Wooden block

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Individual dose volume was adjusted according to body weight and dose level. All rats were dosed by oral gavage (day 0) using a BD 1 mL disposable syringe. Rats were fasted overnight prior to dosing and until three hours post-dosing.
Doses:
300 mg Uric Acid/kg body weight and 2000 mg Uric Acid/kg body weight
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
As no information available of test item, the first set (set I) of three female rats was given a single dose of 300 mg Uric Acid/kg body weight. No mortality was observed at this dose level so a second set (set II) of three female rats was administered with same dose level of 300 mg Uric Acid/kg body weight. No mortality was observed at this dose level so a third set (set III) of three female rats was administered with higher dose level of 2000 mg Uric Acid/kg body weight. No mortality was observed at this dose level so a fourth set (set IV) of three female rats was administered with same dose level of 2000 mg Uric Acid/kg body weight. No mortality was observed at this dose level hence the endpoint was achieved and further testing was not required.
Statistics:
Mean and standard deviation for body weight.

Results and discussion

Preliminary study:
no
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed in rats treated at the dose level of 300 & 2000 mg Uric Acid/kg body weight.
Clinical signs:
No clinical sign was observed in rats treated with 300 & 2000 mg Uric Acid/kg body weight.
Body weight:
Normal gain in body weight was observed in all rats.
Gross pathology:
External
External examination of terminally sacrificed rats did not reveal any abnormality.
Internal
Visceral examination of the terminally sacrificed rats did not reveal any lesion.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No mortality was observed in rats treated at the dose level of 300 & 2000 mg Uric Acid/kg body weight.
Executive summary:

No mortality was observed in rats treated at the dose level of 300 & 2000 mgUric Acid/kg body weight. The acute oral LD50cut-off value ofUric Acidin Wistar rats was found to be 5000 mg/kg body weight.