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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1964
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The information on this study is in the form of a letter report. It was conducted prior to international guidelines and good laboratory practice standards. The study appears to be robust.

Data source

Reference
Reference Type:
other: Letter Report
Title:
Unnamed
Year:
1964

Materials and methods

Principles of method if other than guideline:
Conducted generally as modern studies - a single gavage dose to six groups of rats with observation for 14 days followed by sacrifice with gross necropsies.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The test material was administered as a 50% weight/volume suspension in water.
Doses:
0, 215, 464, 1000, 2150, 4640 and 10000 mg/kg bw
No. of animals per sex per dose:
5 M/dose
Control animals:
yes
Details on study design:
The test material was administered orally by stomach tube to 6 groups, each composed of 5 male albino rats (Dublin Sprague-Dawley strain, 201-291 g in weight). The test material was administered as a 50% weight/volume suspension in water. Food was withheld for approximately 18 hr prior to dosing. Food (commercial pellets) and water was then available ad libitum. The rats were housed in groups in wire mesh cages suspended above the droppings. All animals were observed closely for gross signs of systemic toxicity and mortality several times during the day of dosage, and at frequent intervals thereafter for a total of 14 days. At the end of the 14 d observation period, rats were weighed, sacrificed by cerebral concussion, and gross necropsies performed.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Mortality:
None due to test article toxicity. One death at 464 mg/kg due to gavage error.
Clinical signs:
none
Body weight:
no changes attributable to test article
Gross pathology:
see remarks

Any other information on results incl. tables

One rat at the 464 mg/kg dose was found dead on the third experimental day. Necropsy findings indicated the death was due to gavage error (e.g. intratracheal). No other mortalities occurred during the 14-day observation. The oral LD50 was determined to be > 10000 mg/kg bw. The average body weight gain in each group was reported as within the normal limits for rats of the age, sex and strain employed in the study. At gross necropsy on termination, slight congestion of the kidney was observed in rats at the lower dose levels, and moderate to marked congestion of the kidneys were observed at the highest dose level. 

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment