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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP and according to internationally accepted guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.1175 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
Initial doses were considered range-finding, then limit test conducted.
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Rats purchased from Charles River, Massachusetts at 6-10 weeks of age. Animals were in ranges of 146 -165 grams in rangefinder, and 174-266 grams for limit test. Rats were housed individually @ 18 - 26 degrees C, 12 hr/ light/12 hr dark cycles at 40 - 70% humidity. Rats were fasted prior to dosing (time unspecified), and given diet (Wayne Teklad Lab Blox) and water ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
The vehicle was corn oil administered as control & with test chemical at dosing volume of 10 ml/kg. Test chemical was suspended in corn oil with use of Polytron at concentrations of 50, 250 and 500 mg/ml to achieve delivered doses of 500, 2500 & 5000 mg/kg bw (single dose). The limit dose of 5000 mg/kg bw was prepared in the same manner.
No. of animals per sex per dose:
The rangefinder employed 1 male, 1 female rat for each of 3 doses. The limit test used 5 rats of each sex.
Control animals:
no
Details on study design:
Rats were observed daily for signs of gross behavior & mortality. Body weights were recorded on days 0, 7, and 14. Animals were subjected to necropsies following sacrifice on day 14.
Statistics:
None

Results and discussion

Preliminary study:
0/2 rats died within 72 hr at the 500, 2500 or 5000 mg/kg bw dose.
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LDLo
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Mortality:
1 of 5 male rats died at the limit dose (5000 mg/kg bw) on Day 7 of the test while 0/5 females died.
Clinical signs:
Females exhibited no adverse signs during 14 day observation period. Males showed decreased activity & muscular tone (2/5), and diarrhea 3/5).
Body weight:
Body weight gains occurred in both sexes. Without controls, can not conclude no effects present.
Gross pathology:
Pale color observed for kidneys, liver, and spleen in males; no adverse signs in females.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Test chemical exhibits very low toxicity following single dose by oral gavage. LD50 >5000 mg/kg.
Executive summary:

An oral gavage test was conducted in rats. Following pilot study that showed no lethality up to dose of 5000 mg/kg bw, a limit test was conducted. Test chemical exhibits very low toxicity following single dose by oral gavage with LD50 >5000 mg/kg bw.