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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: Performed according to standard guidelines and good laboratory practices.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed

Test animals

Species:
rat
Strain:
other: CD [Crl:DC (SD)IGS BR]
Sex:
female
Details on test animals and environmental conditions:
Rats 7 weeks old on arrival at test laboratory. Housed individually in suspended, stainless steel, wire mesh cages. Acclimated for 7 d prior to test initiation. Weight 166-179 g at randomiization. Identified by microchip implant. Euthanized via CO2 inhalation at end of test. Fed Block Lab Diet (Certified Rodent Diet #5002, PMI Nutrition Internation, Inc). Tap water and diet available ad libitum. Temp 69-74F, Humidity 46-69%.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Administered as a single dose by oral gavage in corn oil. Observed for 14 daays.
Doses:
2000 mg/Kg
No. of animals per sex per dose:
5
Details on study design:
Initially, one animal was dosed at 2000 mg/kg at a dose volume of 10 ml/Kg. Approximately 3 d later, an additional 4 animals were dosed at 2000 mg/Kg at dose volume of 10 ml/Kg. Each animal was dosed once via oral gavage. The test article formulations were stirred continuously during dosing. Individual doses were based on the most recent body weights. Animals were observed for mortality and toxicity for 14 days post-dosing.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None.
Clinical signs:
No clinical signs of toxicity were observed.
Body weight:
No effect of body weight was observered.
Gross pathology:
No gross macroscopic findings were evident.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Under the conditions of this study, where female rats were given a single oral (gavage) dose of SAYTEX RB-79 at 2000 mg/KG, no deaths occured and no test article-related signs of toxicity were noted. The LD5 0 was > 2000 mg/kg in female rats.
Executive summary:

Under the conditions of this study, where female rats were given a single oral (gavage) dose of SAYTEX RB-79 at 2000 mg/KG, no deaths occured and no test article-related signs of toxicity were noted. The LD5 0 was > 2000 mg/kg in female rats.