Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
A group of Sprague-Dawley derived, albino rats was received from Ace Animals, Inc., Boyertown, PA, The animals were singly housed in suspended stainless steel caging with mesh floors. Litter paper was placed beneath the cages and was changed at least three times per week. The animal room was temperature controlled and had a 1 2-hour light/dark cycle. The animals were fed Purina Rodent Chow #5012 and filtered tap water was supplied ad libitum by an automatic watering system.

Following acclimation to the laboratory, a group of animals was fasted for approximately 17 hours by removing feed from their cages. After the lasting period, ten rats (five male and five female) were selected for test based on health and initial bodyweights. Individual doses were calculated based on these bodyweights, taking into account the specific gravity (determined by PSL) of the test substance. Each animal received 5,000 mg/kg of the test substance by intubation using a stainless steel ball-tipped gavage needle attached to an appropriate syringe. After administration, each animal was returned to its designated cage. Feed was replaced approximately 3 hours after dosing.

The animals were observed for signs of gross toxicity and behavioral changes at least once daily for 14 days or until mortality. Individual bodyweights of the animals were recorded prior to test substance administration (initial) and again on Days 7 and 14 (termination) or after death. Surviving animals were euthanized by CO2 inhalation on Day 14. Gross necropsies were performed on all decedents and euthanized animals. Tissues and organs of the thoracic and abdominal cavities were: examined.
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/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Limit test: 5000 mg/kg
No. of animals per sex per dose:
5 male and 5 female at the dose of 5000 mg/kg
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw

Any other information on results incl. tables

One male died within two days of test substance administration. Toxic signs prior to death included prone posture and ataxia. Most surviving animals exhibited hunched posture, hypoactivity, piloerection, facial staining, reduced fecal volume and/or loss of balance, but recovered from these symptoms by Day 10. Although two surviving males lost bodyweight through Day 7, all survivors gained weight over the entire 14-day observation period. Gross necropsy of the decedent rewealed discoloration of the lungs and intestines. Gross necropsy findings at terminal sacrifice were unremarkable. No gross abnormalities were noted for the animals when necropsied at the conclusion of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The Single Dose Acute Oral LD50 of the test substance is greater than 5,000 mg/kg of bodyweight when administered as received.