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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:
September 2002 - October 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Data is from study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
The purpose of this study was to assess the Toxicological profile of test item to a single administration via oral route to rats.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: healthy rats
- Weight at study initiation: The pretest body weight range was 316- 350 grams for males and 243- 276 grams for females. The weight variation of the animals used did not exceed +/- 20% of the mean weight.
- Fasting period before study: 16-20 hours
- Housing/Identification/Bedding: The animals were identified by cage notation and indelible body marks, and housed 5/sex/cage in suspended wire cages. Bedding was placed beneath the cages and changed at least three times/week.
- Diet (e.g. ad libitum): Fresh PMI Rat Chow was freely available except for 16-20 hours prior to dosing.
- Water (e.g. ad libitum): Water was freely available at all times.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled
- Air changes (per hr): was kept clean and vermin free.
- Photoperiod (hrs dark / hrs light): a 12 hour light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
not specified
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 1, 2 and 4 hours postdose and once daily for 14 days for toxicity effects. The animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination.
- Necropsy of survivors performed: yes, All animals were humanely sacrificed using CO2 and examined for gross pathology. Abnormal tissues were preserved in 10% buffered formalin for possible future microscopic examination.
Statistics:
An estimate of the LD50 was made based on the results.

Results and discussion

Preliminary study:
not specified
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at 2000 mg/kg bw.
Clinical signs:
Instances of lethargy, wet anogenital area, ataxia, soiled anogenital area and diarrhea were noted on the day of dosing. All animals appeared normal from day 1 to day 14.
Body weight:
Body weight changes were normal.
Gross pathology:
Necropsy results were normal in 9/10 animals. One animal had mottled kidneys.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The lethal concentration (LD50) value for acute oral toxicity test was considered to be >2000 mg/kgbw, when male and female wistar rats were treated with test chemical orally via gavage according to OECD Guideline 401 (Acute Oral Toxicity).
Executive summary:

The acute oral toxicity profile of the given test chemical was conducted according to OECD Guideline 401 (Acute Oral Toxicity) in Wistar rats.

10 Healthy male and female wistar rats were used for the study. The given test chemical was administered via oral gavage route with the dose concentration of 2000 mg/kg b.w.

Animals were observed 1, 2 and 4 hours postdose and once daily for 14 days for toxicity effects. The animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination. All animals were humanely sacrificed using CO2 and examined for gross pathology. Abnormal tissues were preserved in 10% buffered formalin for possible future microscopic examination. An estimate of the LD50 was made based on the results.

No mortality was observed at 2000 mg/kg bw. Instances of lethargy, wet anogenital area, ataxia, soiled anogenital area and diarrhea were noted on the day of dosing. All animals appeared normal from day 1 to day 14. Body weight changes were normal. Necropsy results were normal in 9/10 animals. One animal had mottled kidneys.

Under the condition of the study, the lethal concentration (LD50) value for acute oral toxicity test was considered to be >2000 mg/kgbw,  when male and female wistar rats were treated with test chemical orally via gavage according to OECD Guideline 401 (Acute Oral Toxicity).