Registration Dossier

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:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
BtJTASAN, off-white powder
Purity: 99.9 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sasco, Inc., O’Fallon, MO.
- Age at study initiation: Approximately 8 weeks
- Weight at study initiation: 216—232 grams (males) and 160—178 grams (females)
- Fasting period before study: fasted overnight
- Housing: one per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: animals were quarantined for at least five days.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: administered as a 434 mg/ml suspension in corn oil
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made three times within the first eight hours after dosing and twice daily (morning and afternoon) thereafter until sacrifice, with the exception of one day when observations were only recorded once.
Body weights were recorded on days 0 (day of dosing), 7, and 14,.
- Necropsy of survivors performed: yes


Statistics:
No data

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths were observed in animals of either sex.
Clinical signs:
Diarrhea occurred in three males and five female rats on the day of dosing, but this effect was probably induced by the corn oil used
as the dosing vehicle.
No other clinical abnormalities were observed.
Body weight:
No effects.
Gross pathology:
No abnormalities were observed at necropsy.

Applicant's summary and conclusion