Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented report of a guideline study conducted to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: OS#61349
- Substance type: organic
- Physical state: solid
- Analytical purity: not specified
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: 100%
- Purity test date: not specified
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Stability under test conditions: stable
- Storage condition of test material: not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: 200-300 g
- Fasting period before study: yes (but not water)
- Housing: not specified
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified

IN-LIFE DATES: From: 12/03/1981 To: 01/04/1981

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% weigh/volume suspension in water


VEHICLE
- Concentration in vehicle: 500 mg/ml
- Amount of vehicle (if gavage):
- Justification for choice of vehicle: water soluble test substance
- Lot/batch no. (if required): not specified
- Purity: not specified

MAXIMUM DOSE VOLUME APPLIED: 4 ml
Doses:
500, 1000, 2000, 4000, and 8000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: periodicity not specified
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
1 830 mg/kg bw
Based on:
test mat.
95% CL:
990 - 3 390
Mortality:
At 500mg/kg: no deaths were observed.
At 1000 mg/kg: deaths occurred in 2 animals after 4 hours. These animals remained moribund for the next 2-3 days during which time an additional death occurred.
At 2000 mg/kg: 3 animals died 3 hours after dosing.
At 4000 mg/kg: 2 animals died after 3 hours. The remaining animals were semi-comatose for the next 72 hours, with an additional 2 animals expiring on days 3 and 4.
At 8000 mg/kg : all animals died within 15 minutes.
Clinical signs:
At the lowest dose tested, the animals were lethargic and ruffled after 2 hours. Their condition appeared essentially unchanged after 24 hours. The rats appeared normal within 48 hours. No unscheduled deaths occurred in this group.
Animals receiving 1000 mg/kg were lethargic, ruffled and drooling after 1 hour. They were severely depressed after 3 hours. The surviving animals were semi-comatose after 24 hours. These animals remained moribund for the next 2-3 days. The two remaining animals in this group recovered after day 7-8.
Animals receiving 2000 mg/kg were lethargic, ruffled and drooling after 30 minutes.They were severely depressed after 2 hours. The surviving animals remained severely depressed or semi-comatose for several days before recovery at 7-9 days. Animals receiving 4000 mg/kg were severely depressed, ruffled and drooling 30 minutes after administration of the test article. Two animals died after 3 hours. The remaining animals were semi-comatose for the next 72 hours. The sole surviving animal recovered by day 9.

Gross pathology:
No remarkable gross pathological findings were observed.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of ATBS at 14 days in the rat was calculated to be 1830 mg/kg bw (Confidence limits = 990-3900).