Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V (Acute Toxic Class Method)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test animals

Species:
other: Rat (Charles River)

Administration / exposure

Vehicle:
other: Purified water

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Female: 300 mg/kg bw; Number of animals: 3; Number of deaths: 1
Female: 300 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 1
Clinical signs:
Signs of toxicity related to dose levels:
Mortality:

One female dosed at 300 mg/kg died on Day 3 and one female
dosed at 2000 mg/kg died on Day 1 of treatment.


Clinical Signs:

Salivation was noted immediately after dosing on Day 1
occurring in two females treated at 2000 mg/kg. This sign
was resolved by approximately 30 minutes after dosing.


Bodyweight:

A bodyweight loss was recorded for one female dosed at 2000
mg/kg on Day 15. Low bodyweight gain was noted for one
female on Day 15 dosed at 2000 mg/kg and two females on Day
15 dosed at 300 mg/kg.
Gross pathology:
Effects on organs:
Macroscopic examination of the decedent treated at 300 mg/kg
revealed congestion (characterised by darkened
tissues/organs or blood vessels injected) of the
subcutaneous tissue, brain, heart, lungs and liver; together
with an enlarged/swollen/thickened heart, fluid contents of
the duodenum, small intestine, and thoracic cavity, and a
small caecum. Examination of the decedent treated at 2000
mg/kg revealed congestion (characterised by darkened
tissues/organs or blood vessels injected) of the lungs and
stomach and duodenum, and fluid contents in the stomach.
Macroscopic examination at study termination on Day 15
revealed white nodules in the large intestine of two females
treated at 2000 mg/kg. Congestion (characterised by
darkened tissues/organs) of the spleen was noted in one
female treated at 300 mg/kg.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU