Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
other: Rat (Wistar albino)

Administration / exposure

Route of administration:
other: Distilled water

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 350 mg/kg bw
Mortality:
Male: 500 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 600 mg/kg bw; Number of animals: 5; Number of deaths: 2
Male: 750 mg/kg bw; Number of animals: 5; Number of deaths: 4
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 5
Female: 250 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 350 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 500 mg/kg bw; Number of animals: 5; Number of deaths: 5
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 5
Clinical signs:
Signs of toxicity related to dose levels:
100% mortality was seen in females at 500 mg/kg and both
sexes at 2000 mg/kg. All these deaths occurred on the day of
dosing. Male deaths at 600 and 700 mg/kg occurred within
2-days post-dosing. Decedents at 2000 mg/kg showed ptosis,
prostation and coma prior to death. Signs seen in other
groups, except females at 250 mg/kg were lethargy, ataxia,
diarrhea, flaccid muscle tone and piloerection. In addition,
staining of the mouth and nose area and wetness of the
uriogenital area was seen after dosing in these groups.
No signs of toxicity were observed in females at 250 mg/kg.
Gross pathology:
Effects on organs:
Discolouration and/or distension of the gastrointestinal
tract, liver and pancreas was seen in animals treated with
500 mg/kg and above. In addition, congestion of lungs was
seen in males at 750 mg/kg.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU