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 (B1 bis)
GLP compliance:
yes
Test type:
fixed dose procedure

Test animals

Species:
other: Rat (Wistar)

Administration / exposure

Vehicle:
other: Distilled water
No. of animals per sex per dose:
Preliminary sighting study: 2 (male)
Preliminary sighting study: 2 (female)
Main study: 5 (male)
Main study: 5 (female)

Results and discussion

Preliminary study:
Species/strain: Rat (Wistar)
mg/kg bw: Evident toxicity: ; Mortality:
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
50 mg/kg bw
Dose descriptor:
other: 50 mg/kg bw (fixed dose initial)
Remarks on result:
other: No. with evident toxicity: ; No. of deaths: ; No. of animals used:
Dose descriptor:
other: 50 mg/kg bw (fixed dose initial)
Remarks on result:
other: No. with evident toxicity: ; No. of deaths: 0; No. of animals used: 5
Clinical signs:
Signs of toxicity:
In a preliminary study one male animal died 6 hours after
dosing with 500 mg/kg. Clinical signs of toxicity observed
in one male and one female were hunched posture, lethargy,
pilo-erection, decreased respiratory rate ataxia and
increased salivation. There were no deaths or clinical signs
of toxicity observed in animals dosed with 50 mg/kg in the
main study.
Gross pathology:
Effects on organs:
There were no pathological abnormalitites noted at necropsy
in the main study.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information