Registration Dossier

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:
other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V, B1
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Rat (Sprague-Dawley (CD))
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Vehicle:
corn oil

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
570 mg/kg bw
95% CL:
424 - 766
Remarks on result:
other: Slope of the mortality curve: 5.6
Mortality:
Male: 400 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 400 mg/kg bw; Number of animals: 5; Number of deaths: 1
Female: 640 mg/kg bw; Number of animals: 5; Number of deaths: 3
Female: 800 mg/kg bw; Number of animals: 5; Number of deaths: 4
Clinical signs:
Signs of toxicity related to dose levels:
One female at 400mg/kg, three females at 640 mg/kg and four
females at 800mg/kg died during the study. All deaths
occurred within ca. 48 hours of dosing. A slight bodyweight
loss was recorded for the majority of decedents.


Clinical signs of reaction to treatment included
piloerection, hunched posture, waddling /unsteady gait,
lethargy, respiratory distress, partially closed eyelids,
pallid extremities, increased salivation, walking on toes
and cold body surfaces, seen in all rats at all doses.


In addition, faecal disturbances, increased lacrimation,
body tremors, prostration, swollen abdomen and thin
appearance were seen among rats at one or more dose levels.


Recovery of surviving rats was complete in all instances by
Day 11.
Gross pathology:
Effects on organs:
Macroscopic examination of decedents revealed congestive
changes (characterised by dark tissue, prominent blood
vessels / inflammation), in the majority of organs and
tissues.

No abnormalities were revealed at the macroscopic
examination of surviving rats on Day 15.

Applicant's summary and conclusion

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