Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
repeated dose 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
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
no

Test animals

Species:
other: Rat(Sprague-Dawley)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: Polyethylene glycol 400.
Details on oral exposure:
Method of administration:
Gavage.
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 400 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 400 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
Mortality Data:

There were no deaths during the study that could be
considered attributable to test material toxicity. One
female treated with 400 mg/kg/day was found dead on Day 21.


Clinical Observations:

No clinically observable signs of toxicity were detected in
test or control animals throughout the study period.


Behavioural Assessment:

No treatment-related changes were detected.


Functional Performance Tests:

No treatment-related changes were detected.


Sensory Reactivity Assessments:

No treatment-related changes were detected.


Bodyweight:

No adverse effect on bodyweight development was detected.


Food Consumption:

No adverse effect on dietary intake or food efficiency was
detected.


Water Consumption:

No intergroup differences were detected.

Laboratory findings:
Haematology:

No treatment-related effects were detected.


Blood Chemistry:

No treatment-related effects were detected.

Effects in organs:
Necropsy:

No treatment-related macroscopic abnormalities were detected
at terminal kill. The interim death showed normal post
mortem changes.


Organ Weights:

No treatment-related effects were detected.


Histopathology:

No treatment-related microscopic abnormalities were

observed.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Classified as: Not classified