Registration Dossier

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:
other: 96/54/EG, B.7; OECD 407 (1995)
GLP compliance:
yes
Limit test:
no

Test animals

Species:
other: rat, Wistar CRL:(WI) BR

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 1 % aqueous methylcellulose
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 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 250 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 250 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
There were no treatment-related deaths or other differences
from control for other parameters measured, including
clinical appearance, body weight, food and water consumption
that were considered to be related to treatment.

There were no abnormalities noted in the functional
observation battery (in sensory reactivity to different
types of stimuli, in grip strength or motor activity).

Laboratory findings:
There were no test substance-related effects on hematology
and clinical biochemistry parameters at termination of the
treatment which could be considered of biological
significance.

Effects in organs:
There were no changes in organ weights, macroscopic and
microscopic examination that were considered to be an effect
of treatment.

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