Registration Dossier

Administrative data

Endpoint:
short-term repeated dose 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:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
GLP compliance:
yes (incl. certificate)
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Method of administration:
Gavage
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
28 days
Frequency of treatment:
7 days/week
No. of animals per sex per dose:
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Male: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
Mortality: There were no deaths during the study period.

Clinical observations : There were no toxicologically
significant findings.

Behavioural assessment: No treatment-related behavioural
differences were detected.

Functional Performance tests: There wer no treatment-related
changes in sensory reactivity.

bOdyweight: No adverse effect on bodyweight development was
detected.

Food consumption; There was no treatment- related effect on
food consumption or on food efficiency during the study.

Water consumption: Daily visual inspection of the water
bottles revealed no intergroup differences.

Laboratory findings:
Haematology : No treatment-related effects were detected.


Blood chemistry: No treatment related effects were detected.

Effects in organs:
Organ weights: No toxicologically significant effects were
detected in the parameters measured.

Necropsy: No macroscopic abnormalities were detected.

Histopathology: Tubular basophilia/ degeneration was
observed in the kidneys in relatio to treatment for the
female rats dosed at 1000 and 150 mg/kg/day

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (nominal)
Sex:
male
Dose descriptor:
NOEL
Effect level:
15 mg/kg bw/day (nominal)
Sex:
female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Classified as: Not classified