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 Hsd Cpb:WU

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: diet
Details on oral exposure:
Method of administration:
diet
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 10 animals at 0 mg/kg bw/day
Male: 10 animals at 9.5 mg/kg bw/day
Male: 10 animals at 97 mg/kg bw/day
Male: 10 animals at 963 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 10 animals at 10.9 mg/kg bw/day
Female: 10 animals at 108 mg/kg bw/day
Female: 10 animals at 1093 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
There were no mortalities during the course of the study No
treatment-related clinical signs were recorded throughout
the treatment period in either sex. Body weigt and food
consumption were unaffected in any dose group in either sex.

Effects in organs:
Hematological investigations and clinical biochemistry did
not show changes of toxicological relevance at any dose
level in either sex. Mean terminal body weights revealed no
relevant changes when compared to controls. Decreased organ
weights of the pituitary in all male treatment groups in
comparison to control organs were not found to be of
toxicological relevance, because this change was not found
to be dose related and not associated with relevant
histopathological changes.

Effect levels

Dose descriptor:
NOEL
Effect level:
963 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