Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley

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: 7days/week
No. of animals per sex per dose:
Male: 6 animals at 0 mg/kg bw/day
Male: 6 animals at 100 mg/kg bw/day
Male: 6 animals at 300 mg/kg bw/day
Male: 6 animals at 1000 mg/kg bw/day
Female: 6 animals at 0 mg/kg bw/day
Female: 6 animals at 100 mg/kg bw/day
Female: 6 animals at 300 mg/kg bw/day
Female: 6 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
No deaths and no clinical signs of toxicity.

laboratory findings:
Platelet counts were increased in both sexes in the top dose

group and serum calcium was slightly increased in top dose females.

Effects in organs:
Absolute and relative liver and adrenal weights were increased in both sexes in the top dose group only. The only effect seen microscopically was hypertrophy of the centrilobular cells of the liver.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
30 mg/kg bw/day (nominal)
Basis for effect level:
other: original NeD unit is mg/kgfday
Dose descriptor:
NOEL
Effect level:
30 mg/kg bw/day (nominal)
Basis for effect level:
other: original NeD unit is mg/kgfday

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Classified as: Not classified